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Sample records for randomly chosen pilot

  1. The signature of positive selection at randomly chosen loci.

    Science.gov (United States)

    Przeworski, Molly

    2002-03-01

    In Drosophila and humans, there are accumulating examples of loci with a significant excess of high-frequency-derived alleles or high levels of linkage disequilibrium, relative to a neutral model of a random-mating population of constant size. These are features expected after a recent selective sweep. Their prevalence suggests that positive directional selection may be widespread in both species. However, as I show here, these features do not persist long after the sweep ends: The high-frequency alleles drift to fixation and no longer contribute to polymorphism, while linkage disequilibrium is broken down by recombination. As a result, loci chosen without independent evidence of recent selection are not expected to exhibit either of these features, even if they have been affected by numerous sweeps in their genealogical history. How then can we explain the patterns in the data? One possibility is population structure, with unequal sampling from different subpopulations. Alternatively, positive selection may not operate as is commonly modeled. In particular, the rate of fixation of advantageous mutations may have increased in the recent past.

  2. Effect of sodium selenite on chosen anti- and pro-oxidative parameters in rats treated with lithium: A pilot study.

    Science.gov (United States)

    Musik, Irena; Kocot, Joanna; Kiełczykowska, Małgorzata

    2015-06-01

    Selenium is an essential element of antioxidant properties. Lithium is widely used in medicine but its administration can cause numerous side effects including oxidative stress. The present study aimed at evaluating if sodium selenite could influence chosen anti- and pro-oxidant parameters in rats treated with lithium. The experiment was performed on four groups of Wistar rats: I (control) - treated with saline; II (Li) - treated with lithium (2.7 mgLi/kg b.w. as Li2CO3), III (Se) - treated with selenium (0.5 mgSe/kg b.w. as Na2SeO3), IV (Li+Se) - treated with Li2CO3 and Na2SeO3 together at the same doses as in group II and III, respectively. All treatments were performed by stomach tube for three weeks in form of water solutions. The following anti- and pro-oxidant parameters: total antioxidant status (TAS) value, catalase (CAT) activity, concentrations of ascorbic acid (AA) and malonyldialdehyde (MDA) in plasma as well as whole blood superoxide dismutase (SOD) and glutathione peroxidase (GPx) activities were measured. Selenium given alone markedly enhanced whole blood GPx and diminished plasma CAT vs. Lithium significantly decreased plasma CAT and slightly increased AA vs. Selenium co-administration restored these parameters to the values observed in control animals. Furthermore, selenium co-administration significantly increased GPx in Li-treated rats. All other parameters (TAS, SOD and MDA) were not affected by lithium and/or selenium. Further research seems to be warranted to decide if application of selenium as an adjuvant in lithium therapy is worth considering. Copyright © 2014 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

  3. Developing leadership capacity for guideline use: a pilot cluster randomized control trial.

    Science.gov (United States)

    Gifford, Wendy A; Davies, Barbara L; Graham, Ian D; Tourangeau, Ann; Woodend, A Kirsten; Lefebre, Nancy

    2013-02-01

    The importance of leadership to influence nurses' use of clinical guidelines has been well documented. However, little is known about how to develop and evaluate leadership interventions for guideline use. The purpose of this study was to pilot a leadership intervention designed to influence nurses' use of guideline recommendations when caring for patients with diabetic foot ulcers in home care nursing. This paper reports on the feasibility of implementing the study protocol, the trial findings related to nursing process outcomes, and leadership behaviors. A mixed methods pilot study was conducted with a post-only cluster randomized controlled trial and descriptive qualitative interviews. Four units were randomized to control or experimental groups. Clinical and management leadership teams participated in a 12-week leadership intervention (workshop, teleconferences). Participants received summarized chart audit data, identified goals for change, and created a team leadership action. Criteria to assess feasibility of the protocol included: design, intervention, measures, and data collection procedures. For the trial, chart audits compared differences in nursing process outcomes. 8-item nursing assessments score. Secondary outcome: 5-item score of nursing care based on goals for change identified by intervention participants. Qualitative interviews described leadership behaviors that influenced guideline use. Conducting this pilot showed some aspects of the study protocol were feasible, while others require further development. Trial findings observed no significant difference in the primary outcome. A significant increase was observed in the 5-item score chosen by intervention participants (p = 0.02). In the experimental group more relations-oriented leadership behaviors, audit and feedback and reminders were described as leadership strategies. Findings suggest that a leadership intervention has the potential to influence nurses' use of guideline recommendations

  4. Duration of bed occupancy as calculated at a random chosen day in an acute care ward. Implications for the use of scarce resources in psychiatric care

    Directory of Open Access Journals (Sweden)

    Restan Asbjørn

    2005-05-01

    Full Text Available Abstract Background Psychiatric acute wards are obliged to admit patients without delay according to the Act on Compulsive Psychiatric Care. Residential long term treatment facilities and rehabilitation facilities may use a waiting list. Patients, who may not be discharged from the acute ward or should not wait there, then occupy acute ward beds. Materials and methods Bed occupancy in one acute ward at a random day in 2002 was registered (n = 23. Successively, the length of stay of all patients was registered, together with information on waiting time after a decision was made on further treatment needs. Eleven patients waited for further resident treatment. The running cost of stay was calculated for the acute ward and in the different resident follow-up facilities. Twenty-three patients consumed a total of 776 resident days. 425 (54.8% of these were waiting days. Patients waited up to 86 days. Results Total cost of treatment was 0.69 million Euro (0.90 mill. $, waiting costs were 54.8% of this, 0.38 million Euro (0.50 million $. The difference between acute care costs and the costs in the relevant secondary resident facility was defined as the imputed loss. Net loss by waiting was 0.20 million Euro (0.26 million $ or 28.8% of total cost. Discussion This point estimate study indicates that treating patients too sick to be released to anything less than some other intramural facility locks a sizable amount of the resources of a psychiatric acute ward. The method used minimized the chance of financially biased treatment decisions. Costs of frustration to staff and family members, and delayed effect of treatment was set to zero. Direct extrapolation to costs per year is not warranted, but it is suggested that our findings would be comparable to other acute wards as well. The study shows how participant observation and cost effectiveness analysis may be combined.

  5. Sleep education improves the sleep duration of adolescents: a randomized controlled pilot study

    National Research Council Canada - National Science Library

    Kira, Geoff; Maddison, Ralph; Hull, Michelle; Blunden, Sarah; Olds, Timothy

    2014-01-01

    .... A parallel, two-arm randomized controlled pilot trial was conducted. High school students (13 to 16 years) were randomly allocated to either a classroom-based sleep education program intervention...

  6. A randomized pilot study of naturopathic medicine in multiple sclerosis.

    Science.gov (United States)

    Shinto, Lynne; Calabrese, Carlo; Morris, Cynthia; Yadav, Vijayshree; Griffith, Debbie; Frank, Rachel; Oken, Barry S; Baldauf-Wagner, Sara; Bourdette, Dennis

    2008-06-01

    Complementary and alternative medicine (CAM) use is high in people with multiple sclerosis (MS), yet there are limited reports on safety and effectiveness of CAM in MS. Naturopathic medicine encompasses a broad range of CAM modalities and may improve quality of life in patients with MS. To assess quality of life in MS subjects who received interventions designed to "model" the "whole practice" of naturopathy. A pilot, randomized, controlled study with a 6-month intervention period. Participants who met criteria for clinically definite MS. The 3 intervention arms were usual care, naturopathic medicine plus usual care, and MS education plus usual care. The primary outcome measure was quality of life (36-item short form health survey [SF-36]). Secondary outcome measures included fatigue (Modified Fatigue Impact Scale); depression (Beck Depression Inventory); cognition battery (Stroop test and Paced Auditory Serial Addition Test 3), and neurologic impairment (Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite). Adverse event reporting and laboratory measures were used to assess safety. Forty-five (45) participants (15 per group) were randomized and all completed the 6-month intervention. There were no significant differences between groups on any outcome measure. There was a trend in favoring the naturopathic group in the General Health subscale of the SF-36 (p = 0.11), Timed Walk (p = 0.11), and neurologic impairment (EDSS) (p = 0.07). There was a trend favoring the Education group in the Stroop attention test (p = 0.07). There was no difference between groups in adverse events or laboratory changes. Naturopathic medicine combined with usual care for MS showed a trend in improvement in the General Health subscale of the SF-36, Timed Walk, and neurologic impairment. Evaluation of naturopathic medicine, as a multimodality regimen, warrants further investigation.

  7. Impact of Killing in War: A Randomized, Controlled Pilot Trial.

    Science.gov (United States)

    Maguen, Shira; Burkman, Kristine; Madden, Erin; Dinh, Julie; Bosch, Jeane; Keyser, Jessica; Schmitz, Martha; Neylan, Thomas C

    2017-09-01

    The purpose of this pilot study was to test the effectiveness of Impact of Killing (IOK), a novel, cognitive-behavioral treatment (CBT) aimed at reducing mental health symptoms and functional impairment. Participants were 33 combat Veterans with a posttraumatic stress disorder (PTSD) diagnosis who had completed trauma-focused psychotherapy and reported distress regarding killing or feeling responsible for the deaths of others in war. Veterans were randomized to either IOK treatment or a 6-week waitlist condition, after which Veterans could receive IOK. IOK is a 6- to 8-session, weekly, individual, CBT, lasting 60-90 minutes, and focused on key themes, including physiology of killing responses, moral injury, self-forgiveness, spirituality, making amends, and improved functioning. We found that compared to controls (N = 16), the IOK group (N = 17) experienced a significant improvement in PTSD symptoms, general psychiatric symptoms, and quality of life functional measures. Veterans who received IOK reported that the treatment was acceptable and feasible. These results provide preliminary evidence that Veterans can benefit from a treatment focused on the impact of killing after initial trauma therapy. © 2017 Wiley Periodicals, Inc.

  8. Preoperative therapeutic exercise in frail elderly scheduled for total hip replacement: A randomized pilot trial

    NARCIS (Netherlands)

    Hoogeboom, T.J.; Dronkers, J.J.; Ende, C.H.M. van den; Oosting, E.; Meeteren, N.L.U. van

    2010-01-01

    Objective: To evaluate the feasibility and preliminary effectiveness of therapeutic exercise before total hip replacement in frail elderly. Design: A single-blind, randomized clinical pilot trial. Setting: Outpatient physiotherapy department. Subjects: Frail elderly with hip osteoarthritis awaiting

  9. Meditation for migraines: a pilot randomized controlled trial.

    Science.gov (United States)

    Wells, Rebecca Erwin; Burch, Rebecca; Paulsen, Randall H; Wayne, Peter M; Houle, Timothy T; Loder, Elizabeth

    2014-10-01

    Our objective was to assess the safety, feasibility, and effects of the standardized 8-week mindfulness-based stress reduction (MBSR) course in adults with migraines. Stress is a well-known trigger for headaches. Research supports the general benefits of mind/body interventions for migraines, but there are few rigorous studies supporting the use of specific standardized interventions. MBSR is a standardized 8-week mind/body intervention that teaches mindfulness meditation/yoga. Preliminary research has shown MBSR to be effective for chronic pain syndromes, but it has not been evaluated for migraines. We conducted a randomized controlled trial with 19 episodic migraineurs randomized to either MBSR (n = 10) or usual care (n = 9). Our primary outcome was change in migraine frequency from baseline to initial follow-up. Secondary outcomes included change in headache severity, duration, self-efficacy, perceived stress, migraine-related disability/impact, anxiety, depression, mindfulness, and quality of life from baseline to initial follow-up. MBSR was safe (no adverse events), with 0% dropout and excellent adherence (daily meditation average: 34 ± 11 minutes, range 16-50 minutes/day). Median class attendance from 9 classes (including retreat day) was 8 (range [3, 9]); average class attendance was 6.7 ± 2.5. MBSR participants had 1.4 fewer migraines/month (MBSR: 3.5 to 1.0 vs control: 1.2 to 0 migraines/month, 95% confidence interval CI [-4.6, 1.8], P = .38), an effect that did not reach statistical significance in this pilot sample. Headaches were less severe, although not significantly so (-1.3 points/headache on 0-10 scale, [-2.3, 0.09], P = .053) and shorter (-2.9 hours/headache, [-4.6, -0.02], P = .043) vs control. Migraine Disability Assessment and Headache Impact Test-6 dropped in MBSR vs control (-12.6, [-22.0, -1.0], P = .017 and -4.8, [-11.0, -1.0], P = .043, respectively). Self-efficacy and mindfulness improved in MBSR vs control (13.2 [1.0, 30.0], P

  10. Controllability of the better chosen partial networks

    Science.gov (United States)

    Liu, Xueming; Pan, Linqiang

    2016-08-01

    How to control large complex networks is a great challenge. Recent studies have proved that the whole network can be sufficiently steered by injecting control signals into a minimum set of driver nodes, and the minimum numbers of driver nodes for many real networks are high, indicating that it is difficult to control them. For some large natural and technological networks, it is impossible and not feasible to control the full network. For example, in biological networks like large-scale gene regulatory networks it is impossible to control all the genes. This prompts us to explore the question how to choose partial networks that are easy for controlling and important in networked systems. In this work, we propose a method to achieve this goal. By computing the minimum driver nodes densities of the partial networks of Erdös-Rényi (ER) networks, scale-free (SF) networks and 23 real networks, we find that our method performs better than random method that chooses nodes randomly. Moreover, we find that the nodes chosen by our method tend to be the essential elements of the whole systems, via studying the nodes chosen by our method of a real human signaling network and a human protein interaction network and discovering that the chosen nodes from these networks tend to be cancer-associated genes. The implementation of our method shows some interesting connections between the structure and the controllability of networks, improving our understanding of the control principles of complex systems.

  11. Relaxing Chosen-Ciphertext Security

    DEFF Research Database (Denmark)

    Canetti, Ran; Krawczyk, Hugo; Nielsen, Jesper Buus

    2003-01-01

    Security against adaptive chosen ciphertext attacks (or, CCA security) has been accepted as the standard requirement from encryption schemes that need to withstand active attacks. In particular, it is regarded as the appropriate security notion for encryption schemes used as components within...... general protocols and applications. Indeed, CCA security was shown to suffice in a large variety of contexts. However, CCA security often appears to be somewhat too strong: there exist encryption schemes (some of which come up naturally in practice) that are not CCA secure, but seem sufficiently secure...... “for most practical purposes.” We propose a relaxed variant of CCA security, called Replayable CCA (RCCA) security. RCCA security accepts as secure the non-CCA (yet arguably secure) schemes mentioned above; furthermore, it suffices for most existing applications of CCA security. We provide three...

  12. Melodic Intonation Therapy in chronic aphasia: evidence from a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ineke Van Der Meulen

    2016-11-01

    Full Text Available AbstractMelodic Intonation Therapy (MIT is a language production therapy for severely non-fluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT examining the efficacy of MIT are rare. In an earlier publication, we presented the results of an RCT on MIT in subacute aphasia and found that MIT was effective on trained and untrained items. Further, we observed a clear trend in improved functional language use after MIT. Subacute aphasic patients receiving MIT improved considerably on language tasks measuring connected speech and daily life verbal communication. Here, we present the results of a pilot RCT on MIT in chronic aphasia and compare these to the results observed in subacute aphasia. We used a multicenter waiting-list randomized controlled trial design. Patients with chronic (>1 year post-stroke aphasia were randomly allocated to the experimental group (6 weeks MIT or to the control group (6 weeks no intervention followed by 6 weeks MIT. Assessments were done at baseline (T1, after 6 weeks (T2, and 6 weeks later (T3. Efficacy was evaluated at T2 using univariable linear regression analyses. Outcome measures were chosen to examine several levels of therapy success: improvement on trained items, generalization to untrained items, and generalization to verbal communication. Of 17 included patients, 10 were allocated to the experimental condition and 7 to the control condition. MIT significantly improved repetition of trained items (β=13.32, p=.02. This effect did not remain stable at follow-up assessment. In contrast to earlier studies, we found only a limited and temporary effect of MIT, without generalization to untrained material or to functional communication. The results further suggest that the effect of MIT in chronic aphasia is more restricted than its effect in earlier stages post stroke. This

  13. Melodic Intonation Therapy in Chronic Aphasia: Evidence from a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Van Der Meulen, Ineke; Van De Sandt-Koenderman, Mieke W M E; Heijenbrok, Majanka H; Visch-Brink, Evy; Ribbers, Gerard M

    2016-01-01

    Melodic Intonation Therapy (MIT) is a language production therapy for severely non-fluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT) examining the efficacy of MIT are rare. In an earlier publication, we presented the results of an RCT on MIT in subacute aphasia and found that MIT was effective on trained and untrained items. Further, we observed a clear trend in improved functional language use after MIT: subacute aphasic patients receiving MIT improved considerably on language tasks measuring connected speech and daily life verbal communication. Here, we present the results of a pilot RCT on MIT in chronic aphasia and compare these to the results observed in subacute aphasia. We used a multicenter waiting-list RCT design. Patients with chronic (>1 year) post-stroke aphasia were randomly allocated to the experimental group (6 weeks MIT) or to the control group (6 weeks no intervention followed by 6 weeks MIT). Assessments were done at baseline (T1), after 6 weeks (T2), and 6 weeks later (T3). Efficacy was evaluated at T2 using univariable linear regression analyses. Outcome measures were chosen to examine several levels of therapy success: improvement on trained items, generalization to untrained items, and generalization to verbal communication. Of 17 included patients, 10 were allocated to the experimental condition and 7 to the control condition. MIT significantly improved repetition of trained items (β = 13.32, p = 0.02). This effect did not remain stable at follow-up assessment. In contrast to earlier studies, we found only a limited and temporary effect of MIT, without generalization to untrained material or to functional communication. The results further suggest that the effect of MIT in chronic aphasia is more restricted than its effect in earlier stages post stroke. This is in line with studies showing larger

  14. Sample size calculations for pilot randomized trials: a confidence interval approach.

    Science.gov (United States)

    Cocks, Kim; Torgerson, David J

    2013-02-01

    To describe a method using confidence intervals (CIs) to estimate the sample size for a pilot randomized trial. Using one-sided CIs and the estimated effect size that would be sought in a large trial, we calculated the sample size needed for pilot trials. Using an 80% one-sided CI, we estimated that a pilot trial should have at least 9% of the sample size of the main planned trial. Using the estimated effect size difference for the main trial and using a one-sided CI, this allows us to calculate a sample size for a pilot trial, which will make its results more useful than at present. Copyright © 2013 Elsevier Inc. All rights reserved.

  15. A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

    Science.gov (United States)

    Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

    2011-01-01

    We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

  16. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  17. Randomized controlled trial of bottle weaning intervention: a pilot study.

    Science.gov (United States)

    Kahn, Richard; Bonuck, Karen; Trombley, Michelle

    2007-03-01

    Inappropriate baby bottle use is associated with tooth decay, anemia, and overweight, and it may adversely affect dietary patterns. Parents often do not follow guidance to wean by 18 months of life. We piloted a brief, counseling-based weaning intervention in an urban WIC agency among primarily Hispanic parent/toddler dyads. At baseline (n = 48), toddlers consumed a mean 4.7 bottles/day. At follow-up (n = 39), the intervention group consumed fewer mean bottles/day than controls (0.09 vs 2.0 bottles/day, P < .045). Half the toddlers in the experimental group and one third of the control groups weaned completely. Parents of weaned children were satisfied with the outcome.

  18. Effect of Playful Balancing Training - A Pilot Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Lund, Henrik Hautop; Jessen, Jari Due

    2013-01-01

    We used the modular playware in the form of modular interactive tiles for playful training of community-dwelling elderly with balancing problem. During short-term play on the modular interactive tiles, the elderly were playing physical, interactive games that were challenging their dynamic balance......, agility, endurance, and sensor-motoric reaction. A population of 12 elderly (average age: 79) with balancing problems (DGI average score: 18.7) was randomly assigned to control group or tiles training group, and tested before and after intervention. The tiles training group had statistical significant...

  19. Reducing TV watching during adult obesity treatment: two pilot randomized controlled trials.

    Science.gov (United States)

    Raynor, Hollie A; Steeves, Elizabeth Anderson; Bassett, David R; Thompson, Dixie L; Gorin, Amy A; Bond, Dale S

    2013-12-01

    The more time adults spend being sedentary, the greater the risk of obesity. The effect of reducing television (TV) watching, a prominent sedentary behavior, on weight loss has not been tested in an adult standard behavioral obesity intervention, and the mechanisms by which reducing TV watching influences energy balance behaviors are not well understood. Two, 8-week, pilot, randomized controlled trials were conducted examining the effect of a reduced TV watching prescription on energy balance behaviors and weight loss within an adult standard behavioral obesity intervention. In the first study, participants (n=24) were randomized into one of two conditions: (a) reduce energy intake and increase moderate to vigorous physical activity (MVPA) (INCREASE PA); or (b) reduce energy intake and decrease TV watching (DECREASE TV). As findings from the first pilot study did not show an increase in MVPA in the DECREASE TV group, the second study was designed to examine the effect of adding a reduced TV prescription to a standard intervention to optimize outcomes. In Pilot Study 2, participants (n=28) were randomized to INCREASE PA or to INCREASE PA+DECREASE TV. Outcomes included objectively measured TV watching and MVPA, self-reported light physical activity (LPA-Pilot Study 2 only), self-reported dietary intake while watching TV, and weight. Conditions with TV watching prescriptions significantly reduced TV watching. Both studies showed medium to large effect sizes for conditions with TV watching prescriptions to show greater reductions in dietary intake while watching TV. Pilot Study 1 found a trend for an increase in MVPA in INCREASE PA and Pilot Study 2 found significant increases in MVPA in both conditions. Pilot Study 2 found a significant increase in LPA in the INCREASE PA+DECREASE TV. Results indicate adding a TV watching prescription to a standard obesity intervention did not enhance increases in MVPA, but may assist with reducing dietary intake while TV watching and

  20. Preoperative therapeutic programme for elderly patients scheduled for elective abdominal oncological surgery: A randomized controlled pilot study

    NARCIS (Netherlands)

    Dronkers, J.J.; Lamberts, H.; Reutelingsperger, I.M.M.D.; Naber, R.H.; Dronkers-Landman, C.M.; Veldman, A.; Meeteren, N.L.U. van

    2010-01-01

    Objective: Investigation of the feasibility and preliminary effect of a short-term intensive preoperative exercise programme for elderly patients scheduled for elective abdominal oncological surgery. Design: Single-blind randomized controlled pilot study. Setting: Ordinary hospital in the

  1. Mesalazine in the initial management of severely acutely malnourished children with environmental enteric dysfunction: a pilot randomized controlled trial

    National Research Council Canada - National Science Library

    Jones, Kelsey D J; Hünten-Kirsch, Barbara; Laving, Ahmed M R; Munyi, Caroline W; Ngari, Moses; Mikusa, Jenifer; Mulongo, Musa M; Odera, Dennis; Nassir, H Samira; Timbwa, Molline; Owino, Moses; Fegan, Greg; Murch, Simon H; Sullivan, Peter B; Warner, John O; Berkley, James A

    2014-01-01

    .... In this pilot double-blind randomized placebo-controlled trial, 44 children with severe acute malnutrition and evidence of EED were assigned to treatment with mesalazine or placebo for 28 days...

  2. Mesalazine in the initial management of severely acutely malnourished children with environmental enteric dysfunction: a pilot randomized controlled trial

    National Research Council Canada - National Science Library

    Jones, Kelsey D J; Hünten-Kirsch, Barbara; Laving, Ahmed M R; Munyi, Caroline W; Ngari, Moses; Mikusa, Jenifer; Mulongo, Musa M; Odera, Dennis; Nassir, H Samira; Timbwa, Molline; Owino, Moses; Fegan, Greg; Murch, Simon H; Sullivan, Peter B; Warner, John O; Berkley, James A

    2014-01-01

    .... In this pilot double-blind randomized placebo-controlled trial, 44 children with severe acute malnutrition and evidence of EED were assigned to treatment with mesalazine or placebo for 28 days during...

  3. Coadministration of lorcaserin and phentermine for weight management: A 12?week, randomized, pilot safety study

    OpenAIRE

    Smith, Steven R.; Garvey, W. Timothy; Greenway, Frank L.; Zhou, Sharon; Fain, Randi; Pilson, Robert; Fujioka, Ken; Aronne, Louis J.

    2017-01-01

    Objective To assess the short?term tolerability of lorcaserin alone or with two dose regimens of phentermine. Methods This was a 12?week, randomized, double?blind, pilot safety study of N?=?238 nondiabetic patients with obesity or overweight with ?1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting???1 of 9 potentially serotonergic adverse events (AE...

  4. A pilot randomized controlled trial of EKG for neonatal resuscitation.

    Directory of Open Access Journals (Sweden)

    Anup Katheria

    Full Text Available The seventh edition of the American Academy of Pediatrics Neonatal Resuscitation Program recommends the use of a cardiac monitor in infants that need resuscitation. Previous trials have shown that EKG heart rate is available before pulse rate from a pulse oximeter. To date no trial has looked at how the availability of electrocardiogram (EKG affects clinical interventions in the delivery room.To determine whether the availability of an EKG heart rate value and tracing to the clinical team has an effect on physiologic measures and related interventions during the stabilization of preterm infants.Forty (40 premature infants enrolled in a neuro-monitoring study (The Neu-Prem Trial: NCT02605733 who had an EKG monitor available were randomized to have the heart rate information from the bedside EKG monitor either displayed or not displayed to the clinical team. Heart rate, oxygen saturation, FiO2 and mean airway pressure from a data acquisition system were recorded every 2 seconds. Results were averaged over 30 seconds and the differences analyzed using two-tailed t-test. Interventions analyzed included time to first change in FiO2, first positive pressure ventilation, first increase in airway pressure, and first intubation.There were no significant differences in time to clinical interventions between the blinded and unblinded group, despite the unblinded group having access to a visible heart rate at 66 +/- 20 compared to 114 +/- 39 seconds for the blinded group (p < .0001. Pulse rate from oximeter was lower than EKG heart rate during the first 2 minutes of life, but this was not significant.EKG provides an earlier, and more accurate heart rate than pulse rate from an oximeter during stabilization of preterm infants, allowing earlier intervention. All interventions were started earlier in the unblinded EKG group but these numbers were not significant in this small trial. Earlier EKG placement before pulse oximeter placement may affect other

  5. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial.

    Science.gov (United States)

    Morris, Jill K; Vidoni, Eric D; Johnson, David K; Van Sciver, Angela; Mahnken, Jonathan D; Honea, Robyn A; Wilkins, Heather M; Brooks, William M; Billinger, Sandra A; Swerdlow, Russell H; Burns, Jeffrey M

    2017-01-01

    There is increasing interest in the role of physical exercise as a therapeutic strategy for individuals with Alzheimer's disease (AD). We assessed the effect of 26 weeks (6 months) of a supervised aerobic exercise program on memory, executive function, functional ability and depression in early AD. This study was a 26-week randomized controlled trial comparing the effects of 150 minutes per week of aerobic exercise vs. non-aerobic stretching and toning control intervention in individuals with early AD. A total of 76 well-characterized older adults with probable AD (mean age 72.9 [7.7]) were enrolled and 68 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. Neuropsychological tests and surveys were conducted at baseline,13, and 26 weeks to assess memory and executive function composite scores, functional ability (Disability Assessment for Dementia), and depressive symptoms (Cornell Scale for Depression in Dementia). Cardiorespiratory fitness testing and brain MRI was performed at baseline and 26 weeks. Aerobic exercise was associated with a modest gain in functional ability (Disability Assessment for Dementia) compared to individuals in the ST group (X2 = 8.2, p = 0.02). There was no clear effect of intervention on other primary outcome measures of Memory, Executive Function, or depressive symptoms. However, secondary analyses revealed that change in cardiorespiratory fitness was positively correlated with change in memory performance and bilateral hippocampal volume. Aerobic exercise in early AD is associated with benefits in functional ability. Exercise-related gains in cardiorespiratory fitness were associated with improved memory performance and reduced hippocampal atrophy, suggesting cardiorespiratory fitness gains may be important in driving brain benefits. ClinicalTrials.gov NCT01128361.

  6. Postural control and shoulder steadiness in F-16 pilots: a randomized controlled study.

    Science.gov (United States)

    Lange, Britt; Murray, Mike; Chreiteh, Shadi S; Toft, Palle; Jørgensen, Marie B; Søgaard, Karen; Sjøgaard, Gisela

    2014-04-01

    During maneuvering, fighter pilots experience loads of up to 50-70 kg on their necks. Neck disorders are common and have been linked to impairment in muscle control. We conducted an intervention study introducing targeted training for 24 wk that reduced neck pain. The current study reports the results of the secondary objective, which was to increase the understanding of possible mechanisms underlying such neck pain and its intervention-related relief. In a parallel, single-blinded, randomized controlled study, 55 F-16 pilots were evaluated at baseline and randomized to a control group (CG; N = 28) or training group (TG; N = 27). Postural control was tested in four different settings: Romberg with open and closed eyes, unilateral stance, and perturbation. Maximal voluntary contraction and force steadiness was measured for shoulder elevation. At follow-up, there was a significant between-group difference in the Romberg test with closed eyes only (95% confidence ellipse area; CG: 761 +/- 311 mm2; TG: 650 +/- 405 mm2). Prior to randomization, there were no significant differences in postural control and steadiness between 30 pilots who experienced neck pain within the previous 3 mo and 25 pilots without such pain. Impaired postural control and steadiness may only be quantifiable in individuals experiencing acute neck pain of certain intensity, and there may be a ceiling effect in the ability to improve these parameters. For individuals with highly developed physiological capacity, a battery of tests with more stringent demands should be considered, e.g., increased number of repetitions, prolonged duration of the tests, or testing with eyes closed.

  7. Effect of E-Bike Versus Bike Commuting on Cardiorespiratory Fitness in Overweight Adults: A 4-Week Randomized Pilot Study.

    Science.gov (United States)

    Höchsmann, Christoph; Meister, Steffen; Gehrig, Damiana; Gordon, Elisa; Li, Yanlei; Nussbaumer, Monique; Rossmeissl, Anja; Schäfer, Juliane; Hanssen, Henner; Schmidt-Trucksäss, Arno

    2017-06-29

    To assess if active commuting with an electrically assisted bicycle (e-bike) during a 4-week period can induce increases in cardiorespiratory fitness measured as peak oxygen uptake (V[Combining Dot Above]O2peak) in untrained, overweight individuals, and if these changes are comparable with those induced by a conventional bicycle. Four-week randomized pilot study. Controlled laboratory. Thirty-two volunteers (28 men) participated. Seventeen {median age 37 years [interquartile range (IQR) 34, 45], median body mass index [BMI] 29 kg/m [IQR 27, 31]} were randomized to the E-Bike group and 15 [median age 43 years (IQR 38, 45), median BMI 28 kg/m (IQR 26, 29)] to the Bike group. Participants in both groups were instructed to use the bicycle allocated to them (e-bike or conventional bicycle) for an active commute to work in the Basel (Switzerland) area at a self-chosen speed on at least 3 days per week during the 4-week intervention period. V[Combining Dot Above]O2peak was assessed before and after the intervention in an all-out exercise test on a bicycle ergometer. V[Combining Dot Above]O2peak increased by an average of 3.6 mL/(kg·min) [SD 3.6 mL/(kg·min)] in the E-Bike group and by 2.2 mL/(kg·min) [SD 3.5 mL/(kg·min)] in the Bike group, with an adjusted difference between the 2 groups of 1.4 mL/(kg·min) [95% confidence interval, -1.4-4.1; P = 0.327]. E-bikes may have the potential to improve cardiorespiratory fitness similar to conventional bicycles despite the available power assist, as they enable higher biking speeds and greater elevation gain.

  8. Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study.

    Directory of Open Access Journals (Sweden)

    Lynne Shinto

    Full Text Available Multiple sclerosis is the most common chronic disabling disease in the central nervous system in young to middle aged adults. Depression is common in multiple sclerosis (MS affecting between 50–60% of patients. Pilot studies in unipolar depression report an improvement in depression when omega-3 fatty acids are given with antidepressants. The objective of this study was to investigate whether omega-3 fatty acid supplementation, as an augmentation therapy, improves treatment-resistant major depressive disorder (MDD in people with MS. We performed a randomized, double-blind, placebo-controlled pilot study of omega-3 fatty acids at six grams per day over three months. The primary outcome was a 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS. Thirty-nine participants were randomized and thirty-one completed the 3-month intervention. Improvement on MADRS between groups was not significantly different at the 3-month end point with 47.4% in the omega-3 fatty acid group and 45.5% in the placebo group showing 50% or greater improvement (p = 0.30. Omega-3 fatty acids as an augmentation therapy for treatment-resistant depression in MS was not significantly different than placebo in this pilot trial. Omega-3 fatty acid supplementation at the dose given was well-tolerated over 3 months.ClinicalTrials.gov NCT00122954.

  9. Omega-3 Fatty Acids for Depression in Multiple Sclerosis: A Randomized Pilot Study.

    Science.gov (United States)

    Shinto, Lynne; Marracci, Gail; Mohr, David C; Bumgarner, Lauren; Murchison, Charles; Senders, Angela; Bourdette, Dennis

    2016-01-01

    Multiple sclerosis is the most common chronic disabling disease in the central nervous system in young to middle aged adults. Depression is common in multiple sclerosis (MS) affecting between 50–60% of patients. Pilot studies in unipolar depression report an improvement in depression when omega-3 fatty acids are given with antidepressants. The objective of this study was to investigate whether omega-3 fatty acid supplementation, as an augmentation therapy, improves treatment-resistant major depressive disorder (MDD) in people with MS. We performed a randomized, double-blind, placebo-controlled pilot study of omega-3 fatty acids at six grams per day over three months. The primary outcome was a 50% or greater improvement on the Montgomery-Asberg Depression Rating Scale (MADRS). Thirty-nine participants were randomized and thirty-one completed the 3-month intervention. Improvement on MADRS between groups was not significantly different at the 3-month end point with 47.4% in the omega-3 fatty acid group and 45.5% in the placebo group showing 50% or greater improvement (p = 0.30). Omega-3 fatty acids as an augmentation therapy for treatment-resistant depression in MS was not significantly different than placebo in this pilot trial. Omega-3 fatty acid supplementation at the dose given was well-tolerated over 3 months. ClinicalTrials.gov NCT00122954.

  10. Weight management for overweight and obese men delivered through professional football clubs: a pilot randomized trial

    Science.gov (United States)

    2013-01-01

    Background The prevalence of male obesity is increasing, but men are less likely than women to attend existing weight management programmes. We have taken a novel approach to reducing perceived barriers to weight loss for men by using professional football (soccer) clubs to encourage participation in a weight management group programme, gender-sensitised in content and style of delivery. Football Fans in Training (FFIT) provides 12 weeks of weight loss, physical activity and healthy eating advice at top professional football clubs in Scotland. This pilot randomized trial explored the feasibility of using these clubs as a setting for a randomized controlled trial of 12 month weight loss following men’s participation in FFIT. Methods A two-arm pilot trial at two Scottish Premier League football clubs (one large, one smaller), with 103 men (aged 35–65, body mass index (BMI) ≥27 kg/m2) individually randomized to the intervention (n=51, received the pilot programme (p-FFIT) immediately) and waitlist comparison (n=52, received p-FFIT after four months) groups. Feasibility of recruitment, randomization, data collection and retention were assessed. Objective physical measurements (weight, waist circumference, blood pressure, body composition) and questionnaires (self-reported physical activity, diet, alcohol consumption, psychological outcomes) were obtained from both groups by fieldworkers trained to standard protocols at baseline and 12 weeks, and from the intervention group at 6 and 12 months. Qualitative methods elicited men’s experiences of participation in the pilot trial. Results Following a short recruitment period, the recruitment target was achieved at the large, but not smaller, club. Participants’ mean age was 47.1±8.4 years; mean BMI 34.5±5.0 kg/m2. Retention through the trial was good (>80% at 12 weeks and 6 months; >75% at 12 months), and 76% attended at least 80% of available programme delivery sessions. At 12 weeks, the intervention group lost

  11. Weight management for overweight and obese men delivered through professional football clubs: a pilot randomized trial.

    Science.gov (United States)

    Gray, Cindy M; Hunt, Kate; Mutrie, Nanette; Anderson, Annie S; Treweek, Shaun; Wyke, Sally

    2013-10-30

    The prevalence of male obesity is increasing, but men are less likely than women to attend existing weight management programmes. We have taken a novel approach to reducing perceived barriers to weight loss for men by using professional football (soccer) clubs to encourage participation in a weight management group programme, gender-sensitised in content and style of delivery. Football Fans in Training (FFIT) provides 12 weeks of weight loss, physical activity and healthy eating advice at top professional football clubs in Scotland. This pilot randomized trial explored the feasibility of using these clubs as a setting for a randomized controlled trial of 12 month weight loss following men's participation in FFIT. A two-arm pilot trial at two Scottish Premier League football clubs (one large, one smaller), with 103 men (aged 35-65, body mass index (BMI) ≥27 kg/m²) individually randomized to the intervention (n=51, received the pilot programme (p-FFIT) immediately) and waitlist comparison (n=52, received p-FFIT after four months) groups. Feasibility of recruitment, randomization, data collection and retention were assessed. Objective physical measurements (weight, waist circumference, blood pressure, body composition) and questionnaires (self-reported physical activity, diet, alcohol consumption, psychological outcomes) were obtained from both groups by fieldworkers trained to standard protocols at baseline and 12 weeks, and from the intervention group at 6 and 12 months. Qualitative methods elicited men's experiences of participation in the pilot trial. Following a short recruitment period, the recruitment target was achieved at the large, but not smaller, club. Participants' mean age was 47.1 ± 8.4 years; mean BMI 34.5 ± 5.0 kg/m². Retention through the trial was good (>80% at 12 weeks and 6 months; >75% at 12 months), and 76% attended at least 80% of available programme delivery sessions. At 12 weeks, the intervention group lost significantly more weight

  12. Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial.

    Science.gov (United States)

    Duffett, Mark; Choong, Karen; Foster, Jennifer; Gilfoyle, Elaine; Lacroix, Jacques; Pai, Nikhil; Thabane, Lehana; Cook, Deborah J

    2017-01-01

    Despite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Stress ulcer prophylaxis may have unintended consequences-increasing the risk of nosocomial infections-which may be more serious and common than the bleeding which these drugs are prescribed to prevent. Randomized controlled trials (RCTs) in pediatric critical care are exceptionally challenging to complete, thus a rigorous pilot RCT is crucial. The objective of this pilot RCT is to assess the feasibility of a large multicentre RCT of stress ulcer prophylaxis with pantoprazole to prevent upper GI bleeding vs. placebo. A multi-centre blinded pilot RCT of 120 children in six Canadian PICUs. Children expected to require mechanical ventilation for more than 48 h will be randomized to receive intravenous pantoprazole 1 mg/kg or identical placebo once daily until they no longer need mechanical ventilation. We have four feasibility outcomes and will consider the trial successful if we achieve:Effective screening: If >80% of eligible patients are approached for consent.Timely enrollment: if >80% of participants receive their first dose of the assigned study drug within 1 day of becoming eligible.Participant accrual: If the average monthly enrolment is two or more participants per centre per month.Protocol adherence: if >90% of doses are administered according to the protocol. There are many uncertainties about the risks and benefits of stress ulcer prophylaxis. In an era of widespread use-where clinicians prescribe prophylaxis to the more severely ill-a large, rigorous RCT is required. A trial to determine if a strategy of withholding stress ulcer prophylaxis is not inferior to a strategy of routine stress ulcer prophylaxis will be challenging. A carefully designed and implemented pilot trial is essential. ClinicalTrials.gov:NCT02929563 (Registered October 3, 2016).

  13. Pilot study of the Korean Parent Training Program using a partial group randomized experimental study

    Science.gov (United States)

    Kim, Eunjung; Cain, Kevin; Boutain, Doris; Chun, Jin-Joo; Kim, Sangho; Im, Hyesang

    2017-01-01

    Problems Korean American (KA) children experience mental health problems due to difficulties in parenting dysfunction complicated by living in two cultures. Methods Korean Parent Training Program (KPTP) was pilot tested with 48 KA mothers of children (ages 3–8) using partial group randomized controlled experimental study design. Self-report survey and observation data were gathered. Findings Analyses using generalized estimating equation indicated the intervention group mothers increased effective parenting and their children decreased behavior problems and reported less acculturation conflict with mothers. Conclusions The KPTP is a promising way to promote effective parenting and increase positive child mental health in KA families. PMID:24645901

  14. Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study.

    Science.gov (United States)

    Hanselman, Andrew E; Tidwell, John E; Santrock, Robert D

    2015-02-01

    Treatment options for plantar fasciitis have resulted in varied patient outcomes. The aim of this study was to compare a novel treatment, cryopreserved human amniotic membrane (c-hAM), to a traditional treatment, corticosteroid. Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes. A randomized, controlled, double-blind, single-center pilot study was completed. Patients were randomized into one of 2 treatment groups: c-hAM or corticosteroid. Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up. Total follow-up was obtained for 12 weeks after the most recent injection. The primary outcome measurement was the Foot Health Status Questionnaire (FHSQ). The secondary outcome measurements were the Visual Analog Scale (VAS) and verbally reported percentage improvement. Data were analyzed between groups for the 2 different cohorts (1 injection versus 2 injections). Twenty-three patients had complete follow-up. Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM. Three patients in each group received second injections. With the numbers available, the majority of outcome measurements showed no statistical difference between groups. The corticosteroid did, however, have greater FHSQ shoe fit improvement (P = .0244) at 6 weeks, FHSQ general health improvement (P = .0132) at 6 weeks, and verbally reported improvement (P = .041) at 12 weeks in the one-injection cohort. Cryopreserved hAM had greater FHSQ foot pain improvement (P = .0113) at 18 weeks in the 2-injection cohort. Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis. This is a pilot study and requires further investigation. Level I, prospective randomized trial. © The Author(s) 2014.

  15. A pilot randomized trial of two cognitive rehabilitation interventions for mild cognitive impairment: caregiver outcomes.

    Science.gov (United States)

    Cuc, Andrea V; Locke, Dona E C; Duncan, Noah; Fields, Julie A; Snyder, Charlene Hoffman; Hanna, Sherrie; Lunde, Angela; Smith, Glenn E; Chandler, Melanie

    2017-12-01

    This study aims to provide effect size estimates of the impact of two cognitive rehabilitation interventions provided to patients with mild cognitive impairment: computerized brain fitness exercise and memory support system on support partners' outcomes of depression, anxiety, quality of life, and partner burden. A randomized controlled pilot trial was performed. At 6 months, the partners from both treatment groups showed stable to improved depression scores, while partners in an untreated control group showed worsening depression over 6 months. There were no statistically significant differences on anxiety, quality of life, or burden outcomes in this small pilot trial; however, effect sizes were moderate, suggesting that the sample sizes in this pilot study were not adequate to detect statistical significance. Either form of cognitive rehabilitation may help partners' mood, compared with providing no treatment. However, effect size estimates related to other partner outcomes (i.e., burden, quality of life, and anxiety) suggest that follow-up efficacy trials will need sample sizes of at least 30-100 people per group to accurately determine significance. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  16. Mindfulness training for loneliness among Chinese college students: A pilot randomized controlled trial.

    Science.gov (United States)

    Zhang, Na; Fan, Fu-Min; Huang, Si-Yuan; Rodriguez, Marcus A

    2016-10-05

    Loneliness has been found to predict a wide range of physical and mental health problems. It is suggested that China's One-Child Policy places young Chinese people at a particularly high risk for loneliness. Although loneliness is most prevalent in late adolescence and early adulthood, interventions have primarily targeted children or older adults with limited success. The current study examines a pilot randomized controlled trial of a mindfulness training program among Chinese college students. Participants with elevated loneliness (N = 50, ages 17-25) were randomized into either an 8-week mindfulness training or a control group. Self-reported measures of loneliness and mindfulness were administered at baseline and posttest. The training group also completed a program evaluation form and a 3-month follow-up assessment. Results provided preliminary evidence indicating that the intervention was feasible and effective at reducing loneliness among Chinese college students. Limitations and future directions were discussed. © 2016 International Union of Psychological Science.

  17. Vasopressin vs Dopamine for Treatment of Hypotension in ELBW Infants: A Randomized, Blinded Pilot Study

    Science.gov (United States)

    Rios, Danielle R.; Kaiser, Jeffrey R.

    2015-01-01

    Objective To evaluate vasopressin vs dopamine as initial therapy in ELBW infants with hypotension during the first 24 hours of life. Study design Hypotensive ELBW infants ≤ 30 weeks’ gestation and ≤ 24 hours old randomly received treatment with vasopressin or dopamine in a blinded fashion. Normotensive infants not receiving vasopressor support served as a comparison group. Results Twenty hypotensive ELBW infants received vasopressin (n=10) or dopamine (n=10), and 50 were enrolled for comparison. Mean gestational age was 25.6 ± 1.4 weeks and birth weight 705 ± 154 g. Response to vasopressin paralleled that of dopamine in time to adequate mean BP (Kaplan-Meier curve, p=0.986); 90% of infants in each treatment group responded with adequate BP. The vasopressin group received fewer doses of surfactant (phypotension appeared safe. This pilot study supports a larger randomized controlled trial of vasopressin vs dopamine therapy in ELBW infants with hypotension. PMID:25641242

  18. Progesterone for smoking relapse prevention following delivery: A pilot, randomized, double-blind study.

    Science.gov (United States)

    Forray, Ariadna; Gilstad-Hayden, Kathryn; Suppies, Cristine; Bogen, Debra; Sofuoglu, Mehmet; Yonkers, Kimberly A

    2017-12-01

    Close to half of women who were smokers prior to conception quit smoking in pregnancy, when endogenous progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop. The current pilot study tested the feasibility and preliminary efficacy of postpartum progesterone replacement in preventing relapse to smoking in postpartum women with a history of pre-pregnancy smoking. This was an 8-week, double-blind, parallel, randomized, placebo-controlled pilot trial of 41 women with a history of pre-pregnancy smoking who achieved abstinence by 32 weeks of gestation. Immediately following delivery women were randomized to oral micronized progesterone (200mg twice daily) or placebo via computerized urn randomization program. The main outcome measures were descriptions of study feasibility: recruitment and retention. Secondary outcomes were 7-day point prevalence of abstinence at week 8, time to relapse and smoking cravings. The trial was feasible with adequate randomization, 64% (41/64) of eligible women, and trial retention, 78% (32/41) completed the trial. Women taking progesterone were 1.8 times more likely to be abstinent during week 8 and took longer to relapse (10 vs. 4 weeks) compared to the placebo group, although these differences did not reach statistical significance. After adjusting for age and pre-quit smoking level, the number needed to treat was 7. There was a 10% greater decline per week in craving ratings in the progesterone group compared to placebo (β=-0.10, 95% CI: -0.15, -0.04, p<0.01). No serious adverse events occurred during the trial. These preliminary findings support the promise of progesterone treatment in postpartum smokers and could constitute a therapeutic breakthrough.If these preliminary findings can be evaluated and replicated in a larger study with sufficient power, this may constitute an acceptable and safe smoking relapse prevention strategy for use

  19. Using music to reduce anxiety among older adults in the emergency department: a randomized pilot study.

    Science.gov (United States)

    Belland, Laura; Rivera-Reyes, Laura; Hwang, Ula

    2017-11-01

    An emergency department (ED) visit may be distressing and anxiety-provoking for older adults (age > 65 years). No studies have specifically evaluated the effect of music listening on anxiety in older adults in the ED. The objective of this pilot study was to evaluate the effect of music listening on anxiety levels in older ED patients. This was a randomized pilot study in the geriatric ED of an urban academic tertiary medical center. This was a sample of English-speaking adults (age > 65 years) who were not deaf (n = 35). Subjects consented to participate and were randomized to receive up to 60 min of music listening with routine care, while the control group received routine care with no music. Subjects in the music treatment group received headphones and an electronic tablet with pre-downloaded music, and were allowed to choose from 5 selections. The primary outcome was change in anxiety levels, measured by the state-trait anxiety inventory (STAI), at enrollment and 1 h later. A total of 35 participants were enrolled: 74% were female, 40% were white, and 40% were black; of these, 32 subjects completed the study protocol. When comparing control (n = 18) against intervention subjects (n = 17), there were no significant differences in enrollment STAI scores (43.00 ± 15.00 vs. 40.30 ± 12.80, P = 0.57). STAI scores 1 hour after enrollment (after the music intervention) were significantly reduced in the intervention subjects compared to the control subjects (with reduction of 10.00 ± 12.29 vs. 1.88 ± 7.97, P = 0.03). These pilot results suggest that music listening may be an effective tool for reducing anxiety among older adults in the ED.

  20. Acupuncture in shoulder pain and functional impairment after neck dissection: A prospective randomized pilot study.

    Science.gov (United States)

    Deganello, Alberto; Battat, Nir; Muratori, Enrico; Cristofaro, Glauco; Buongiorno, Ana; Mannelli, Giuditta; Picconi, Mario; Giachetti, Rita; Borsotti, Giulia; Gallo, Oreste

    2016-08-01

    The efficacy of conventional physiotherapy and antiinflammatory/analgesic drugs in the management of shoulder pain and functional disability following neck dissection is often disappointing. Acupuncture is a safe and well-tolerated method. We report the results regarding our pilot trial of acupuncture versus conventional care in the management of postoperative shoulder pain and dysfunction after neck dissection. Pilot study. Patients at a tertiary university center with chronic pain or dysfunction attributed to neck dissection were randomly assigned to either weekly acupuncture or usual care (eg., physical therapy, analgesia, and/or antiinflammatory drugs) for 5 consecutive weeks. The Constant-Murley score, a composite measure of pain, function, and activities of daily living, was the primary outcome measure. As secondary end point, The Neck Dissection Impairment Index (NDII) was used to quantify site-specific, self-reported quality of life (QOL). After randomization, 48 patients completed the study (23 and 25 patients on acupuncture and control arms, respectively). Constant-Murley scores improved more in the acupuncture group (gain difference between groups 13.6, P pain and dysfunction related to neck dissection. 2b. Laryngoscope, 126:1790-1795, 2016. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

  1. Intensive, Manual-based Intervention for Pediatric Feeding Disorders: Results From a Randomized Pilot Trial.

    Science.gov (United States)

    Sharp, William G; Stubbs, Kathryn H; Adams, Heyward; Wells, Brian M; Lesack, Roseanne S; Criado, Kristen K; Simon, Elizabeth L; McCracken, Courtney E; West, Leanne L; Scahill, Larry D

    2016-04-01

    The aim of this pilot study was to investigate feasibility and preliminary efficacy of an intensive, manual-based behavioral feeding intervention for children with chronic food refusal and dependence on enteral feeding or oral nutritional formula supplementation. Twenty children ages 13 to 72 months (12 boys and 8 girls) meeting criteria for avoidant/restrictive food intake disorder were randomly assigned to receive treatment for 5 consecutive days in a day treatment program (n = 10) or waitlist (n = 10). A team of trained therapists implemented treatment under the guidance of a multidisciplinary team. Parent training was delivered to support generalization of treatment gains. We tracked parental attrition and attendance, as well as therapist fidelity. Primary outcome measures were bite acceptance, disruptions, and grams consumed during meals. Caregivers reported high satisfaction and acceptability of the intervention. Three participants (1 intervention; 2 waitlist) dropped out of the study before endpoint. Of the expected 140 treatment meals for the intervention group, 137 (97.8%) were actually attended. The intervention group showed significantly greater improvements (P treatment gains. Results from this pilot study corroborate evidence from single-subject and nonrandomized studies on the positive effects of behavioral intervention. Findings support the feasibility and preliminary efficacy of this manual-based approach to intervention. These results warrant a large-scale randomized trial to test the safety and efficacy of this intervention.

  2. Using Press Ganey Provider Feedback to Improve Patient Satisfaction: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Newgard, Craig D; Fu, Rongwei; Heilman, James; Tanski, Mary; John Ma, O; Lines, Alan; Keith French, L

    2017-09-01

    The objective was to conduct a pilot randomized controlled trial to assess the feasibility, logistics, and potential effect of monthly provider funnel plot feedback reports from Press Ganey data and semiannual face-to-face coaching sessions to improve patient satisfaction scores. This was a pilot randomized controlled trial of 25 emergency medicine faculty providers in one urban academic emergency department. We enrolled full-time clinical faculty with at least 12 months of baseline Press Ganey data, who anticipated working in the ED for at least 12 additional months. Providers were randomized into intervention or control groups in a 1:1 ratio. The intervention group had an initial 20-minute meeting to introduce the funnel plot feedback tool and standardized feedback based on their baseline Press Ganey scores and then received a monthly e-mail with their individualized funnel plot depicting cumulative Press Ganey scores (compared to their baseline score and the mean score of all providers) for 12 months. The primary outcome was the difference in Press Ganey "doctor-overall" scores between treatment groups at 12 months. We used a weighted analysis of covariance model to analyze the study groups, accounting for variation in the number of surveys by provider and baseline scores. Of 36 eligible faculty, we enrolled 25 providers, 13 of whom were randomized to the intervention group and 12 to the control group. During the study period, there were 815 Press Ganey surveys returned, ranging from four to 71 surveys per provider. For the standardized overall doctor score over 12 months (primary outcome), there was no difference between the intervention and control groups (difference = 1.3 points, 95% confidence interval = -2.4 to 5.9, p = 0.47). Similarly, there was no difference between groups when evaluating the four categories of doctor-specific patient satisfaction scores from the Press Ganey survey (all p > 0.05). In this pilot trial of monthly provider funnel plot

  3. Modified step aerobics training and neuromuscular function in osteoporotic patients: a randomized controlled pilot study.

    Science.gov (United States)

    Behrens, Martin; Müller, Karoline; Kilb, Jill-Isabel; Schleese, Lennart; Herlyn, Philipp K E; Bruhn, Sven; Mittlmeier, Thomas; Schober, Hans-Christof; Fischer, Dagmar-C

    2017-02-01

    Training programs directed to improve neuromuscular and musculoskeletal function of the legs are scarce with respect to older osteoporotic patients. We hypothesized that a modified step aerobics training program might be suitable for this purpose and performed a randomized controlled pilot study to assess the feasibility of conducting a large study. Here we report on the training-related effects on neuromuscular function of the plantar flexors. Twenty-seven patients with an age of at least 65 years were enrolled and randomized into control and intervention group. The latter received supervised modified step aerobics training (twice weekly, 1 h per session) over a period of 6 months. At baseline, and after 3 and 6 months neuromuscular function of the plantar flexors, i.e., isometric maximum voluntary torque, rate of torque development and twitch torque parameters were determined in detail in all patients of both groups. Twenty-seven patients (median age 75 years; range 66-84 years) were randomized (control group n = 14; intervention group n = 13). After 3 and 6 months of training, maximum voluntary contraction strength in the intervention group was significantly higher by 7.7 Nm (9.1%; 95% CI 3.3-12.2 Nm, P training program in a large randomized trial. However, a detailed neuromuscular assessment appears feasible only in a subset of participants.

  4. Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

    Science.gov (United States)

    Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

    2015-03-01

    ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

  5. A cognitive behavioral smoking abstinence intervention for adults with chronic pain: a randomized controlled pilot trial.

    Science.gov (United States)

    Hooten, W Michael; Townsend, Cynthia O; Hays, J Taylor; Ebnet, Kaye L; Gauvin, Thomas R; Gehin, Jessica M; Laures, Heidi J; Patten, Christi A; Warner, David O

    2014-03-01

    Current evidence suggests it may be difficult for patients with chronic pain to quit smoking and, based on previous formative work, a 7-session individual and group-based cognitive behavioral (CB) intervention was developed. The primary aim of this randomized controlled pilot trial was to test the hypothesis that abstinence at month 6 would be greater among patients with chronic pain who received the CB intervention compared to a control condition. Upon admission to a 3-week interdisciplinary pain treatment (IPT) program, patients were randomized to receive the CB intervention (n=30) or the control condition (n=30). The 7-day point prevalence of self-reported smoking status was assessed at week 3 (upon completion of the 3-week IPT program) and at month 6 in an intent-to-treat analysis. At week 3, 30% (n=9) of patients in the CB condition were abstinent from smoking compared to 10% (n=3) in the control group (P=.104). At month 6, 20% (n=6) of patients who received the CB intervention were abstinent compared to none in the control group (P=.024). At week 3, a significant group by time interaction effect was found where the CB patients experienced greater improvements in self-efficacy from baseline compared to the control group (P=.002). A greater proportion of patients randomized to the CB group completed the IPT program (P=.052). The findings of this pilot trial suggest that integration of a CB-based smoking abstinence intervention into ongoing pain therapy may be an effective treatment for smokers with chronic pain. Copyright © 2013 Elsevier Ltd. All rights reserved.

  6. Feasibility of a home-based exercise intervention with remote guidance for patients with stable grade II and III gliomas : A pilot randomized controlled trial

    NARCIS (Netherlands)

    Gehring, K.; Kloek, C.J.J.; Aaronson, Neil K; Janssen, K.; Jones, Lee; Sitskoorn, M.M.; Stuiver, M.

    2018-01-01

    Objective: In this pilot study, we investigated the feasibility of a home-based, remotely guided exercise intervention for patients with gliomas. Design: Pilot randomized controlled trial (RCT) with randomization (2:1) to exercise or control group. Subjects: Patients with stable grade II and III

  7. A pilot randomized controlled trial of pioglitazone for the treatment of poorly controlled asthma in obesity.

    Science.gov (United States)

    Dixon, Anne E; Subramanian, Meenakumari; DeSarno, Michael; Black, Kendall; Lane, Lisa; Holguin, Fernando

    2015-11-26

    Obese asthmatics tend to have poorly controlled asthma, and resistance to standard asthma controller medications. The purpose of this study was to determine the efficacy of pioglitazone, an anti-diabetic medication which can alter circulating adipokines and have direct effects on asthmatic inflammation, in the treatment of asthma in obesity. A two-center, 12-week, randomized, placebo-controlled, double-blinded trial. Treatments were randomly assigned with concealment of allocation. The primary outcome was difference in change in airway reactivity between participants assigned to pioglitazone versus placebo at 12 weeks. Twenty-three participants were randomized to treatment, 19 completed the study. Median airway reactivity, measured by PC20 to methacholine was 1.99 (IQR 3.08) and 1.60 (5.91) mg/ml in placebo and pioglitazone group at baseline, and 2.37 (15.22) and 5.08 (7.42) mg/ml after 12 weeks, p = 0.38. There was no difference in exhaled nitric oxide, asthma control or lung function between treatment groups over the 12 week trial. Participants assigned to pioglitazone gained a significant amount more weight than those assigned to placebo (pioglitazone group mean weight 113.6, CI 94.5-132.7 kg at randomization and 115.9, CI 96.9-135.1 at 12 weeks; placebo mean weight 127.5, CI 108.4 - 146.6 kg at randomization and 124.5, CI 105.4 - 143.6 kg at 12 weeks; p = 0.04). This pilot study suggests limited efficacy for pioglitazone in the treatment of poorly controlled asthma in obesity, and also the potential for harm, given the weight gain in those assigned to active treatment, and the association between increased weight and worse outcomes in asthma. Clinicaltrials.gov (NCT00634036).

  8. Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome: study protocol for a randomized controlled pilot trial.

    Science.gov (United States)

    Kim, Jung-Eun; Cho, Junghyo; Kwon, Ojin; Kim, Ae-Ran; Park, Hyo-Ju; Jung, So-Young; Kim, Joo-Hee; Kim, Mikyung; Lee, Hye-Yoon; Lee, Jun-Hwan

    2017-03-21

    The aim of this study is to explore the efficacy of Guizhifulingwan (GFW) in the treatment of climacteric syndrome in women. This is a single-center, randomized, placebo-controlled, parallel-group design pilot trial. Fifty participants with climacteric syndrome will be randomly allocated to the GFW or placebo group in a 1:1 ratio. The participants will be administered GFW or placebo granules three times a day for 4 weeks and will be followed up for a further 4 weeks. The primary outcome is the mean change in menopause rating scale score at 5 weeks after randomization. Secondary outcomes include the World Health Organization quality of life-BREF scores, degrees of upward movement of qi and lower abdominal resistance and tenderness, blood stasis pattern questionnaire scores, and results of blood tests including assays for lipid profile, high sensitivity C-reactive protein, follicle-stimulating hormone, and estradiol. The feasibility outcomes include recruitment and completion rates and adherence to medication. The results of this study will provide basic data for the design of a large-scale clinical trial for evaluating the efficacy of GFW in the treatment of climacteric syndrome in women. Clinical Research Information Service (CRIS), Republic of Korea, KCT0002040 . Registered on 5 September 2016.

  9. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    John, Bindu; Bellipady, Sumanth Shetty; Bhat, Shrinivasa Undaru

    2016-01-01

    Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118.

  10. Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Bindu John

    2016-01-01

    Full Text Available Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n=34; control group, n=24. Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118.

  11. Virtual reality in the rehabilitation of the arm after hemiplegic stroke: a randomized controlled pilot study.

    Science.gov (United States)

    Crosbie, J H; Lennon, S; McGoldrick, M C; McNeill, M D J; McDonough, S M

    2012-09-01

    To assess the feasibility of a trial to investigate the effectiveness of virtual reality-mediated therapy compared to conventional physiotherapy in the motor rehabilitation of the arm following stroke, and to provide data for a power analysis to determine numbers for a future main trial. Pilot randomized controlled trial. Clinical research facility. Eighteen people with a first stroke, 10 males and 8 females, 7 right and 2 left side most affected. Mean time since stroke 10.8 months. Participants were randomized to a virtual reality group or a conventional arm therapy group for nine sessions over three weeks. The upper limb Motricity Index and the Action Research Arm Test were completed at baseline, post intervention and six weeks follow-up. Outcome data were obtained from 95% of participants at the end of treatment and at follow-up: one participant withdrew. Compliance was high; only two people reported side-effects from virtual reality exposure. Both groups demonstrated small (7-8 points on upper limb Motricity Index and 4 points on the Action Research Arm Test), but non-significant, changes to their arm impairment and activity levels. A randomized controlled trial of virtual reality-mediated therapy comparable to conventional therapy would be feasible, with some suggested improvements in recruitment and outcome measures. Seventy-eight participants (39 per group) would be required for a main trial.

  12. Raloxifene for women with Alzheimer disease: A randomized controlled pilot trial.

    Science.gov (United States)

    Henderson, Victor W; Ala, Tom; Sainani, Kristin L; Bernstein, Allan L; Stephenson, B Sue; Rosen, Allyson C; Farlow, Martin R

    2015-12-01

    To determine whether raloxifene, a selective estrogen receptor modulator, improves cognitive function compared with placebo in women with Alzheimer disease (AD) and to provide an estimate of cognitive effect. This pilot study was conducted as a randomized, double-blind, placebo-controlled trial, with a planned treatment of 12 months. Women with late-onset AD of mild to moderate severity were randomly allocated to high-dose (120 mg) oral raloxifene or identical placebo provided once daily. The primary outcome compared between treatment groups at 12 months was change in the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog). Forty-two women randomized to raloxifene or placebo were included in intent-to-treat analyses (mean age 76 years, range 68-84), and 39 women contributed 12-month outcomes. ADAS-cog change scores at 12 months did not differ significantly between treatment groups (standardized difference 0.03, 95% confidence interval -0.39 to 0.44, 2-tailed p = 0.89). Raloxifene and placebo groups did not differ significantly on secondary analyses of dementia rating, activities of daily living, behavior, or a global cognition composite score. Caregiver burden and caregiver distress were similar in both groups. Results on the primary outcome showed no cognitive benefits in the raloxifene-treated group. This study provides Class I evidence that for women with AD, raloxifene does not have a significant cognitive effect. The study lacked the precision to exclude a small effect. © 2015 American Academy of Neurology.

  13. Behavioral couples therapy for smoking cessation: A pilot randomized clinical trial.

    Science.gov (United States)

    LaChance, Heather; Cioe, Patricia A; Tooley, Erin; Colby, Suzanne M; O'Farrell, Timothy J; Kahler, Christopher W

    2015-09-01

    Behavioral couples therapy (BCT) has been found to improve long-term abstinence rates in alcohol- and substance-dependent populations but has not been tested for smoking cessation. This pilot study examined the feasibility and acceptability of BCT for smoking-discordant couples. Forty-nine smokers (smoking >10 cigarettes/day) with nonsmoking partners were randomized to receive a couples social support (BCT-S) intervention or an individually delivered, standard smoking cessation treatment (ST). The couples were married or had been cohabiting for at least 1 year, with partners who had never smoked or had not used tobacco in 1 year. Both treatments included 7 weekly sessions and 8 weeks of nicotine replacement therapy. Participants were followed for 6 months posttreatment. The Partner Interaction Questionnaire was used to measure perceived smoking-specific partner support. Participants were 67% male and 88% White. Biochemically verified cessation rates were 40.9%, 50%, and 45% in BCT-S and 59.1%, 50%, and 55% in ST at end of treatment, after 3 month, and after 6 months, respectively, and did not differ significantly between treatment conditions at any time point. Perceived smoking-specific partner support at posttreatment did not significantly differ between treatment groups. Results of this pilot study do not provide support for the efficacy of BCT in smoking-discordant couples. (c) 2015 APA, all rights reserved).

  14. Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy.

    Science.gov (United States)

    Bricker, Jonathan B; Mull, Kristin E; Kientz, Julie A; Vilardaga, Roger; Mercer, Laina D; Akioka, Katrina J; Heffner, Jaimee L

    2014-10-01

    There is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered acceptance and commitment therapy (ACT) application for smoking cessation vs. an application following US Clinical Practice Guidelines. Adult participants were recruited nationally into the double-blind randomized controlled pilot trial (n=196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). We recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (pacceptance of cravings at baseline (n=88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6-20.7). ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  15. Probiotics for fibromyalgia: study design for a pilot double-blind, randomized controlled trial.

    Science.gov (United States)

    Roman, Pablo; Estévez, Ángeles F; Sánchez-Labraca, Nuria; Cañadas, Fernando; Miras, Alonso; Cardona, Diana

    2017-10-24

    Fibromyalgia syndrome (FMS) is a chronic, generalized and diffuse pain disorder accompanied by other symptoms such as emotional and cognitive deficits. The FMS patients show a high prevalence of gastrointestinal symptoms. Recently it has been found that microbes in the gut may regulate brain processes through the gut-microbiota-brain axis, modulating thus affection, motivation and higher cognitive functions. Therefore, the use of probiotics might be a new treatment that could improve the physical, psychological and cognitive state in FMS; however, no evidence about this issue is available. This paper describes the design and protocol of a double-blind, placebo-controlled and randomized pilot study. We use validated questionnaires, cognitive task through E-Prime and biological measures like urine cortisol and stool fecal samples. The trial aim is to explore the effects of eight weeks of probiotics therapy in physical (pain, impact of the FMS and quality of life), emotional (depression, and anxiety) and cognitive symptoms (attention, memory, and impulsivity) in FMS patients as compared to placebo. This pilot study is the first, to our knowledge, to evaluate the effects of probiotics in FMS. The primary hypothesis was that FMS patients will show a better performance on cognitive tasks, and an improvement in emotional and physical symptoms. These results will contribute to a better understanding in the gut-brain axis. Here we present the design and protocol of the study.

  16. Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer.

    Science.gov (United States)

    Robb, Sheri L; Haase, Joan E; Perkins, Susan M; Haut, Paul R; Henley, Amanda K; Knafl, Kathleen A; Tong, Yan

    2017-03-01

    To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. A pilot two-group randomized trial was conducted with parents/children (ages 3-8 years) receiving AME + P ( n  =  9) or attention control ( n  =  7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Despite child benefit, findings do not support parent delivery of AME + P.

  17. Chiropractor interaction and treatment equivalence in a pilot randomized controlled trial

    DEFF Research Database (Denmark)

    Salsbury, Stacie A; DeVocht, James W; Hondras, Maria

    2014-01-01

    and study participants regarding treatment group assignment. METHODS: We conducted an observational analysis of digital video-recordings derived from study visits conducted during a pilot randomized trial of conservative therapies for temporomandibular pain. A theory-based, iterative process developed...... the 13-item Chiropractor Interaction and Treatment Equivalence Instrument. A trained evaluator masked to treatment assignment coded video-recordings of clinical encounters between one chiropractor and multiple visits of 26 participants allocated to active or sham chiropractic treatment groups. Non......-parametric statistics were calculated. RESULTS: The trial ran from January 2010 to October 2011. We analyzed 111 complete video-recordings (54 active, 57 sham). Chiropractor interactions differed between the treatment groups in 7 categories. Active participants received more interactions with clinical information (8 vs...

  18. Pilot randomized trial of bupropion for adolescent methamphetamine abuse/dependence.

    Science.gov (United States)

    Heinzerling, Keith G; Gadzhyan, Janette; van Oudheusden, Henry; Rodriguez, Felipe; McCracken, James; Shoptaw, Steven

    2013-04-01

    To perform a pilot clinical trial of bupropion for methamphetamine abuse/dependence among adolescents. Nineteen adolescents with methamphetamine abuse (n = 2) or dependence (n = 17) were randomly assigned to bupropion SR 150 mg twice daily or placebo for 8 weeks with outpatient substance abuse counseling. Bupropion was well-tolerated except for one female in the bupropion group who was hospitalized for suicidal ideation during a methamphetamine relapse. Adolescents receiving bupropion and females provided significantly fewer methamphetamine-free urine tests compared to participants receiving placebo (p = .043) and males (p = .005) respectively. Results do not support the feasibility of additional trials of bupropion for adolescent methamphetamine abuse/dependence. Future studies should investigate the influence of gender on adolescent methamphetamine abuse and treatment outcomes. Copyright © 2013 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  19. Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study

    Directory of Open Access Journals (Sweden)

    Lavinia Fiorentino

    2009-12-01

    Full Text Available Lavinia Fiorentino1, John R McQuaid2, Lianqi Liu3, Loki Natarajan4, Feng He4, Monique Cornejo3, Susan Lawton3, Barbara A Parker6, Georgia R Sadler5, Sonia Ancoli-Israel31Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA, USA; 2Department of Psychiatry, University of California, San Francisco, CA, USA; 3Department of Psychiatry, 4Department of Family and Preventive Medicine, 5Department of Surgery, University of California, San Diego School of Medicine, La Jolla, CA, USA; 6Moores UCSD Cancer Center, La Jolla, CA, USAPurpose: Estimates of insomnia in breast cancer patients are high, with reports of poor sleep lasting years after completion of cancer treatment. This randomized controlled crossover pilot study looked at the effects of individual cognitive behavioral therapy for insomnia (IND-CBT-I on sleep in breast cancer survivors.Patients and methods: Twenty-one participants were randomly assigned to either a treatment group (six weekly IND-CBT-I sessions followed by six weeks of follow up or a delayed treatment control group (no treatment for six weeks followed by six weekly IND-CBT-I sessions. Of these, 14 participants completed the pilot study (six in the treatment group and eight in the delayed treatment control group.Results: Self-rated insomnia was significantly improved in the treatment group compared to the waiting period in the delayed treatment control group. The pooled pre–post-IND-CBT-I analyses revealed improvements in self-rated insomnia, sleep quality, and objective measures of sleep.Conclusions: These preliminary results suggest that IND-CBT-I is appropriate for improving sleep in breast cancer survivors. Individual therapy in a clinic or private practice may be a more practical option for this population as it is more easily accessed and readily available in an outpatient setting.Keywords: insomnia, breast cancer, cognitive behavioral therapy

  20. Early active rehabilitation after arthroscopic rotator cuff repair: a prospective randomized pilot study.

    Science.gov (United States)

    Raschhofer, Rudolf; Poulios, Nikos; Schimetta, Wolfgang; Kisling, Rüdiger; Mittermaier, Christian

    2017-10-01

    To compare two different rehabilitation strategies, primary passive motion versus early isometric loading of the rotator cuff. Prospective randomized controlled observer-blinded pilot study. Institute of Physical Medicine and Rehabilitation. Thirty patients after rotator cuff surgery. All participants were randomly assigned to one of the two outpatient treatment groups: primary passive motion versus early isometric loading of the rotator cuff. Both groups were treated for 12 weeks and performed additionally a home exercise program. The primary outcome measure for functional assessment was the Constant Murley score. The secondary outcome measures were the Disabilities of the Arm, Shoulder and Hand score (DASH), active range of motion, pain level and strength. Patients were assessed before, 6, 12 and 24 weeks after surgery. Repeatedly measured metric variables were compared by the Quade rank analysis of covariance and revealed substantially better Constant Murley scores in the early activated group at all 3 assessments (6 weeks: 41 [31;45] versus 30 [23;37]; 12 weeks: 68 [56;77] versus 59 [53;62]; 24 weeks: 79 [76;81] versus 66 [62;74]; data as median [25%;75%]). Postoperative changes of Constant score were in favour of the active group with the biggest difference at week 12 (28 [38;12] versus 9 [27;-4]). Maximal pain levels showed clear more reduction 6 and 24 weeks after surgery in the early activated group. This pilot study with early isometric loading of the rotator cuff shows better function and less maximal pain. Further research is warranted to confirm our results.

  1. Feasibility and acceptability of a multiple risk factor intervention: The Step Up randomized pilot trial

    Directory of Open Access Journals (Sweden)

    Richards Julie

    2011-03-01

    Full Text Available Abstract Background Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52. This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity. Methods Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months. Results The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01- 12.10], p = 0.05 and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85 - 37.30], p = 0.004 Conclusions Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field. Trial registration The trial is registered with ClinicalTrials.gov (NCT00644995.

  2. Stress Management-Augmented Behavioral Weight Loss Intervention for African American Women: A Pilot, Randomized Controlled Trial

    Science.gov (United States)

    Cox, Tiffany L.; Krukowski, Rebecca; Love, ShaRhonda J.; Eddings, Kenya; DiCarlo, Marisha; Chang, Jason Y.; Prewitt, T. Elaine; West, Delia Smith

    2013-01-01

    The relationship between chronic stress and weight management efforts may be a concern for African American (AA) women, who have a high prevalence of obesity, high stress levels, and modest response to obesity treatment. This pilot study randomly assigned 44 overweight/obese AA women with moderate to high stress levels to either a 12-week…

  3. The Coping Cat Program for Children with Anxiety and Autism Spectrum Disorder: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    McNally Keehn, Rebecca H.; Lincoln, Alan J.; Brown, Milton Z.; Chavira, Denise A.

    2013-01-01

    The purpose of this pilot study was to evaluate whether a modified version of the Coping Cat program could be effective in reducing anxiety in children with autism spectrum disorder (ASD). Twenty-two children (ages 8-14; IQ greater than or equal to 70) with ASD and clinically significant anxiety were randomly assigned to 16 sessions of the Coping…

  4. Laparoscopic Surgical Treatment of Severe Obesity Combined with Gastroesophageal Reflux Disease: A Pilot Randomized Two-Arm Controlled Clinical Study

    Science.gov (United States)

    Ospanov, Oral B.; Orekeshova, Akzhunis M.; Fursov, Roman A.; Yelemesov, Aset A.

    2016-01-01

    Obesity and gastroesophageal reflux disease (GERD) are serious medical, social, and economic problems of modern society. A pilot randomized two-arm controlled clinical study was conducted to compare laparoscopic plication of the greater gastric curvature combined with Nissen fundoplication (LFN+LGP) versus only Nissen fundoplication (LFN). The…

  5. Promoting the use of outcome measures by an educational programme for physiotherapists in stroke rehabilitation : A pilot randomized controlled trial

    NARCIS (Netherlands)

    Peppen, R.P.S. van; Schuurmans, M.J.; Stutterheim, E.C.; Lindeman, E.; Meeteren, N.L.U. van

    2009-01-01

    Objective: To determine the influence of tutor expertise on the uptake of a physiotherapists' educational programme intended to promote the use of outcome measures in the management of patients with stroke. Design: Pilot randomized controlled trial. Methods: Thirty physiotherapists involved in

  6. Emotion Regulation Enhancement of Cognitive Behavior Therapy for College Student Problem Drinkers: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Ford, Julian D.; Grasso, Damion J.; Levine, Joan; Tennen, Howard

    2018-01-01

    This pilot randomized clinical trial tested an emotion regulation enhancement to cognitive behavior therapy (CBT) with 29 college student problem drinkers with histories of complex trauma and current clinically significant traumatic stress symptoms. Participants received eight face-to-face sessions of manualized Internet-supported CBT for problem…

  7. Single-blind, randomized, pilot study combining shiatsu and amitriptyline in refractory primary headaches.

    Science.gov (United States)

    Villani, Veronica; Prosperini, Luca; Palombini, Fulvio; Orzi, Francesco; Sette, Giuliano

    2017-06-01

    Complementary alternative medicine, such as shiatsu, can represent a suitable treatment for primary headaches. However, evidence-based data about the effect of combining shiatsu and pharmacological treatments are still not available. Therefore, we tested the efficacy and safety of combining shiatsu and amitriptyline to treat refractory primary headaches in a single-blind, randomized, pilot study. Subjects with a diagnosis of primary headache and who experienced lack of response to ≥2 different prophylactic drugs were randomized in a 1:1:1 ratio to receive shiatsu plus amitriptyline, shiatsu alone, or amitriptyline alone for 3 months. Primary endpoint was the proportion of patients experiencing ≥50%-reduction in headache days. Secondary endpoints were days with headache per month, visual analogue scale, and number of pain killers taken per month. After randomization, 37 subjects were allocated to shiatsu plus amitriptyline (n = 11), shiatsu alone (n = 13), and amitriptyline alone (n = 13). Randomization ensured well-balanced demographic and clinical characteristics at baseline. Although all the three groups improved in terms of headache frequency, visual analogue scale score, and number of pain killers (p < 0.05), there was no between-group difference in primary endpoint (p = ns). Shiatsu (alone or in combination) was superior to amitriptyline in reducing the number of pain killers taken per month (p < 0.05). Seven (19%) subjects reported adverse events, all attributable to amitriptyline, while no side effects were related with shiatsu treatment. Shiatsu is a safe and potentially useful alternative approach for refractory headache. However, there is no evidence of an additive or synergistic effect of combining shiatsu and amitriptyline. These findings are only preliminary and should be interpreted cautiously due to the small sample size of the population included in our study. Trial registration 81/2010 (Ethical Committee, S. Andrea Hospital

  8. Does Scapula Taping Facilitate Recovery for Shoulder Impingement Symptoms? A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Miller, Peter; Osmotherly, Peter

    2009-01-01

    Scapula taping is a commonly used adjunctive treatment for shoulder impingement pathology. However, this intervention has not previously been subject to formal investigation. A pilot single-blind randomized controlled trial was conducted to evaluate facilitatory taping as an adjunct to routine physiotherapy management. Twenty-two subjects with unilateral shoulder impingement symptoms were randomized into a taping with routine physiotherapy or a routine physiotherapy only group. The intervention group had scapula taping applied three times per week for the first two weeks of their treatment. All subjects were assessed at baseline, then at 2 and 6 weeks after the commencement of treatment. Pain and functional ability were assessed using the Shoulder Pain and Disability Index, range of shoulder elevation, and self-reported pain on elevation. At 2 weeks, the taping group demonstrated a strong trend toward reduced pain both on self-reported activity (SPADI pain subscale mean for taping 27.0 versus 41.5 for control) and pain during measured abduction (mean VAS 22.8 for taped, 46.8 for control), statistical power being limited by small sample size. No similar trend was evident in the SPADI disability subscale. The magnitude of the differences was reduced at 6-week follow-up. This study provides preliminary evidence for a short-term role for scapula taping as an adjunct to routine physiotherapy in the management of shoulder impingement symptoms but also highlights the need for consideration on a case basis relating to risk factors for skin reaction. PMID:20046559

  9. Effect of Mozart music on heel prick pain in preterm infants: a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Cristina Cavaiuolo

    2015-02-01

    Full Text Available Objective: The aim of this pilot study was to determine the effect of music by Mozart on heel prick procedural pain in premature infants.Background: Painful procedures are routinely performed in the setting of neonatal intensive care unit (NICU. Pain may exert short- and long-term deleterious effects on premature babies. Many non-pharmacological interventions have been proven efficacious for blunting neonatal pain.Study design: Randomized, controlled trial.Methods: The study was carried out in the NICU of the “G. Rummo” Hospital in Benevento, Italy. The sample consisted of 42 preterm infants, with no hearing loss or significant cerebral lesions on cranial ultrasound. They were randomized to receive heel lance during a music condition or a no-music control condition. We set strict criteria for selecting and delivering the music. Baseline and postprocedural heart rate and transcutaneous oxygen saturation were manually recorded. The Premature Infant Pain Profile (PIPP score was used to measure the behavioral response to prick. An unpaired t-test was performed for the intergroup comparisons.Results: There were significant differences between groups on heart rate increase, oxygen saturation reduction and PIPP score following the procedure.Conclusions: Listening to Mozart music during heel prick is a simple and inexpensive tool for pain alleviating in preterm stable neonates.

  10. Teacher-Child Interaction Training: A Pilot Study With Random Assignment.

    Science.gov (United States)

    Fernandez, Melanie A; Adelstein, Jonathan S; Miller, Samantha P; Areizaga, Margaret J; Gold, Dylann C; Sanchez, Amanda L; Rothschild, Sara A; Hirsch, Emily; Gudiño, Omar G

    2015-07-01

    Teacher-Child Interaction Training (TCIT), adapted from Parent-Child Interaction Therapy (PCIT), is a classroom-based program designed to provide teachers with behavior management skills that foster positive teacher-student relationships and to improve student behavior by creating a more constructive classroom environment. The purpose of this pilot study was to evaluate TCIT in more classrooms than previously reported in the literature, with older children than previously reported, using random assignment of classrooms to TCIT or to a no-TCIT control condition and conducting all but two sessions within the classroom to enhance feasibility. Participants included 11 kindergarten and first grade classroom teachers and their 118 students from three urban, public schools in Manhattan, with five classrooms randomly assigned to receive TCIT and six to the no-TCIT control condition. Observations of teacher skill acquisition were conducted before, during, and after TCIT for all 11 teachers, and teacher reports of student behavior were obtained at these same time points. Teacher satisfaction with TCIT was assessed following training. Results suggested that after receiving TCIT, teachers increased rates of positive attention to students' appropriate behavior, decreased rates of negative attention to misbehavior, reported significantly less distress related to student disruptive behavior, and reported high satisfaction with the training program. Our study supports the growing evidence-base suggesting that TCIT is a promising approach for training teachers in positive behavior management strategies and for improving student disruptive behavior in the classroom. Copyright © 2015. Published by Elsevier Ltd.

  11. A randomized pilot trial of a full subsidy vs. a partial subsidy for obesity treatment.

    Science.gov (United States)

    Tsai, Adam G; Felton, Sue; Hill, James O; Atherly, Adam J

    2012-09-01

    Intensive obesity treatment is mandated by federal health care reform but is costly. A partial subsidy for obesity treatment could lower the cost of treatment, without reducing its efficacy. This study sought to test whether a partial subsidy for obesity treatment would be feasible, as compared to a fully subsidized intervention. The study was a pilot randomized trial. Participants (n = 50) were primary care patients with obesity and at least one comorbid condition (diabetes, hypertension, dyslipidemia, or obstructive sleep apnea). Each participant received eight weight loss counseling visits as well as portion-controlled foods for weight loss. Participants were randomized to full subsidy or partial subsidy (2 vs. 1 meal per day provided). The primary outcome was weight change after 4 months. Secondary outcomes included changes in blood pressure, waist circumference, and health-related quality of life. Participants in the full and partial subsidy groups lost 5.9 and 5.3 kg, equivalent to 5.3% and 5.1% of initial weight, respectively (P = 0.71). Changes in secondary outcomes were similar in the two groups. A partial subsidy was feasible and induced a clinically similar amount of weight loss, compared to a full subsidy. Large-scale testing of economic incentives for weight control is merited given the federal mandate to offer weight loss counseling to obese patients.

  12. Interpersonal psychotherapy versus brief supportive therapy for depressed infertile women: first pilot randomized controlled trial.

    Science.gov (United States)

    Koszycki, Diana; Bisserbe, Jean-Claude; Blier, Pierre; Bradwejn, Jacques; Markowitz, John

    2012-06-01

    Infertility is strongly associated with depression, yet treatment research for depressed infertile women is sparse. This study tested for the first time the feasibility and preliminary efficacy of interpersonal psychotherapy (IPT), the evidence-based antidepressant intervention with the greatest peripartum research support, as treatment for depressed women facing fertility problems. Patients who met DSM-IV criteria for major depressive disorder of at least moderate severity were randomized to either 12 sessions of IPT (n = 15) or brief supportive psychotherapy (BSP; n = 16), our control intervention. Eighty percent of IPT and 63 % of BSP patients completed the 12 sessions of therapy. Patients in both treatments improved. IPT produced a greater response rate than BSP, with more than two-thirds of women achieving a >50 % reduction in scores on the Montgomery-Åsberg Depression Rating Scale (MADRS). IPT also tended to have lower posttreatment scores on the Beck Depression Inventory, Clinical Global Impression-Severity Scale, and anxiety subscale of the Hamilton Depression Rating Scale, with between-group effect sizes ranging from 0.61 to 0.76. Gains persisted at 6-month follow-up. This pilot trial suggests that IPT is a promising treatment for depression in the context of infertility and that it may fare better than a rigorous active control condition. Should subsequent randomized controlled trials support these findings, this will inform clinical practice and take an important step in assuring optimal care for depressed women struggling with infertility.

  13. Energy conservation for fatigue management in multiple sclerosis: a pilot randomized controlled trial.

    Science.gov (United States)

    García Jalón, E Guiomar; Lennon, Sheila; Peoples, Louise; Murphy, Sam; Lowe-Strong, Andrea

    2013-01-01

    To develop and test the feasibility of an energy conservation programme to manage fatigue in multiple sclerosis. A pilot randomized controlled trial. Community setting. People with multiple sclerosis reporting fatigue. An energy conservation programme was compared to a peer support group. Both interventions were delivered in group format with 2-hour sessions once a week for five weeks. Patients' views about the interventions were sought in discussion groups one week post intervention. The primary feasibility outcomes were recruitment and adherence. Other outcome measures were the Fatigue Impact Scale, Fatigue Severity Scale, MS-Impact Scale-29, MS Self-efficacy Scale, Beck's Depression Scale-Fast Screen and Epworth Sleepiness Scale. Outcomes were administered at baseline, post intervention, 6-week and 3-month follow-up. Almost 30% of the people approached to take part in the study did not commit to participation because of transport/time issues. Twenty-three patients took part in the study. Three patients dropped out, one reporting adverse effects. A power calculation indicated that a sample of 56 (28 per group) would be required for a main randomized controlled trial. Patients valued peer support and those in the energy conservation group described the programme as useful, but reported difficulties completing some practice activities. An energy conservation programme in the community is feasible and welcomed by people with multiple sclerosis. However, future research needs to consider longer follow-ups and practical issues to improve recruitment rate by accommodating to patients' needs.

  14. Virtual reality for upper extremity rehabilitation in early stroke: a pilot randomized controlled trial.

    Science.gov (United States)

    Yin, Chan Wai; Sien, Ng Yee; Ying, Low Ai; Chung, Stephanie Fook-Chong Man; Tan May Leng, Dawn

    2014-11-01

    To investigate the effect of virtual reality (VR) rehabilitation on upper extremity motor performance of patients with early stroke. Pilot randomized controlled trial. Rehabilitation wards. Twenty three adults with stroke (mean age (SD) = 58.35 (13.45) years and mean time since stroke (SD) = 16.30 (7.44) days). Participants were randomly assigned to VR group (n=11) or control group (n=12). VR group received nine 30 minutes upper extremity VR therapy in standing (five weekdays in two weeks) plus conventional therapy, which included physical and occupational therapy. Control group received only conventional therapy, which was comparable to total training time received by VR group (mean training hours (SD):VR = 17.07 (2.86); control = 15.50 (2.79)). The main outcome measure was the Fugl-Meyer Assessment (FMA). Secondary outcomes included Action Research Arm Test, Motor Activity Log and Functional Independence Measure. Results were taken at baseline, post intervention and 1-month post intervention. Participants' feedback and adverse effects were recorded. All participants improved in FMA scores (mean change (SD) = 11.65 (8.56), Pstroke. © The Author(s) 2014.

  15. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    Science.gov (United States)

    Acarturk, Ceren; Konuk, Emre; Cetinkaya, Mustafa; Senay, Ibrahim; Sijbrandij, Marit; Cuijpers, Pim; Aker, Tamer

    2015-01-01

    Background The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating PTSD symptoms in a refugee camp population. Objective Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15) or wait-list control (n=14). The main outcome measures were Impact of Event Scale-Revised (IES-R) and Beck Depression Inventory (BDI-II) at posttreatment and 4-week follow-up. Results Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64). The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92). Conclusion The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost-) effectiveness of EMDR in similar populations are needed. PMID:25989952

  16. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ceren Acarturk

    2015-05-01

    Full Text Available Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD. Eye movement desensitization and reprocessing (EMDR is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT has been published on treating PTSD symptoms in a refugee camp population. Objective: Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method: Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15 or wait-list control (n=14. The main outcome measures were Impact of Event Scale-Revised (IES-R and Beck Depression Inventory (BDI-II at posttreatment and 4-week follow-up. Results: Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64. The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92. Conclusion: The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost- effectiveness of EMDR in similar populations are needed.

  17. Enhancing physical activity and reducing obesity through smartcare and financial incentives: A pilot randomized trial.

    Science.gov (United States)

    Shin, Dong Wook; Yun, Jae Moon; Shin, Jung-Hyun; Kwon, Hyuktae; Min, Hye Yeon; Joh, Hee-Kyung; Chung, Won Joo; Park, Jin Ho; Jung, Kee-Taig; Cho, BeLong

    2017-02-01

    A pilot randomized trial assessed the feasibility and effectiveness of an intervention combining Smartcare (activity tracker with a smartphone application) and financial incentives. A three-arm, open-label randomized controlled trial design involving traditional education, Smartcare, and Smartcare with financial incentives was involved in this study. The latter group received financial incentives depending on the achievement of daily physical activity goals (process incentive) and weight loss targets (outcome incentive). Male university students (N = 105) with body mass index of ≥27 were enrolled. The average weight loss in the traditional education, Smartcare, and Smartcare with financial incentives groups was -0.4, -1.1, and -3.1 kg, respectively, with significantly greater weight loss in the third group (both Ps incentives groups (odds ratio for the Smartcare with financial incentive vs. Smartcare = 7.27, 95% confidence interval: 1.45-36.47). Levels of physical activity were significantly higher in this group. The addition of financial incentives to Smartcare was effective in increasing physical activity and reducing obesity. © 2017 The Obesity Society.

  18. Dynamic splinting after treatment with botulinum toxin type-A: a randomized controlled pilot study.

    Science.gov (United States)

    Lai, Jenny M; Francisco, Gerard E; Willis, F Buck

    2009-02-01

    Over 1.5 million Americans are diagnosed with a stroke each year, and excessive flexion or extension (hypertonia) of upper extremity joints are common secondary conditions. The purpose of this study was to compare the efficacy of botulinum toxin type-A and manual therapy, with the adjunct treatment of dynamic splinting on range of motion, spasticity, and elbow flexor hypertonia, in a randomized trial. Thirty-six subjects were recruited for this pilot study and all exhibited hypertonia in elbow flexion. Six patients were excluded due to noncompliance. Testing was done with pre/post active range of motion in elbow extension, and the Modified Ashworth Scale (extension) for spasticity. All patients received the current standard of care: botulinum toxin type-A injections and manual therapy. Experimental patients were randomly assigned adjunct treatment with Elbow Extension Dynasplint. Thirty patients completed the study (mean age [SD] 52+/-17 years). The percentage of change in active range of motion in elbow extension was greater for the experimental than for control subjects (33.5% vs. 18.7%). The Modified Ashworth Scale (extension) scores showed comparable changes of a mean 9.3% improvement for experimental versus 8.6% for the control subjects. This study confirmed the efficacy of botulinum toxin type-A in tone management and occupational therapy in contracture reduction. It also showed the value of dynamic splinting in maintaining gains in range of motion.

  19. The Effects of Experimentally Manipulated Social Status on Acute Eating Behavior: A Randomized, Crossover Pilot Study

    Science.gov (United States)

    Cardel, MI; Johnson, SL; Beck, J; Dhurandhar, E; Keita, AD; Tomczik, AC; Pavela, G; Huo, T; Janicke, DM; Muller, K; Piff, PK; Peters, JC; Hill, JO; Allison, DB

    2016-01-01

    Both subjective and objectively measured social status has been associated with multiple health outcomes, including weight status, but the mechanism for this relationship remains unclear. Experimental studies may help identify the causal mechanisms underlying low social standing as a pathway for obesity. Our objective was to investigate the effects of experimentally manipulated social status on ad libitum acute dietary intakes and stress-related outcomes as potential mechanisms relating social status and weight. This was a pilot feasibility, randomized, crossover study in Hispanic young adults (n=9; age 19–25; 67% female; BMI ≥18.5 and ≤30 kg/m2). At visit 1, participants consumed a standardized breakfast and were randomized to a high social status position (HIGH) or low social status position (LOW) in a rigged game of Monopoly™. The rules for the game differed substantially in terms of degree of ‘privilege’ depending on randomization to HIGH or LOW. Following Monopoly™, participants were given an ad libitum buffet meal and energy intakes (kcal) were estimated by pre- and post-weighing foods consumed. Stress-related markers were measured at baseline, after the game of Monopoly™, and after lunch. Visit 2 used the same standardized protocol; however, participants were exposed to the opposite social status condition. When compared to HIGH, participants in LOW consumed 130 more calories (p=0.07) and a significantly higher proportion of their daily calorie needs in the ad libitum buffet meal (39% in LOW versus 31% in HIGH; p=0.04). In LOW, participants reported decreased feelings of pride and powerfulness following Monopoly™ (p=0.05) and after their lunch meal (p=0.08). Relative to HIGH, participants in LOW demonstrated higher heart rates following Monopoly™ (p=0.06), but this relationship was not significant once lunch was consumed (p=0.31). Our pilot data suggest a possible causal relationship between experimentally manipulated low social status

  20. Inversion therapy in patients with pure single level lumbar discogenic disease: a pilot randomized trial.

    Science.gov (United States)

    Prasad, K S Manjunath; Gregson, Barbara A; Hargreaves, Gerard; Byrnes, Tiernan; Winburn, Philip; Mendelow, A David

    2012-01-01

    Backache and sciatica due to protuberant disc disease is a major cause of lost working days and health expenditure. Surgery is a well-established option in the management flowchart. There is no strong evidence proving that traction for sciatica is effective. We report a pilot prospective randomized controlled trial comparing inversion traction and physiotherapy with standard physiotherapy alone in patients awaiting lumbar disc surgery. This study sought to study the feasibility of a randomized controlled trial on the effect of inversion therapy in patients with single level lumbar discogenic disease, who had been listed for surgery. This was a single centre prospective randomized controlled trial undertaken at the Regional Neurosciences Centre, Newcastle Upon Tyne, UK. It was a prospective randomized controlled trial where patients awaiting surgery for pure lumbar discogenic disease within the ambit of the prestated inclusion/exclusion criteria were allocated to either physiotherapy or physiotherapy and intermittent traction with an inversion device. Post-treatment assessment made by blinded observers at 6 weeks for various outcome measures included the Roland Morris Disability Questionnaire (RMDQ) Score, Short Form 36 (SF 36), Oswestry Disability Index (ODI), Visual Analogue Pain Score (VAS), magnetic resonance imaging (MRI) appearance and the need for surgery. Avoidance of surgery was considered a treatment success. Twenty-six patients were enrolled and 24 were randomized [13 to inversion + physiotherapy and 11 to physiotherapy alone (control)]. Surgery was avoided in 10 patients (76.9%) in the inversion group, whereas it was averted in only two patients (22.2%) in the control group. Cancellation of the proposed operation was a clinical decision based on the same criteria by which the patient was listed for surgery initially. There were no significant differences in the RMDQ, SF 36, ODI, VAS or MRI results between the two groups. Intermittent traction with an

  1. A randomized controlled pilot study of motivational interviewing for patients with psychotic and drug use disorders.

    Science.gov (United States)

    Martino, Steve; Carroll, Kathleen M; Nich, Charla; Rounsaville, Bruce J

    2006-10-01

    This pilot study examined the efficacy of a two-session motivational interview adapted for dually diagnosed psychotic and drug-related disordered patients (DDMI) in comparison to a two-session standard psychiatric interview (SI). The study used a randomized controlled trial design. Participants received either DDMI or SI and were assessed at baseline, 4-, 8- and 12-week follow-up points. The principal analysis for examination of treatment effects across time was a random effects regression model. Both DDMI and SI interviews served as pre-admission intake interventions to an ambulatory specialty dual diagnosis intensive out-patient and partial hospital program. Forty-four treatment-seeking participants (DDMI = 24; SI = 20) who had co-occurring psychotic and drug-related disorders were assigned randomly to the treatment conditions. Measurements Primary outcomes were days of primary drug use, secondary drug use, alcohol use and psychotropic medication adherence, proportion of participants admitted into the program and days of attendance. DDMI and SI resulted in improved treatment outcomes, but there were no main effects for the sample as a whole. Separate examination of primary cocaine and primary marijuana using subsamples, however, suggested that DDMI resulted in significantly better primary drug treatment outcomes for the cocaine-using group, whereas SI resulted in significantly better primary drug treatment outcomes for the marijuana-using group. These findings indicate that MI may not work equally well for all types of psychotic disordered dually diagnosed patients and that alternative approaches may be as effective in fostering improved substance use treatment outcomes for subgroups of these individuals.

  2. Managing mobility outcomes in vulnerable seniors ( MMOVeS): a randomized controlled pilot study.

    Science.gov (United States)

    Figueiredo, Sabrina; Morais, Jose A; Mayo, Nancy

    2017-12-01

    To estimate feasibility and potential for efficacy of an individualized, exercise-focused, self-management program (i.e. Managing Mobility Outcomes In Vulnerable Seniors ( MMOVeS)), in comparison to exercise information in improving mobility after six months among seniors recently discharged from hospital. Randomized pilot study. Two McGill University-teaching hospitals. Community dwelling seniors, aged 70 years and older, recently discharged from either participating hospitals. The physiotherapy-facilitated intervention consisted of (1) evaluation of mobility capacity, (2) setting short- and long-term goals, (3) delineation of an exercise treatment plan, (4) an educational booklet to enhance mobility self-management skills, and (5) six monthly telephone calls. Control group received a booklet with information on exercises targeting mobility limitations in seniors. Mobility, pain, and health status were assessed at baseline and at six months using multiple indicators drawn from Disabilities of the Arm, Shoulder, and Hand (DASH) Score, Lower Extremity Functional Scale (LEFS) and Short-Form (SF)-36. In all, 26 people were randomized to the intervention (mean age: 81 ± 8; 39% women), and 23 were randomized to the control (mean age: 79 ± 7; 33% women). The odds ratio for the mobility outcomes combined was 3.08 and the 95% confidence interval excluded 1 (1.65-5.77). The odds ratio for pain and health perception favored the MMOVeS group, but the 95% confidence interval included the null value. This feasibility study highlights the potential for efficacy of an individualized, exercise-focused, self-management program in comparison to exercise information in improving mobility outcome for seniors. Furthermore, a home-program combining self-management skills and exercise taught with minimal supervision prove to be feasible. Finally, data from this study can be used to estimate sample size for a confirmatory trial.

  3. Coadministration of lorcaserin and phentermine for weight management: A 12-week, randomized, pilot safety study.

    Science.gov (United States)

    Smith, Steven R; Garvey, W Timothy; Greenway, Frank L; Zhou, Sharon; Fain, Randi; Pilson, Robert; Fujioka, Ken; Aronne, Louis J

    2017-05-01

    To assess the short-term tolerability of lorcaserin alone or with two dose regimens of phentermine. This was a 12-week, randomized, double-blind, pilot safety study of N = 238 nondiabetic patients with obesity or overweight with ≥1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting ≥ 1 of 9 potentially serotonergic adverse events (AEs), mean weight loss (WL), and ≥5% WL are reported. N = 238 were randomized, and N = 235 were treated. N = 94 reported potentially serotonergic AEs: 37.2% LOR BID, 42.3% LOR BID+PHEN QD, and 40.5% LOR BID+PHEN BID. AEs leading to discontinuation were reported approximately twice as often in the LOR BID+PHEN BID group versus the LOR BID group. Mean WL was 3.5 kg/3.3%, 7.0 kg/6.7%, and 7.6 kg/7.2% for LOR BID, LOR BID+PHEN QD, and LOR BID+PHEN BID, respectively. At least 5% WL was achieved by 28.2% LOR BID, 59.0% LOR BID+PHEN QD (P = 0.0002 vs. LOR BID), and 70.9% LOR BID+PHEN BID (P lorcaserin enhanced short-term weight loss but did not increase incidence of potentially serotonergic AEs; however, phentermine twice daily increased discontinuation compared to both lorcaserin alone and lorcaserin plus phentermine once daily. © 2017 The Authors. Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

  4. Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Samuel Oliveira de Afonseca

    Full Text Available CONTEXT AND OBJECTIVEOxaliplatin is one of the chemotherapy regimens most used for treating colorectal cancer. One of the main limitations to its use is induction of peripheral neuropathy. Previous studies have shown that vitamin E can reduce the incidence of peripheral neuropathy by 50%. This study aimed to assess the effectiveness of vitamin E for prevention of oxaliplatin-induced peripheral neuropathy.DESIGN AND SETTINGProspective, phase II, randomized pilot study developed at a university hospital in the Greater ABC region.METHODSPatients were randomized five days before starting oxaliplatin treatment, to receive either vitamin E or placebo until the end of the chemotherapy regimen. The outcome was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE, version 3, and specific gradation scales for oxaliplatin-induced peripheral neuropathy. Patients with colorectal and gastric cancer who had been scheduled to receive oxaliplatin-based chemotherapy were included. Both groups received calcium and magnesium supplementation before and after oxaliplatin infusions.RESULTSEighteen patients were randomized to the vitamin E group and 16 to the placebo group. Cumulative incidence of 83% with peripheral neuropathy grades 1/2 was observed in the vitamin E group, versus 68% in the placebo group (P = 0.45. A trend towards more diarrhea was observed among patients who received vitamin E (55.6% vs. 18.8%; P = 0.06. There were no other significant differences in toxicity between the groups.CONCLUSIONSNo significant decrease in the incidence of acute oxaliplatin-induced peripheral neuropathy was demonstrated through vitamin E use.CLINICAL TRIAL REGISTRATIONNCT01523574.

  5. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study.

    Directory of Open Access Journals (Sweden)

    Martina Kollmann

    Full Text Available Early bonding by skin-to-skin contact (SSC has been demonstrated to be beneficial for mothers and newborns following vaginal delivery. The aim of this study was to investigate the impact of intraoperative bonding (early SSC after cesarean section on neonatal adaptation, maternal pain and stress response.This prospective, randomized-controlled pilot study was performed at a single academic tertiary hospital (Department of Obstetrics and Gynecology, Medical University of Graz, Austria between September 2013 and January 2014. Women were randomly assigned to intraoperative ("early" SCC (n = 17 versus postoperative ("late" SCC (n = 18. Main variables investigated were neonatal transition (Apgar score, arterial oxygen saturation, heart rate and temperature, maternal pain perception and both maternal and neonatal stress response by measuring the stress biomarkers salivary free cortisol and salivary alpha amylase.There was no evidence for differences in parameters reflecting neonatal transition or stress response between the 'Early SSC Group' and the 'Late SSC Group'. Maternal salivary cortisol and alpha-amylase levels as well as maternal wellbeing and pain did not differ between the groups. However, the rise of maternal salivary alpha-amylase directly after delivery was higher in the 'Early SSC Group' compared to the 'Late SSC Group' (p = 0.004.This study did not reveal significant risks for the newborn in terms of neonatal transition when early SSC is applied in the operating room. Maternal condition and stress marker levels did not differ either, although the rise of maternal salivary alpha-amylase directly after delivery was higher in the 'Early SSC Group' compared to the 'Late SSC Group', which may indicate a stressor sign due to intensive activation of the sympathetic-adreno-medullary-system. This needs to be further evaluated in a larger prospective randomized trial.ClinicalTrials.gov NCT01894880.

  6. Oxytocin for male subjects with autism spectrum disorder and comorbid intellectual disabilities: A randomized pilot study

    Directory of Open Access Journals (Sweden)

    Toshio eMunesue

    2016-01-01

    Full Text Available Approximately half of autism spectrum disorder (ASD individual suffer from comorbid intellectual disabilities (ID. Oxytocin (OXT receptors are highly expressed in temporal lobe structures and are likely to play a modulatory role in excitatory/inhibitory balance, at least based on animal model findings. Thus, it is feasible that in the highly representative group of Kanner type ASD subjects OXT could have a beneficial effect on social communication and social interaction. The aim of this pilot study was to investigate the feasibility and adverse events, such as epilepsy, of the long-term administration of intranasal OXT for adolescent and adult ASD subjects with ID because such patients frequently have seizures. We also addressed the question on how to scale the OXT effects to the core symptoms of social deficits because of the relative difficulty in obtaining objective measurements. Twenty-nine males (aged 15-40 years old participated in a randomized, double-blind, placebo-controlled crossover study (each for 8 weeks with OXT (16 international units per day. Except for seizures experienced by one participant, other serious adverse events did not occur. The primary and secondary outcomes measured using the Childhood Autism Rating Scale and several standard scales, respectively, revealed no difference between the OXT and placebo groups. Instead, in an exploratory analysis, the social interactions observed in the play sessions or in daily-life were significantly more frequent in the initial half period in the OXT-first arm of the crossover trial. There were also significant correlations between the plasma OXT concentration and subscale scores for irritability on the Aberrant Behavior Checklist. In conclusion, this pilot study demonstrates that long-term administration of intranasal OXT is tolerable in a representative cohort of ASD individuals with ID and suggests that future multicenter trials of OXT are warranted and should include measurements

  7. Can repetitive magnetic stimulation improve cognition in schizophrenia? Pilot data from a randomized controlled trial.

    Science.gov (United States)

    Barr, Mera S; Farzan, Faranak; Rajji, Tarek K; Voineskos, Aristotle N; Blumberger, Daniel M; Arenovich, Tamara; Fitzgerald, Paul B; Daskalakis, Zafiris J

    2013-03-15

    Working memory represents a core cognitive domain that is impaired in schizophrenia for which there are currently no satisfactory treatments. Repetitive transcranial magnetic stimulation (rTMS) targeted over the dorsolateral prefrontal cortex has been shown to modulate neurophysiological mechanisms linked to working memory in schizophrenia and improves working memory performance in healthy subjects and might therefore represent a treatment modality for schizophrenia patients. The objectives were to evaluate the effects of rTMS on working memory performance in schizophrenia patients and evaluate whether rTMS normalizes performance to healthy subject levels. In a 4-week randomized double-blind sham-controlled pilot study design, 27 medicated schizophrenia patients were tested at the Centre for Addiction and Mental Health (a university teaching hospital that provides psychiatric care to a large urban catchment area and serves as a tertiary referral center for the province of Ontario). Patients performed the verbal working memory n-back task before and after rTMS magnetic resonance image targeted bilaterally sequentially to left and right dorsolateral prefrontal cortex 750 pulses/side at 20 Hz for 20 treatments. The main outcome measure was mean magnitude of change in the n-back accuracy for target responses with active (n = 13) or sham (n = 12) rTMS treatment course. The rTMS significantly improved 3-back accuracy for targets compared with placebo sham (Cohen's d = .92). The improvement in 3-back accuracy was also found to be at a level comparable to healthy subjects. These pilot data suggest that bilateral rTMS might be a novel, efficacious, and safe treatment for working memory deficits in patients with schizophrenia. Copyright © 2013 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

  8. Randomized evaluation of live attenuated vs. inactivated influenza vaccines in schools (RELATIVES) pilot study: a cluster randomized trial.

    Science.gov (United States)

    Kwong, Jeffrey C; Pereira, Jennifer A; Quach, Susan; Pellizzari, Rosana; Dusome, Edwina; Russell, Margaret L; Hamid, Jemila S; Feinberg, Yael; Winter, Anne-Luise; Gubbay, Jonathan B; Sirtonski, Brittany; Moher, Deanna; Sider, Doug; Finkelstein, Michael; Loeb, Mark

    2015-01-15

    School-based influenza immunization can effectively address accessibility barriers, but injected inactivated influenza vaccines (IIV) may not be acceptable to some children and parents in school settings. To better understand the feasibility of offering intranasal live attenuated influenza vaccines (LAIV) through schools, we assessed uptake, stakeholder acceptability, and cost of school-based delivery of LAIV compared to IIV. We piloted an open-label cluster randomized trial involving 10 elementary schools in Peterborough, Ontario during the 2013-2014 influenza vaccination campaign. Schools were randomized to having students receive IIV or LAIV at publicly-funded school-based clinics organized by the local public health department. We measured the percentage of students vaccinated with at least one dose of influenza vaccine at school. Stakeholder acceptability was evaluated through a questionnaire of parents and interviews of public health department personnel and school principals. We compared the costs per dose of vaccine administered, including staff time and costs of vaccines and supplies. Single-dose influenza vaccine uptake was higher for the five schools offering LAIV than for the five offering IIV (19.3% vs. 12.2%, p=0.02). Interviews with nine school principals and five public health department personnel suggested that the clinics ran smoothly with little disruption to school routines, and that LAIV was associated with increased efficiency and calmer children. All interviewees cited unfamiliarity with LAIV and the study recruitment package length as potential reasons for low uptake. The cost per vaccine dose administered was $38.67 for IIV and $43.50 for LAIV. Use of LAIV in school-based clinics was associated with increased vaccine uptake and the perception among immunizing staff of reduced child anxiety, but also slightly higher vaccine administration costs, compared to IIV. However, uptake was low for both groups. More effective strategies to promote

  9. Meals Enhancing Nutrition After Discharge: Findings from a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Buys, David R; Campbell, Anthony D; Godfryd, Alice; Flood, Kellie; Kitchin, Elizabeth; Kilgore, Meredith L; Allocca, Sally; Locher, Julie L

    2017-04-01

    After older adults experience episodes of poor health or are hospitalized, they may not return to premorbid or prehospitalization eating behaviors. Furthermore, poor nutrition increases hospital readmission risk, but evidence-based interventions addressing these risks are limited. This pilot study's objective was to evaluate the feasibility of conducting a randomized controlled trial assessing a post-discharge home-delivered meal program's impact on older adults' nutritional intake and hospital readmissions and to assess patient acceptability and satisfaction with the program. The aims of the study were to evaluate successful recruitment, randomization, and retention of at least 80% of the 24 participants sought; to compare the outcomes of hospital readmission and total daily caloric intake between participants in the intervention and control groups; and to assess patient acceptability and satisfaction with the program. This study used a two-arm randomized controlled trial design, and baseline data were collected at enrollment; three 24-hour food recalls were collected during the intervention period; and health services utilization and intervention satisfaction was evaluated 45 days post-discharge. Twenty-four patients from the University of Alabama at Birmingham Hospital's Acute Care for Elders (ACE) Unit were enrolled from May 2014 to June 2015. They were 65 years or older; at risk for malnutrition; cognitively intact; able to communicate; discharged to a place where the patient or family was responsible for preparing meals; and diagnosed with congestive heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, or pneumonia. Final analysis included 21 participants. The intervention group received 10 days of home-delivered meals and nutrition education; the control group received usual care and nutrition education. The main outcome was intervention feasibility, measured by recruitment and retention goals. Hospital readmissions, caloric

  10. A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Adolescents With Body Dysmorphic Disorder.

    Science.gov (United States)

    Mataix-Cols, David; Fernández de la Cruz, Lorena; Isomura, Kayoko; Anson, Martin; Turner, Cynthia; Monzani, Benedetta; Cadman, Jacinda; Bowyer, Laura; Heyman, Isobel; Veale, David; Krebs, Georgina

    2015-11-01

    Body dysmorphic disorder (BDD) typically starts in adolescence, but evidence-based treatments are yet to be developed and formally evaluated in this age group. We designed an age-appropriate cognitive-behavioral therapy (CBT) protocol for adolescents with BDD and evaluated its acceptability and efficacy in a pilot randomized controlled trial. Thirty adolescents aged 12 to 18 years (mean = 16.0, SD = 1.7) with a primary diagnosis of BDD, together with their families, were randomly assigned to 14 sessions of CBT delivered over 4 months or a control condition of equivalent duration, consisting of written psycho-education materials and weekly telephone monitoring. Blinded evaluators assessed participants at baseline, midtreatment, posttreatment, and at 2-month follow-up. The primary outcome measure was the Yale-Brown Obsessive-Compulsive Scale Modified for BDD, Adolescent Version (mean baseline score = 37.13, SD = 4.98, range = 24-43). The CBT group showed a significantly greater improvement than the control group, both at posttreatment (time × group interaction coefficient [95% CI] = -11.26 [-17.22 to -5.31]; p = .000) and at 2-month follow-up (time × group interaction coefficient [95% CI] = -9.62 [-15.74 to -3.51]; p = .002). Six participants (40%) in the CBT group and 1 participant (6.7%) in the control condition were classified as responders at both time points (χ(2) = 4.658, p = .031). Improvements were also seen on secondary measures, including insight, depression, and quality of life at posttreatment. Both patients and their families deemed the treatment as highly acceptable. Developmentally tailored CBT is a promising intervention for young people with BDD, although there is significant room for improvement. Further clinical trials incorporating lessons learned in this pilot study and comparing CBT and pharmacological therapies, as well as their combination, are warranted. Cognitive-Behaviour Therapy for Adolescents With Body Dysmorphic Disorder; http

  11. A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women with Pure Stress Urinary Incontinence.

    Directory of Open Access Journals (Sweden)

    Huanfang Xu

    Full Text Available Acupuncture is a potential conservative therapy for women with stress urinary incontinence (SUI. There is limited evidence to support its effectiveness due to the poor quality of existing studies.We performed a pilot randomized, controlled trial to preliminarily assess the efficacy of electroacupuncture (EA in women with pure SUI. A total of 80 women with pure SUI were randomly assigned to receive EA with deep needling at BL33 and BL35 (n = 40 or sham EA with non-penetrating needling at sham acupoints (n = 40 three sessions per week for 6 weeks. The women were followed for 24 weeks. The primary outcome was the change from baseline in the amount of urine leakage measured by a 1-hour pad test after 6 weeks. The secondary outcomes included the 72-hour incontinence episode frequency (IEF, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF score, and patient self-evaluation of therapeutic effect. Adverse events (AEs were monitored throughout the trial.The median decrease from baseline of urine leakage measured by the 1-hour pad test was 2.5 g [interquartile range (IQR: 1.80-14.6 in the EA group, which was greater than the median decrease of 0.05 g (IQR: -2.80-+0.50 in the sham EA group after 6 weeks (p<0.01. The differences between groups in the decrease from baseline of 72-hour IEF became statistically significant at week 30 with a median decrease of 3.25 g (IQR: 1.25-5.69 in the EA group, and a median decrease of 1.00 g (IQR: -0.69-+2.88 in the sham EA group (p = 0.01. The participants in the EA group showed greater decreases in ICIQ-SF score and higher ratings in the help they received from the treatment than those in the sham EA group at weeks 6,18 and 30 (all p<0.05. No obvious AEs were observed in either group.EA may effectively and safely relieve urinary incontinence symptoms and improve quality of life in women with pure SUI. EA demonstrated more than a placebo effect. Since this is a pilot study, results should be

  12. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p yoga intervention and walking control over the course of the study. Conclusion Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing

  13. Water-based exercise for patients with chronic arm lymphedema: a randomized controlled pilot trial.

    Science.gov (United States)

    Johansson, Karin; Hayes, Sandi; Speck, Rebecca M; Schmitz, Kathryn H

    2013-04-01

    The aim of this study was to evaluate the feasibility and effect of a water-based exercise program on lymphedema status and shoulder range of motion among women with breast cancer-related lymphedema. This was a single-blinded, randomized controlled pilot trial. Twenty-nine eligible breast cancer survivors (median, 10 yrs after surgery) with arm lymphedema (median, 21% interlimb difference) were included and randomized into the intervention (n = 15) or control (n = 14) group. Twenty-five participants completed the study. The intervention was at least twice-weekly water-based exercise for 8 wks, initially supervised but performed independently during the study period. Outcomes of interest were feasibility as measured by retention and adherence; lymphedema status as measured by optoelectronic perometry, bioimpedance spectroscopy, and tissue dielectric constant; and shoulder range of motion as measured by goniometer. Four participants were not measured at postintervention and were not included in the analysis (retention). Four participants in the intervention group did not perform the minimum water-based exercise criteria set (adherence). No effect was found on lymphedema status. Compared with the control group, median range of motion change for flexion was 6 (1-10) degrees (P < 0.001) and 6 (0-15.5) degrees (P = 0.07) for external rotation.A clinically relevant increase in the intervention group was found for 36% in flexion (P ≤ 0.05) and 57% in external rotation (P ≤ 0.05) compared with controls. This study shows that water-based exercise is feasible for breast cancer survivors with arm lymphedema and that shoulder range of motion can be improved years after cancer treatment has been completed.

  14. Effect of Vibration on Pain Response to Heel Lance: A Pilot Randomized Control Trial.

    Science.gov (United States)

    McGinnis, Kate; Murray, Eileen; Cherven, Brooke; McCracken, Courtney; Travers, Curtis

    2016-12-01

    Applied mechanical vibration in pediatric and adult populations has been shown to be an effective analgesic for acute and chronic pain, including needle pain. Studies among the neonatal population are lacking. According to the Gate Control Theory, it is expected that applied mechanical vibration will have a summative effect with standard nonpharmacologic pain control strategies, reducing behavioral and physiologic pain responses to heel lancing. To determine the safety and efficacy of mechanical vibration for relief of heel lance pain among neonates. In this parallel design randomized controlled trial, eligible enrolled term or term-corrected neonates (n = 56) in a level IV neonatal intensive care unit were randomized to receive either sucrose and swaddling or sucrose, swaddling, and vibration for heel lance analgesia. Vibration was applied using a handheld battery-powered vibrator (Norco MiniVibrator, Hz = 92) to the lateral aspect of the lower leg along the sural dermatome throughout the heel lance procedure. Neonatal Pain, Agitation, and Sedation Scale (N-PASS) scores, heart rate, and oxygen saturations were collected at defined intervals surrounding heel lancing. Infants in the vibration group (n = 30) had significantly lower N-PASS scores and more stable heart rates during heel stick (P = .006, P = .037) and 2 minutes after heel lance (P = .002, P = .016) than those in the nonvibration group. There were no adverse behavioral or physiologic responses to applied vibration in the sample. Applied mechanical vibration is a safe and effective method for managing heel lance pain. This pilot study suggests that mechanical vibration warrants further exploration as a nonpharmacologic pain management tool among the neonatal population.

  15. Computerized patient reported symptom assessment in radiotherapy: a pilot randomized, controlled trial

    Science.gov (United States)

    Holliday, Emma B.; Nail, Lillian M.; Lyons, Karen S.; Hribar, Michelle R.; Thomas, Charles R.

    2016-01-01

    Purpose Computer-based, patient-reported symptom survey tools have been described for patients undergoing chemotherapy. We hypothesized that patients undergoing radiotherapy might also benefit, so we developed a computer application to acquire symptom ratings from patients and generate summaries for use at point of care office visits and conducted a randomized-controlled pilot trial to test its feasibility. Methods Subjects were randomized prior to beginning radiotherapy. Both control and intervention group subjects completed the computerized symptom assessment, but only for the intervention group were printed symptom summaries made available before each weekly office visit. Metrics compared included the Global Distress Index (GDI), concordance of patient-reported symptoms and symptoms discussed by the physician and numbers of new and/or adjusted symptom management medications prescribed. Results 112 patients completed the study: 54 in the control and 58 in the intervention arms. There were no differences in GDI over time between the control and intervention groups. In the intervention group, more patient-reported symptoms were actually discussed in radiotherapy office visits: 46/202 vs. 19/230. A sensitivity analysis to account for within-subjects correlation yielded 23.2% vs. 10.3% (p=.03). Medications were started or adjusted at 15.4% (43/280) of control visits compared to 20.4% (65/319) of intervention visits (p=.07). Conclusions This computer application is easy to use and makes extensive patient-reported outcome data available at the point of care. Although no differences were seen in symptom trajectory, patients who had printed symptom summaries had improved communication during office visits and a trend towards more active symptom management during radiotherapy. PMID:26471280

  16. Exercise or Social Intervention for Nursing Home Residents with Dementia: A Pilot Randomized, Controlled Trial.

    Science.gov (United States)

    de Souto Barreto, Philipe; Cesari, Matteo; Denormandie, Philippe; Armaingaud, Didier; Vellas, Bruno; Rolland, Yves

    2017-09-01

    To compare the effects of exercise with those of a structured nonphysical intervention on ability to perform activities of daily living (ADLs) and physical and cognitive function of persons with dementia (PWDs) living in nursing homes (NH). Cluster-randomized pilot-controlled trial. Seven French NHs. PWDs living in NHs. NHs were randomized to an exercise group (4 NHs, n = 47) or structured social activity group (3 NHs, n = 50) for a 24-week intervention performed twice per week for 60 minutes per session. The main endpoint was ADL performance (Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease Scale (ADCS-ADL-sev); range 0-54, higher is better); secondary endpoints were overall cognitive function (Mini-Mental State Examination (MMSE)) and performance-based tests of physical function (Short Physical Performance Battery (SPPB), usual gait speed). Ninety-one participants with at least one postbaseline ADL assessment were included in efficacy analysis. Groups differed at baseline in terms of sex, neuropsychiatric symptoms, and nutritional status. Multilevel analysis adjusted for baseline differences between groups found no significant difference between effects of exercise and social activity (group-by-time interaction), with adjusted mean differences at 6 months of 1.9 points for ADCS-ADL-sev and 0.55 points for MMSE favoring social activity and 0.6 points for SPPB and 0.05 m/s favoring exercise. Adverse events did not differ between groups, except that the social activity group had more falls than the exercise group. A larger, longer trial is required to determine whether exercise has greater health benefits than nonphysical interventions for institutionalized PWDs. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  17. Dialectical Behavior Therapy for Adolescents with Bipolar Disorder: Results from a Pilot Randomized Trial

    Science.gov (United States)

    Fersch-Podrat, Rachael K.; Rivera, Maribel; Axelson, David A.; Merranko, John; Yu, Haifeng; Brent, David A.; Birmaher, Boris

    2015-01-01

    Abstract Objective: The purpose of this study was to conduct a pilot randomized trial of dialectical behavior therapy (DBT) versus psychosocial treatment as usual (TAU) for adolescents diagnosed with bipolar disorder (BP). Methods: We recruited participants 12–18 years of age with a primary BP diagnosis (I, II, or operationalized not otherwise specified [NOS] criteria) from a pediatric specialty clinic. Eligible patients were assigned using a 2:1 randomization structure to either DBT (n=14) or psychosocial TAU (n=6). All patients received medication management from a study-affiliated psychiatrist. DBT included 36 sessions (18 individual, 18 family skills training) over 1 year. TAU was an eclectic psychotherapy approach consisting of psychoeducational, supportive, and cognitive behavioral techniques. An independent evaluator, blind to treatment condition, assessed outcomes including affective symptoms, suicidal ideation and behavior, nonsuicidal self-injurious behavior, and emotional dysregulation, quarterly over 1 year. Results: Adolescents receiving DBT attended significantly more therapy sessions over 1 year than did adolescents receiving TAU, possibly reflecting greater engagement and retention; both treatments were rated as highly acceptable by adolescents and parents. As compared with adolescents receiving TAU, adolescents receiving DBT demonstrated significantly less severe depressive symptoms over follow-up, and were nearly three times more likely to demonstrate improvement in suicidal ideation. Models indicate a large effect size, for more weeks being euthymic, over follow-up among adolescents receiving DBT. Although there were no between-group differences in manic symptoms or emotional dysregulation with treatment, adolescents receiving DBT, but not those receiving TAU, evidenced improvement from pre- to posttreatment in both manic symptoms and emotional dysregulation. Conclusions: DBT may offer promise as an adjunct to pharmacotherapy in the treatment

  18. Guided Imagery for Total Knee Replacement: A Randomized, Placebo-Controlled Pilot Study.

    Science.gov (United States)

    Jacobson, Ann F; Umberger, Wendy A; Palmieri, Patrick A; Alexander, Thomas S; Myerscough, Rodney P; Draucker, Claire B; Steudte-Schmiedgen, Susann; Kirschbaum, Clemens

    2016-07-01

    To determine the effect of guided imagery (GI) on functional outcomes of total knee replacement (TKR), explore psychological and neuroimmune mediators, and assess feasibility of study implementation. Investigator-blinded, randomized, placebo-controlled pilot study. Hospital, surgeon's office, participant's home. 82 persons undergoing TKR. Audiorecordings of TKR-specific GI scripts or placebo-control audiorecordings of audiobook segments. Gait velocity and Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function scale. Outcomes for 58 participants (29 receiving GI and 29 controls) were analyzed at 6 months after surgery. The most frequent reason for noncompletion was protocol-driven exclusion at 6 months for having the contralateral knee replaced before the study endpoint (n = 15). With imaging ability as a moderator, gait velocity, but not WOMAC Function score, was significantly improved at 6 months in the GI group. Participants in the GI group, but not the control group, had lower WOMAC Pain scores at 3 weeks after surgery than at baseline. Hair cortisol concentration was significantly lower at 6 months after surgery than at baseline in the GI group but not the control group. GI group participants had lower treatment adherence but greater treatment credibility than the control group. Randomized controlled trials of GI in the TKR population are feasible, but inclusion/exclusion criteria influence attrition. Further studies are needed to elaborate this study's findings, which suggest that guided imagery improves objective, but not patient-reported, outcomes of TKR. Hair cortisol concentration results suggest that engagement in a time-limited guided imagery intervention may contribute to stress reduction even after the intervention is terminated. Further investigation into optimal content and dosing of GI is needed.

  19. An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial

    Directory of Open Access Journals (Sweden)

    Mark W. Vander Weg

    2016-08-01

    Full Text Available Abstract Background Tobacco use remains prevalent among Veterans of military service and those residing in rural areas. Smokers frequently experience tobacco-related issues including risky alcohol use, post-cessation weight gain, and depressive symptoms that may adversely impact their likelihood of quitting and maintaining abstinence. Telephone-based interventions that simultaneously address these issues may help to increase treatment access and improve outcomes. Methods This study was a two-group randomized controlled pilot trial. Participants were randomly assigned to an individually-tailored telephone tobacco intervention combining counseling for tobacco use and related issues including depressive symptoms, risky alcohol use, and weight concerns or to treatment provided through their state tobacco quitline. Selection of pharmacotherapy was based on medical history and a shared decision interview in both groups. Participants included 63 rural Veteran smokers (mean age = 56.8 years; 87 % male; mean number of cigarettes/day = 24.7. The primary outcome was self-reported 7-day point prevalence abstinence at 12 weeks and 6 months. Results Twelve-week quit rates based on an intention-to-treat analysis did not differ significantly by group (Tailored = 39 %; Quitline Referral = 25 %; odds ratio [OR]; 95 % confidence interval [CI] = 1.90; 0.56, 5.57. Six-month quit rates for the Tailored and Quitline Referral conditions were 29 and 28 %, respectively (OR; 95 % CI = 1.05; 0.35, 3.12. Satisfaction with the Tailored tobacco intervention was high. Conclusions Telephone-based treatment that concomitantly addresses other health-related factors that may adversely affect quitting appears to be a promising strategy. Larger studies are needed to determine whether this approach improves cessation outcomes. Trial registration ClinicalTrials.gov identifier number NCT01592695 registered 11 April 2012.

  20. A Group-Based Yoga Therapy Intervention for Urinary Incontinence in Women: A Pilot Randomized Trial

    Science.gov (United States)

    Huang, Alison J.; Jenny, Hillary E.; Chesney, Margaret A.; Schembri, Michael; Subak, Leslee L.

    2015-01-01

    Objective To examine the feasibility, efficacy, and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence. Methods We conducted a pilot randomized trial of ambulatory women aged 40 years and older with stress, urgency, or mixed-type incontinence. Women were randomized to a 6-week yoga therapy program (N=10) consisting of twice weekly group classes and once weekly home practice or a waitlist control group (N=9). All participants also received written pamphlets about standard behavioral self-management strategies for incontinence. Changes in incontinence were assessed by 7-day voiding diaries. Results Mean (±SD) age was 61.4 (±8.2) years, and mean baseline frequency of incontinence was 2.5 (±1.3) episodes/day. After 6 weeks, total incontinence frequency decreased by 66% (1.8 [±0.9] fewer episodes/day) in the yoga therapy versus 13% (0.3 [±1.7] fewer episodes/day) in the control group (P=0.049). Participants in the yoga therapy group also reported an average 85% decrease in stress incontinence frequency (0.7 [±0.8] fewer episodes/day) compared to a 25% increase in controls (0.2 [± 1.1] more episodes/day) (P=0.039). No significant differences in reduction in urgency incontinence were detected between the yoga therapy versus control groups (1.0 [±1.0] versus 0.5 [±0.5] fewer episodes/day, P=0.20). All women starting the yoga therapy program completed at least 90% of group classes and practice sessions. Two participants in each group reported adverse events unrelated to the intervention. Conclusions Findings provide preliminary evidence to support the feasibility, efficacy, and safety of a group-based yoga therapy intervention to improve urinary incontinence in women. PMID:24763156

  1. Cupping for treating neck pain in video display terminal (VDT) users: a randomized controlled pilot trial.

    Science.gov (United States)

    Kim, Tae-Hun; Kang, Jung Won; Kim, Kun Hyung; Lee, Min Hee; Kim, Jung Eun; Kim, Joo-Hee; Lee, Seunghoon; Shin, Mi-Suk; Jung, So-Young; Kim, Ae-Ran; Park, Hyo-Ju; Hong, Kwon Eui

    2012-01-01

    This was a randomized controlled pilot trial to evaluate the effectiveness of cupping therapy for neck pain in video display terminal (VDT) workers. Forty VDT workers with moderate to severe neck pain were recruited from May, 2011 to February, 2012. Participants were randomly allocated into one of the two interventions: 6 sessions of wet and dry cupping or heating pad application. The participants were offered an exercise program to perform during the participation period. A 0 to 100 numeric rating scale (NRS) for neck pain, measure yourself medical outcome profile 2 score (MYMOP2 score), cervical spine range of motion (C-spine ROM), neck disability index (NDI), the EuroQol health index (EQ-5D), short form stress response inventory (SRI-SF) and fatigue severity scale (FSS) were assessed at several points during a 7-week period. Compared with a heating pad, cupping was more effective in improving pain (adjusted NRS difference: -1.29 [95% CI -1.61, -0.97] at 3 weeks (p=0.025) and -1.16 [-1.48, -0.84] at 7 weeks (p=0.005)), neck function (adjusted NDI difference: -0.79 [-1.11, -0.47] at 3 (p=0.0039) and 7 weeks (pcupping and 0.91 [0.86, 0.91] with heating pad treatment, p=0.0054). Four participants reported mild adverse events of cupping. Two weeks of cupping therapy and an exercise program may be effective in reducing pain and improving neck function in VDT workers.

  2. Online suicide risk screening and intervention with college students: a pilot randomized controlled trial.

    Science.gov (United States)

    King, Cheryl A; Eisenberg, Daniel; Zheng, Kai; Czyz, Ewa; Kramer, Anne; Horwitz, Adam; Chermack, Stephen

    2015-06-01

    This pilot randomized controlled trial examined the effect of an online intervention for college students at risk for suicide, Electronic Bridge to Mental Health Services (eBridge), which included personalized feedback and optional online counseling delivered in accordance with motivational interviewing principles. Primary outcomes were readiness to seek information or talk with family and friends about mental health treatment, readiness to seek mental health treatment, and actual treatment linkage. Participants were 76 college students (45 women, 31 men; mean age = 22.9 years, SD = 5.0 years) at a large public university who screened positive for suicide risk, defined by at least 2 of the following: suicidal thoughts, history of suicide attempt, depression, and alcohol abuse. Racial/ethnic self-identifications were primarily Caucasian (n = 54) and Asian (n = 21). Students were randomized to eBridge or the control condition (personalized feedback only, offered in plain report format). Outcomes were measured at 2-month follow-up. Despite relatively modest engagement in online counseling (29% of students posted ≥1 message), students assigned to eBridge reported significantly higher readiness for help-seeking scores, especially readiness to talk to family, talk to friends, and see a mental health professional. Students assigned to eBridge also reported lower stigma levels and were more likely to link to mental health treatment. Findings suggest that offering students personalized feedback and the option of online counseling, using motivational interviewing principles, has a positive impact on students' readiness to consider and engage in mental health treatment. Further research is warranted to determine the robustness of this effect, the mechanism by which improved readiness and treatment linkage occurs, and the longer term impact on student mental health outcomes. (c) 2015 APA, all rights reserved).

  3. A feasibility and pilot randomized controlled trial of the "Timing it Right Stroke Family Support Program".

    Science.gov (United States)

    Cameron, Jill I; Naglie, Gary; Green, Theresa L; Gignac, Monique A M; Bayley, Mark; Huijbregts, Maria; Silver, Frank L; Czerwonka, Anna

    2015-11-01

    Examine feasibility of conducting a randomized controlled trial of the Timing it Right Stroke Family Support Program (TIRSFSP) and collect pilot data. Multi-site mixed method randomized controlled trial. Acute and community care in three Canadian cities. Caregivers were family members or friends providing care to individuals who experienced their first stroke. The TIRSFSP offered in two formats, self-directed by the caregiver or stroke support person-directed over time, were compared to standard care. Caregivers completed baseline and follow-up measures 1, 3 and 6 months post-stroke including Centre for Epidemiological Studies Depression, Positive Affect, Social Support, and Mastery Scales. We completed in-depth qualitative interviews with caregivers and maintained intervention records describing support provided to each caregiver. Thirty-one caregivers received standard care (n=10), self-directed (n=10), or stroke support person-directed (n=11) interventions. We retained 77% of the sample through 6-months. Key areas of support derived from intervention records (n=11) related to caregiver wellbeing, caregiving strategies, patient wellbeing, community re-integration, and service delivery. Compared to standard care, caregivers receiving the stroke support person-directed intervention reported improvements in perceived support (estimate 3.1, P=.04) and mastery (estimate .35, P=.06). Qualitative caregiver interviews (n=19) reflected the complex interaction between caregiver needs, preferences and available options when reporting on level of satisfaction. Preliminary findings suggest the research design is feasible, caregivers' needs are complex, and the support intervention may enhance caregivers' perceived support and mastery. The intervention will be tested further in a large scale trial. © The Author(s) 2014.

  4. Massage therapy and exercise therapy in patients with multiple sclerosis: a randomized controlled pilot study.

    Science.gov (United States)

    Negahban, Hossein; Rezaie, Solmaz; Goharpey, Shahin

    2013-12-01

    The primary aim was to investigate the comparative effects of massage therapy and exercise therapy on patients with multiple sclerosis. The secondary aim was to investigate whether combination of both massage and exercise has an additive effect. Randomized controlled pilot trial with repeated measurements and blinded assessments. Local Multiple Sclerosis Society. A total of 48 patients with multiple sclerosis were randomly assigned to four equal subgroups labelled as massage therapy, exercise therapy, combined massage-exercise therapy and control group. The treatment group received 15 sessions of supervised intervention for five weeks. The massage therapy group received a standard Swedish massage. The exercise therapy group was given a combined set of strength, stretch, endurance and balance exercises. Patients in the massage-exercise therapy received a combined set of massage and exercise treatments. Patients in the control group were asked to continue their standard medical care. Pain, fatigue, spasticity, balance, gait and quality of life were assessed before and after intervention. Massage therapy resulted in significantly larger improvement in pain reduction (mean change 2.75 points, P = 0.001), dynamic balance (mean change, 3.69 seconds, P = 0.009) and walking speed (mean change, 7.84 seconds, P = 0.007) than exercise therapy. Patients involved in the combined massage-exercise therapy showed significantly larger improvement in pain reduction than those in the exercise therapy (mean change, 1.67 points, P = 0.001). Massage therapy could be more effective than exercise therapy. Moreover, the combination of massage and exercise therapy may be a little more effective than exercise therapy alone.

  5. Online Suicide Risk Screening and Intervention with College Students: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    King, Cheryl A.; Eisenberg, Daniel; Zheng, Kai; Czyz, Ewa; Kramer, Anne; Horwitz, Adam; Chermack, Steve

    2015-01-01

    Objective This pilot randomized controlled trial examined the effect of an online intervention for college students at risk for suicide, Electronic Bridge to Mental Health Services (eBridge), which included personalized feedback and optional online counseling delivered in accordance with motivational interviewing principles. Primary outcomes were readiness to seek information or talk with family and friends about mental health treatment, readiness to seek mental health treatment, and actual treatment linkage. Method Participants were 76 college students (45 women, 31 men; mean age = 22.9 years, SD = 5.0 years) at a large public university who screened positive for suicide risk, defined by at least two of the following: suicidal thoughts, history of suicide attempt, depression, and alcohol abuse. Racial/ethnic self-identifications were primarily Caucasian (n = 54) and Asian (n = 21). Students were randomized to eBridge or the control condition (personalized feedback only, offered in plain report format). Outcomes were measured at 2-month follow-up. Results Despite relatively modest engagement in online counseling (29% of students posted ≥ 1 message), students assigned to eBridge reported significantly higher readiness for help-seeking scores, especially readiness to talk to family, talk to friends, and see a mental health professional. Students assigned to eBridge also reported lower stigma levels and were more likely to link to mental health treatment. Conclusions Findings suggest that offering students personalized feedback and the option of online counseling, using motivational interviewing principles, has a positive impact on students’ readiness to consider and engage in mental health treatment. Further research is warranted to determine the robustness of this effect, the mechanism by which improved readiness and treatment linkage occurs, and the longer term impact on student mental health outcomes. PMID:25688811

  6. Smoking cessation intervention after ischemic stroke or transient ischemic attack. A randomized controlled pilot trial.

    Science.gov (United States)

    Brunner Frandsen, Nicole; Sørensen, Margit; Hyldahl, Tanja Kirstine; Henriksen, Rikke Mitzi; Bak, Søren

    2012-04-01

    Smoking cessation is widely recommended for secondary stroke prevention. However, little is known about the efficacy of smoking cessation intervention after stroke or transient ischemic attack (TIA). Ninety-four smokers under age 76, admitted with ischemic stroke or TIA were randomized to minimal smoking cessation intervention or intensive smoking cessation intervention. All patients attended a 30-min individual counseling by the study nurse. Patients randomized to intensive smoking cessation intervention also participated in a 5-session outpatient smoking cessation program by an authorized smoking cessation instructor, a 30-min outpatient visit after 6 weeks, and 5 telephone counseling sessions by the study nurse. Free samples of nicotine replacement therapy were offered as part of the intensive smoking cessation program. Smoking cessation rates at 6 months were determined by self-report and verified by measurement of exhaled carbon monoxide (CO). Fewer patients than expected were recruited, which renders this report a pilot study. The 6-month self-reported smoking cessation rate was 37.8% in the minimal intervention group and 42.9% in the intensive intervention group. Smoking cessation rates verified by exhaled CO levels in the minimal intervention group and the intensive intervention group were 28.9% and 32.7%, respectively. No difference was found between the two groups (χ(2) = 0.16, p = .69). Overall smoking cessation rates were moderate and comparable to the results from other studies. Intensive smoking cessation intervention was not superior to short smoking cessation intervention. Thus, other factors than intensity of smoking cessation intervention might influence the smoking cessation rates after stroke or TIA.

  7. A Pilot Randomized, Controlled Trial of a Wall Climbing Intervention for Gynecologic Cancer Survivors.

    Science.gov (United States)

    Crawford, Jennifer J; Vallance, Jeff K; Holt, Nicholas L; Bell, Gordon J; Steed, Helen; Courneya, Kerry S

    2017-01-01

    To examine the feasibility and preliminary efficacy of an eight-week supervised climbing intervention for gynecologic cancer survivors (GCSs).
. A pilot randomized, controlled trial.
. The Wilson Climbing Center in Edmonton, Alberta, Canada.
. 35 GCSs who had completed cancer therapy.
. GCSs were randomized to an eight-week (16 session) supervised wall climbing intervention (WCI) (n = 24) or usual care (UC) (n = 11).
. Feasibility outcomes included recruitment rate, adherence rate, skill performance, and safety. Preliminary efficacy outcomes were objective health-related and functional fitness assessed before and after the eight-week intervention using the Senior Fitness Test.
. Median adherence to the WCI was 13.5 of 16 sessions. Most GCSs were proficient on 16 of 24 skill assessment items. No serious adverse events were reported. Based on intention-to-treat analyses, the WCI group was superior to the UC group for the 6-minute walk, 30-second chair stand, 30-second arm curls, sit and reach, 8-foot up-and-go, grip strength-right, and grip strength-left assessments.
. The Gynecologic Cancer Survivors Wall Climbing for Total Health (GROWTH) Trial demonstrated that an eight-week supervised WCI was safe, feasible, and improved functional fitness in GCSs. Phase II and III trials are warranted to further establish the safety, feasibility, and efficacy of WCIs in cancer survivors.
. Oncology nurses may consider a climbing wall as an alternative type of physical activity for improving functional fitness in GCSs.

  8. Antiaggressive effect of cyproterone versus haloperidol in Alzheimer's disease: a randomized double-blind pilot study.

    Science.gov (United States)

    Huertas, David; López-Ibor Aliño, Juan J; Molina, Juan D; Chamorro, Lorenzo; Balanza, Juana; Jiménez, María P; Hornillos, Mercedes

    2007-03-01

    Alzheimer's disease (AD) is commonly accompanied by aggressive behavior. In the elderly, effective and safe antiaggressive treatment is lacking. Risks of antipsychotics in this population demand therapeutic alternatives. This randomized, double-blind, pilot trial examined the efficacy and safety of cyproterone in the treatment of agitated AD. The subjects were 27 elderly patients referred to the University Hospital of Guadalajara Psychogeriatric Clinic diagnosed with AD and associated aggressive behavior (mean Staff Observation Aggression Scale [SOAS] score >or=2). Each patient underwent a 15-day washout for psychotropics and then was randomly assigned to receive stable doses of either cyproterone (100 mg/day) or haloperidol (2 mg/day) for 90 days. The primary outcome measure was the SOAS score. This trial was conducted between October 27, 1993, and March 24, 1998. Of the 27 patients, 19 (70.4%) were women, and the mean age was 80.7 years. The trial was completed by 24 (88.9%) of the subjects (13 in the cyproterone group and 11 in the haloperidol group for 90 days). Three patients (11.1%) dropped out, all after adverse effects in the haloperidol group. Baseline aggression level in the sample was mild (mean SOAS score of 4.48 [SD = 2.04]). Efficacy analyses for all intent-to-treat patients showed that 9 (69.2%) in the cyproterone group achieved complete elimination of aggression at endpoint, in contrast to 2 patients (14.2%) in the haloperidol group (p = .012). Ten patients (71.4%) taking haloperidol had adverse events, compared with 4 (30.7%) taking cyproterone (p = .035). Cyproterone showed significantly better efficacy and safety than haloperidol in controlling mild aggression associated with AD. Additional research is needed to confirm if these results can be ratified in a larger study and generalized to patients whose aggression is more severe.

  9. Imagery intelligence from low altitudes: chosen aspects

    Science.gov (United States)

    Walczykowski, P.; Kedzierski, M.

    2017-04-01

    Remote acquisition of information about phenomena and objects from an imagery is the main objective of remote sensing. The ability to realize aims of image intelligence depends on the quality of acquired remote sensing data. The imagery intelligence can be carried out from different altitudes- from satellite level to terrestrial platforms. In this article, authors are focused on chosen aspects of imagery intelligence from low altitudes. Unfortunately the term low altitudes is not precise defined, therefore, for the purpose of this article is assumed that low altitudes, are altitudes in which operate the mini unmanned aerial vehicles (mini UAVs).The quality of imagery acquired determines the level of analysis that can be performed. The imagery quality depends on many factors, such as platforms on which the sensor is mounted, imaging sensors, height from which the data are acquired and object that is investigated. The article will also present the methods for assessing the quality of imagery in terms of detection, identification, description and technical analysis of investigated objects, as well as in terms of the accuracy of their location in the images (targeting).

  10. A pilot randomized controlled trial of cognitive bias modification to reduce fear of breast cancer recurrence.

    Science.gov (United States)

    Lichtenthal, Wendy G; Corner, Geoffrey W; Slivjak, Elizabeth T; Roberts, Kailey E; Li, Yuelin; Breitbart, William; Lacey, Stephanie; Tuman, Malwina; DuHamel, Katherine N; Blinder, Victoria S; Beard, Courtney

    2017-04-15

    The most common, persistent concern among survivors of breast cancer is the fear that their disease will return, yet to the authors' knowledge, few interventions targeting fear of cancer recurrence (FCR) have been developed to date. The current pilot study examined the feasibility, acceptability, and preliminary efficacy of a home-delivered cognitive bias modification intervention to reduce FCR. The intervention, called Attention and Interpretation Modification for Fear of Breast Cancer Recurrence (AIM-FBCR), targeted 2 types of cognitive biases (ie, attention and interpretation biases). A total of 110 survivors of breast cancer were randomized to receive 8 sessions of 1 of 2 versions of AIM-FBCR or a control condition program. Computer-based assessments of cognitive biases and a self-report measure of FCR were administered before the intervention, after the intervention, and 3 months after the intervention. Improvements in health worries (P = .019) and interpretation biases (rates of threat endorsement [Pcancer. Future research should attempt to replicate these findings in a larger-scale trial using a more sophisticated, user-friendly program and additional measures of improvement in more diverse samples. Cancer 2017;123:1424-1433. © 2016 American Cancer Society. © 2017 American Cancer Society.

  11. Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

    Science.gov (United States)

    Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

    2011-01-01

    Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

  12. Mobile application as a prenatal education and engagement tool: A randomized controlled pilot.

    Science.gov (United States)

    Ledford, Christy J W; Canzona, Mollie Rose; Cafferty, Lauren A; Hodge, Joshua A

    2016-04-01

    Research has shown that mobile applications provide a powerful alternative to traditional paper diaries; however, little data exists in comparing apps to the traditional mode of paper as a patient education and engagement tool in the clinical setting. This study was designed to compare the effectiveness of a mobile app versus a spiral-notebook guide throughout prenatal care. This randomized (n=173) controlled pilot was conducted at an East Coast community hospital. Chi-square and repeated-measures analysis of variance was used to test intervention effects in the sample of 127 pregnant mothers who completed their prenatal care in the healthcare system. Patients who were distributed the mobile application used the tool to record information about pregnancy more frequently (p=.04) and developed greater patient activation (p=.02) than patients who were distributed notebooks. No difference was detected on interpersonal clinical communication. A mobile application successfully activated a patient population in which self-management is a critical factor. This study shows that mobile apps can prompt greater use and result in more activated patients. Findings may be translated to other patient populations who receive recurring care for chronic disease. Published by Elsevier Ireland Ltd.

  13. Reducing sexual victimization among adolescent girls: a randomized controlled pilot trial of my voice, my choice.

    Science.gov (United States)

    Rowe, Lorelei Simpson; Jouriles, Ernest N; McDonald, Renee

    2015-05-01

    Despite extensive efforts to develop and implement programs to prevent sexual violence, few programs have empirically-demonstrated efficacy. The primary exceptions are programs that emphasize risk-reduction skills; yet even these programs are not consistently effective. This study seeks to add to the literature by evaluating the effects of My Voice, My Choice (MVMC), a 90-minute assertive resistance training program that emphasizes skill practice in an immersive virtual environment (IVE). We hypothesized that MVMC would reduce male-to-female sexual victimization among adolescent girls over a 3-month follow-up period. We also examined whether these results would generalize to other forms of male-to-female relationship violence and to girls' psychological distress. Eighty-three female students from an urban public high school were randomized to MVMC (n=47) or to a wait-list control condition (n=36); 78 provided data over the 3-month follow-up period. Participants assigned to MVMC were less likely than control participants to report sexual victimization during the follow-up period. Our results also suggest that MVMC reduced risk for psychological victimization and for psychological distress among participants with greater prior victimization at baseline. The promising results of this pilot trial suggest that MVMC may help girls evade male-to-female relationship violence. Copyright © 2014. Published by Elsevier Ltd.

  14. Competence feedback improves CBT competence in trainee therapists: A randomized controlled pilot study.

    Science.gov (United States)

    Weck, Florian; Kaufmann, Yvonne M; Höfling, Volkmar

    2017-07-01

    The development and improvement of therapeutic competencies are central aims in psychotherapy training; however, little is known about which training interventions are suitable for the improvement of competencies. In the current pilot study, the efficacy of feedback regarding therapeutic competencies was investigated in cognitive behavioural therapy (CBT). Totally 19 trainee therapists and 19 patients were allocated randomly to a competence feedback group (CFG) or control group (CG). Two experienced clinicians and feedback providers who were blind to the treatment conditions independently evaluated therapeutic competencies on the Cognitive Therapy Scale at five treatment times (i.e., at Sessions 1, 5, 9, 13, and 17). Whereas CFG and CG included regular supervision, only therapists in the CFG additionally received written qualitative and quantitative feedback regarding their demonstrated competencies in conducting CBT during treatment. We found a significant Time × Group interaction effect (η² = .09), which indicates a larger competence increase in the CFG in comparison to the CG. Competence feedback was demonstrated to be suitable for the improvement of therapeutic competencies in CBT. These findings may have important implications for psychotherapy training, clinical practice, and psychotherapy research. However, further research is necessary to ensure the replicability and generalizability of the findings.

  15. A Randomized Pilot Study of a Phone-Based Mindfulness and Weight Loss Program.

    Science.gov (United States)

    Carpenter, Kelly M; Vickerman, Katrina A; Salmon, Erica E; Javitz, Harold S; Epel, Elissa S; Lovejoy, Jennifer C

    2017-10-06

    This study evaluated the feasibility and efficacy of integrating mindfulness training into a phone-based weight loss program to improve outcomes in those with high levels of emotional eating. Participants were 75 enrollees into an employer-sponsored weight loss program who reported high levels of overeating in response to thoughts and feelings. Seventy-five overweight and obese participants (92% female, 65% Caucasian, aged 26 to 68 years) were randomized to the new mindfulness weight loss program (n = 50) or the standard behavioral weight loss program (n = 25). Both programs consisted of 11 coaching calls with health coaches and registered dietitians with supplemental online materials. Satisfaction, engagement, and percent weight lost did not significantly differ for intervention vs. control at six months. Intervention participants had significantly better scores at six-month follow-up on mindful eating, binge eating, experiential avoidance, and one mindfulness subscale. Exploratory analyses showed that improvements on several measures predicted more weight loss in the intervention group. This pilot study found that integrating mindfulness into a brief phone-based behavioral weight loss program was feasible and acceptable to participants, but did not produce greater weight loss on average, despite hypothesized changes in mindful eating. Only one third of intervention participants reported participating in mindfulness exercises regularly. Mechanisms of change observed within the intervention group suggest that for adults with high levels of emotional eating those who embrace mindful eating and meditation may lose more weight with a mindfulness intervention.

  16. Gait training with a robotic leg brace after stroke: a randomized controlled pilot study.

    Science.gov (United States)

    Stein, Joel; Bishop, Lauri; Stein, Daniel J; Wong, Christopher Kevin

    2014-11-01

    Robot-aided exercise therapy is a promising approach to enhance walking ability in stroke survivors. This study was designed to test a new robotic knee brace for restoring mobility in stroke survivors. Twenty-four ambulatory individuals with chronic hemiparesis after stroke were enrolled in this pilot study. The participants were randomly assigned in equal numbers to either treatment with the experimental device or to a group exercise program and received a total of 18 hrs of their assigned therapy during a 6-wk training period. The primary outcome was gait velocity, as measured with the 10-m walk test. Secondary measures included 6-min walk test, Timed Up and Go test, Five-Times-Sit-to-Stand test, Romberg test, Emory Functional Ambulation Profile, Berg Balance scale, and the California Functional Evaluation 40. Twenty subjects completed the entire protocol and all follow-up visits. No significant differences between the two groups were found for the primary outcome measure at either the completion of training (week 6) or at the 3-mo follow-up (week 19), with inconsistent findings for secondary measures. No within-group changes were seen in the primary outcome measure (10-m walk test) in either group. Within-group improvements were seen in several of the secondary measures for both groups. No complications of robotic therapy were observed. Robotic therapy for ambulatory stroke patients with chronic hemiparesis using a robotic knee brace resulted in only modest functional benefits that were comparable with a group exercise intervention.

  17. Efficacy of increasing physical activity to reduce children's visceral fat: a pilot randomized controlled trial.

    Science.gov (United States)

    Saelens, Brian E; Grow, H Mollie; Stark, Lori J; Seeley, Randy J; Roehrig, Helmut

    2011-04-01

    To examine whether differentially targeting physical activity within the context of pilot family-based pediatric weight control treatment results in differential change in abdominal fat, particularly visceral fat. Twenty-nine overweight children (>85(th) body mass index [BMI] percentile) and at least one participating parent were randomly assigned to one of two family-based behavioral weight management conditions that either targeted 1) primarily dietary change (STANDARD; n = 15) or 2) dietary plus physical activity change (ADDED; n = 14). Differences at post-treatment in overall child weight status (e.g., BMI), whole-body composition (measured by dual x-ray absorptiometry), and abdominal fat (measured by waist circumference and magnetic resonance imaging) were assessed using intent-to-treat analyses, as were post-treatment parent BMI and waist circumference. Child and parent physical activity and dietary behavior changes were also evaluated. Results. At post-treatment, overall child weight status, whole-body composition, and child dietary measures did not differ by condition. Children in the ADDED condition tended to have higher physical activity and lower visceral abdominal fat at post-treatment relative to children in the STANDARD condition. Increasing physical activity may be important to optimize reductions in abdominal fat, especially visceral fat, among overweight children provided with family-based behavioral weight management treatment. ClinicalTrials.gov identifier: NCT00359957.

  18. Alcohol interventions for mandated students: behavioral outcomes from a randomized controlled pilot study.

    Science.gov (United States)

    Logan, Diane E; Kilmer, Jason R; King, Kevin M; Larimer, Mary E

    2015-01-01

    This study investigated the effectiveness of three single-session interventions with high-risk mandated students while considering the influence of motivational interviewing (MI) microskills. This randomized, controlled pilot trial evaluated single-session interventions: Alcohol Skills Training Program (ASTP), Brief Alcohol Screening and Intervention for College Students (BASICS) feedback sessions, and treatment-as-usual Alcohol Diversion Program (ADP) educational groups. Participants were 61 full-time undergraduates at a southern U.S. campus sanctioned to a clinical program following violation of an on-campus alcohol policy (Mage = 19.16 years; 42.6% female). RESULTS revealed a significant effect of time for reductions in estimated blood alcohol concentration (eBAC) and number of weekly drinks but not in alcohol-related consequences. Although ASTP and BASICS participants reported significant decreases in eBAC over time, ADP participant levels did not change (with no intervention effects on quantity or consequences). MI microskills were not related to outcomes. RESULTS from this study suggest equivalent behavioral impacts for the MI-based interventions, although individual differences in outcome trajectories suggest that research is needed to further customize mandated interventions. Given the overall decrease in eBAC following the sanction, the lack of reduction in the ADP condition warrants caution when using education-only interventions.

  19. Mental techniques during manual stretching in spasticity--a pilot randomized controlled trial.

    Science.gov (United States)

    Bovend'Eerdt, Thamar J H; Dawes, Helen; Sackley, Cath; Izadi, Hooshang; Wade, Derick T

    2009-02-01

    To evaluate the feasibility and effects of using motor imagery during therapeutic stretching in individuals with spasticity. Randomized single-blind controlled pilot trial. Chronic day care unit, neurological rehabilitation unit and in the community. Eleven individuals with spasticity in the arm requiring stretching as part of their normal routine. In addition to their normal stretching routine, subjects in the experimental group received motor imagery during their stretches (n = 6). The control group received progressive muscle relaxation during their stretches (n = 5). The dose varied between 8 and 56 sessions over eight weeks. Resistance to passive movement, measured with a torque transducer, passive range of movement, measured with an electro-goniometer, Modified Ashworth Scale (MAS) and level of discomfort during the MAS were assessed at baseline and after eight weeks by an independent assessor. These measures were recorded before and after a stretch intervention on both assessments. Participants, therapists and carers tolerated the techniques well. Compliance was variable and adherence was good. Mixed ANOVA showed no difference over time and no difference between the motor imagery and progressive muscle relaxation group on the primary and secondary outcome measures (P>0.05). It is feasible to use motor imagery during therapeutic stretching. Statistical power was low due to the large variability in the population and the small sample size. Post-hoc sample size calculation suggests that future studies of this subject should include at least 54 participants per group. Further research is warranted.

  20. Changes in Hepatic Venous Pressure Gradient Induced by Physical Exercise in Cirrhosis: Results of a Pilot Randomized Open Clinical Trial

    OpenAIRE

    Mac?as-Rodr?guez, Ricardo U; Ilarraza-Lomel?, Hermes; Ruiz-Marg?in, Astrid; Ponce-de-Le?n-Rosales, Sergio; Vargas-Vor?ckov?, Florencia; Garc?a-Flores, Octavio; Torre, Aldo; Duarte-Rojo, Andr?s

    2016-01-01

    OBJECTIVES: Exercise has been scarcely studied in patients with cirrhosis, and prior evidence showed hepatic venous pressure gradient (HVPG) to be increased in response to exercise. The aim of this study was to investigate the effects of a supervised physical exercise program (PEP) in patients with cirrhosis. METHODS: In an open-label, pilot clinical trial, patients with cirrhosis were randomized to PEP (cycloergometry/kinesiotherapy plus nutritional therapy, n=14) or control (nutritional the...

  1. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome: a randomized controlled pilot-study

    National Research Council Canada - National Science Library

    Boers, Inge; Muskiet, Frits A. J; Berkelaar, Evert; Schut, Erik; Penders, Ria; Hoenderdos, Karine; Wichers, Harry J; Jong, Miek C

    2014-01-01

    Background: The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome...

  2. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome: a randomized controlled pilot-study

    National Research Council Canada - National Science Library

    Boers, I; Muskiet, F.A.J; Berkelaar, E; Schut, E; Penders, R; Hoenderdos, K; Jong, de, M.C; Wichers, H.J

    2014-01-01

    Background The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome...

  3. Mandibular response after rapid maxillary expansion in class II growing patients: a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Roberta Lione

    2017-11-01

    Full Text Available Abstract Background The aim of this pilot randomized controlled trial (RCT was to evaluate the sagittal mandibular response induced by rapid maxillary expansion (RME therapy in mixed dentition patients with class II malocclusion, comparing the effects of bonded RME and banded RME with a matched untreated class II control group. Methods This RCT was designed in parallel with an allocation ratio of 1:1:1. The sample consisted of 30 children with a mean age of 8.1 ± 0.6 years who were randomly assigned to three groups: group 1 treated with bonded RME, group 2 treated with banded RME, and group 3 the untreated control group. All patients met the following inclusion criteria: early mixed dentition, class II molar relationship, transverse discrepancy ≥ 4 mm, overjet ≥ 5 mm, and prepubertal skeletal maturity stage (CS1–CS2. The expansion screw was activated one quarter of a turn per day (0.25 mm until overcorrection was reached. For each subject, lateral cephalograms and plaster casts were obtained before treatment (T1 and after 1 year (T2. A randomization list was created for the group assignment, with an allocation ratio of 1:1:1. The observer who performed all the measurements was blinded to group assignment. The study was single-blinded in regard to statistical analysis. Results RME was effective in the correction of maxillary deficiency. Class II patients treated with both types of RME showed no significant improvement of the anteroposterior relationship of the maxilla and the mandible at both skeletal and occlusal levels. The acrylic splint RME had significant effects on reducing the skeletal vertical dimension and the gonial angle. Conclusions The orthopedic expansion did not affect the sagittal relationship of class II patients treated in the early mixed dentition when compared with the untreated control group. Additional studies with a larger sample are warranted to elucidate individual variations in dento-skeletal mandibular

  4. Mandibular response after rapid maxillary expansion in class II growing patients: a pilot randomized controlled trial.

    Science.gov (United States)

    Lione, Roberta; Brunelli, Valerio; Franchi, Lorenzo; Pavoni, Chiara; Quiroga Souki, Bernardo; Cozza, Paola

    2017-11-06

    The aim of this pilot randomized controlled trial (RCT) was to evaluate the sagittal mandibular response induced by rapid maxillary expansion (RME) therapy in mixed dentition patients with class II malocclusion, comparing the effects of bonded RME and banded RME with a matched untreated class II control group. This RCT was designed in parallel with an allocation ratio of 1:1:1. The sample consisted of 30 children with a mean age of 8.1 ± 0.6 years who were randomly assigned to three groups: group 1 treated with bonded RME, group 2 treated with banded RME, and group 3 the untreated control group. All patients met the following inclusion criteria: early mixed dentition, class II molar relationship, transverse discrepancy ≥ 4 mm, overjet ≥ 5 mm, and prepubertal skeletal maturity stage (CS1-CS2). The expansion screw was activated one quarter of a turn per day (0.25 mm) until overcorrection was reached. For each subject, lateral cephalograms and plaster casts were obtained before treatment (T1) and after 1 year (T2). A randomization list was created for the group assignment, with an allocation ratio of 1:1:1. The observer who performed all the measurements was blinded to group assignment. The study was single-blinded in regard to statistical analysis. RME was effective in the correction of maxillary deficiency. Class II patients treated with both types of RME showed no significant improvement of the anteroposterior relationship of the maxilla and the mandible at both skeletal and occlusal levels. The acrylic splint RME had significant effects on reducing the skeletal vertical dimension and the gonial angle. The orthopedic expansion did not affect the sagittal relationship of class II patients treated in the early mixed dentition when compared with the untreated control group. Additional studies with a larger sample are warranted to elucidate individual variations in dento-skeletal mandibular response to the maxillary expansion protocol in class

  5. Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY: a pilot cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Pai Menaka

    2013-01-01

    Full Text Available Abstract Background Venous thromboembolism (VTE is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. Methods We conducted a 16-week pilot cluster randomized controlled trial (RCT to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians’ orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place. Blinding was not used. Results A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022, and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE

  6. Using Robots at Home to Support Patients With Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Broadbent, Elizabeth; Garrett, Jeff; Jepsen, Nicola; Li Ogilvie, Vickie; Ahn, Ho Seok; Robinson, Hayley; Peri, Kathryn; Kerse, Ngaire; Rouse, Paul; Pillai, Avinesh; MacDonald, Bruce

    2018-02-13

    Socially assistive robots are being developed for patients to help manage chronic health conditions such as chronic obstructive pulmonary disease (COPD). Adherence to medication and availability of rehabilitation are suboptimal in this patient group, which increases the risk of hospitalization. This pilot study aimed to investigate the effectiveness of a robot delivering telehealth care to increase adherence to medication and home rehabilitation, improve quality of life, and reduce hospital readmission compared with a standard care control group. At discharge from hospital for a COPD admission, 60 patients were randomized to receive a robot at home for 4 months or to a control group. Number of hospitalization days for respiratory admissions over the 4-month study period was the primary outcome. Medication adherence, frequency of rehabilitation exercise, and quality of life were also assessed. Implementation interviews as well as benefit-cost analysis were conducted. Intention-to-treat and per protocol analyses showed no significant differences in the number of respiratory-related hospitalizations between groups. The intervention group was more adherent to their long-acting inhalers (mean number of prescribed puffs taken per day=48.5%) than the control group (mean 29.5%, P=.03, d=0.68) assessed via electronic recording. Self-reported adherence was also higher in the intervention group after controlling for covariates (P=.04). The intervention group increased their rehabilitation exercise frequency compared with the control group (mean difference -4.53, 95% CI -7.16 to -1.92). There were no significant differences in quality of life. Of the 25 patients who had the robot, 19 had favorable attitudes. This pilot study suggests that a homecare robot can improve adherence to medication and increase exercise. Further research is needed with a larger sample size to further investigate effects on hospitalizations after improvements are made to the robots. The robots could be

  7. Recruitment to online therapies for depression: pilot cluster randomized controlled trial.

    Science.gov (United States)

    Jones, Ray B; Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J

    2013-03-05

    Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues. We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies. Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting "leaked" and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations. Measuring the impact on LLTTF use was

  8. Recruitment to Online Therapies for Depression: Pilot Cluster Randomized Controlled Trial

    Science.gov (United States)

    Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J

    2013-01-01

    Background Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. Objective To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues. Methods We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies. Results Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting “leaked” and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations

  9. South Asian Heart Risk Assessment (SAHARA): Randomized Controlled Trial Design and Pilot Study

    Science.gov (United States)

    Samaan, Zainab; Schulze, Karleen M; Middleton, Catherine; Irvine, Jane; Joseph, Phillip; Mente, Andrew; Shah, Baiju R; Pare, Guillaume; Desai, Dipika

    2013-01-01

    Background People of South Asian origin suffer a high burden of premature myocardial infarction (MI). South Asians form a growing proportion of the Canadian population and preventive strategies to mitigate the risk of MI in this group are needed. Prior studies have shown that multimedia interventions are effective and feasible in inducing health behavior changes among the obese, smokers, and among those who are sedentary. Objective Among at-risk South Asians living in Canada, our objectives are to determine: (1) the feasibility of a culturally tailored multimedia intervention to induce positive behavioral changes associated with reduced MI risk factors, and (2) the effectiveness and acceptability of information communicated by individualized MI and genetic risk score (GRS) reports. Methods The South Asian HeArt Risk Assessment (SAHARA) pilot study enrolled 367 individuals of South Asian origin recruited from places of worship and community centers in Ontario, Canada. MI risk factors including the 9p21 genetic variant status were provided to all participants after the baseline visit. Participants were randomly allocated to receive a multimedia intervention or control. The intervention group selected health goals and received personalized health messages to promote adherence to their selected goals. After 6 months, all participants had their MI risk factors repeated. The methods and results of this study are reported based on the CONSORT-EHEALTH guidelines. Results The mean age of participants was 53.8 years (SD 11.4), 52.0% (191/367) were women, and 97.5% (358/367) were immigrants to Canada. The mean INTERHEART risk score was 13.0 (SD 5.8) and 73.3% (269/367) had one or two copies of the risk allele for the 9p21 genetic variant. Both the intervention and control groups made some progress in health behavior changes related to diet and physical activity over 6 months. Participants reported that their risk score reports motivated behavioral changes, although half of

  10. Randomized Controlled Pilot Trial of Behavioral Insomnia Treatment for Chronic Migraine With Comorbid Insomnia.

    Science.gov (United States)

    Smitherman, Todd A; Walters, A Brooke; Davis, Rachel E; Ambrose, Carrie E; Roland, Malcolm; Houle, Timothy T; Rains, Jeanetta C

    2016-02-01

    Migraine frequently co-occurs with and is triggered by sleep disturbance, particularly insomnia, and the large majority of patients with chronic migraine (CM) have comorbid insomnia. Limited evidence suggests that behavioral regulation of sleep may reduce migraine frequency, but studies to date have not assessed the viability of stimulus control and sleep restriction interventions or included objective measurement of sleep parameters. The aim of this study, thus, was to pilot-test the efficacy of a brief behavioral insomnia intervention for adults with CM and comorbid insomnia; headache diaries and actigraphy were included to assess outcomes throughout the trial. This randomized parallel-arm pilot trial recruited adults with both CM and comorbid insomnia. Participants were randomly assigned to three 30-minute biweekly sessions of cognitive-behavioral therapy for insomnia (CBTi) or control treatment. Participants were blinded to treatment and control conditions to control for outcome expectations. Each treatment condition involved training in and daily practice in 5 instructions/skills. The CBTi group learned and practiced skills pertaining to stimulus control and sleep restriction. The control intervention was the same as used by Calhoun and Ford (2007) and involved training in and daily practice of skills pertaining to keeping a consistent food/liquid intake, range of motion exercises, and acupressure. Participants provided outcome data via daily headache diaries, actigraphy, and self-report measures. The primary outcome was reduction in headache frequency at 2 weeks post-treatment and 6-week follow-up; secondary outcomes included other headache parameters, objective actigraphic and subjective changes in sleep, and treatment effect sizes and perceived credibility. Generalized estimating equations with a binomial logit link and inverse probability weights were used to assess the primary outcome among the intent-to-treat sample, and repeated measures generalized

  11. Randomized controlled expressive writing pilot in individuals with Parkinson's disease and their caregivers.

    Science.gov (United States)

    Cash, Therese Verkerke; Lageman, Sarah K

    2015-11-30

    Individuals with Parkinson's disease (PD) and their caregivers are at risk for emotional distress and hypercortisolism. Expressive writing is an effective complementary intervention to ameliorate the psychological and physiological effects of chronic illness. This pilot study aimed to evaluate feasibility and preliminary effectiveness of an expressive writing intervention for individuals with PD and their caregivers. Individuals with PD (N = 27) and their caregivers (N = 14) were randomly assigned to expressive (N = 15 patients, eight caregivers) or neutral (N = 12 patients, six caregivers) writing conditions. Cortisol awakening response (CAR), non-motor functioning, quality of life, and performance on tests of cognitive functioning were assessed at baseline, immediate post, 4-month, and 10-month post intervention. Attrition was a challenge as eight patients (29.62 %) and four caregivers (28.57 %) chose to discontinue before beginning the intervention or were lost to follow up prior to completing the intervention or the first follow up visit. Significant reduction in anxiety, marginally significant improvement in depression and caregiver burden, and significant improvements in performance on tests of learning and memory were observed, but these changes did not differ by writing condition. CAR significantly differed over time between patients and caregivers and writing conditions. Some evidence for the feasibility and effectiveness of writing to alleviate hypercortisolism was demonstrated in a small sample of PD patients; however, relatively high attrition rates and the lack of difference between expressive and neutral writing conditions on emotional and neurocognitive outcomes suggests expressive writing procedure modifications may be needed to obtain optimal results for this population. ClinicalTrials.gov, NCT02217735 , Study Start Date: August 30, 2011.

  12. Technology-enhanced program for child disruptive behavior disorders: development and pilot randomized control trial.

    Science.gov (United States)

    Jones, Deborah J; Forehand, Rex; Cuellar, Jessica; Parent, Justin; Honeycutt, Amanda; Khavjou, Olga; Gonzalez, Michelle; Anton, Margaret; Newey, Greg A

    2014-01-01

    Early onset disruptive behavior disorders are overrepresented in low-income families; yet these families are less likely to engage in behavioral parent training (BPT) than other groups. This project aimed to develop and pilot test a technology-enhanced version of one evidence-based BPT program, Helping the Noncompliant Child (HNC). The aim was to increase engagement of low-income families and, in turn, child behavior outcomes, with potential cost-savings associated with greater treatment efficiency. Low-income families of 3- to 8-year-old children with clinically significant disruptive behaviors were randomized to and completed standard HNC (n = 8) or Technology-Enhanced HNC (TE-HNC; n = 7). On average, caregivers were 37 years old; 87% were female, and 80% worked at least part-time. More than half (53%) of the youth were boys; the average age of the sample was 5.67 years. All families received the standard HNC program; however, TE-HNC also included the following smartphone enhancements: (a) skills video series, (b) brief daily surveys, (c) text message reminders, (d) video recording home practice, and (e) midweek video calls. TE-HNC yielded larger effect sizes than HNC for all engagement outcomes. Both groups yielded clinically significant improvements in disruptive behavior; however, findings suggest that the greater program engagement associated with TE-HNC boosted child treatment outcome. Further evidence for the boost afforded by the technology is revealed in family responses to postassessment interviews. Finally, cost analysis suggests that TE-HNC families also required fewer sessions than HNC families to complete the program, an efficiency that did not compromise family satisfaction. TE-HNC shows promise as an innovative approach to engaging low-income families in BPT with potential cost-savings and, therefore, merits further investigation on a larger scale.

  13. Efficacy of a biobehavioral intervention for hot flashes: a randomized controlled pilot study.

    Science.gov (United States)

    Barton, Debra L; Schroeder, Kelliann C Fee; Banerjee, Tanima; Wolf, Sherry; Keith, Timothy Z; Elkins, Gary

    2017-07-01

    The need for effective nonhormonal treatments for hot flash management without unwanted side effects continues. The primary aim of this pilot study was to evaluate the effect of combining a nonhormonal pharmacologic agent with a behavioral treatment for hot flash reduction. Seventy-one postmenopausal women were randomized to one of four groups: venlafaxine 75 mg + hypnosis (VH) versus venlafaxine 75 mg + sham hypnosis (VSH) versus a placebo pill + hypnosis (PH) versus placebo pill + sham hypnosis (PSH). Women recorded hot flash severity and frequency in a daily diary, in real time. The intrapatient difference in hot flash score (frequency × severity) at 8 weeks was analyzed using a General Estimating Equation model, using VSH as the referent arm, controlling for baseline hot flashes. The active arms including PH or VH were not statistically significantly different than VSH (P = 0.34, P = 0.05, respectively). Women in each active arm reported hot flash reductions of about 50%, with the PSH group reporting a 25% reduction. Women receiving the PSH reported statistically significantly smaller reductions in hot flash score than women in the referent VSH arm (P = 0.001). There were no significant negative side effects during the course of the study. Hypnosis alone reduced hot flashes equal to venlafaxine alone, but the combination of hypnosis and venlafaxine did not reduce hot flashes more than either treatment alone. More research is needed to clarify whether combining hypnosis with a different antidepressant would provide synergistic benefits.

  14. Effect of Raw Milk on Lactose Intolerance: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Mummah, Sarah; Oelrich, Beibei; Hope, Jessica; Vu, Quyen; Gardner, Christopher D.

    2014-01-01

    PURPOSE This pilot study aimed to determine whether raw milk reduces lactose malabsorption and/or lactose intolerance symptoms relative to pasteurized milk. METHODS We performed a crossover trial involving 16 adults with self-reported lactose intolerance and lactose malabsorption confirmed by hydrogen (H2) breath testing. Participants underwent 3, 8-day milk phases (raw vs 2 controls: pasteurized, soy) in randomized order separated by 1-week washout periods. On days 1 and 8 of each phase, milk consumption was 473 mL (16 oz); on days 2 to 7, milk dosage increased daily by 118 mL (4 oz), beginning with 118 mL (4 oz) on day 2 and reaching 710 mL (24 oz) on day 7. Outcomes were area under the breath H2 curve (AUC ∆H2) and self-reported symptom severity (visual analog scales: flatulence/gas, audible bowel sounds, abdominal cramping, diarrhea). RESULTS AUC ∆H2 (mean ± standard error of the mean) was higher for raw vs pasteurized on day 1 (113 ± 21 vs 71 ± 12 ppm·min·10−2, respectively, P = .01) but not day 8 (72 ± 14 vs 74 ± 15 ppm·min·10−2, respectively, P = .9). Symptom severities were not different for raw vs pasteurized on day 7 with the highest dosage (P >.7). AUC ∆H2 and symptom severities were higher for both dairy milks compared with soy milk. CONCLUSIONS Raw milk failed to reduce lactose malabsorption or lactose intolerance symptoms compared with pasteurized milk among adults positive for lactose malabsorption. These results do not support widespread anecdotal claims that raw milk reduces the symptoms of lactose intolerance. PMID:24615309

  15. Effects of neurofeedback versus stimulant medication in attention-deficit/hyperactivity disorder: a randomized pilot study.

    Science.gov (United States)

    Ogrim, Geir; Hestad, Knut A

    2013-09-01

    The purpose of this pilot study was to compare the effects of 30 sessions of neurofeedback (NF) with stimulant medication on attention-deficit/hyperactivity disorder (ADHD) patients. Thirty-two medication-naïve ADHD patients, ages 7-16, from a neuropsychiatric clinic, were randomized to NF (n=16) or drug treatment (n=16). Other actions, such as parent management training, information, or support in school were given as needed, with no differences between the groups. All participants were assessed before treatment on two rating scales, each with parent and teacher forms. In addition, quantitative electroencephalogram (QEEG) and event-related potentials (ERPs), which included behavioral data from a go/no go test were administered. NF training took place in the clinic over a period of 7-11 months, and was followed by a repeat of the same assessment tools. The mean time interval between pre- and postassesment was not significantly different in the two groups. The 18 symptoms of ADHD (American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV)) were used as the primary outcome measure. Analysis of covariance revealed a significant difference between the groups at evaluation in favor of medication, with a large effect size. This picture was confirmed by other outcome measures. The QEEG spectral power in the theta and beta bands did not change in either group. In ERP, the P3 no go component increased significantly in 8 of 12 patients who had a clinically relevant medication effect, but did not increase in the medication nonresponders or the NF group. Our study supports effects for stimulants, but not for NF. Effects of NF may require thorough patient selection, frequent training sessions, a system for excluding nonresponders, and active transfer training. The P3 no go ERP component may be a marker for treatment response.

  16. Pharmacokinetic Comparison of Omeprazole Granule and Suspension Forms in Children: A Randomized, Parallel Pilot Trial.

    Science.gov (United States)

    Karami, S; Dehghanzadeh, G; Haghighat, M; Mirzaei, R; Rahimi, H R

    2016-03-01

    Although, omeprazole is widely used for treatment of gastric acid-mediated disorders. However, its pharmacokinetic and chemical instability does not allow simple aqueous dosage form formulation synthesis for therapy of, especially child, these patients. The aim of this study was at first preparation of suspension dosage form omeprazole and second to compare the blood levels of 2 oral formulations/dosage forms of suspension & granule by high performance liquid chromatography (HPLC). The omeprazole suspension was prepared; in this regard omeprazole powder was added to 8.4% sodium bicarbonate to make final concentration 2 mg/ml omeprazole. After that a randomized, parallel pilot trial study was performed in 34 pediatric patients with acid peptic disorder who considered usage omeprazole. Selected patients were received suspension and granule, respectively. After oral administration, blood samples were collected and analyzed for omeprazole levels using validated HPLC method. The mean omeprazole blood concentration before usage the next dose, (trough level) were 0.12±0.08 µg/ml and 0.18±0.15 µg/ml for granule and suspension groups, respectively and mean blood level after dosing (C2 peak level) were 0.68±0.61 µg/ml and 0.86±0.76 µg/ml for granule and suspension groups, respectively. No significant changes were observed in comparison 2 dosage forms 2 h before (P=0.52) and after (P=0.56) the last dose. These results demonstrate that omeprazole suspension is a suitable substitute for granule in pediatrics. © Georg Thieme Verlag KG Stuttgart · New York.

  17. Improving Post-Discharge Medication Adherence in Patients with CVD: A Pilot Randomized Trial

    Directory of Open Access Journals (Sweden)

    Alfredo D. Oliveira-Filho

    2014-12-01

    Full Text Available Background: Effective interventions to improve medication adherence are usually complex and expensive. Objective: To assess the impact of a low-cost intervention designed to improve medication adherence and clinical outcomes in post-discharge patients with CVD. Method: A pilot RCT was conducted at a teaching hospital. Intervention was based on the four-item Morisky Medication Adherence Scale (MMAS-4. The primary outcome measure was medication adherence assessed using the eight-item MMAS at baseline, at 1 month post hospital discharge and re-assessed 1 year after hospital discharge. Other outcomes included readmission and mortality rates. Results: 61 patients were randomized to intervention (n = 30 and control (n = 31 groups. The mean age of the patients was 61 years (SD 12.73, 52.5% were males, and 57.4% were married or living with a partner. Mean number of prescribed medications per patient was 4.5 (SD 3.3. Medication adherence was correlated to intervention (p = 0.04 and after 1 month, 48.4% of patients in the control group and 83.3% in the intervention group were considered adherent. However, this difference decreased after 1 year, when adherence was 34.8% and 60.9%, respectively. Readmission and mortality rates were related to low adherence in both groups. Conclusion: The intervention based on a validated patient self-report instrument for assessing adherence is a potentially effective method to improve adherent behavior and can be successfully used as a tool to guide adherence counseling in the clinical visit. However, a larger study is required to assess the real impact of intervention on these outcomes.

  18. Treating insomnia improves mood state, sleep, and functioning in bipolar disorder: a pilot randomized controlled trial.

    Science.gov (United States)

    Harvey, Allison G; Soehner, Adriane M; Kaplan, Kate A; Hein, Kerrie; Lee, Jason; Kanady, Jennifer; Li, Descartes; Rabe-Hesketh, Sophia; Ketter, Terence A; Neylan, Thomas C; Buysse, Daniel J

    2015-06-01

    To determine if a treatment for interepisode bipolar disorder I patients with insomnia improves mood state, sleep, and functioning. Alongside psychiatric care, interepisode bipolar disorder I participants with insomnia were randomly allocated to a bipolar disorder-specific modification of cognitive behavior therapy for insomnia (CBTI-BP; n = 30) or psychoeducation (PE; n = 28) as a comparison condition. Outcomes were assessed at baseline, the end of 8 sessions of treatment, and 6 months later. This pilot was conducted to determine initial feasibility and generate effect size estimates. During the 6-month follow-up, the CBTI-BP group had fewer days in a bipolar episode relative to the PE group (3.3 days vs. 25.5 days). The CBTI-BP group also experienced a significantly lower hypomania/mania relapse rate (4.6% vs. 31.6%) and a marginally lower overall mood episode relapse rate (13.6% vs. 42.1%) compared with the PE group. Relative to PE, CBTI-BP reduced insomnia severity and led to higher rates of insomnia remission at posttreatment and marginally higher rates at 6 months. Both CBTI-BP and PE showed statistically significant improvement on selected sleep and functional impairment measures. The effects of treatment were well sustained through follow-up for most outcomes, although some decline on secondary sleep benefits was observed. CBTI-BP was associated with reduced risk of mood episode relapse and improved sleep and functioning on certain outcomes in bipolar disorder. Hence, sleep disturbance appears to be an important pathway contributing to bipolar disorder. The need to develop bipolar disorder-specific sleep diary scoring standards is highlighted. (c) 2015 APA, all rights reserved).

  19. Shockwave treatment for medial tibial stress syndrome: A randomized double blind sham-controlled pilot trial.

    Science.gov (United States)

    Newman, Phil; Waddington, Gordon; Adams, Roger

    2017-03-01

    Up to 35% of runners develop medial tibial stress syndrome (MTSS) which often results in lengthy disruption to training and sometimes affects daily activities. There is currently no high quality evidence to support any particular intervention for MTSS. This study aims to investigate the effect of shockwave therapy for MTSS. A randomized, sham-controlled, pilot trial in a university-based health clinic including 28 active adults with MTSS. Intervention included standard dose shockwave therapy for the experimental group versus sham dose for the control group, delivered during Week 1-3, 5 and 9. Main outcome measures were pain measured during bone and muscle pressure as well as during running using a numerical rating scale (0-10) and running was measured as pain-limited distance (m), at Week 1 (baseline) and Week 10 (post-intervention). Self-perception of change was measured using the Global Rating of Change Scale (-7 to +7) at Week 10 (post-intervention). Pain (palpation) was reduced in the experimental group by 1.1 out of 10.0 (95% CI -2.3 to 0.0) less than the control group. There were no other statistically significant differences between the groups. Standard dose shockwave therapy is not more effective than sham dose at improving pain or running distance in MTSS. However, the sham dose may have had a clinical effect. Further investigation including a no intervention control is warranted to evaluate the effect of shockwave therapy in the management of MTSS. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  20. The Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Maiken Pontoppidan

    Full Text Available Infancy is an important period of life; adverse experiences during this stage can have both immediate and lifelong impacts on the child's mental health and well-being. This study evaluates the effects of offering the Incredible Years Parents and Babies (IYPB program as a universal intervention.We conducted a pragmatic, two-arm, parallel pilot randomized controlled trial; 112 families with newborns were randomized to the IYPB program (76 or usual care (36 with a 2:1 allocation ratio. The primary outcome was parenting confidence at 20 weeks(Karitane Parenting Confidence Scale and Parental Stress Scale. Secondary outcomes include measures of parent health, parent-child relationship, infant development, parent-child activities, and network. Interviewers and data analysts were blind to allocation status. Multiple linear-regression analyses were used for evaluating the effects of the intervention.There were no intervention effects on the primary outcomes. Only one effect was detected for secondary outcomes, intervention mothers reported a significantly smaller network than control mothers (β = -0.15 [-1.85,-0.28]. When examining the lowest-functioning mothers in moderator analyses, we found that intervention mothers reported significantly higher parent stress (β = 5.33 [0.27,10.38], lower parenting confidence (β = -2.37 [-4.45,-0.29], and worse mental health than control mothers (β = -18.62 [-32.40,-4.84]. In contrast, the highest functioning intervention mothers reported significantly lower parent stress post-intervention (β = -6.11 [-11.07,-1.14].Overall, we found no effects of the IYPB as a universal intervention for parents with infants. The intervention was developed to be used with groups of low functioning families and may need to be adapted to be effective with universal parent groups. The differential outcomes for the lowest and highest functioning families suggest that future research should evaluate the effects of delivering the IYPB

  1. The Incredible Years Parents and Babies Program: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Pontoppidan, Maiken; Klest, Sihu K; Sandoy, Tróndur Møller

    2016-01-01

    Infancy is an important period of life; adverse experiences during this stage can have both immediate and lifelong impacts on the child's mental health and well-being. This study evaluates the effects of offering the Incredible Years Parents and Babies (IYPB) program as a universal intervention. We conducted a pragmatic, two-arm, parallel pilot randomized controlled trial; 112 families with newborns were randomized to the IYPB program (76) or usual care (36) with a 2:1 allocation ratio. The primary outcome was parenting confidence at 20 weeks(Karitane Parenting Confidence Scale and Parental Stress Scale). Secondary outcomes include measures of parent health, parent-child relationship, infant development, parent-child activities, and network. Interviewers and data analysts were blind to allocation status. Multiple linear-regression analyses were used for evaluating the effects of the intervention. There were no intervention effects on the primary outcomes. Only one effect was detected for secondary outcomes, intervention mothers reported a significantly smaller network than control mothers (β = -0.15 [-1.85,-0.28]). When examining the lowest-functioning mothers in moderator analyses, we found that intervention mothers reported significantly higher parent stress (β = 5.33 [0.27,10.38]), lower parenting confidence (β = -2.37 [-4.45,-0.29]), and worse mental health than control mothers (β = -18.62 [-32.40,-4.84]). In contrast, the highest functioning intervention mothers reported significantly lower parent stress post-intervention (β = -6.11 [-11.07,-1.14]). Overall, we found no effects of the IYPB as a universal intervention for parents with infants. The intervention was developed to be used with groups of low functioning families and may need to be adapted to be effective with universal parent groups. The differential outcomes for the lowest and highest functioning families suggest that future research should evaluate the effects of delivering the IYPB

  2. Transdermal rivastigmine for HIV-associated cognitive impairment: A randomized pilot study

    Science.gov (United States)

    Moltó, José; Garolera, Maite; Pérez-Álvarez, Núria; Díez-Quevedo, Crisanto; Miranda, Cristina; Fumaz, Carmina R.; Ferrer, Maria J.; Clotet, Bonaventura

    2017-01-01

    Objective To assess the efficacy and safety of transdermal rivastigmine for the treatment of HIV-associated cognitive impairment. Methods We recruited HIV-infected patients with cognitive impairment on stable antiretroviral therapy in a randomized controlled pilot trial with a 48-week follow-up. An additional assessment was held at 12 weeks. Participants received transdermal rivastigmine (9.5 mg daily), lithium (400 mg twice daily, titrated progressively), or remained in a control group (no new medication). The primary efficacy endpoint was change in a global cognitive score (NPZ-7). Secondary endpoints included change in specific cognitive measures, domains, and functional parameters. Safety covered the frequency of adverse events and changes in laboratory results. Results Seventy-six subjects were screened, and 29 were finally enrolled. Better cognitive outcomes were observed in all groups, although there were no significant differences between the arms (mean NPZ-7 change [SD]): rivastigmine, 0.35 (0.14); lithium, 0.25 (0.40); control, 0.20 (0.44) (p = 0.78). The rivastigmine group showed the highest positive trend (mean NPZ-7 [SD], baseline vs week 48): rivastigmine, –0.47 (0.22) vs –0.11 (0.29), p = 0.06; lithium, –0.50 (0.40) vs –0.26 (0.21), p = 0.22; control, –0.52 (0.34) vs –0.32 (0.52), p = 0.44. The cognitive domains with the highest positive trends were information processing speed at week 12 and executive function at week 48 (rivastigmine vs control): information processing speed, 0.35 (0.64) vs –0.13 (0.25), p = 0.17, d = 0.96; and executive functioning, 0.73 (0.33) vs 0.03 (0.74), p = 0.09, d = 1.18. No relevant changes were observed regarding functional outcomes. A total of 12 (41%) individuals dropped out of the study: 2 (20%) were due to medication-related effects in the rivastigmine group and 4 (36%) in the lithium group. No severe adverse events were reported. Conclusions The results from this small randomized trial indicate that

  3. A randomized, controlled pilot study of mindfulness-based stress reduction for pediatric chronic pain.

    Science.gov (United States)

    Jastrowski Mano, Kristen E; Salamon, Katherine S; Hainsworth, Keri R; Anderson Khan, Kimberly J; Ladwig, Renee J; Davies, W Hobart; Weisman, Steven J

    2013-01-01

    It is estimated that 1 in 5 children in the United States is affected by chronic pain. Increasing adaptive coping strategies and decreasing stress may be important in treatment. Research has suggested that mindfulness can help alleviate symptoms associated with medical illnesses and increase quality of life. Little is known about the effectiveness of mindfulness-based stress reduction (MBSR) in youth, partly due to insufficient methodological rigor in related studies. The primary purpose of the present study was to examine the feasibility, acceptability, and effectiveness of MBSR for a treatment-seeking sample of youth with chronic pain. The current study was the first randomized, controlled pilot study of MBSR for pediatric chronic pain. The research team had intended to use block randomization involving a total of five recruitment waves, with each wave consisting of one MBSR group and one psychoeducation group. Due to difficulties with recruitment and attrition before the start of either group, however, only MBSR was conducted at each wave after the first wave. Participants were recruited from a multidisciplinary pain clinic in a large, Midwestern children's hospital. The final sample included six adolescents between the ages of 12 and 17 y, four in the MBSR group and two in the psychoeducation group. Weekly sessions for the MBSR group were 90 min in length and followed a structured protocol. Sessions included a review of homework, an introduction to and practice of meditation, discussion of the session, and a review of the home practice assignment. The psychoeducation group participated in six group sessions, which were based on a cognitive-behavioral model of pain, and discussion topics included the nature of chronic pain and stress management. Health-related quality of life, pain catastrophizing, anxiety, functional disability, mindfulness, and treatment acceptability were all assessed pre- and postintervention as well as at follow-up. Recruitment and

  4. Online narratives and peer support for colorectal cancer screening: a pilot randomized trial.

    Science.gov (United States)

    Hwang, Kevin O; Ottenbacher, Allison J; Graham, Amanda L; Thomas, Eric J; Street, Rick L; Vernon, Sally W

    2013-07-01

    Delivering personal narratives and peer support for CRC screening in an online weight-loss community could be an efficient approach to engaging individuals at increased risk, because obesity is associated with excess colorectal cancer (CRC) mortality and lower screening rates. Evaluate user engagement and impact of narratives and peer support for promoting CRC screening in an online weight-loss community. Pilot randomized trial. Members of an online weight-loss community who were not up-to-date with CRC screening were enrolled in the study in 2011. Basic and Enhanced groups (n=153 each) both received education. The Enhanced group also received narratives and peer support for CRC screening in online forums. The main measures were user engagement, psychosocial outcomes, and self-report CRC screening at 6 months. Analyses were conducted with (1) the full sample of participants and (2) a minimum dose sample of those who participated in their assigned intervention to a minimum degree. Analyses were completed in 2012. Participants were mostly female (92%) with a mean age of 56 years. More than 90% in both groups viewed the educational information. Only 57% in the Enhanced group joined the online team. The Enhanced group had greater improvement in motivation for screening than the Basic group at 1 month (p=0.03). In the full sample, there was no difference in CRC screening at 6 months (Enhanced 19% vs Basic 16%, adjusted OR=1.33, 95% CI=0.73, 2.42). In the minimum dose sample, fecal occult blood testing was higher in the Enhanced (14%) vs Basic (7%) group (adjusted OR=2.49, 95% CI=1.01, 6.17). Although no between-group differences in CRC screening were seen at 6 months, this study did demonstrate that it is feasible to deploy a narrative and peer support intervention for CRC screening in a randomized trial among members of an online community. However, modifications are needed to improve user engagement. This study is registered at ClinicalTrials.gov NCT01411826

  5. Feasibility and Outcomes of an Internet-Based Mindfulness Training Program: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Kvillemo, Pia; Brandberg, Yvonne; Bränström, Richard

    2016-07-22

    Interventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs. This randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program. Participants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant's experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed. In the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More frequent contact with study coordinators was

  6. Oxcarbazepine--efficacy and tolerability during treatment of alcohol withdrawal: a double-blind, randomized, placebo-controlled multicenter pilot study.

    Science.gov (United States)

    Koethe, Dagmar; Juelicher, Antje; Nolden, Brit M; Braunwarth, Wolf-Dietrich; Klosterkötter, Joachim; Niklewski, Günter; Wodarz, Norbert; Klatt, Jan; Burtscheidt, Wilhelm; Gaebel, Wolfgang; Markus Leweke, F

    2007-07-01

    Alcohol withdrawal syndrome (AWS) is a serious complication of alcohol dependence and often requires intensive medical treatment. Antiepileptic drugs (AEDs) have been shown to be as efficacious in the treatment of AWS in several controlled trials as benzodiazepines and superior to placebo in relieving alcohol withdrawal symptoms. Oxcarbazepine (OXC), a newer anticonvulsive drug, has a favorable safety profile over carbamazepine (CBZ) and other older AEDs due to its excellent efficacy and better side-effect profile. The efficacy and tolerability of OXC versus placebo were investigated in 50 inpatients during a 6-day treatment of alcohol withdrawal in a 4-site, double-blind, randomized, placebo-controlled pilot study. The amount of rescue medication of clomethiazole (CLO) capsules needed was chosen as the primary variable. The data were collected between May 2003 and September 2004. No initial differences were found regarding sociodemographic data and alcohol-related parameters, indicating successful randomization. No differences were found in the need for rescue medication CLO, decrease of withdrawal symptoms, or craving for alcohol between the OXC and the placebo group. Subjectively experienced side effects, normalization of vegetative parameters, craving, or improvement of psychopathological parameters were not different between the groups. Despite the negative finding, which may be attributable to the design of the study, OXC still poses an interesting alternative to CBZ and other drugs because other studies have found it not only as efficient but also as having no addictive potential, while additionally possessing an anti-craving effect. Therefore, well-designed investigations with larger cohorts are required to further elucidate this issue.

  7. A Pilot Randomized Controlled Trial of a Guided Self-Help Intervention to Manage Chronic Orofacial Pain.

    Science.gov (United States)

    Goldthorpe, Joanna; Lovell, Karina; Peters, Sarah; McGowan, Linda; Nemeth, Imola; Roberts, Christopher; Aggarwal, Vishal R

    2017-01-01

    To conduct a pilot trial to test the feasibility of a guided self-help intervention for chronic orofacial pain. A pilot randomized controlled trial was conducted to compare the intervention with usual treatment. A total of 37 patients with chronic orofacial pain were randomized into either the intervention group (n = 19) or the usual treatment (control) group (n = 18). Validated outcome measures were used to measure the potential effectiveness of the intervention over a number of domains: physical and mental functioning (Short Form 36 [SF-36]); anxiety and depression (Hospital Anxiety and Depression Scale [HADS]); pain intensity and interference with life (Brief Pain Inventory [BPI]); disability (Manchester Orofacial Pain Disability Scale [MOPDS]); and illness behavior (Revised Illness Perceptions Questionnaire [IPQr]). Bootstrap confidence intervals were computed for the treatment effect (ES) posttreatment and at 3 months follow-up and adjusted for baseline values of the outcome measure by using analysis of covariance. At posttreatment and the 3-month follow-up, 11 participants in the intervention group and 7 in the control group failed to complete outcome measures. The intervention was acceptable and could be feasibly delivered face to face or over the telephone. Although the pilot trial was not powered to draw conclusions about the effectiveness, it showed significant (P orofacial pain. It showed potential effectiveness on outcome domains related to functioning and illness perception. Further research is needed to understand the cost effectiveness of the intervention for chronic orofacial pain.

  8. The effects of yoga on psychosocial variables and exercise adherence: a randomized, controlled pilot study.

    Science.gov (United States)

    Bryan, Stephanie; Pinto Zipp, Genevieve; Parasher, Raju

    2012-01-01

    Physical inactivity is a serious issue for the American public. Because of conditions that result from inactivity, individuals incur close to $1 trillion USD in health-care costs, and approximately 250 000 premature deaths occur per year. Researchers have linked engaging in yoga to improved overall fitness, including improved muscular strength, muscular endurance, flexibility, and balance. Researchers have not yet investigated the impact of yoga on exercise adherence. The research team assessed the effects of 10 weeks of yoga classes held twice a week on exercise adherence in previously sedentary adults. The research team designed a randomized controlled pilot trial. The team collected data from the intervention (yoga) and control groups at baseline, midpoint, and posttest (posttest 1) and also collected data pertaining to exercise adherence for the yoga group at 5 weeks posttest (posttest 2). The pilot took place in a yoga studio in central New Jersey in the United States. The pretesting occurred at the yoga studio for all participants. Midpoint testing and posttesting occurred at the studio for the yoga group and by mail for the control group. Participants were 27 adults (mean age 51 y) who had been physically inactive for a period of at least 6 months prior to the study. Interventions The intervention group (yoga group) received hour-long hatha yoga classes that met twice a week for 10 weeks. The control group did not participate in classes during the research study; however, they were offered complimentary post research classes. Outcome Measures The study's primary outcome measure was exercise adherence as measured by the 7-day Physical Activity Recall. The secondary measures included (1) exercise self-efficacy as measured by the Multidimensional Self-Efficacy for Exercise Scale, (2) general well-being as measured by the General Well-Being Schedule, (3) exercise-group cohesion as measured by the Group Environment Questionnaire (GEQ), (4) acute feeling response

  9. Randomized Intervention Trial to Decrease Bisphenol A Urine Concentrations in Women: Pilot Study.

    Science.gov (United States)

    Hagobian, Todd; Smouse, Allison; Streeter, Mikaela; Wurst, Chloe; Schaffner, Andrew; Phelan, Suzanne

    2017-02-01

    Previous studies have shown that women have higher concentrations of the endocrine disruptor bisphenol A (BPA), but an intervention to reduce BPA is lacking in women. To test the hypothesis that an intervention to reduce BPA would decrease urinary BPA concentrations over 3 weeks, 24 women (mean ± standard deviation [SD]; 22.1 ± 2.8 kg/m2 body mass index, 20.9 ± 1.5 years) were randomly assigned to an intervention or control. The intervention included weekly face-to-face meetings to reduce BPA exposures from food, cosmetics, and other packaged products. Women were provided with BPA-free cosmetics, hygiene, glass food/water containers, and daily self-monitored major sources of BPA. Fasting urine BPA and creatinine concentrations, and weight were assessed at study entry and after 3 weeks. A significant (p = 0.04) treatment × time interaction effect was observed on creatinine-adjusted BPA concentrations. From study entry to 3 weeks, women in the intervention significantly decreased geometric mean creatinine-adjusted urinary BPA by -0.71 ng/m, whereas women in the control significantly increased urinary BPA by 0.32 ng/mL (p = 0.04). Additionally, from study entry to 3 weeks, women in the intervention significantly lost weight -0.28 ± 0.44 kg, whereas women in the control significantly gained weight +1.65 ± 0.74 kg (p = 0.03). Changes in creatinine-adjusted BPA concentrations and weight were not significantly related (p = 0.67). In this pilot study, a 3-week intervention decreased urinary BPA concentrations in women. Future clinical trials are needed to confirm these results and to examine whether a similar BPA intervention positively impacts risk markers in the pathogenesis of cardiovascular disease and diabetes.

  10. Exercise and Counseling for Smoking Cessation in Smokers With Depressive Symptoms: A Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Bernard, Paquito; Ninot, Gregory; Cyprien, Fabienne; Courtet, Philippe; Guillaume, Sebastien; Georgescu, Vera; Picot, Marie-Christine; Taylor, Adrian; Quantin, Xavier

    2015-01-01

    Despite various strategies to help smokers with depressive disorders to quit, the smoking relapse rate remains high. The purpose of this pilot study was to estimate the effects of adding an exercise and counseling intervention to standard smoking cessation treatment for smokers with depressive disorders. We hypothesized that the exercise and counseling intervention would lead to improved abstinence, reduced depressive symptoms, and increased physical activity. Seventy smokers with current depressive disorders were randomly assigned to standard smoking cessation treatment plus exercise and counseling (n = 35) or standard treatment plus a time-to-contact control intervention on health education (n = 35). Both programs involved 10 sessions over 8 weeks. The primary outcome was continuous abstinence since the quit date and was measured at week 8 (end of the intervention) and again at 12-, 24-, and 52-week follow-ups. Nearly 60% of participants were female (n = 41), 38 (52.3%) were single, 37 (52.9%) had education beyond high school, and 32 (45.7%) met criteria for major depressive disorder or dysthymia. Participants in the two treatment conditions differed at baseline only in marital status (χ(2) = 4.28, df = 1, p =.04); and smoking abstinence self-efficacy, t(66) = -2.04, p =.04). The dropout rate did not differ significantly between groups and participants attended 82% and 75% of the intervention and control sessions, respectively. Intention-to-treat analysis showed that, at 12 weeks after the beginning of the intervention, continuous abstinence did not vary significantly between the intervention and control groups: 48.5% versus 28.5%, respectively, ORadj = 0.40, 95% CI [0.12-1.29], p =.12. There were no group differences in depressive symptoms, but the intervention group did outperform the control group on the 6-minute walking test (Mint = 624.84, SD = 8.17, vs. Mcon = 594.13, SD = 8.96, p =.015) and perceived physical control (Mint = 2.84, SD = 0.16, vs. Mcon = 2

  11. Self-compassion training for binge eating disorder: a pilot randomized controlled trial.

    Science.gov (United States)

    Kelly, Allison C; Carter, Jacqueline C

    2015-09-01

    The present pilot study sought to compare a compassion-focused therapy (CFT)-based self-help intervention for binge eating disorder (BED) to a behaviourally based intervention. Forty-one individuals with BED were randomly assigned to 3 weeks of food planning plus self-compassion exercises; food planning plus behavioural strategies; or a wait-list control condition. Participants completed weekly measures of binge eating and self-compassion; pre- and post-intervention measures of eating disorder pathology and depressive symptoms; and a baseline measure assessing fear of self-compassion. Results showed that: (1) perceived credibility, expectancy, and compliance did not differ between the two interventions; (2) both interventions reduced weekly binge days more than the control condition; (3) the self-compassion intervention reduced global eating disorder pathology, eating concerns, and weight concerns more than the other conditions; (4) the self-compassion intervention increased self-compassion more than the other conditions; and (5) participants low in fear of self-compassion derived significantly more benefits from the self-compassion intervention than those high in fear of self-compassion. Findings offer preliminary support for the usefulness of CFT-based interventions for BED sufferers. Results also suggest that for individuals to benefit from self-compassion training, assessing and lowering fear of self-compassion will be crucial. Individuals with BED perceive self-compassion training self-help interventions, derived from CFT, to be as credible and as likely to help as behaviourally based interventions. The cultivation of self-compassion may be an effective approach for reducing binge eating, and eating, and weight concerns in individuals with BED. Teaching individuals with BED CFT-based self-help exercises may increase their self-compassion levels over a short period of time. It may be important for clinicians to assess and target clients' fear of self

  12. Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D): a study protocol for a randomized controlled pilot trial

    National Research Council Canada - National Science Library

    Mailhot, Tanya; Cossette, Sylvie; Bourbonnais, Anne; Côté, José; Denault, André; Côté, Marie-Claude; Lamarche, Yoan; Guertin, Marie-Claude

    2014-01-01

    .... Therefore, this randomized pilot trial examines the acceptability, feasibility, and preliminary efficacy of an experimental nursing intervention to help family caregivers manage post-cardiac surgery...

  13. Metaphor use and health literacy: a pilot study of strategies to explain randomization in cancer clinical trials.

    Science.gov (United States)

    Krieger, Janice L; Parrott, Roxanne L; Nussbaum, Jon F

    2011-01-01

    Patients often have difficulty understanding what randomization is and why it is needed in Phase III clinical trials. Physicians commonly report using metaphorical language to convey the role of chance in being assignment to treatment; however, the effectiveness of this strategy as an educational tool has not been explored. Guided by W. McGuire's (1972) information-processing model, the purpose of this pilot study was to explore effects of metaphors to explain randomization on message acceptance and behavioral intention to participate in a Phase III clinical trial among a sample of low-income, rural women (N = 64). Participants were randomly assigned to watch a video that explained randomization using 1 of 3 message strategies: a low-literacy definition, standard metaphor (i.e., flip of a coin), or a culturally derived metaphor (i.e., sex of a baby). The influence of attention on behavioral intentions to participate in clinical trials was partially moderated by message strategy. Under conditions of low attention, participants in the culturally derived metaphor condition experienced significantly higher intentions to participate in clinical trials compared with participants in the standard metaphor condition. However, as attention increased, differences in intentions among the conditions diminished. Having a positive affective response to the randomization message was a strong, positive predictor of behavioral intentions to participate in clinical trials. The authors discuss the theoretical and practical implications of these findings.

  14. Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Williams, Christopher; McClay, Carrie-Anne; Martinez, Rebeca; Morrison, Jill; Haig, Caroline; Jones, Ray; Farrand, Paul

    2016-04-27

    Low mood is a common mental health problem with significant health consequences. Studies have shown that cognitive behavioural therapy (CBT) is an effective treatment for low mood and anxiety when delivered one-to-one by an expert practitioner. However, access to this talking therapy is often limited and waiting lists can be long, although a range of low-intensity interventions that can increase access to services are available. These include guided self-help materials delivered via books, classes and online packages. This project aims to pilot a randomized controlled trial of an online CBT-based life skills course with community-based individuals experiencing low mood and anxiety. Individuals with elevated symptoms of depression will be recruited directly from the community via online and newspaper advertisements. Participants will be remotely randomized to receive either immediate access or delayed access to the Living Life to the Full guided online CBT-based life skills package, with telephone or email support provided whilst they use the online intervention. The primary end point will be at 3 months post-randomization, at which point the delayed-access group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. This pilot study will test the trial design, and ability to recruit and deliver the intervention. Drop-out rates will be assessed and the completion and acceptability of the package will be investigated. The study will also inform a sample size power calculation for a subsequent substantive randomized controlled trial. ISRCTN ISRCTN12890709.

  15. Evaluation of a pilot healthy eating intervention in restaurants and food stores of a rural community: a randomized community trial.

    Science.gov (United States)

    Martínez-Donate, Ana P; Riggall, Ann Josie; Meinen, Amy M; Malecki, Kristen; Escaron, Anne L; Hall, Bev; Menzies, Anne; Garske, Gary; Nieto, F Javier; Nitzke, Susan

    2015-02-12

    Research suggests that the food environment influences individual eating practices. To date, little is known about effective interventions to improve the food environment of restaurants and food stores and promote healthy eating in rural communities. We tested "Waupaca Eating Smart " (WES), a pilot intervention to improve the food environment and promote healthy eating in restaurants and supermarkets of a rural community. WES focused on labeling, promoting, and increasing the availability of healthy foods. We conducted a randomized community trial, with two Midwestern U.S. communities randomly assigned to serve as intervention or control site. We collected process and outcome data using baseline and posttest owner and customer surveys and direct observation methods. The RE-AIM framework was used to guide the evaluation and organize the results. Seven of nine restaurants and two of three food stores invited to participate in WES adopted the intervention. On a 0-4 scale, the average level of satisfaction with WES was 3.14 (SD=0.69) for restaurant managers and 3 (SD=0.0) for store managers. On average, 6.3 (SD=1.1) out of 10 possible intervention activities were implemented in restaurants and 9.0 (SD=0.0) out of 12 possible activities were implemented in food stores. One month after the end of the pilot implementation period, 5.4 (SD=1.6) and 7.5 (SD=0.7) activities were still in place at restaurants and food stores, respectively. The intervention reached 60% of customers in participating food outlets. Restaurant food environment scores improved from 13.4 to 24.1 (p restaurant-and food store-based interventions in rural communities. Pilot outcome data indicated very modest levels of effectiveness, but additional research adequately powered to test the impact of this intervention on food environment scores and customer behaviors needs to be conducted in order to identify its potential to promote healthy eating in rural community settings.

  16. Randomized pilot study of cabergoline, a dopamine receptor agonist: effects on body weight and glucose tolerance in obese adults.

    Science.gov (United States)

    Gibson, C D; Karmally, W; McMahon, D J; Wardlaw, S L; Korner, J

    2012-04-01

    Dopaminergic hypofunction and hyperprolactinaemia have been implicated in the pathogenesis of obesity and glucose intolerance. The aim of this pilot study was to determine the efficacy of cabergoline, a dopamine receptor agonist, on body weight and glucose tolerance in obese non-diabetic persons with normal plasma prolactin levels. This 16-week double blind, placebo-controlled pilot study randomized non-diabetic obese adults (body mass index 30-42 kg/m(2) ) to placebo or cabergoline (0.25 mg twice weekly for 4 weeks followed by 0.5 mg twice weekly for the next 12 weeks). Of 40 subjects enrolled, 29 completed 16 weeks: 16 randomized to placebo and 13 to cabergoline. All subjects were counselled on a 500 kcal/day calorie deficit diet. A 75-g oral glucose tolerance test was performed at baseline and at 16 weeks. As expected, prolactin levels decreased after cabergoline (p Weight loss was similar after placebo compared with cabergoline treatment: 1.0 vs. 1.2% body weight, respectively. Fasting glucose levels did not differ between groups after treatment, however, 90-min postprandial glucose and insulin decreased in the cabergoline group only (p = 0.029). HOMA-IR (homeostasis model of assessment) increased by 40% after placebo and 1.5% after cabergoline treatment. This pilot study suggests that cabergoline therapy may improve glucose tolerance independent of weight loss, however, a larger, longer term study of dopamine receptor agonist therapy in obese individuals is warranted to confirm this finding. © 2011 Blackwell Publishing Ltd.

  17. Autologous fat grafting does not improve burn scar appearance: A prospective, randomized, double-blinded, placebo-controlled, pilot study.

    Science.gov (United States)

    Gal, Shaili; Ramirez, Jesus Ignacio; Maguina, Pirko

    2017-05-01

    It has been proposed that fat grafts can improve the appearance of mature burn scars. The pluripotent progenitor cells contained within autologous adipose tissue grafts are believed to induce skin repair and improve scar appearance. We conducted a prospective, randomized, double-blinded, placebo-controlled study to evaluate the effects of fat grafts on the appearance of mature burn scars. Pediatric burn survivors with mature scars were recruited for this study. A homogeneous scar measuring 10×5cm was randomized into two halves: one was injected with autologous fat graft and the other with normal saline. Scar injection was performed using standard Coleman technique. Appearance of the two scar halves was assessed, six to twelve months later by the operating surgeon, by blinded observers and by the blinded patients. Eight patients completed the study pilot with 6-12 month follow-up. Assessment by the patients did not clearly favor fat grafts or saline injections; the operating surgeon did not identify any differences on any of the patients; the blinded observers measured all scars using Vancouver Scar Scale and noticed no differences in pigmentation, vascularity and height; differences in pliability showed similar changes in both the fat grafted and control arms. After the pilot was completed, decision was made to stop enrolling patients for this study since no benefit to fat grafting was observed. Single treatment with autologous fat grafts did not improve mature pediatric burn scars when compared to normal saline injections. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  18. A play and joint attention intervention for teachers of young children with autism: a randomized controlled pilot study.

    Science.gov (United States)

    Wong, Connie S

    2013-05-01

    The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms. Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers (n = 14). The 14 preschool special education teachers were randomly assigned to one of three groups: (1) symbolic play then joint attention intervention, (2) joint attention then symbolic intervention, and (3) wait-list control period then further randomized to either group 1 or group 2. In the intervention, teachers participated in eight weekly individualized 1-h sessions with a researcher that emphasized embedding strategies targeting symbolic play and joint attention into their everyday classroom routines and activities. The main child outcome variables of interest were collected through direct classroom observations. Findings indicate that teachers can implement an intervention to significantly improve joint engagement of young children with autism in their classrooms. Furthermore, multilevel analyses showed significant increases in joint attention and symbolic play skills. Thus, these pilot data emphasize the need for further research and implementation of classroom-based interventions targeting play and joint attention skills for young children with autism.

  19. Promoting the use of outcome measures by an educational programme for physiotherapists in stroke rehabilitation: a pilot randomized controlled trial.

    Science.gov (United States)

    Van Peppen, R P S; Schuurmans, M J; Stutterheim, E C; Lindeman, E; Van Meeteren, N L U

    2009-11-01

    To determine the influence of tutor expertise on the uptake of a physiotherapists' educational programme intended to promote the use of outcome measures in the management of patients with stroke. Pilot randomized controlled trial. Thirty physiotherapists involved in stroke management were randomized into two groups and participated in five tutor-guided educational sessions (the Physiotherapists' Educational Programme on Clinimetrics in Stroke, PEPCiS). Groups differed from each other with respect to tutors: one experienced and one inexperienced in stroke care. Primary outcome was 'actual use' (the frequencies of data of seven recommended outcome measures in the patient records of the participating physiotherapists). The actual use of instruments shifted from a median of 3 to 6 in the expert tutor group and from 3 to 4 in the non-expert tutor group (P = 0.07). Physiotherapists educated by the expert tutor used a broader variety of instruments and appreciated the educational programme, their own knowledge gain and all three scales of tutor style aspects significantly more than their colleagues of the non-expert tutor group (all Ptutors' performance, that were associated with a change score of the use of two or more outcome measures by individual physiotherapists after the educational programme. In this pilot trial it was not proven that tutor expertise in stroke care influences the actual use of outcome measures, but it warrants a future study with sufficient power to investigate the influence of the tutor.

  20. Sialendoscopy of salivary glands affected by Sjögren syndrome: a randomized controlled pilot study

    NARCIS (Netherlands)

    Jager, D.J.; Karagozoglu, K.H.; Maarse, F.; Brand, H.S.; Forouzanfar, T.

    2016-01-01

    Purpose: Sialendoscopy of the major salivary glands could alleviate the oral symptoms of Sjögren syndrome (SS) and restore salivary function. The aim of this pilot study was to evaluate the effect of sialendoscopy of the major salivary glands on salivary flow, saliva composition, and mouthfeel in

  1. Hemodialysis Infection Prevention Protocols Ontario—Shower Technique (HIPPO-ST: A Pilot Randomized Trial

    Directory of Open Access Journals (Sweden)

    S. Daisy Kosa

    2017-03-01

    Discussion: This HIPPO-ST pilot study demonstrated the feasibility of the larger HIPPO-ST study, especially given the high levels of education success with the HIPPO-ST arm and the low levels of contamination in the control arm.

  2. Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

    Science.gov (United States)

    Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

    2018-01-01

    To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

  3. The Development of an Internet-Based Treatment for Problem Gamblers and Concerned Significant Others: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Nilsson, Anders; Magnusson, Kristoffer; Carlbring, Per; Andersson, Gerhard; Gumpert, Clara Hellner

    2017-07-11

    Problem gambling creates significant harm for the gambler and for concerned significant others (CSOs). While several studies have investigated the effects of individual cognitive behavioral therapy (CBT) for problem gambling, less is known about the effects of involving CSOs in treatment. Behavioral couples therapy (BCT) has shown promising results when working with substance use disorders by involving both the user and a CSO. This pilot study investigated BCT for problem gambling, as well as the feasibility of performing a larger scale randomized controlled trial. 36 participants, 18 gamblers and 18 CSOs, were randomized to either BCT or individual CBT for the gambler. Both interventions were Internet-delivered self-help interventions with therapist support. Both groups of gamblers improved on all outcome measures, but there were no differences between the groups. The CSOs in the BCT group lowered their scores on anxiety and depression more than the CSOs of those randomized to the individual CBT group did. The implications of the results and the feasibility of the trial are discussed.

  4. Is ginger effective for the treatment of irritable bowel syndrome? A double blind randomized controlled pilot trial.

    Science.gov (United States)

    van Tilburg, Miranda A L; Palsson, Olafur S; Ringel, Yehuda; Whitehead, William E

    2014-02-01

    Ginger is one of the most commonly used herbal medicines for irritable bowel syndrome (IBS) but no data exists about its effectiveness. Double blind randomized controlled trial. University of North Carolina, Chapel Hill, North Carolina, USA. Forty-five IBS patients were randomly assigned to three groups: placebo, 1g of ginger, and 2g of ginger daily for 28 days. The IBS severity scale (IBS-SS) was administered, as well as adequate relief of symptoms scale. A responder was defined as having at least 25% reduction in IBS-SS post-treatment. There were 57.1% responders to placebo, 46.7% to 1g and 33.3% to 2g of ginger. Adequate relief was reported by 53.3% on placebo and 53.3% in both ginger groups combined. Side effects were mild and reported by 35.7% in the placebo and 16.7% in the ginger groups. This double blind randomized controlled pilot study suggests ginger is well tolerated but did not perform better than placebo. Larger trials are needed before any definitive conclusions can be drawn. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. [PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

    Science.gov (United States)

    Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

    2017-10-12

    Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

  6. Effectiveness of aerobic gymnastic exercise on stress, fatigue, and sleep quality during postpartum: A pilot randomized controlled trial.

    Science.gov (United States)

    Yang, Chiu-Ling; Chen, Chung-Hey

    2018-01-01

    Gymnastics is a preferable safe exercise for postnatal women performing regularly. The aim of this pilot randomized controlled trial was to determine whether the aerobic gymnastic exercise improves stress, fatigue, sleep quality and depression in postpartum women. Single-blinded, randomized controlled trial held from December 2014 until September 2015. Postnatal clinic of a medical center in southern Taiwan. 140 eligible postnatal women were systematically assigned, with a random start to experimental (n=70) or a control (n=70) group. Engage in aerobic gymnastic exercise at least three times (15min per section) a week for three months using compact disc in the home. Perceived Stress Scale, Postpartum Fatigue Scale, Postpartum Sleep Quality Scale, and Edinburgh Postnatal Depression Scale. In a two-way ANOVA with repeated measures, the aerobic gymnastic exercise group showed significant decrease in fatigue after practicing exercise 4 weeks and the positive effects extended to the 12-week posttests. Paired t-tests revealed that aerobic gymnastic exercise participants had improved significantly in perceived stress and fatigue after 4 weeks gymnastic exercise; these positive effects extended to the 12-week posttests. In addition, the changes in physical symptoms-related sleep inefficiency after 12 weeks gymnastic exercise were significantly decreased in the experimental group compared with the control group. The findings can be used to encourage postnatal women to perform moderate-intensity gymnastic exercise in their daily life to reduce their stress, fatigue and improve sleep quality. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Meal replacements followed by topiramate for the treatment of adolescent severe obesity: A pilot randomized controlled trial.

    Science.gov (United States)

    Fox, Claudia K; Kaizer, Alexander M; Rudser, Kyle D; Nathan, Brandon M; Gross, Amy C; Sunni, Muna; Jennifer Abuzzahab, M; Schwartz, Betsy L; Kumar, Seema; Petryk, Anna; Billington, Charles J; Ryder, Justin R; Kelly, Aaron S

    2016-12-01

    To assess the safety and efficacy of short-term meal replacement therapy followed by topiramate for body mass index (BMI) reduction in adolescents with severe obesity. Adolescents (ages 12-18 years) with severe obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m2 ) were recruited for this double-blind, randomized, placebo-controlled trial. Participants completed 4 weeks of meal replacement therapy followed by randomization (1:1) to either 24 weeks of topiramate 75 mg/day or placebo. Mean changes were compared between groups. Thirty adolescents (mean age 15.2 ± 1.7 years, mean BMI 40.3 ± 4.6 kg/m2 ) completed the meal replacement phase and were randomized; 21 completed the study. The difference in mean percent change in BMI between the topiramate and placebo groups was not significant (-1.9%; 95% CI: -5.2% to +1.5%; P = 0.291). Significant improvements in visceral fat and very-low-density lipoprotein cholesterol were observed in the topiramate compared with the placebo group. There were no concerning changes in neurocognitive function or bone health. In this pilot study, 4 weeks of meal replacement therapy followed by 24 weeks of low-dose topiramate compared with meal replacement therapy alone did not result in significant BMI reduction for adolescents with severe obesity. © 2016 The Obesity Society.

  8. Aprotinin decreases the incidence of cognitive deficit following CABG and cardiopulmonary bypass: a pilot randomized controlled study.

    LENUS (Irish Health Repository)

    Harmon, Dominic C

    2012-02-03

    PURPOSE: Cognitive deficit after coronary artery bypass surgery (CABG) has a high prevalence and is persistent. Meta-analysis of clinical trials demonstrates a decreased incidence of stroke after CABG when aprotinin is administrated perioperatively. We hypothesized that aprotinin administration would decrease the incidence of cognitive deficit after CABG. METHODS: Thirty-six ASA III-IV patients undergoing elective CABG were included in a prospective, randomized, single-blinded pilot study. Eighteen patients received aprotinin 2 x 10(6) KIU (loading dose), 2 x 10(6) KIU (added to circuit prime) and a continuous infusion of 5 x 10(5) KIU.hr(-1). A battery of cognitive tests was administered to patients and spouses (n = 18) the day before surgery, four days and six weeks postoperatively. RESULTS: Four days postoperatively new cognitive deficit (defined by a change in one or more cognitive domains using the Reliable Change Index method) was present in ten (58%) patients in the aprotinin group compared to 17 (94%) in the placebo group [95% confidence interval (CI) 0.10-0.62, P = 0.005); (P = 0.01)]. Six weeks postoperatively, four (23%) patients in the aprotinin group had cognitive deficit compared to ten (55%) in the placebo group (95% CI 0.80-0.16, P = 0.005); (P = 0.05). CONCLUSION: In this prospective pilot study, the incidence of cognitive deficit after CABG and cardiopulmonary bypass is decreased by the administration of high-dose aprotinin.

  9. Effects of quetiapine and olanzapine in patients with psychosis and violent behavior: a pilot randomized, open-label, comparative study.

    Science.gov (United States)

    Gobbi, Gabriella; Comai, Stefano; Debonnel, Guy

    2014-01-01

    Patients suffering from psychosis are more likely than the general population to commit aggressive acts, but the therapeutics of aggressive behavior are still a matter of debate. This pilot randomized, open-label study compared the efficacy of quetiapine versus olanzapine in reducing impulsive and aggressive behaviors (primary endpoints) and psychotic symptoms (secondary endpoints) from baseline to days 1, 7, 14, 28, 42, 56, and 70, in 15 violent schizophrenic patients hospitalized in a maximum-security psychiatric hospital. Quetiapine (525±45 mg) and olanzapine (18.5±4.8 mg) were both efficacious in reducing Impulsivity Rating Scale from baseline to day 70. In addition, both treatments reduced the Brief Psychiatric Rating Scale, Positive and Negative Syndrome Scale, and Clinical Global Impression Scale scores at day 70 compared to baseline, and no differences were observed between treatments. Moreover, quetiapine, but not olanzapine, yielded an improvement of depressive symptoms in the items "depression" in Brief Psychiatric Rating Scale and "blunted affect" in Positive and Negative Syndrome Scale. Modified Overt Aggression Scale scores were also decreased from baseline to the endpoint, but due to the limited number of patients, it was not possible to detect a significant difference. In this pilot study, quetiapine and olanzapine equally decreased impulsive and psychotic symptoms after 8 weeks of treatment. Double-blind, large studies are needed to confirm the validity of these two treatments in highly aggressive and violent schizophrenic patients.

  10. Chosen-Prefix Collisions for MD5 and Applications

    NARCIS (Netherlands)

    M.M.J. Stevens (Marc); A.K. Lenstra (Arjen); B. de Weger (Benne)

    2012-01-01

    textabstractWe present a novel, automated way to find differential paths for MD5. Its main application is in the construction of \\emph{chosen-prefix collisions}. We have shown how, at an approximate expected cost of $2^{39}$ calls to the MD5 compression function, for any two chosen

  11. A Pilot Randomized Trial of a Video Patient Decision Aid to Facilitate Early Intervention Referrals From Primary Care.

    Science.gov (United States)

    Jimenez, Manuel E; DuRivage, Nathalie E; Bezpalko, Orysia; Suh, Andrew; Wade, Roy; Blum, Nathan J; Fiks, Alexander G

    2017-03-01

    Many young children identified with developmental concerns in pediatric settings do not receive early intervention (EI). We assessed the impact of a video decision aid and text message reminder on knowledge and attitudes regarding developmental delay and EI as well as referral completion. We conducted a pilot randomized controlled trial in an urban setting and enrolled 64 parent-child dyads referred to EI. Compared with controls, participants who received the intervention demonstrated increased knowledge regarding developmental delay and EI as well as more favorable attitudes in certain topics. Although we did not find a significant difference between arms in EI intake and evaluation, we found a pattern suggestive of increased intake and evaluation among participants with low health literacy in the intervention arm. Additional study is needed to identify strategies that improve the EI referral process for families and to understand the potential targeted role for decision aids and text messages.

  12. A double-blind randomized controlled pilot trial examining the safety and efficacy of therapeutic touch in premature infants.

    Science.gov (United States)

    Whitley, Julie Anne; Rich, Bonnie L

    2008-12-01

    To explore the hypothesis that nontouch therapy such as therapeutic touch (TT) reduces stress to a clinically important degree and is safe to use in preterm infants. A pilot randomized, double-blind, controlled trial. Two groups of 10 infants were enrolled and randomly assigned to treatment or nontreatment groups. Gestational age was less than 29 weeks. Demographic descriptions of the 2 groups were statistically similar. The observer and staff were blinded to assignment; the TT practitioner was blinded to observed measurements. Each infant received either TT or no therapeutic touch (NTT) for 5 minutes on 3 consecutive days at the same time of day, behind a curtain. Heart period variability (HPV) was measured 5 minutes before, during, and after the treatment phase. Examination of the parameters of oxygen saturation and episodes of apnea demonstrated no increase in adverse events in TT group compared with NTT group. Repeated-measures multivariate analysis of variance on HPV revealed differences in the interaction of group assignment with low-frequency, high-frequency, and low-to-high- frequency ratio interaction (F2,143 = 8.076, P = .000) and for group, day, and low-frequency, high-frequency, and low-to-high-frequency ratio (F2,288 = 3.146, P = .015), and in the posttreatment time period (F1,16 = 6.259, P = .024), reflective of greater parasympathetic activity in TT group. In this pilot trial, HPV showed an increase for the TT group compared with the NTT group. The study reveals no adverse effects of TT in preterm infants.

  13. Randomized trial of telephone-delivered acceptance and commitment therapy versus cognitive behavioral therapy for smoking cessation: a pilot study.

    Science.gov (United States)

    Bricker, Jonathan B; Bush, Terry; Zbikowski, Susan M; Mercer, Laina D; Heffner, Jaimee L

    2014-11-01

    We conducted a pilot randomized trial of telephone-delivered acceptance and commitment therapy (ACT) versus cognitive behavioral therapy (CBT) for smoking cessation. Participants were 121 uninsured South Carolina State Quitline callers who were adult smokers (at least 10 cigarettes/day) and who wanted to quit within the next 30 days. Participants were randomized to 5 sessions of either ACT or CBT telephone counseling and were offered 2 weeks of nicotine replacement therapy (NRT). ACT participants completed more calls than CBT participants (M = 3.25 in ACT vs. 2.23 in CBT; p = .001). Regarding satisfaction, 100% of ACT participants reported their treatment was useful for quitting smoking (vs. 87% for CBT; p = .03), and 97% of ACT participants would recommend their treatment to a friend (vs. 83% for CBT; p = .06). On the primary outcome of intent-to-treat 30-day point prevalence abstinence at 6 months postrandomization, the quit rates were 31% in ACT versus 22% in CBT (odds ratio [OR] = 1.5, 95% confidence interval [CI] = 0.7-3.4). Among participants depressed at baseline (n = 47), the quit rates were 33% in ACT versus 13% in CBT (OR = 1.2, 95% CI = 1.0-1.6). Consistent with ACT's theory, among participants scoring low on acceptance of cravings at baseline (n = 57), the quit rates were 37% in ACT versus 10% in CBT (OR = 5.3, 95% CI = 1.3-22.0). ACT is feasible to deliver by phone, is highly acceptable to quitline callers, and shows highly promising quit rates compared with standard CBT quitline counseling. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  14. Free radicals and antioxidant enzymes in older adults after regular senior elastic band exercising: an experimental randomized controlled pilot study.

    Science.gov (United States)

    Liao, Lin Yu; Chung, Wei Sheng; Chen, Kuei Min

    2017-01-01

    The aim of this study was to pilot test the effects of regular senior elastic band exercises on the generation of free radicals and antioxidant enzyme activities in older adults. Long-term regular exercises have positive health promotion outcomes. On the contrary, high-intensity, high-speed and short-term exercises in older adults may increase free radicals and cause chronic disease and ageing effect. A prospective randomized controlled pilot study. Data were collected during 2012. Twenty-five older adults were recruited from a community care centre, southern Taiwan and were randomly assigned to either an experimental or control group. Twenty-two participants completed the study: experimental group (n = 10) and control group (n = 12). The experimental group performed 6-month senior elastic band exercises while the control group kept regular daily routines. Both groups received blood tests (thiobarbituric acid-reacting substances and glutathione peroxidase) 30 minutes before the study began and 1 hour after the final intervention treatment. At the end of the 6-month senior elastic band exercises, no statistically significant differences in thiobarbituric acid-reacting substances and glutathione peroxidase values between the experimental and control groups. No significant differences existed in both thiobarbituric acid-reacting substances and glutathione peroxidase values before and after the 6-month senior elastic band exercises either. Regular senior elastic band exercises did not increase the generation of free radicals and antioxidant enzyme activities. Senior elastic band exercises have the potential to be promoted among older adults in the community as an exercise option without adverse effects on free radicals and have potential for mitigating ageing and increasing disease control. © 2016 John Wiley & Sons Ltd.

  15. A pilot randomized controlled trial of a brief parenting intervention in low-resource settings in Panama.

    Science.gov (United States)

    Mejia, Anilena; Calam, Rachel; Sanders, Matthew R

    2015-07-01

    The aim of this study was to determine whether an intervention from the Triple P Positive Parenting Program system was effective in reducing parental reports of child behavioral difficulties in urban low-income settings in Panama City. A pilot parallel-group randomized controlled trial was carried out. A total of 108 parents of children 3 to 12 years old with some level of parent-rated behavioral difficulties were randomly assigned to a discussion group on "dealing with disobedience" or to a no intervention control. Blinded assessments were carried out prior to the intervention, 2 weeks, 3 months, and 6 months later. Results indicated that parental reports of child behavioral difficulties changed over time and decreased more steeply in the intervention than in the control group. The effects of the intervention on parental reports of behavioral difficulties were moderate at post-intervention and 3-month follow-up, and large at 6-month follow-up. Parents who participated in the discussion group reported fewer behavioral difficulties in their children after the intervention than those in the control condition. They also reported reduced parental stress and less use of dysfunctional parenting practices. There is a limited amount of evidence on the efficacy of parenting interventions in low-resource settings. This pilot trial was carried out using a small convenience sample living in low-income urban communities in Panama City, and therefore, the findings are of reduced generalizability to other settings. However, the methodology employed in this trial represents an example for future work in other low-resource settings.

  16. Influence of expectations plus mobilization with movement in patient with lateral epicondylalgia: a pilot randomized controlled trial.

    Science.gov (United States)

    Martínez-Cervera, Francisco Vicente; Olteanu, Theodor Emanuel; Gil-Martínez, Alfonso; Díaz-Pulido, Belén; Ferrer-Peña, Raúl

    2017-02-01

    The aim of this study was to determine the influence of expectations plus mobilization with movement (MWM) in kinesiophobia, perceived disability and sensorimotor variables in patients with lateral epicondylalgia. A pilot randomized controlled trial in 24 patients with lateral epicondylalgia was conducted. Perceived pain, pain-free grip strength, pressure pain detection threshold, kinesiophobia measured with the short version of Tampa Scale of Kinesiophobia, perceived disability of the upper limb measured with disability of the arm, hand and shoulder questionnaire, and perceived disability specifically for the elbow joint measured with patient-rating tennis elbow evaluation, and also satisfaction were assessed. Participants were randomized to receive written instructions in order to create positive expectations regarding the technique in one group (n=12) or neutral expectations in the other one (n=12). All patients were treated for three sessions with the MWM technique. Measures were recorded before and after treatment. The effect size was calculated by Rosenthal "r" for nonparametrical tests. There were no significant statistical differences (P>0.05) between groups after receiving the treatment for none of the physical analyzed variables. The Wilcoxon test showed statistically significant changes in kinesiophobia (Z=-2.278, r=0.47, P=0.023) and perceived disability (Z= -2.934, r=0.61, P=0.003) within positive expectations group. In conclusion this pilot study shows that a positive expectation almost given in a sealed envelope before treatment plus MWM produced changes in kinesiophobia and perceived disability in the immediate term, in patients with lateral epicondylalgia.

  17. Influence of expectations plus mobilization with movement in patient with lateral epicondylalgia: a pilot randomized controlled trial

    Science.gov (United States)

    Martínez-Cervera, Francisco Vicente; Olteanu, Theodor Emanuel; Gil-Martínez, Alfonso; Díaz-Pulido, Belén; Ferrer-Peña, Raúl

    2017-01-01

    The aim of this study was to determine the influence of expectations plus mobilization with movement (MWM) in kinesiophobia, perceived disability and sensorimotor variables in patients with lateral epicondylalgia. A pilot randomized controlled trial in 24 patients with lateral epicondylalgia was conducted. Perceived pain, pain-free grip strength, pressure pain detection threshold, kinesiophobia measured with the short version of Tampa Scale of Kinesiophobia, perceived disability of the upper limb measured with disability of the arm, hand and shoulder questionnaire, and perceived disability specifically for the elbow joint measured with patient-rating tennis elbow evaluation, and also satisfaction were assessed. Participants were randomized to receive written instructions in order to create positive expectations regarding the technique in one group (n=12) or neutral expectations in the other one (n=12). All patients were treated for three sessions with the MWM technique. Measures were recorded before and after treatment. The effect size was calculated by Rosenthal “r” for nonparametrical tests. There were no significant statistical differences (P>0.05) between groups after receiving the treatment for none of the physical analyzed variables. The Wilcoxon test showed statistically significant changes in kinesiophobia (Z=−2.278, r=0.47, P=0.023) and perceived disability (Z= −2.934, r=0.61, P=0.003) within positive expectations group. In conclusion this pilot study shows that a positive expectation almost given in a sealed envelope before treatment plus MWM produced changes in kinesiophobia and perceived disability in the immediate term, in patients with lateral epicondylalgia. PMID:28349041

  18. Randomized Trial of Telephone-Delivered Acceptance and Commitment Therapy Versus Cognitive Behavioral Therapy for Smoking Cessation: A Pilot Study

    Science.gov (United States)

    Bush, Terry; Zbikowski, Susan M.; Mercer, Laina D.; Heffner, Jaimee L.

    2014-01-01

    Objective: We conducted a pilot randomized trial of telephone-delivered acceptance and commitment therapy (ACT) versus cognitive behavioral therapy (CBT) for smoking cessation. Method: Participants were 121 uninsured South Carolina State Quitline callers who were adult smokers (at least 10 cigarettes/day) and who wanted to quit within the next 30 days. Participants were randomized to 5 sessions of either ACT or CBT telephone counseling and were offered 2 weeks of nicotine replacement therapy (NRT). Results: ACT participants completed more calls than CBT participants (M = 3.25 in ACT vs. 2.23 in CBT; p = .001). Regarding satisfaction, 100% of ACT participants reported their treatment was useful for quitting smoking (vs. 87% for CBT; p = .03), and 97% of ACT participants would recommend their treatment to a friend (vs. 83% for CBT; p = .06). On the primary outcome of intent-to-treat 30-day point prevalence abstinence at 6 months postrandomization, the quit rates were 31% in ACT versus 22% in CBT (odds ratio [OR] = 1.5, 95% confidence interval [CI] = 0.7–3.4). Among participants depressed at baseline (n = 47), the quit rates were 33% in ACT versus 13% in CBT (OR = 1.2, 95% CI = 1.0–1.6). Consistent with ACT’s theory, among participants scoring low on acceptance of cravings at baseline (n = 57), the quit rates were 37% in ACT versus 10% in CBT (OR = 5.3, 95% CI = 1.3–22.0). Conclusions: ACT is feasible to deliver by phone, is highly acceptable to quitline callers, and shows highly promising quit rates compared with standard CBT quitline counseling. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. PMID:24935757

  19. Alcohol withdrawal prevention: a randomized evaluation of lorazepam and ethanol--a pilot study

    National Research Council Canada - National Science Library

    Fullwood, Joyce E; Mostaghimi, Zhila; Granger, Christopher B; Washam, Jeffrey B; Bride, Wanda; Zhao, Yanfang; Granger, Bradi B

    2013-01-01

    .... To perform a randomized evaluation of lorazepam and ethanol/lorazepam to evaluate the safety and efficacy of these 2 strategies for preventing alcohol withdrawal syndrome in patients with acute coronary syndromes. Patients (n = 57...

  20. Treating major depression with yoga: A prospective, randomized, controlled pilot trial

    National Research Council Canada - National Science Library

    Sudha Prathikanti; Renee Rivera; Ashly Cochran; Jose Gabriel Tungol; Nima Fayazmanesh; Eva Weinmann

    2017-01-01

    .... Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression...

  1. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome: a randomized controlled pilot-study

    NARCIS (Netherlands)

    Boers, I.; Muskiet, F.A.J.; Berkelaar, E.; Schut, E.; Penders, R.; Hoenderdos, K.; Jong, de M.C.; Wichers, H.J.

    2014-01-01

    Background The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome. Next we searched for outcome variables that might become favourably influenced by a

  2. Results From a European Multicenter Randomized Trial of Physical Activity and/or Healthy Eating to Reduce the Risk of Gestational Diabetes Mellitus: The DALI Lifestyle Pilot

    NARCIS (Netherlands)

    Simmons, D.; Jelsma, J.G.M.; Galjaard, S.; Devlieger, R.; van Assche, A.; Jans, G.; Corcoy, R.; Adelantado, J.M.; Dunne, F.; Desoye, G.; Harreiter, J.; Kautzky-Willer, A.; Damm, P.; Mathiesen, E.R.; Jensen, D.M.; Andersen, L.L.; Lapolla, A.; Dalfra, M.; Bertolotto, A.; Wender-Ozegowska, E.; Zawiejska, A.; Hill, D.; Rebollo, P.; Snoek, F.J.; van Poppel, M.N.M.

    2015-01-01

    OBJECTIVE Ways to prevent gestational diabetes mellitus (GDM) remain unproven. We compared the impact of three lifestyle interventions (healthy eating [HE], physical activity [PA], and both HE and PA [HE+PA]) on GDM risk in a pilot multicenter randomized trial. RESEARCH DESIGN AND METHODS Pregnant

  3. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome : a randomized controlled pilot-study

    NARCIS (Netherlands)

    Boers, Inge; Muskiet, Frits A. J.; Berkelaar, Evert; Schut, Erik; Penders, Ria; Hoenderdos, Karine; Wichers, Harry J.; Jong, Miek C.

    2014-01-01

    Background: The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome. Next we searched for outcome variables that might become favourably influenced by a

  4. Implementing a Pilot Trial of an Infection Control Program in Nursing Homes: Results of a Matched Cluster Randomized Trial.

    Science.gov (United States)

    McConeghy, Kevin W; Baier, Rosa; McGrath, Kevin P; Baer, Christof J; Mor, Vincent

    2017-08-01

    Hand hygiene is the single-most important nursing home (NH) infection control measure. We piloted a multifaceted hand-washing/surface cleaning intervention in 5 NHs. Our aims were to assess the feasibility of implementing this intervention by assessing staff participation, satisfaction, hand-washing compliance, and whether the intervention was associated with reductions in infection rates, new antimicrobial orders, or overall hospitalization rates. We conducted a randomized, pair-matched pilot intervention in 10 Colorado NHs to reduce infections for all NH residents from October 1, 2015 through May 31, 2016. To evaluate process, we determined online education participation rates, recorded intervention fidelity through weekly reporting measures on microbial surface counts, hand-washing, and infection reporting, and conducted a survey of participating employees. To evaluate potential impacts on clinical outcomes, we collected information on monthly infection log data, new antibiotic orders, and hospitalizations. Three of 5 sites had education participation rates >90%, the other 2 were poor (13% and 23%). The majority of participation survey respondents (58%) were promoters of the intervention. Directors of nursing reported hygiene hand-washing data for 19.6/24 (81.8%) weeks and microbial surface count data for 20.4/24 (85.1%) weeks. For the first 4 weeks of the study, the bacterial counts averaged 351.4 ± 497.5 relative light units, the mean value for the last 4 weeks was 127.7 ± 85.1 (P value = .12). The number of hand-washing occasions per NH resident was steady over time but differed by treatment facility (P = .03). We observed nonsignificant reductions for total infections (6.7%) and lower respiratory tract infections (19.9%) vs control NHs. There were no significant differences in antimicrobial orders or hospitalization rates pre-post intervention. This multifaceted hand-washing and surface cleaning intervention was designed to reduce infection rates

  5. A Randomized Controlled Trial of Corticosteroids in Pediatric Septic Shock: A Pilot Feasibility Study.

    Science.gov (United States)

    Menon, Kusum; McNally, Dayre; O'Hearn, Katharine; Acharya, Anand; Wong, Hector R; Lawson, Margaret; Ramsay, Tim; McIntyre, Lauralyn; Gilfoyle, Elaine; Tucci, Marisa; Wensley, David; Gottesman, Ronald; Morrison, Gavin; Choong, Karen

    2017-06-01

    To determine the feasibility of conducting a randomized controlled trial of corticosteroids in pediatric septic shock. Randomized, double-blind, placebo controlled trial. Seven tertiary level PICUs in Canada. Children newborn to 17 years old inclusive with suspected septic shock. Administration of IV hydrocortisone versus placebo until hemodynamic stability is achieved or for a maximum of 7 days. One hundred seventy-four patients were potentially eligible of whom 101 patients met eligibility criteria. Fifty-seven patients were randomized, and 49 patients (23 and 26 patients in the hydrocortisone and placebo groups, respectively) were included in the final analysis. The mean time from screening to randomization was 2.4 ± 2.1 hours and from screening to first dose of study drug was 3.8 ± 2.6 hours. Forty-two percent of potentially eligible patients (73/174) received corticosteroids prior to randomization: 38.5% (67/174) were already on corticosteroids for shock at the time of screening, and in 3.4% (6/174), the treating physician wished to administer corticosteroids. Six of 49 randomized patients (12.2%) received open-label steroids, three in each of the hydrocortisone and placebo groups. Time on vasopressors, days on mechanical ventilation, PICU and hospital length of stay, and the rate of adverse events were not statistically different between the two groups. This study suggests that a large randomized controlled trial on early use of corticosteroids in pediatric septic shock is potentially feasible. However, the frequent use of empiric corticosteroids in otherwise eligible patients remains a significant challenge. Knowledge translation activities, targeted recruitment, and alternative study designs are possible strategies to mitigate this challenge.

  6. Randomized controlled clinical pilot trial of titanium vs. glass fiber prefabricated posts: preliminary results after up to 3 years.

    Science.gov (United States)

    Naumann, Michael; Sterzenbac, Guido; Alexandra, Franke; Dietrich, Thomas

    2007-01-01

    This randomized parallel-group clinical pilot study aimed to compare the clinical outcome of prefabricated rigid titanium to glass fiber endodontic posts when luted with self-adhesive universal resin cement. Ninety-eight patients in need of postendodontic restoration were assessed for eligibility. Ninety-one patients met the selection criteria and were randomized and allocated to 2 intervention groups. Forty-five participants were treated using a titanium post and 46 participants received a glass fiber post, each in combination with composite core buildups for postendodontic restoration. All posts had a diameter of 1.4 mm and a length of 13 mm and were cemented 8 mm within the root canal with self-adhesive universal resin cement. A circumferential ferrule of 2 mm was always provided. Surgical crown lengthening was necessary in 13 cases. Patients were observed in intervals of 3, 6, 12, 24, and 36 months after post placement. After 24 to 36 months (mean +/- SD: 27.9 +/- 5.6) of observation following post placement, 1 tooth was extracted because of changes of the prosthetic treatment plan. No failures were observed among the 88 patients with follow-up data. Both titanium and glass fiber reinforced composite posts result in successful treatment outcomes after 2 years. The material combination used seems to be appropriate in the short term for cementing endodontic posts, irrespective of the post material.

  7. kinesiotaping reduces pain and modulates sensory function in patients with focal dystonia: a randomized crossover pilot study.

    Science.gov (United States)

    Pelosin, Elisa; Avanzino, Laura; Marchese, Roberta; Stramesi, Paola; Bilanci, Martina; Trompetto, Carlo; Abbruzzese, Giovanni

    2013-10-01

    Pain is one of the most common and disabling "nonmotor" symptoms in patients with dystonia. No recent study evaluated the pharmacological or physical therapy approaches to specifically treat dystonic pain symptoms. To evaluate the effectiveness of KinesioTaping in patients with cervical dystonia (CD) and focal hand dystonia (FHD) on self-reported pain (primary objective) and on sensory functions (secondary objective). Twenty-five dystonic patients (14 with CD and 11 FHD) entered a randomized crossover pilot study. The patients were randomized to 14-day treatment with KinesioTaping or ShamTaping over neck (in CD) or forearm muscles (in FHD), and after a 30-day washout period, they received the other treatment. The were 3 visual analog scales (VASs) for usual pain, worst pain, and pain relief. Disease severity changes were evaluated by means of the Toronto Western Spasmodic Torticollis Rating Scale (CD) and the Writer's Cramp Rating Scale (FHD). Furthermore, to investigate possible KinesioTaping-induced effects on sensory functions, we evaluated the somatosensory temporal discrimination threshold. Treatment with KinesioTape induced a decrease in the subjective sensation of pain and a modification in the ability of sensory discrimination, whereas ShamTaping had no effect. A significant, positive correlation was found in both groups of patients between the improvement in the subjective sensation of pain and the reduction of somatosensory temporal discrimination threshold values induced by KinesioTaping. These preliminary results suggest that KinesioTaping may be useful in treating pain in patients with dystonia.

  8. Guided imagery to improve functional outcomes post-anterior cruciate ligament repair: randomized-controlled pilot trial.

    Science.gov (United States)

    Maddison, R; Prapavessis, H; Clatworthy, M; Hall, C; Foley, L; Harper, T; Cupal, D; Brewer, B

    2012-12-01

    Imagery can improve functional outcomes post-anterior cruciate ligament repair (ACLR). Research is needed to investigate potential mechanisms for this effect. The aim of this study was to (a) evaluate the effectiveness of an imagery intervention to improve functional outcomes post-ACLR, and (b) explore potential mechanisms. A randomized-controlled pilot trial was conducted. Participants were randomized to guided imagery and standard rehabilitation or standard rehabilitation alone (control). The primary outcome was knee strength 6-month post-operatively. Secondary outcomes were knee laxity at 6-months, and change in psychological (self-efficacy) and neurohormonal (adrenaline, noradrenaline, dopamine) variables. Participants (n=21; 62% male) were 34.86 (SD 8.84) years. Following the intervention, no statistical differences between groups for knee strength extension at 180°/s (t=-0.43, P=0.67), or at 60°/s (t=-0.72, P=0.48) were found. A statistically significant effect was found for knee laxity, F=4.67, Pimagery intervention improved knee laxity and healing-related neurobiological factors. © 2011 John Wiley & Sons A/S.

  9. Sage tea-thyme-peppermint hydrosol oral rinse reduces chemotherapy-induced oral mucositis: A randomized controlled pilot study.

    Science.gov (United States)

    Mutluay Yayla, Ezgi; Izgu, Nur; Ozdemir, Leyla; Aslan Erdem, Sinem; Kartal, Murat

    2016-08-01

    This pilot study aimed to investigate the preventive effect of sage tea-thyme-peppermint hydrosol oral rinse used in conjunction with basic oral care on chemotherapy-induced oral mucositis. An open-label randomized controlled study. Two oncology hospitals in Ankara, Turkey. Patients receiving 5-fluorouracil-based chemotherapy regimens were divided into the intervention group (N=30) and control group (N=30). Basic oral care was prescribed to the control group, while the intervention group was prescribed sage tea-thyme-peppermint hydrosol in addition to basic oral care. All patients were called to assess their compliance with the study instructions on day 5 and 14. Oral mucositis was evaluated using an inspection method or by assessing oral cavity photos based on the World Health Organization oral toxicity scale on day 5 and 14. Most of the patients in the intervention group did not develop oral mucositis on day 5. In addition, the incidence of grade 1 oral mucositis was statistically lower in the intervention group (10%) than the control group (53.3%) on day 5. By day 14, the majority of patients in both the groups had grade 0 oral mucositis. Sage tea-thyme-peppermint hydrosol oral rinse has promising results in alleviating oral mucositis. This hydrosol can be recommended for clinical use as it is well tolerated and cost-effective. However, further randomized controlled trials are needed to support the study. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. The effect of Spirulina platensis versus soybean on insulin resistance in HIV-infected patients: a randomized pilot study.

    Science.gov (United States)

    Marcel, Azabji-Kenfack; Ekali, Loni G; Eugene, Sobngwi; Arnold, Onana E; Sandrine, Edie D; von der Weid, Denis; Gbaguidi, Emmanuel; Ngogang, Jeanne; Mbanya, Jean C

    2011-07-01

    HIV-infected patients develop abnormalities of glucose metabolism due to the virus and antiretroviral drugs. Spirulina and soybean are nutritional supplements that are cheap, accessible in our community and affect glucose metabolism. We carried out a randomized study to assess the effect of Spirulina platensis versus soybean as a food supplement on HIV/HAART-associated insulin resistance (IR) in 33 insulin-resistant HIV-infected patients. The study lasted for two months at the National Obesity Centre of Cameroon. Insulin resistance was measured using the short insulin tolerance test. Physical activity and diet did not change over the study duration. On-treatment analysis was used to analyze data. The Mann-Whitney U test, the Students T test and the Chi square test were used as appropriate. Curve gradients were analyzed using ANCOVA. Seventeen subjects were randomized to spirulina and 16 to soybean. Each received 19 g of supplement daily. The follow up rate was 65% vs. 100% for spirulina and soybean groups, respectively, and both groups were comparable at baseline. After eight weeks, insulin sensitivity (IS) increased by 224.7% vs. 60% in the spirulina and soybean groups respectively (p spirulina versus soybean, respectively, improved their IS (p = 0.049) with a 1.45 (1.05-2.02) chance of improving insulin sensitivity on spirulina. This pilot study suggests that insulin sensitivity in HIV patients improves more when spirulina rather than soybean is used as a nutritional supplement. ClinicalTrials.gov identifier NCT01141777.

  11. Fecal Microbial Transplant In Children With Ulcerative Colitis: A Randomized, Double-Blinded, Placebo-Controlled Pilot Study.

    Science.gov (United States)

    Michail, Sonia

    2017-10-06

    Ulcerative colitis (UC) is a condition characterized by chronic inflammation of the colon and is related to a genetically and environmentally-generated altered immune response to the enteric microbiome. Previous work in the PI laboratory suggests that children with UC harbor a unique gut microbial profile, which can predict therapeutic response. We hypothesized that children with ulcerative colitis will benefit from fecal transplant therapy (FMT). To this date there have been a number of reports describing the role of FMT in this disease albeit without uniform success and without controlled pediatric studies. Therefore, there is a strong need to determine its safety and efficacy in controlled trials. We report pilot data in a randomized, double-blinded, controlled study to evaluate the safety and efficacy of FMT from healthy donor versus placebo (subject's own stools) in combination with 5-ASA in mild to moderate disease. Twelve children were randomized to receive FMT or placebo. Subjects were monitored for 12 months. Remission or a 20-point improvement of PUCAI scores were seen in 60% of children receiving FMT versus 28% receiving placebo. More importantly, children receiving FMT did not require escalation of therapy in contrast to 71% receiving placebo. No serious adverse events related to FMT. Bloating and fever were adverse events that were considered related to FMT. To summarize, there appears to be a prospect of benefit in this small number of children receiving FMT for mild to moderate ulcerative colitis. FMT appeared to be safe in this patient population.

  12. Effects of exercise and Kinesio taping on abdominal recovery in women with cesarean section: a pilot randomized controlled trial.

    Science.gov (United States)

    Gürşen, Ceren; İnanoğlu, Deniz; Kaya, Serap; Akbayrak, Türkan; Baltacı, Gül

    2016-03-01

    Abdominal muscle strength decreases and fat ratio in the waist region increases following cesarean section. Kinesio taping (KT) is an easily applicable method and stimulates muscle activation. The aim of this pilot randomized controlled trial (RCT) was to investigate the effects of KT combined with exercise in women with cesarean section on abdominal recovery compared to the exercise alone. Twenty-four women in between the fourth and sixth postnatal months who had cesarean section were randomly assigned to KT + exercise (n = 12) group or exercise group (n = 12). KT was applied twice a week for 4 weeks on rectus abdominis, oblique abdominal muscles and cesarean incision. All women were instructed to carry out posterior pelvic tilt, core stabilization and abdominal correction exercises. Outcome measures were evaluated with the manual muscle test, sit-up test, abdominal endurance test, Visual Analog Scale (VAS), circumference measurements and Roland Morris Disability Questionnaire (RMDQ). Mann-Whitney U and Wilcoxon tests were used to analyze data. p exercise group was significantly greater compared to the exercise group in terms of the strength of the rectus abdominis muscle, sit-up test, VAS, measurements of the waist circumference and RMDQ (p exercises in the postnatal physiotherapy program provides greater benefit for the abdominal recovery in women with cesarean section. Further studies with larger sample sizes and long-term follow-up are needed to verify these results.

  13. Enhancing Resourcefulness to Improve Outcomes in Family Caregivers and Persons with Alzheimer’s Disease: A Pilot Randomized Trial

    Directory of Open Access Journals (Sweden)

    Elizabeth W. Gonzalez

    2014-01-01

    Full Text Available This pilot randomized trial tested an intervention aimed at enhancing resourcefulness in family caregivers of persons with dementia, postulating that caregivers’ emotional outcomes (anxiety and depression and role outcomes (reward, strain, mutuality, and preparedness would be improved, and problem behaviors in the care recipients (persons with dementia would be reduced as a result of the intervention. Subjects were stratified by race (white or African American and by baseline resourcefulness (high or low. Family caregivers were randomly assigned to an intervention group in which subjects attended six resourcefulness training sessions, meeting for 2 hours weekly over 6 weeks, or to a control group that received no treatment. Small to medium effects were shown for the intervention program on resourcefulness, anxiety, and preparedness of the caregivers and on frequency of behavior problems in the care recipients. Caregivers in the intervention group reported significantly more resourcefulness skills, with a medium effect at week 6 and a small effect 12 weeks later, compared with the control group. Persons with dementia had fewer behavior problems in the intervention group compared with control, although the difference was not significant. Caregivers’ anxiety was reduced in the intervention group at 12 weeks.

  14. Tai-Chi for Residential Patients with Schizophrenia on Movement Coordination, Negative Symptoms, and Functioning: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Rainbow T. H. Ho

    2012-01-01

    Full Text Available Objective. Patients with schizophrenia residing at institutions often suffer from negative symptoms, motor, and functional impairments more severe than their noninstitutionalized counterparts. Tai-chi emphasizes body relaxation, alertness, and movement coordination with benefits to balance, focus, and stress relief. This pilot study explored the efficacy of Tai-chi on movement coordination, negative symptoms, and functioning disabilities towards schizophrenia. Methods. A randomized waitlist control design was adopted, where participants were randomized to receive either the 6-week Tai-chi program and standard residential care or only the latter. 30 Chinese patients with schizophrenia were recruited from a rehabilitation residency. All were assessed on movement coordination, negative symptoms, and functional disabilities at baseline, following intervention and 6 weeks after intervention. Results. Tai-chi buffered from deteriorations in movement coordination and interpersonal functioning, the latter with sustained effectiveness 6 weeks after the class was ended. Controls showed marked deteriorations in those areas. The Tai-chi group also experienced fewer disruptions to life activities at the 6-week maintenance. There was no significant improvement in negative symptoms after Tai-chi. Conclusions. This study demonstrated encouraging benefits of Tai-chi in preventing deteriorations in movement coordination and interpersonal functioning for residential patients with schizophrenia. The ease of implementation facilitates promotion at institutional psychiatric services.

  15. Auricular Point Acupressure to Manage Chronic Low Back Pain in Older Adults: A Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Chao Hsing Yeh

    2014-01-01

    Full Text Available This prospective, randomized clinical trial (RCT pilot study was designed to (1 assess the feasibility and tolerability of an easily administered, auricular point acupressure (APA intervention and (2 provide an initial assessment of effect size as compared to a sham treatment. Thirty-seven subjects were randomized to receive either the real or sham APA treatment. All participants were treated once a week for 4 weeks. Self-report measures were obtained at baseline, weekly during treatment, at end-of-intervention (EOI, and at a 1-month follow-up. A dropout rate of 26% in the real APA group and 50% in the sham group was observed. The reduction in worst pain from baseline to EOI was 41% for the real and 5% for the sham group with a Cohen’s effect size of 1.22 P<0.00. Disability scores on the Roland Morris Disability Questionnaire (RMDQ decreased in the real group by 29% and were unchanged in the sham group (+3% P<0.00. Given the high dropout rate, results must be interpreted with caution; nevertheless, our results suggest that APA may provide an inexpensive and effective complementary approach for the management of back pain in older adults, and further study is warranted.

  16. Switching to Clozapine Using Immediate Versus Gradual Antipsychotic Discontinuation: A Pilot, Double-Blind, Randomized Controlled Trial.

    Science.gov (United States)

    Takeuchi, Hiroyoshi; Lee, Jimmy; Fervaha, Gagan; Foussias, George; Agid, Ofer; Remington, Gary

    2017-02-01

    To examine effects of different antipsychotic discontinuation strategies on clinical outcomes in patients with schizophrenia undergoing a switch to clozapine. This pilot, 8-week, double-blind, randomized controlled trial was conducted from May 1999 to July 2004. Outpatients with a diagnosis of schizophrenia or schizoaffective disorder based on the Structured Clinical Interview for DSM-IV and eligible for a switch to clozapine were included. Participants were randomly assigned to the immediate discontinuation (prior antipsychotics were discontinued at baseline) or gradual discontinuation (prior antipsychotics were reduced by 25% each week) group. For each group, clozapine was gradually increased to 300 mg/d at day 12, with this dose maintained for 3 weeks and thereafter adjusted as needed. Clinical outcome measures included the Brief Psychiatric Rating Scale (BPRS), UKU Side Effect Rating Scale, and extrapyramidal symptoms scales. Thirty-three patients were enrolled; 15 and 18 patients were assigned to the immediate and gradual discontinuation groups, respectively. While significant improvements were observed in BPRS total scores after the switch to clozapine in both groups (P values clozapine in patients with schizophrenia; however, due to the small sample size, larger-scale trials are needed to confirm these results. ClinicalTrials.gov identifier: NCT02640300.

  17. The impact of tailored text messages on health beliefs and medication adherence in adults with diabetes: A randomized pilot study.

    Science.gov (United States)

    Gatwood, Justin; Balkrishnan, Rajesh; Erickson, Steven R; An, Lawrence C; Piette, John D; Farris, Karen B

    2016-01-01

    Inadequate medication adherence reduces optimal health outcomes and can lead to increased costs, particularly in patients with diabetes. Efforts to improve adherence have resulted in limited effects; approaches leveraging mobile technology have emerged, but their focus has mainly been limited to simple reminder messages. The purpose of this pilot study was to test the effectiveness of tailored text messages focusing on improving medication adherence and health beliefs in adults with diabetes. Adults aged 21-64, with uncontrolled diabetes, and taking at least one anti-diabetic medication were recruited and randomized into 2 study arms: daily tailored text messaging for 90 days or standard care. Comparing baseline and endpoint survey responses, changes in theory-driven health beliefs and attitudes were assessed. The impact on medication adherence was evaluated using pharmacy claims by calculating the percent of days covered (PDC). A total of 75 subjects were consented, and 48 were randomized. Mean PDC at baseline were comparable between cohorts (84.4% and 87.1%, respectively). Declines in adherence were observed in both groups over time but no significant differences were observed between groups or from baseline to the end of the active study period. Unadjusted tests suggested that perceived benefits and competence might have improved in the intervention arm. Tailoring mobile phone text messages is a novel way to address medication nonadherence and health beliefs; further investigation to this combined technique is needed to better understand its impact on behavior change in adults with diabetes. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Effects of the addition of transcranial direct current stimulation to virtual reality therapy after stroke: a pilot randomized controlled trial.

    Science.gov (United States)

    Viana, R T; Laurentino, G E C; Souza, R J P; Fonseca, J B; Silva Filho, E M; Dias, S N; Teixeira-Salmela, L F; Monte-Silva, K K

    2014-01-01

    Upper limb (UL) impairment is the most common disabling deficit following a stroke. Previous studies have suggested that transcranial direct current stimulation (tDCS) enhances the effect of conventional therapies. This pilot double-blind randomized control trial aimed to determine whether or not tDCS, combined with Wii virtual reality therapy (VRT), would be superior to Wii therapy alone in improving upper limb function and quality of life in chronic stroke individuals. Twenty participants were randomly assigned either to an experimental group that received VRT and tDCS, or a control group that received VRT and sham tDCS. The therapy was delivered over 15 sessions with 13 minutes of active or sham anodal tDCS, and one hour of virtual reality therapy. The outcomes included were determined using the Fugl-Meyer scale, the Wolf motor function test, the modified Ashworth scale (MAS), grip strength, and the stroke specific quality of life scale (SSQOL). Minimal clinically important differences (MCID) were observed when assessing outcome data. Both groups demonstrated gains in all evaluated areas, except for the SSQOL-UL domain. Differences between groups were only observed in wrist spasticity levels in the experimental group, where more than 50% of the participants achieved the MCID. These findings support that tDCS, combined with VRT therapy, should be investigated and clarified further.

  19. Vasopressin versus dopamine for treatment of hypotension in extremely low birth weight infants: a randomized, blinded pilot study.

    Science.gov (United States)

    Rios, Danielle R; Kaiser, Jeffrey R

    2015-04-01

    To evaluate vasopressin vs dopamine as initial therapy in extremely low birth weight (ELBW) infants with hypotension during the first 24 hours of life. ELBW infants with hypertension ≤ 30 weeks' gestation and ≤ 24 hours old randomly received treatment with vasopressin or dopamine in a blinded fashion. Normotensive infants not receiving vasopressor support served as a comparison group. Twenty ELBW infants with hypertension received vasopressin (n = 10) or dopamine (n = 10), and 50 were enrolled for comparison. Mean gestational age was 25.6 ± 1.4 weeks and birth weight 705 ± 154 g. Response to vasopressin paralleled that of dopamine in time to adequate mean blood pressure (Kaplan-Meier curve, P = .986); 90% of infants in each treatment group responded with adequate blood pressure. The vasopressin group received fewer doses of surfactant (P hypotension appeared safe. This pilot study supports a larger randomized controlled trial of vasopressin vs dopamine therapy in ELBW infants with hypotension. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study.

    Science.gov (United States)

    Bacić, Ivan; Druzijanić, Nikica; Karlo, Robert; Skifić, Ivan; Jagić, Stjepan

    2010-02-12

    Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy.

  1. Graduated exercise training and progressive resistance training in adolescents with chronic fatigue syndrome: a randomized controlled pilot study.

    Science.gov (United States)

    Gordon, Brett A; Knapman, Leona M; Lubitz, Lionel

    2010-12-01

    to investigate the differential effects of aerobic graded exercise and progressive resistance training on exercise tolerance, fatigue and quality of life in adolescent patients with chronic fatigue syndrome (CFS). single-blind, randomized controlled pilot trial. a major metropolitan hospital in Melbourne, Australia. twenty-two adolescents aged 13-18 years diagnosed with CFS and admitted to the inpatient chronic fatigue rehabilitation programme. patients were randomized to either graded aerobic exercise training or a progressive resistance training programme, for five days/week for four weeks. The graded aerobic training consisted of 20-40 minutes of stationary cycling and treadmill exercise. The progressive resistance training involved 16 exercises performed with single set, moderate load and high repetitions. exercise tolerance (time to fatigue) measured on a graded sub-maximal treadmill test, metabolic equivalents and quality of life, along with muscular strength (maximium push-ups) and endurance (sit-to-stand) and questionnaires evaluating depressive symptoms and fatigue severity. no intervention was significantly better than the other for any outcome. However, physical capacity and quality of life significantly improved in both groups, while fatigue severity and symptoms of depression improved only with aerobic training. resistance and aerobic training resulted in similar changes to physical capacity, quality of life and fatigue severity. Generally, patients who completed resistance training or aerobic training experienced significant improvements in outcomes from baseline when they entered the programme. Whether these improvements can be attributed to the treatment is unknown.

  2. Problem-solving education to prevent depression among low-income mothers of preterm infants: a randomized controlled pilot trial.

    Science.gov (United States)

    Silverstein, Michael; Feinberg, Emily; Cabral, Howard; Sauder, Sara; Egbert, Lucia; Schainker, Elisabeth; Kamholz, Karen; Hegel, Mark; Beardslee, William

    2011-08-01

    We sought to assess the feasibility and document key study processes of a problem-solving intervention to prevent depression among low-income mothers of preterm infants. A randomized controlled pilot trial (n = 50) of problem-solving education (PSE) was conducted. We assessed intervention provider training and fidelity; recruitment and retention of subjects; intervention acceptability; and investigators' ability to conduct monthly outcome assessments, from which we could obtain empirical estimates of depression symptoms, stress, and functioning over 6 months. Four of four bachelor-level providers were able to deliver PSE appropriately with standardized subjects within 4 weeks of training. Of 12 randomly audited PSE sessions with actual subjects, all met treatment fidelity criteria. Nineteen of 25 PSE subjects (76%) received full four-session courses; no subjects reported negative experiences with PSE. Eighty-eight percent of scheduled follow-up assessments were completed. Forty-four percent of control group mothers experienced an episode of moderately severe depression symptoms over the follow-up period, compared to 24% of PSE mothers. Control mothers experienced an average 1.19 symptomatic episodes over the 6 months of follow-up, compared to 0.52 among PSE mothers. PSE appears feasible and may be a promising strategy to prevent depression among mothers of preterm infants.

  3. Efficacy of a Peer-Led, Recovery-Oriented Shared Decision-Making System: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Yamaguchi, Sosei; Taneda, Ayano; Matsunaga, Asami; Sasaki, Natsuki; Mizuno, Masashi; Sawada, Yumiko; Sakata, Masuhiro; Fukui, Satoe; Hisanaga, Fumie; Bernick, Peter; Ito, Junichiro

    2017-12-01

    The effects of a comprehensive shared decision-making system based on the CommonGround approach and incorporating peer support and a computerized decision aid were investigated. A pilot randomized controlled trial with six-month follow-up was conducted in Japan. Fifty-six outpatients with mental illness were randomly allocated to a shared decision-making system (intervention) group or treatment as usual (control) group. The implementation process and several outcomes were compared between groups. The core components and processes of shared decision making were observed in the intervention group more frequently than in the control group. The intervention group also reported a significantly more positive participants' view of the relationship with their doctor than the control group. The intervention did not have a significant effect on most clinical and recovery-related outcomes. The shared decision-making system appeared to partly improve patients' perceptions of communication and relationships with doctors but did not have a significant effect on other patient-level outcomes.

  4. Cognitive Behavior Therapy to Treat Sleep Disturbance and Fatigue After Traumatic Brain Injury: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Nguyen, Sylvia; McKay, Adam; Wong, Dana; Rajaratnam, Shantha M; Spitz, Gershon; Williams, Gavin; Mansfield, Darren; Ponsford, Jennie L

    2017-08-01

    To evaluate the efficacy of adapted cognitive behavioral therapy (CBT) for sleep disturbance and fatigue in individuals with traumatic brain injury (TBI). Parallel 2-group randomized controlled trial. Outpatient therapy. Adults (N=24) with history of TBI and clinically significant sleep and/or fatigue complaints were randomly allocated to an 8-session adapted CBT intervention or a treatment as usual (TAU) condition. Cognitive behavior therapy. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) posttreatment and at 2-month follow-up. Secondary measures included the Insomnia Severity Index, Fatigue Severity Scale, Brief Fatigue Inventory (BFI), Epworth Sleepiness Scale, and Hospital Anxiety and Depression Scale. At follow-up, CBT recipients reported better sleep quality than those receiving TAU (PSQI mean difference, 4.85; 95% confidence interval [CI], 2.56-7.14). Daily fatigue levels were significantly reduced in the CBT group (BFI difference, 1.54; 95% CI, 0.66-2.42). Secondary improvements were significant for depression. Large within-group effect sizes were evident across measures (Hedges g=1.14-1.93), with maintenance of gains 2 months after therapy cessation. Adapted CBT produced greater and sustained improvements in sleep, daily fatigue levels, and depression compared with TAU. These pilot findings suggest that CBT is a promising treatment for sleep disturbance and fatigue after TBI. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  5. A Randomized Controlled Pilot Study to Investigate the Effect of Whole-Body Vibration on Lower-Extremity Fatigue.

    Science.gov (United States)

    Ansari, Noureddin Nakhostin; Naghdi, Soofia; Karimi-Zarchi, Hadi; Fakhari, Zahra; Hasson, Scott

    2017-09-01

    Whole-body vibration (WBV) is a type of weight-bearing exercise used in the field of sport and rehabilitation. There is no study on the effects of WBV on muscle recovery after a fatiguing activity. To determine the effects of a single WBV session on lower-extremity fatigue. Randomized controlled pilot study. University Physiotherapy Clinic. A total of 13 healthy young men volunteered to participate in this study. Subjects were randomly assigned into the WBV group (n = 7, mean age: 21 y) or control group (CG; n = 6, mean age: 20 y). Subjects in the WBV group participated in a single-session WBV (30 Hz, amplitude 4 mm, 2 min) after lower-extremity fatigue. Peak force of quadriceps muscle, single leg hop test, and Y-test were measured before inducing muscle fatigue (T0), immediately after completing the fatigue protocol (T1), after WBV (T2), and 15 min following the application of WBV (T3). The same method was applied in the CG while the WBV machine was turned off. Repeated-measure ANOVA revealed no significant differences between groups in any of the outcomes. The findings indicated that WBV was not effective in the recovery of lower-extremity fatigue in healthy young men.

  6. Manual and manipulative therapy in addition to rehabilitation for osteoarthritis of the knee: assessor-blind randomized pilot trial.

    Science.gov (United States)

    Dwyer, Lauren; Parkin-Smith, Gregory F; Brantingham, James W; Korporaal, Charmaine; Cassa, Tammy K; Globe, Gary; Bonnefin, Debra; Tong, Victor

    2015-01-01

    The purpose of this study was to examine the methodological integrity, sample size requirements, and short-term preliminary clinical outcomes of manual and manipulative therapy (MMT) in addition to a rehabilitation program for symptomatic knee osteoarthritis (OA). This was a pilot study of an assessor-blinded, randomized, parallel-group trial in 2 independent university-based outpatient clinics. Participants with knee OA were randomized to 3 groups: 6 MMT sessions alone, training in rehabilitation followed by a home rehabilitation program alone, or MMT plus the same rehabilitation program, respectively. Six MMT treatment sessions (provided by a chiropractic intern under supervision or by an experienced chiropractor) were provided to participants over the 4-week treatment period. The primary outcome was a description of the research methodology and sample size estimation for a confirmatory study. The secondary outcome was the short-term preliminary clinical outcomes. Data were collected at baseline and 5weeks using the Western Ontario and McMasters Osteoarthritis Index questionnaire, goniometry for knee flexion/extension, and the McMaster Overall Therapy Effectiveness inventory. Analysis of variance was used to compare differences between groups. Eighty-three patients were randomly allocated to 1 of the 3 groups (27, 28, and 28, respectively). Despite 5 dropouts, the data from 78 participants were available for analysis with 10% of scores missing. A minimum of 462 patients is required for a confirmatory 3-arm trial including the respective interventions, accounting for cluster effects and a 20% dropout rate. Statistically significant and clinically meaningful changes in scores from baseline to week 5 were found for all groups for the Western Ontario and McMasters Osteoarthritis Index (P ≤ .008), with a greater change in scores for MMT and MMT plus rehabilitation. Between-group comparison did not reveal statistically significant differences between group scores at

  7. Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

    Science.gov (United States)

    McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

    2008-01-01

    No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

  8. Early vibration assisted physiotherapy in toddlers with cerebral palsy - a randomized controlled pilot trial

    NARCIS (Netherlands)

    Stark, C.; Herkenrath, P.; Hollmann, H.; Waltz, S.; Becker, I.; Hoebing, L.; Semler, O.; Hoyer-Kuhn, H.; Duran, I.; Hero, B.; Hadders-Algra, M.; Schoenau, E.

    OBJECTIVES: to investigate feasibility, safety and efficacy of home-based side-alternating whole body vibration (sWBV) to improve motor function in toddlers with cerebral palsy (CP). METHODS: Randomized controlled trial including 24 toddlers with CP (mean age 19 months (SD±3.1); 13 boys).

  9. Aerobic exercise in obese diabetic patients with chronic kidney disease: a randomized and controlled pilot study

    Directory of Open Access Journals (Sweden)

    Cooper Cheryl

    2009-12-01

    Full Text Available Abstract Background Patients with obesity, diabetes, and chronic kidney disease (CKD are generally physically inactive, have a high mortality rate, and may benefit from an exercise program. Methods We performed a 24-week randomized controlled feasibility study comparing aerobic exercise plus optimal medical management to medical management alone in patients with type 2 diabetes, obesity (body mass index [BMI] > 30 kg/m2, and stage 2-4 CKD (estimated glomerular filtration rate [eGFR] 15-90 mL/min/1.73 m2 with persistent proteinuria. Subjects randomized to exercise underwent thrice weekly aerobic training for 6 followed by 18 weeks of supervised home exercise. The primary outcome variable was change in proteinuria. Results Seven subjects randomized to exercise and 4 control subjects completed the study. Exercise training resulted in an increase in exercise duration during treadmill testing, which was accompanied by slight but insignificant decreases in resting systolic blood pressure and 24-hour proteinuria. Exercise did not alter GFR, hemoglobin, glycated hemoglobin, serum lipids, or C-reactive protein (CRP. Caloric intake and body weight and composition also did not change with exercise training. Conclusion Exercise training in obese diabetic patients with CKD is feasible and may have clinical benefits. A large-scale randomized controlled trial to determine the effects of exercise on renal functions, cardiovascular fitness, inflammation, and oxidative stress in diabetic patients with CKD is planned.

  10. Promoting supportive parenting in new mothers with substance-use problems: a pilot randomized trial of residential treatment plus an attachment-based parenting program.

    Science.gov (United States)

    Berlin, Lisa J; Shanahan, Meghan; Appleyard Carmody, Karen

    2014-01-01

    This pilot randomized trial tested the feasibility and efficacy of supplementing residential substance-abuse treatment for new mothers with a brief, yet rigorous, attachment-based parenting program. Twenty-one predominantly (86%) White mothers and their infants living together in residential substance-abuse treatment were randomly assigned to the program (n = 11) or control (n = 10) group. Program mothers received 10 home-based sessions of Dozier's Attachment and Biobehavioral Catch-up (ABC) intervention. Postintervention observations revealed more supportive parenting behaviors among the randomly assigned ABC mothers. © 2013 Michigan Association for Infant Mental Health.

  11. The Effect of Head Massage on the Regulation of the Cardiac Autonomic Nervous System: A Pilot Randomized Crossover Trial.

    Science.gov (United States)

    Fazeli, Mir Sohail; Pourrahmat, Mir-Masoud; Liu, Mailan; Guan, Ling; Collet, Jean-Paul

    2016-01-01

    To evaluate the effect of a single 10-minute session of Chinese head massage on the activity of the cardiac autonomic nervous system via measurement of heart rate variability (HRV). In this pilot randomized crossover trial, each participant received both head massage and the control intervention in a randomized fashion. The study was conducted at Children's & Women's Health Centre of British Columbia between June and November 2014. Ten otherwise healthy adults (6 men and 4 women) were enrolled in this study. The intervention comprised 10 minutes of head massage therapy (HMT) in a seated position compared with a control intervention of sitting quietly on the same chair with eyes closed for an equal amount of time (no HMT). The primary outcome measures were the main parameters of HRV, including total power (TP), high frequency (HF), HF as a normalized unit, pre-ejection period, and heart rate (HR). A single short session (10 minutes) of head massage demonstrated an increase in TP continuing up to 20 minutes after massage and reaching statistical significance at 10 minutes after massage (relative change from baseline, 66% for HMT versus -6.6% for no HMT; p = 0.017). The effect on HF also peaked up to 10 minutes after massage (59.4% for HMT versus 4% for no HMT; p = 0.139). Receiving head massage also decreased HR by more than three-fold compared to the control intervention. This study shows the potential benefits of head massage by modulating the cardiac autonomic nervous system through an increase in the total variability and a shift toward higher parasympathetic nervous system activity. Randomized controlled trials with larger sample size and multiple sessions of massage are needed to substantiate these findings.

  12. Coadministration of lorcaserin and phentermine for weight management: A 12‐week, randomized, pilot safety study

    Science.gov (United States)

    Garvey, W. Timothy; Greenway, Frank L.; Zhou, Sharon; Fain, Randi; Pilson, Robert; Fujioka, Ken; Aronne, Louis J.

    2017-01-01

    Objective To assess the short‐term tolerability of lorcaserin alone or with two dose regimens of phentermine. Methods This was a 12‐week, randomized, double‐blind, pilot safety study of N = 238 nondiabetic patients with obesity or overweight with ≥1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting ≥ 1 of 9 potentially serotonergic adverse events (AEs), mean weight loss (WL), and ≥5% WL are reported. Results N = 238 were randomized, and N = 235 were treated. N = 94 reported potentially serotonergic AEs: 37.2% LOR BID, 42.3% LOR BID+PHEN QD, and 40.5% LOR BID+PHEN BID. AEs leading to discontinuation were reported approximately twice as often in the LOR BID+PHEN BID group versus the LOR BID group. Mean WL was 3.5 kg/3.3%, 7.0 kg/6.7%, and 7.6 kg/7.2% for LOR BID, LOR BID+PHEN QD, and LOR BID+PHEN BID, respectively. At least 5% WL was achieved by 28.2% LOR BID, 59.0% LOR BID+PHEN QD (P = 0.0002 vs. LOR BID), and 70.9% LOR BID+PHEN BID (P lorcaserin enhanced short‐term weight loss but did not increase incidence of potentially serotonergic AEs; however, phentermine twice daily increased discontinuation compared to both lorcaserin alone and lorcaserin plus phentermine once daily. PMID:28440045

  13. Randomized controlled pilot study of a SystemCHANGE™ weight management intervention in stroke survivors: rationale and protocol.

    Science.gov (United States)

    Plow, Matthew; Moore, Shirley M; Kirwan, John P; Frost, Fredrick; Katzan, Irene; Jaeger, Sue; Alberts, Jay

    2013-05-07

    Over 65% of stroke survivors are either overweight or obese and have multiple cardiovascular risk factors. However, few studies have examined the effects of comprehensive lifestyle behavior interventions to promote weight loss and control cardiovascular risk factors in stroke survivors. Thus, the purpose of this study is to examine a novel behavior change approach--SystemCHANGE™--to promote weight loss and improve health and function in stroke survivors. SystemCHANGE™ focuses on redesigning the social environment to achieve a specific goal. We will conduct a randomized controlled pilot study to examine the efficacy, feasibility, and safety of the SystemCHANGE™ weight management program in overweight and obese stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ intervention will help overweight and obese stroke survivors lose 5% of their body weight, thereby improving health and function. Thirty-five stroke survivors will be randomized into either the 6-month SystemCHANGE™ intervention or a contact-control intervention. Outcome measures will be assessed at baseline and again at 3 and 6 months after the interventions. Body composition will be assessed using a Bod Pod. Patient-reported outcomes will be the Stroke Impact Scale and Reintegration to Normal Living Index. Objective outcomes will include the 6-Minute Walking Test and Rivermead Motor Assessment. This study will be the first randomized controlled trial to evaluate the efficacy and safety of a weight management intervention in stroke survivors using the SystemCHANGE™ approach. Furthermore, it will be the first empirically-examined comprehensive lifestyle intervention designed to target physical activity, nutrition, and sleep to promote weight loss in stroke survivors. ClinicalTrials.gov Identifier: NCT01776034.

  14. A Binational Multicenter Pilot Feasibility Randomized Controlled Trial of Early Goal-Directed Mobilization in the ICU.

    Science.gov (United States)

    Hodgson, Carol L; Bailey, Michael; Bellomo, Rinaldo; Berney, Susan; Buhr, Heidi; Denehy, Linda; Gabbe, Belinda; Harrold, Megan; Higgins, Alisa; Iwashyna, Theodore J; Papworth, Rebecca; Parke, Rachael; Patman, Shane; Presneill, Jeffrey; Saxena, Manoj; Skinner, Elizabeth; Tipping, Claire; Young, Paul; Webb, Steven

    2016-06-01

    To determine if the early goal-directed mobilization intervention could be delivered to patients receiving mechanical ventilation with increased maximal levels of activity compared with standard care. A pilot randomized controlled trial. Five ICUs in Australia and New Zealand. Fifty critically ill adults mechanically ventilated for greater than 24 hours. Patients were randomly assigned to either early goal-directed mobilization (intervention) or to standard care (control). Early goal-directed mobilization comprised functional rehabilitation treatment conducted at the highest level of activity possible for that patient assessed by the ICU mobility scale while receiving mechanical ventilation. The ICU mobility scale, strength, ventilation duration, ICU and hospital length of stay, and total inpatient (acute and rehabilitation) stay as well as 6-month post-ICU discharge health-related quality of life, activities of daily living, and anxiety and depression were recorded. The mean age was 61 years and 60% were men. The highest level of activity (ICU mobility scale) recorded during the ICU stay between the intervention and control groups was mean (95% CI) 7.3 (6.3-8.3) versus 5.9 (4.9-6.9), p = 0.05. The proportion of patients who walked in ICU was almost doubled with early goal-directed mobilization (intervention n = 19 [66%] vs control n = 8 [38%]; p = 0.05). There was no difference in total inpatient stay (d) between the intervention versus control groups (20 [15-35] vs 34 [18-43]; p = 0.37). There were no adverse events. Key Practice Points: Delivery of early goal-directed mobilization within a randomized controlled trial was feasible, safe and resulted in increased duration and level of active exercises.

  15. An internet-based self-management program with telephone support for adolescents with arthritis: a pilot randomized controlled trial.

    Science.gov (United States)

    Stinson, Jennifer N; McGrath, Patrick J; Hodnett, Ellen D; Feldman, Brian M; Duffy, Ciaran M; Huber, Adam M; Tucker, Lori B; Hetherington, C Ross; Tse, Shirley M L; Spiegel, Lynn R; Campillo, Sarah; Gill, Navreet K; White, Meghan E

    2010-09-01

    To determine the feasibility of a 12-week Internet-based self-management program of disease-specific information, self-management strategies, and social support with telephone support for youth with juvenile idiopathic arthritis (JIA) and their parents, aimed at reducing physical and emotional symptoms and improving health-related quality of life (HRQOL). A nonblind pilot randomized controlled trial (NCT01011179) was conducted to test the feasibility of the "Teens Taking Charge: Managing Arthritis Online" Internet intervention across 4 tertiary-level centers in Canada. Participants were 46 adolescents with JIA, ages 12 to 18 years, and 1 parent for each participant, who were randomized to the control arm (n = 24) or the Internet intervention (n = 22). The 2 groups were comparable on demographic and disease-related variables and treatment expectation at baseline. Attrition rates were 18.1% and 20.8%, respectively, from experimental and control groups. Ninety-one percent of participants randomized to the experimental group completed all 12 online modules and weekly phone calls with a coach in an average of 14.7 weeks (SD 2.1). The control group completed 90% of weekly attention-control phone calls. The Internet treatment was rated as acceptable by all youth and their parents. In posttreatment the experimental group had significantly higher knowledge (p < 0.001, effect size 1.32) and lower average weekly pain intensity (p = 0.03, effect size 0.78). There were no significant group differences in HRQOL, self-efficacy, adherence, and stress posttreatment. Findings support the feasibility (acceptability, compliance, and user satisfaction) and initial efficacy of Internet delivery of a self-management program for improving disease-specific knowledge and reducing pain in youth with JIA.

  16. Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study.

    Science.gov (United States)

    Stoppe, C; Fahlenkamp, A V; Rex, S; Veeck, N C; Gozdowsky, S C; Schälte, G; Autschbach, R; Rossaint, R; Coburn, M

    2013-09-01

    To date, only limited data exist about the use of xenon as an anaesthetic agent in patients undergoing cardiac surgery. The favourable cardio- and neuroprotective properties of xenon might attenuate postoperative complications, improve outcome, and reduce the incidence of delirium. Thus, the aims of this study were to investigate the feasibility and safety of balanced xenon anaesthesia in patients undergoing cardiac surgery and to gather pilot data for a future randomized multicentre study. Thirty patients undergoing elective coronary artery bypass grafting were enrolled in this randomized, single-blind controlled trial. They were randomized to receive balanced general anaesthesia with either xenon (45-50 vol%) or sevoflurane (1-1.4 vol%). The primary outcome was the occurrence of adverse events (AEs). Secondary outcome parameters were feasibility criteria (bispectral index, perioperative haemodynamic, and respiratory profile) and safety parameters (dosage of study treatments, renal function, intraoperative blood loss, need for inotropic support, regional cerebral tissue oxygenation). Furthermore, at predefined time points, systemic and pulmonary haemodynamics were assessed by the use of a pulmonary artery catheter. There were no patient characteristic differences between the groups. Patients undergoing xenon anaesthesia did not differ with respect to the incidence of AE (6 vs 8, P=0.464) compared with the sevoflurane group. No differences were detected regarding secondary feasibility and safety criteria. The haemodynamic and respiratory profile was comparable between the treatment groups. Balanced xenon anaesthesia is feasible and safe compared with sevoflurane anaesthesia in patients undergoing coronary artery bypass surgery. Acronym CARDIAX: A pre- and post-coronary artery bypass graft implantation disposed application of xenon. Clinical trial registration ClinicalTrials.gov: NCT01285271; EudraCT-number: 2010-023942-63. Approved by the ethics committee 'Ethik

  17. Effects of Positive Psychology Interventions on Risk Biomarkers in Coronary Patients: A Randomized, Wait-List Controlled Pilot Trial.

    Science.gov (United States)

    Nikrahan, Gholam Reza; Laferton, Johannes A C; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C

    2016-01-01

    Among cardiac patients, positive psychologic factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychologic well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of 3 distinct PPIs on risk biomarkers in cardiac patients. In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to (1) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or (2) a wait-list control group. Risk biomarkers were assessed at baseline, postintervention (7 weeks), and at 15-week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Compared with the control group, participants randomized to the Seligman (B = -2.06; p = 0.02) and Fordyce PPI (B = -1.54; p = 0.04) had significantly lower high-sensitivity C-reactive protein levels at 7 weeks. Further, the Lyubomirsky PPI (B = -245.86; p = 0.04) was associated with a significantly lower cortisol awakening response at 7 weeks when compared with control participants. There were no other significant between-group differences. Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. All rights reserved.

  18. Guided Training Relative to Direct Skill Training for Individuals With Cognitive Impairments After Stroke: A Pilot Randomized Trial.

    Science.gov (United States)

    Skidmore, Elizabeth R; Butters, Meryl; Whyte, Ellen; Grattan, Emily; Shen, Jennifer; Terhorst, Lauren

    2017-04-01

    To examine the effects of direct skill training and guided training for promoting independence after stroke. Single-blind randomized pilot study. Inpatient rehabilitation facility. Participants in inpatient rehabilitation with acute stroke and cognitive impairments (N=43). Participants were randomized to receive direct skill training (n=22, 10 sessions as adjunct to usual inpatient rehabilitation) or guided training (n=21, same dose). The FIM assessed independence at baseline, rehabilitation discharge, and months 3, 6, and 12. Linear mixed models (random intercept, other effects fixed) revealed a significant intervention by time interaction (F4,150=5.11, P<.001), a significant main effect of time (F4,150=49.25, P<.001), and a significant effect of stroke severity (F1,150=34.46, P<.001). There was no main effect of intervention (F1,150=.07, P=.79). Change in FIM scores was greater for the direct group at rehabilitation discharge (effect size of between-group differences, d=.28) and greater for the guide group at months 3 (d=.16), 6 (d=.39), and 12 (d=.53). The difference between groups in mean 12-month change scores was 10.57 points. Guided training, provided in addition to usual care, offered a small advantage in the recovery of independence, relative to direct skill training. Future studies examining guided training in combination with other potentially potent intervention elements may further advise best practices in rehabilitation for individuals with cognitive impairments after acute stroke. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  19. Effects of quetiapine and olanzapine in patients with psychosis and violent behavior: a pilot randomized, open-label, comparative study

    Directory of Open Access Journals (Sweden)

    Gobbi G

    2014-05-01

    Full Text Available Gabriella Gobbi,1,2 Stefano Comai,1 Guy Debonnel1,2,† 1Neurobiological Psychiatric Unit, Department of Psychiatry, McGill University and McGill University Health Center, 2Institut Philippe Pinel, Department of Psychiatry, Université de Montréal, Montréal, QC, Canada †Guy Debonnel passed away on November 4, 2006 Objective: Patients suffering from psychosis are more likely than the general population to commit aggressive acts, but the therapeutics of aggressive behavior are still a matter of debate. Methods: This pilot randomized, open-label study compared the efficacy of quetiapine versus olanzapine in reducing impulsive and aggressive behaviors (primary endpoints and psychotic symptoms (secondary endpoints from baseline to days 1, 7, 14, 28, 42, 56, and 70, in 15 violent schizophrenic patients hospitalized in a maximum-security psychiatric hospital. Results: Quetiapine (525±45 mg and olanzapine (18.5±4.8 mg were both efficacious in reducing Impulsivity Rating Scale from baseline to day 70. In addition, both treatments reduced the Brief Psychiatric Rating Scale, Positive and Negative Syndrome Scale, and Clinical Global Impression Scale scores at day 70 compared to baseline, and no differences were observed between treatments. Moreover, quetiapine, but not olanzapine, yielded an improvement of depressive symptoms in the items “depression” in Brief Psychiatric Rating Scale and “blunted affect” in Positive and Negative Syndrome Scale. Modified Overt Aggression Scale scores were also decreased from baseline to the endpoint, but due to the limited number of patients, it was not possible to detect a significant difference. Conclusion: In this pilot study, quetiapine and olanzapine equally decreased impulsive and psychotic symptoms after 8 weeks of treatment. Double-blind, large studies are needed to confirm the validity of these two treatments in highly aggressive and violent schizophrenic patients. Keywords: schizophrenia, aggression

  20. Treating Anxiety Disorders in Inner City Schools: Results from a Pilot Randomized Controlled Trial Comparing CBT and Usual Care

    Science.gov (United States)

    Becker, Kimberly D.; Drazdowski, Tess K.; Tein, Jenn-Yun

    2012-01-01

    Background The effectiveness of cognitive-behavioral treatment (CBT) in inner city schools, when delivered by novice CBT clinicians, and compared to usual care (UC), is unknown. Objective This pilot study addressed this issue by comparing a modular CBT for anxiety disorders to UC in a sample of 32 volunteer youth (mean age 10.28 years, 63% female, 84% African American) seen in school-based mental health programs. Methods Youth were randomly assigned to CBT (n = 17) or UC (n = 15); independent evaluators conducted diagnostic interviews with children and parents at pre- and post-intervention, and at a one-month follow-up. Results Based on intent-to-treat analyses, no differences were found in response rates between groups with 50 and 42% of the children in CBT, compared to 46 and 57% in UC no longer meeting criteria for an anxiety disorder at post-treatment and follow-up respectively. Similar improvements in global functioning were also found in both treatment groups. Baseline predictors of a positive treatment response included lower anxiety, fewer maladaptive thoughts, less exposure to urban hassles, and lower levels of parenting stress. Therapist use of more CBT session structure elements and greater competence in implementing these elements was also related to a positive treatment response. Conclusions Findings from this small pilot failed to show that CBT was superior to UC when delivered by school-based clinicians. Large scale comparative effectiveness trials are needed to determine whether CBT leads to superior clinical outcomes prior to dissemination. PMID:22701295

  1. An application of the theory of planned behavior--a randomized controlled food safety pilot intervention for young adults.

    Science.gov (United States)

    Milton, Alyssa C; Mullan, Barbara A

    2012-03-01

    Approximately 48 million Americans are affected by foodborne illness each year. Evidence suggests that the application of health psychology theory to food safety interventions can increase behaviors that reduce the incidence of illness such as adequately keeping hands, surfaces and equipment clean. This aim of this pilot study was to be the first to explore the effectiveness of a food safety intervention based on the Theory of Planned Behavior (TPB). Young adult participants (N = 45) were randomly allocated to intervention, general control or mere measurement control conditions. Food safety observations and TPB measures were taken at baseline and at 4-week follow-up. Within and between group differences on target variables were considered and regression analyses were conducted to determine the relationship between condition, behavior and the TPB intention constructs; attitude, subjective norm, perceived behavioral control (PBC). TPB variables at baseline predicted observed food safety behaviors. At follow-up, the intervention led to significant increases in PBC (p = .024) and observed behaviors (p = .001) compared to both control conditions. Furthermore, correlations were found between observed and self-reported behaviors (p = .008). The pilot intervention supports the utility of the TPB as a method of improving food safety behavior. Changes in TPB cognitions appear to be best translated to behavior via behavioral intentions and PBC. Further research should be conducted to increase effectiveness of translating TPB variables to food safety behaviors. The additional finding of a correlation between self-reported and observed behavior also has implications for future research as it provides evidence toward the construct validity of self-reported behavioral measures.

  2. The effect of verbal and video feedback on learning direct laryngoscopy among novice laryngoscopists: a randomized pilot study.

    Science.gov (United States)

    Sainsbury, Jennifer E; Telgarsky, Branislav; Parotto, Matteo; Niazi, Ahtsham; Wong, David T; Cooper, Richard M

    2017-03-01

    Skill acquisition in direct laryngoscopy (DL) and tracheal intubation is complex. This pilot study aims to assess feasibility and determine sample size for a subsequent trial comparing DL instruction using a Macintosh-style video laryngoscope (MacVL), with and without video recordings, with conventional DL instruction. Medical students with no prior laryngoscopy experience were recruited during their two-week anesthesia rotation. During the first (TRAINING) week, students were randomized into three groups: Control (Macintosh direct laryngoscope), VL-1 (MacVL with real-time feedback), and VL-2 (MacVL with real-time feedback plus video recordings of laryngoscopies). During the second (TESTING) week, all students were tested using a Macintosh direct laryngoscope. Feasibility objectives were recruitment and attrition rates, ability to time and video record intubations, and the availability of a MacVL. The primary clinical outcome during the TESTING week was total time to intubate, and secondary outcomes included intubation success rate, intubating opportunities, complications, and confidence scores. Sixty-eight of 87 (78%) consecutive medical students approached to participate in the study were recruited over 18 months. Eight (12%) students withdrew from the study, and data are available on the remaining 60 participants. The times to intubate were recorded for 92% of the TESTING intubations, but only 71% of the TRAINING intubations in the VL-2 group were video recorded. The MacVLs were available in 100% of cases. We estimate that 190 participants would be required for a study restricted to a comparison of DL vs video laryngoscopy with real-time feedback. This pilot study establishes feasibility and provides a sample size estimate for a future RCT. Required modifications to the study protocol include wider hospital involvement and consideration regarding standardization of airway education, teaching, feedback, and patient characteristics.

  3. Impact of osteopathic treatment on pain in adult patients with cystic fibrosis--a pilot randomized controlled study.

    Directory of Open Access Journals (Sweden)

    Dominique Hubert

    Full Text Available Pain is a common complication in patients with cystic fibrosis (CF and is associated with shorter survival. We evaluated the impact of osteopathic manipulative treatment (OMT on pain in adults with CF.A pilot multicenter randomized controlled trial was conducted with three parallel arms: OMT (group A, 16 patients, sham OMT (sham treatment, group B, 8 patients and no treatment (group C, 8 patients. Medical investigators and patients were double-blind to treatment for groups A and B, who received OMT or sham OMT monthly for 6 months. Pain was rated as a composite of its intensity and duration over the previous month. The evolution of chest/back pain after 6 months was compared between group A and groups B+C combined (control group. The evolution of cervical pain, headache and quality of life (QOL were similarly evaluated.There was no statistically significant difference between the treatment and control groups in the decrease of chest/back pain (difference = -2.20 IC95% [-4.81; 0.42], p = 0.098; also, group A did not differ from group B. However, chest/back pain decreased more in groups A (p = 0.002 and B (p = 0.006 than in group C. Cervical pain, headache and QOL scores did not differ between the treatment and control groups.This pilot study demonstrated the feasibility of evaluating the efficacy of OMT to treat the pain of patients with CF. The lack of difference between the group treated with OMT and the control group may be due to the small number of patients included in this trial, which also precludes any definitive conclusion about the greater decrease of pain in patients receiving OMT or sham OMT than in those with no intervention.ClinicalTrials.gov NCT01293019.

  4. Delirium prevention in critically ill adults through an automated reorientation intervention - A pilot randomized controlled trial.

    Science.gov (United States)

    Munro, Cindy L; Cairns, Paula; Ji, Ming; Calero, Karel; Anderson, W McDowell; Liang, Zhan

    Explore the effect of an automated reorientation intervention on ICU delirium in a prospective randomized controlled trial. Delirium is common in ICU patients, and negatively affects outcomes. Few prevention strategies have been tested. Thirty ICU patients were randomized to 3 groups. Ten received hourly recorded messages in a family member's voice during waking hours over 3 ICU days, 10 received the same messages in a non-family voice, and 10 (control) did not receive any automated reorientation messages. The primary outcome was delirium free days during the intervention period (evaluated by CAM-ICU). Groups were compared by Fisher's Exact Test. The family voice group had more delirium free days than the non-family voice group, and significantly more delirium free days (p = 0.0437) than the control group. Reorientation through automated, scripted messages reduced incidence of delirium. Using identical scripted messages, family voice was more effective than non-family voice. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Smoking Cessation Intervention After Ischemic Stroke or Transient Ischemic Attack. A Randomized Controlled Pilot Trial

    DEFF Research Database (Denmark)

    Brunner Frandsen, Nicole; Sørensen, Margit; Hyldahl, Tanja Kirstine

    2012-01-01

    BACKGROUND: Smoking cessation is widely recommended for secondary stroke prevention. However, little is known about the efficacy of smoking cessation intervention after stroke or transient ischemic attack (TIA). METHODS: Ninety-four smokers under age 76, admitted with ischemic stroke or TIA were...... randomized to minimal smoking cessation intervention or intensive smoking cessation intervention. All patients attended a 30-min individual counseling by the study nurse. Patients randomized to intensive smoking cessation intervention also participated in a 5-session outpatient smoking cessation program...... by an authorized smoking cessation instructor, a 30-min outpatient visit after 6 weeks, and 5 telephone counseling sessions by the study nurse. Free samples of nicotine replacement therapy were offered as part of the intensive smoking cessation program. Smoking cessation rates at 6 months were determined by self...

  6. A randomized pilot study on single-port versus conventional laparoscopic rectal surgery

    DEFF Research Database (Denmark)

    Bulut, O; Aslak, K K; Levic, K

    2015-01-01

    BACKGROUND: Potential benefits of single-port laparoscopic surgery may include improved cosmetic results, less postoperative pain, surgical trauma and faster recovery. Results of randomized prospective studies with a focus on single-port rectal surgery have not yet been presented. The aim...... of the present study was to compare single-port and conventional laparoscopic surgery for rectal cancer in terms of short-term outcomes including postoperative pain and trauma-induced changes in certain bioactive substances. METHODS: Patients with non-metastasized rectal cancer were prospectively randomized...... groups for plasma IL-6 and TIMP-1 at all time points, while the CRP levels were significantly lower in the single-port group at 6 (p Abdominal incisions lengths were significantly shorter in the single-port group (p = 0.001). There was no significant...

  7. Melodic Intonation Therapy in chronic aphasia: evidence from a pilot randomized controlled trial

    OpenAIRE

    Ineke Van Der Meulen; Ineke Van Der Meulen; Mieke WE Van De Sandt-Koenderman; Mieke WE Van De Sandt-Koenderman; Majanka H Heijenbrok; Majanka H Heijenbrok; Evy Visch-brink; Gerard M Ribbers; Gerard M Ribbers

    2016-01-01

    AbstractMelodic Intonation Therapy (MIT) is a language production therapy for severely non-fluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT) examining the efficacy of MIT are rare. In an earlier publication, we presented the results of an RCT on MIT in subacute aphasia and found that MIT was effective on trained and untrained items. Further, we obs...

  8. Cognitive-Behavioral Treatment of Insomnia and Depression in Adolescents: A Pilot Randomized Trial

    OpenAIRE

    Clarke, Greg; McGlinchey, Eleanor L.; Hein, Kerrie; Gullion, Christina M; Dickerson, John F.; Leo, Michael C.; Harvey, Allison G.

    2015-01-01

    We tested whether augmenting conventional depression treatment in youth by treating sleep issues with cognitive behavioral therapy for insomnia (CBT-I) improved depression outcomes. We randomized youth 12–20 years of age to 10 weekly sessions of a sleep hygiene control condition (SH) combined with CBT for depression (CBT-D) (n=20), or an experimental condition consisting of CBT-I combined with CBT-D (n=21).

  9. Stepped and Standard Care for Childhood Trauma: A Pilot Randomized Clinical Trial

    Science.gov (United States)

    Salloum, Alison; Small, Brent J.; Robst, John; Scheeringa, Michael S.; Cohen, Judith A.; Storch, Eric A.

    2017-01-01

    Objective: This study explored the feasibility of stepped care trauma-focused cognitive behavioral therapy (SC-TF-CBT) relative to TF-CBT with children (aged 8--12). Method: Children (N = 33) with post-traumatic stress symptoms (PTSS) were randomly assigned (2:1) to SC-TF-CBT or TF-CBT. SC-TF-CBT consisted of Step 1, parent-led therapist-assisted…

  10. Alcohol withdrawal prevention: a randomized evaluation of lorazepam and ethanol--a pilot study.

    Science.gov (United States)

    Fullwood, Joyce E; Mostaghimi, Zhila; Granger, Christopher B; Washam, Jeffrey B; Bride, Wanda; Zhao, Yanfang; Granger, Bradi B

    2013-09-01

    Alcohol withdrawal syndrome, characterized by confusion, agitation, and hallucinations, decreases the safety of patients with acute myocardial infarction. Unexpected hospitalization and sudden cessation of alcohol consumption may increase in-hospital complications and length of stay and even precipitate death. To perform a randomized evaluation of lorazepam and ethanol/lorazepam to evaluate the safety and efficacy of these 2 strategies for preventing alcohol withdrawal syndrome in patients with acute coronary syndromes. Patients (n = 57) with myocardial infarction were screened for alcohol dependence by using the CAGE questionnaire and randomized to treatment with lorazepam or ethanol with lorazepam. Demographics and complication rates were analyzed by using χ² tests (categorical variables) and t tests (continuous variables). Safety (composite complication rates) of the treatment strategy was evaluated by using the Fisher exact test, and length of stay by using the Wilcoxon rank-sum test. Safety-associated complication rates (self-extubation, delirium tremens, reinfarction) did not differ between groups (24% lorazepam vs 18% ethanol; P = .56). Days spent in the cardiac intensive care unit (7% lorazepam vs 2% ethanol; P = .32) and overall hospital stay (6% lorazepam vs 6% ethanol; P = .72) did not differ between the 2 groups. These preliminary findings suggest that a randomized evaluation of treatment strategies to prevent complications associated with alcohol withdrawal in patients with acute myocardial infarction is safe and feasible.

  11. Imagine HEALTH: results from a randomized pilot lifestyle intervention for obese Latino adolescents using Interactive Guided ImagerySM.

    Science.gov (United States)

    Weigensberg, Marc J; Lane, Christianne J; Ávila, Quintilia; Konersman, Kati; Ventura, Emily; Adam, Tanja; Shoar, Zohreh; Goran, Michael I; Spruijt-Metz, Donna

    2014-01-17

    There is an urgent need for innovative and developmentally appropriate lifestyle interventions to promote healthy lifestyle behaviors and to prevent the early onset of type 2 diabetes and cardiovascular disease risk in obese Latino adolescents. Guided imagery offers promise to reduce stress and promote lifestyle behavior change to reduce disease risk in obese adolescents. Our objectives were: 1) To pilot test a new 12-wk lifestyle intervention using a randomized trial design in obese Latino adolescents, in order to determine the effects of the mind-body modality of Interactive Guided ImagerySM (IGI), over and above those of a didactic lifestyle education, on insulin resistance, eating and physical activity behaviors, stress and stress biomarkers; and 2) To explore the role of intervention-related changes in stress and stress biomarkers on changes in metabolic outcomes, particularly insulin resistance. Obese (BMI > 95th percentile), Latino adolescents (n = 35, age 14-17) were randomized to receive either 12 weekly sessions of a lifestyle education plus guided imagery program (GI), or lifestyle education plus a digital storytelling computer program (DS). Between-group differences in behavioral, biological, and psychological outcomes were assessed using unpaired T-tests and ANCOVA in the 29 subjects who completed the intervention. The GI group demonstrated significant reductions in leisure sedentary behavior (p < .05) and increases in moderate physical activity (p < .05) compared to DS group, and a trend toward reduced caloric intake in GI vs DS (p = .09). Salivary cortisol was acutely reduced by stress-reduction guided imagery (p < .01). There were no group differences in adiposity, insulin resistance, perceived stress, or stress biomarkers across the 12-week intervention, though decrease in serum cortisol over the course of the intervention was associated with improved insulin sensitivity (p = .03) independent of intervention group and

  12. Vitamin D₃supplementation in Batswana children and adults with HIV: a pilot double blind randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Andrew P Steenhoff

    Full Text Available Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃ in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D.Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0-50.9 years.Sixty subjects randomized within five age groups to either 4000 or 7000 IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D ≥32 ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL, CD4%, anti-retroviral therapy (ART regime, and height-adjusted (HAZ, weight-adjusted (WAZ and Body Mass Index (BMIZ Z scores.Subjects were 50% male, age (mean±SD 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of 1.4 in 22%. From baseline to 12 weeks, 25D increased from 36±9 ng/ml to 56±18 ng/ml (p<0.0001 and 68% and 90% had 25D ≥32 ng/ml, respectively (p = 0.02. Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04. HAZ and CD4% increased and VL decreased in the 7000 IU/d group (p<0.04. Younger (5-13y and older (30-50y subjects had greater Δ25D than those 14-29y (26±17 and 28±12 vs. 11±11 ng/ml, respectively, p≤0.001. Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03.In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers.ClinicalTrials.gov NCT02189902.

  13. A Placebo-Controlled Double-Blinded Randomized Pilot Study of Combination Phytotherapy in Biochemically Recurrent Prostate Cancer.

    Science.gov (United States)

    van Die, M Diana; Williams, Scott G; Emery, Jon; Bone, Kerry M; Taylor, Jeremy M G; Lusk, Elizabeth; Pirotta, Marie V

    2017-05-01

    Men with biochemical recurrence of prostate cancer following local therapies often use natural supplements in an attempt to delay metastases and/or avoid the need for more aggressive treatments with undesirable side-effects. While there is a growing body of research into phytotherapeutic agents in this cohort, with some promising results, as yet no definitive recommendations can be made. This pilot study was undertaken to assess the feasibility of a fully-powered study to examine the effects of this phytotherapeutic intervention (containing turmeric, resveratrol, green tea and broccoli sprouts) on PSA doubling time in men with biochemical recurrence with a moderate PSA rise rate. A double blind, randomized, placebo-controlled parallel trial was conducted with 22 men with biochemically recurrent prostate cancer and a moderate rise rate (PSA doubling time of 4-15 months and no evidence of metastases from conventional imaging methods). Patients were randomized to either the active treatment arm or placebo for 12 weeks. The primary endpoints were feasibility of study recruitment and procedures, and measurement of proposed secondary endpoints (prostate symptoms, quality of life, anxiety, and depression as measured on the EORTC QLQ-C30 and PR-25, the IPSS and HADS). Data were collected to estimate PSA-log slopes and PSA-doubling times, using a mixed model, for both the pre-intervention and post-intervention periods. Adherence to study protocol was excellent, and the phytotherapeutic intervention was well-tolerated, with similar numbers of mild-to-moderate adverse events in the active and placebo arms. Both the intervention and data collection methods were acceptable to participants. No statistical difference between groups on clinical outcomes was expected in this pilot study. There was between-subject variation in the PSA post treatment, but on average the active treatment group experienced a non-significant increase in the log-slope of PSA (pre-treatment doubling time

  14. Translating a child care based intervention for online delivery: development and randomized pilot study of Go NAPSACC

    Directory of Open Access Journals (Sweden)

    Dianne S. Ward

    2017-11-01

    Full Text Available Abstract Background As part of childhood obesity prevention initiatives, Early Care and Education (ECE programs are being asked to implement evidence-based strategies that promote healthier eating and physical activity habits in children. Translation of evidence-based interventions into real world ECE settings often encounter barriers, including time constraints, lack of easy-to-use tools, and inflexible intervention content. This study describes translation of an evidence-based program (NAPSACC into an online format (Go NAPSACC and a randomized pilot study evaluating its impact on centers’ nutrition environments. Methods Go NAPSACC retained core elements and implementation strategies from the original program, but translated tools into an online, self-directed format using extensive input from the ECE community. For the pilot, local technical assistance (TA agencies facilitated recruitment of 33 centers, which were randomized to immediate (intervention, n = 18 or delayed (control, n = 15 access groups. Center directors were oriented on Go NAPSACC tools by their local TA providers (after being trained by researchers, after which they implemented Go NAPSACC independently with minimal TA support. The Environment and Policy Assessment and Observation instrument (self-report, collected prior to and following the 4-month intervention period, was used to assess impact on centers’ nutrition environments. Process data were also collected from a sample of directors and all TA providers to evaluate program usability and implementation. Results Demographic characteristics of intervention and control centers were similar. Two centers did not complete follow-up measures, leaving 17 intervention and 14 control centers in the analytic sample. Between baseline and follow-up, intervention centers improved overall nutrition scores (Cohen’s d effect size = 0.73, p = 0.15, as well as scores for foods (effect size = 0.74, p = 0

  15. Alcohol Withdrawal Prevention: A Randomized Evaluation of Lorazepam and Ethanol (AWARE) Pilot Study

    Science.gov (United States)

    Fullwood, Joyce E.; Mostaghimi, Zhila; Granger, Christopher B.; Washam, Jeffrey B.; Bride, Wanda; Zhao, Yanfang; Granger, Bradi B.

    2015-01-01

    Background Alcohol withdrawal syndrome, characterized by a hyperadrenergic state with confusion, agitation and hallucinations, has detrimental effects on patient safety in the context of acute myocardial infarction (MI). Unexpected hospitalization and sudden cessation of alcohol consumption may result in adverse outcomes including in-hospital complications, increased length of stay, and death. Strategies for safe and effective patient management have not been rigorously studied. Purpose We conducted a randomized evaluation of lorazepam and ethanol/lorazepam to evaluate the safety and efficacy of two strategies for the prevention of alcohol withdrawal syndrome in patients with acute coronary syndromes. Methods Patients (n=57) with myocardial infarction were screened for alcohol dependence using the CAGE questionnaire and randomized to lorazepam or to ethanol with lorazepam. Demographic group differences and complication rates were analyzed using chi square (categorical variables) and t-tests (continuous variables). Safety (composite complication rates) of the treatment strategy was evaluated using Fisher’s exact test. Length of stay was analyzed using Wilcoxon rank-sum test. Results Safety-associated complication rates (self-extubation, delirium tremens, re-infarction) were not different between groups (24% lorazepam vs. 18% ethanol; p=0.56). A trend toward fewer complications in the ethanol group was noted. In addition, no difference was detected between the treatment groups for days spent in the CCU (6.9% lorazepam vs. 2.4% ethanol; p = 0.32) or overall hospital stay (6.2% lorazepam vs. 6.4% ethanol; p = 0.72). Conclusions These findings suggest that a randomized evaluation of treatment strategies to prevent complications associated with alcohol withdrawal in acute MI is safe and feasible. A larger study may provide important evidence for improving clinical outcomes for patients experiencing alcohol withdrawal during acute myocardial infarction. PMID:23996419

  16. Massage Therapy for Patients with Metastatic Cancer: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Toth, Maria; Marcantonio, Edward R.; Davis, Roger B.; Walton, Tracy; Kahn, Janet R.

    2013-01-01

    Abstract Objectives The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. Design This was a randomized controlled trial. Settings/location Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects Subjects were patients with metastatic cancer. Interventions There were three interventions: massage therapy, no-touch intervention, and usual care. Outcome measures Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. Results In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. Conclusions The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings. PMID:23368724

  17. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Levine, David M; Ouchi, Kei; Blanchfield, Bonnie; Diamond, Keren; Licurse, Adam; Pu, Charles T; Schnipper, Jeffrey L

    2018-02-06

    Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. Randomized controlled trial. Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p Home patients were more physically active (median minutes, 209 vs. 78; p home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups. The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety, and patient experience were noted, with more definitive results awaiting a larger trial. Trial Registration NCT02864420.

  18. A randomized, controlled pilot study of acupuncture treatment for menopausal hot flashes.

    Science.gov (United States)

    Avis, Nancy E; Legault, Claudine; Coeytaux, Remy R; Pian-Smith, May; Shifren, Jan L; Chen, Wunian; Valaskatgis, Peter

    2008-01-01

    To investigate the feasibility of conducting a randomized trial of the effect of acupuncture in decreasing hot flashes in peri- and postmenopausal women. Fifty-six women ages 44 to 55 with no menses in the past 3 months and at least four hot flashes per day were recruited from two clinical centers and randomized to one of three treatment groups: usual care (n = 19), sham acupuncture (n = 18), or Traditional Chinese Medicine acupuncture (n = 19). Acupuncture treatments were scheduled twice weekly for 8 consecutive weeks. The sham acupuncture group received shallow needling in nontherapeutic sites. The Traditional Chinese Medicine acupuncture group received one of four treatments based on a Traditional Chinese Medicine diagnosis. Usual care participants were instructed to not initiate any new treatments for hot flashes during the study. Daily diaries were used to track frequency and severity of hot flashes. The mean daily index score was based on the number of mild, moderate, and severe hot flashes. Follow-up analyses were adjusted for baseline values, clinical center, age, and body mass index. There was a significant decrease in mean frequency of hot flashes between weeks 1 and 8 across all groups (P = 0.01), although the differences between the three study groups were not significant. However, the two acupuncture groups showed a significantly greater decrease than the usual care group (P acupuncture significantly reduce hot flash frequency.

  19. Social skills improvement in children with high-functioning autism: a pilot randomized controlled trial.

    Science.gov (United States)

    Baghdadli, A; Brisot, J; Henry, V; Michelon, C; Soussana, M; Rattaz, C; Picot, M C

    2013-07-01

    High-functioning autism (HFA) is characterized by persistent impairment in social interaction despite the absence of mental retardation. Although an increasing number of group-based programs for the improvement of social skills have been described, randomized controlled trials are needed to evaluate their efficacy. To compare the effect of a Social Skills Training Group-based Program (SST-GP) and a Leisure Activities Group-based Program (LA-GP) on the perception of facial emotions and quality of life (QoL) in young people with HFA. Eligible patients were children and adolescents with HFA. Participants were randomized to the SST or LA group. The primary outcome was defined as an improvement of 2 points in error rates for facial emotion labeling (DANVA2) from baseline. After the 6-month training period, the SST Group made fewer errors in labeling anger on adult faces, whereas error rates in the LA Group remained stable. Progress in the ability to recognize anger in the SST Group was due to better recognition of low intensity stimuli on adult faces. QoL increased in the SST Group in the dimension of school environment, as a marker of the transfer of skills acquired in the treatment setting to their use in the community. The SST-GP had higher efficacy than the LA-GP. Data justify replication using larger samples.

  20. Upregulating Positive Affectivity in the Transdiagnostic Treatment of Emotional Disorders: A Randomized Pilot Study.

    Science.gov (United States)

    González-Robles, Alberto; García-Palacios, Azucena; Baños, Rosa; Quero, Soledad; Botella, Cristina

    2017-10-01

    Transdiagnostic cognitive-behavioral therapy for emotional disorders (ED) has proven to be effective. However, current transdiagnostic treatment protocols address only the regulation of negative affectivity, and they do not include treatment components to more directly target the regulation of positive affectivity. In this study, we propose to evaluate the preliminary efficacy and acceptability of a transdiagnostic treatment protocol for ED that includes, as an innovative feature, a specific treatment component to directly upregulate positive affectivity based on positive psychology interventions. A total of 24 participants were randomized to either a transdiagnostic treatment protocol ( n = 12) or a transdiagnostic treatment protocol with an additional component designed to regulate positive affectivity ( n = 12). Participants completed measures of anxiety, depression, positive and negative affectivity, and quality of life, as well as treatment acceptability at pre- and posttreatment and at the 3-month follow-up. Both interventions led to improvements in all measures at posttreatment, and these outcomes were maintained at the 3-month follow-up, with large effect sizes for all measures. The effect sizes for positive affect were larger in the condition that included the component to upregulate positive affectivity. Attrition rate was low, and both treatment protocols were well accepted by participants. The results obtained in this study indicate the feasibility of testing the treatment protocol in a larger, randomized, controlled trial, and they suggest the potential of including treatment components for directly upregulating positive affectivity in future research on transdiagnostic treatment protocols for ED.

  1. A pilot randomized, controlled trial of an in-home drinking water intervention among HIV + persons.

    Science.gov (United States)

    Colford, John M; Saha, Sona R; Wade, Timothy J; Wright, Catherine C; Vu, Mai; Charles, Sandra; Jensen, Peter; Hubbard, Alan; Levy, Deborah A; Eisenberg, Joseph N S

    2005-06-01

    Although immunocompromised persons may be at increased risk for gastrointestinal illnesses, no trials investigating drinking water treatment and gastrointestinal illness in such patients have been published. Earlier results from San Francisco suggested an association (OR 6.76) between tap water and cryptosporidiosis among HIV + persons. The authors conducted a randomized, triple-blinded intervention trial of home water treatment in San Francisco, California, from April 2000 to May 2001. Fifty HIV-positive patients were randomized to externally identical active (N = 24) or sham (N = 26) treatment devices. The active device contained a filter and UV light; the sham provided no treatment. Forty-five (90%) of the participants completed the study and were successfully blinded. Illness was measured using 'highly credible gastrointestinal illness' (HCGI), a previously published measure. There were 31 episodes of HCGI during 1,797 person-days in the sham group and 16 episodes during 1,478 person-days in the active group. The adjusted relative risk was 3.34 (95% CI: 0.99-11.21) times greater in those with the sham device. The magnitude of the point estimate of the risk, its consistency with recently published observational data, and its relevance for drinking water choices by immunocompromised individuals support the need for larger trials.

  2. Immediate Occlusal versus Non-Occlusal Loading of Implants: A Randomized Clinical Pilot Study.

    Science.gov (United States)

    Vogl, Susanne; Stopper, Marlene; Hof, Markus; Wegscheider, Walther A; Lorenzoni, Martin

    2015-06-01

    Immediate occlusal and non-occlusal loading protocols have been discussed and, despite varying success rates, are considered viable in selected cases. Preoperative implant planning and intraoperative transfer are essential to the success of implant-supported reconstructions in partially or completely edentulous jaws. This study was performed to compare clinical outcomes of immediate occlusal versus non-occlusal loading of posterior implants. Of 19 patients with 52 screw-type implants replacing mandibular molars or premolars, nine patients with 21 implants were randomized to a study group that received immediate restorations with occlusal loading, whereas 10 patients with 31 implants were randomized to a control group that received provisional restorations without occlusal loading. Occlusal loading was defined as full loading in maximum intercuspidation. Single-tooth or splinted multiunit restorations were incorporated by screw retention or cementation. Marginal bone defects (MBD), implant survival, and implant success were evaluated 12 months after insertion. Both groups revealed similar MBD levels consistent with previous reports. No implants were lost (overall survival: 100%) or found to fail (overall success: 100%). No significant intergroup differences were noted for any of the evaluated parameters. Immediate restorations in partially edentulous mandibles demonstrated successful clinical and radiographic 12-month results. Larger long-term prospective studies are needed to confirm the final evidence and predictability of immediate functional loading as a standard treatment concept for partially edentulous jaws. © 2013 Wiley Periodicals, Inc.

  3. A pilot randomized controlled trial of smoking cessation in an outpatient respirology clinic

    Science.gov (United States)

    Pakhale, Smita; Baron, Justine; Armstrong, Michael A; Garde, Avanti; Reid, Robert D; Alvarez, Gonzalo; Aitken, Debbie; Mullen, Kerri-Anne; Wells, George; Pipe, Andrew

    2015-01-01

    OBJECTIVE: To assess the feasibility and potential effectiveness of a modified version of the Ottawa Model for Smoking Cessation in an outpatient respirology clinic. METHODS: Adult tobacco smokers attending the respirology clinic and willing to choose a quit date within one month of enrollment were randomly assigned to receive standard care or the intervention. Standard care participants received smoking cessation advice, a brochure and a prescription for smoking cessation medication if requested. Intervention participants received a $110 voucher to purchase smoking cessation pharmacotherapy and were registered to an automated calling system. Answers to automated calls determined which participants required nurse telephone counselling. Feasibility indicators included recruitment and retention rates, and intervention adherence. The effectiveness indicator was self-reported smoking status at 26 to 52 weeks. RESULTS: Forty-nine (54.4%) of 90 eligible smokers were randomly assigned to the intervention (n=23) or control (n=26) group. Self-reported smoking status at 26 to 52 weeks was available for 32 (65.3%) participants. The quit rate for intervention participants was 18.2% compared with 7.7% for controls (OR2.36 [95% CI 0.39 to 14.15]). CONCLUSION: It would be feasible to evaluate this intervention in a larger trial. Alternatives to face-to-face follow-up at the clinic are recommended. PMID:25647168

  4. Cognitive behavioural therapy in multiple sclerosis: a randomized controlled pilot study of acceptance and commitment therapy.

    Science.gov (United States)

    Nordin, Linda; Rorsman, Ia

    2012-01-01

    The aim of this study was to design a trial that could evaluate the effect of acceptance and commitment therapy as a group-intervention for multiple sclerosis patients with psychological distress. Randomized controlled trial with assessment at pretreatment, end of treatment, and at 3-month follow-up. Multiple sclerosis outpatients with elevated symptoms of anxiety and/or depression (n = 21). Patients were randomly assigned to acceptance and commitment therapy or relaxation training. Both treatments consisted of 5 sessions over 15 weeks containing didactic sessions, group discussions, and exercises. Outcome was assessed by self-rated symptoms of anxiety, depression, and a measure of acceptance. At 3-month follow-up, the relaxation training group had a significant decline in anxiety symptoms whereas the acceptance and commitment therapy group showed a maintained improvement in rated acceptance at follow-up. The results reflect the different emphases of the therapies. Acceptance and commitment therapy is aimed at living an active, valued life and increasing acceptance, while relaxation training focuses directly on coping strategies to handle emotional symptoms. The results are preliminary, but supportive of further study of brief group interventions for reducing psychological distress in patients with multiple sclerosis.

  5. Associative self-anchoring interacts with obtainability of chosen objects

    Directory of Open Access Journals (Sweden)

    Dean eMobbs

    2016-01-01

    Full Text Available While there is evidence that implicit self-esteem transfers to chosen objects (associative self-anchoring, it is still unknown whether this phenomenon extends to explicit self-esteem. Moreover, whether the knowledge that these objects might belong to the self in the future or not affects the evaluation of these objects has yet to be tested. Here, we demonstrate that evaluations of chosen objects are further enhanced when they are obtainable as compared to when they are not in participants with high explicit self-esteem, whereas participants with low explicit self-esteem exhibit the opposite pattern. These findings extend previous results and shed new light on the role of self-esteem in altering preferences for chosen objects depending on their obtainability.

  6. The effects of metformin on weight loss in women with gestational diabetes: a pilot randomized, placebo-controlled trial.

    Science.gov (United States)

    Refuerzo, Jerrie S; Viteri, Oscar A; Hutchinson, Maria; Pedroza, Claudia; Blackwell, Sean C; Tyson, Jon E; Ramin, Susan M

    2015-03-01

    We sought to compare weight loss in the first 6 weeks postpartum among women with gestational diabetes mellitus (GDM) treated with metformin or placebo, a promising therapy to reduce later risk of progression to diabetes mellitus. We conducted a pilot, randomized trial of metformin vs placebo in postpartum women with GDM. Women with pre-GDM, unable to tolerate metformin, resumed on insulin or oral hypoglycemic agent, delivered Women were randomized to either metformin 850 mg daily for 7 days, then metformin 850 mg twice a day for the next 5 weeks or placebo prescribed in a similar frequency. The subject, health care provider, and research staff were blinded to the treatment. The primary outcome was weight change from delivery to 6 weeks postpartum. Secondary outcomes included the percentage of women achieving their self-reported prepregnancy weight, reported medication adherence, adverse effects, and satisfaction. Differences in weight change between groups were determined by Wilcoxon rank sum test and in achieving prepregnancy weight by χ(2) test. Of 114 women randomized, 79 (69.3%) completed the 6 weeks; 36 (45.6%) were randomized to metformin and 43 (54.4%) to placebo. Metformin and placebo groups were similar in median weight loss (6.3 kg [range, -0.3 to 19.8] vs 6.5 kg [range, -0.3 to 12.1], P = .988) and percentage of women achieving reported prepregnancy weight (41.7 vs 37.2%, P = .69). Self-reported adherence in taking >50% of medication was 75% at 3 weeks and 97% at 6 weeks. Nausea, diarrhea, and hypoglycemia were reported in approximately 11-17% of women and 56-63% reported dissatisfaction with the medication. Women with GDM lost approximately 6 kg by 6 weeks' postpartum. This was similar in both groups and resulted in women achieving their prepregnancy weight. Although the reported adherence and satisfaction with the medication was high, adverse effects were reported with nearly 1 in 5 women including nausea, diarrhea, and hypoglycemia. Contrary to

  7. Randomized controlled pilot of an intervention to reduce and break-up overweight/obese adults' overall sitting-time.

    Science.gov (United States)

    Júdice, Pedro B; Hamilton, Marc T; Sardinha, Luís B; Silva, Analiza M

    2015-11-02

    Too much prolonged sitting is a prevalent health risk among adults. Interventions have focused mainly on the workplace, with limited attention to non-work settings. The effectiveness of a short-term intervention to reduce and break-up sitting-time in overweight/obese adults was examined. This pilot study sought to determine the feasibility of interrupting sitting to stand/ambulate objectively with ActivPAL devices which provide a valid measurement of sit/stand transitions. This is a cross-over randomized controlled pilot that included 10 participants (aged 37-65 years) and although a small and short-term intervention (1-week intervention; no washout) further informs on the feasibility of interventions on a larger scale. At the workplace, screen-delivered hourly alerts prompted participants to break-up sitting-time through adopting walking behaviors (approximately 30-60 minutes day(-1)). During transportation/home/leisure-time individual goals for steps day(-1) were set and sitting-reduction strategies (including behavioral self-monitoring) were delivered through daily text messages. Change in inclinometer-derived sitting-time is the main outcome. Standing, stepping, number of sit/stand transitions and participant satisfaction were also examined. For the intervention compared to the control-week (mean difference (95 % confidence interval); p value), participants had less sitting-time (1.85 hours (0.96-2.75); p = 0.001), more standing (0.77 hours (0.06-1.48); p = 0.036), and more stepping (1.09 hours (0.79- 1.38); p change in the total number of sit/stand transitions (3.28 (-2.33-8.89); p = 0.218) despite successfully reducing sitting-time and increasing time spent standing and walking. Sitting-time in overweight/obese adults can be reduced following a brief multi-component intervention based on prompts, telephone support, goal setting and behavioral self-monitoring. However, the results from this pilot study provide new insight that when overweight

  8. Lumbar transversus abdominis plane block: the role of local anesthetic volume and concentration-a pilot, prospective, randomized, controlled trial.

    Science.gov (United States)

    Forero, Mauricio; Heikkila, Andrew; Paul, James E; Cheng, Ji; Thabane, Lehana

    2015-01-01

    The lumbar transversus abdominis plane (TAP) block has become an optional part of multimodal analgesia following several abdominal surgeries. There remains a lack of consensus regarding the extent of dermatomal blockade following lumber TAP block, as well as the optimal local anesthetic volumes and concentrations. The objectives of this pilot trial were to assess the feasibility of conducting a similar full-scale trial and gather information on relevant clinical outcomes, namely whether greater local anesthetic volumes would lead to more cephalad dermatomal blockade. The study was a prospective, double-blinded pilot randomized controlled trial (RCT) with three arms, each representing different local anesthetic volumes: 20 ml 0.5% ropivacaine, 30 ml 0.33% ropivacaine, and 40 ml 0.25% ropivacaine. We planned to recruit 30 females undergoing total abdominal hysterectomy for non-malignant pathology, who would then receive bilateral ultrasound-guided midaxillary TAP blocks at the completion of surgery. Randomized patients would be followed for 48 h post-block and would receive multimodal analgesia. The primary outcomes were measurements of patient recruitment and safety, to inform the feasibility of a larger trial. The main secondary outcome was the clinically pertinent endpoint of dermatomal blockade, which was assessed by loss of sensation to ice and pinprick. Our target sample size was reached in 8 months, and the recruitment rate was 52% (31/60). A total of 58 TAP blocks were performed among 29 patients. All but one of the patients who received interventions were successfully followed and assessed up to 48 h. No patient safety-related adverse events were reported during the study period. The mean highest dermatome blocked in each group at any time point was T8. The 20 ml 0.5% ropivacaine group achieved a T9-L1 block that lasted for 48 h. The 30 ml 0.33% ropivacaine group had a sensory block from T9-L1 that regressed to T10-T12 between 24 and 48 h. The 40

  9. Pilot Randomized Controlled Trial of Internet-Delivered Cognitive-Behavioral Treatment for Pediatric Headache.

    Science.gov (United States)

    Law, Emily F; Beals-Erickson, Sarah E; Noel, Melanie; Claar, Robyn; Palermo, Tonya M

    2015-01-01

    To evaluate the feasibility and preliminary effectiveness of an Internet-delivered cognitive-behavioral therapy (CBT) intervention for adolescents with chronic headache. Headache is among the most common pain complaints of childhood. Cognitive-behavioral interventions are efficacious for improving pain among youth with headache. However, many youth do not receive psychological treatment for headache due to poor access, which has led to consideration of alternative delivery modalities such as the Internet. We used a parallel arm randomized controlled trial design to evaluate the feasibility and preliminary effectiveness of an Internet-delivered family-based CBT intervention, Web-based management of adolescent pain. Adolescents were eligible for the trial if they were a new patient being evaluated in a specialized headache clinic, between 11 and 17 years of age, and had recurrent headache for 3 months or more as diagnosed by a pediatric neurologist. Eighty-three youths were enrolled in the trial. An online random number generator was used to randomly assign participants to receive Internet CBT adjunctive to specialized headache treatment (n = 44) or specialized headache treatment alone (n = 39). The primary treatment outcome was headache days. Youth and parents in the Internet CBT group demonstrated high levels of engagement with the web program and reported satisfaction with the intervention. Multilevel modelling (MLM) was used to conduct hypothesis testing for continuous outcomes. For our primary treatment outcome of headache days, adolescents reported a statistically significant reduction in headache days from baseline to post-treatment and baseline to 3-month follow-up in both treatment conditions (main effect for time F(2, 136) = 19.70, P headache treatment group at post-treatment or follow-up (group × time interaction F(2, 134) = 0.94, P = .395). For our secondary treatment outcomes, findings from MLM showed that adolescents in both

  10. Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

    Directory of Open Access Journals (Sweden)

    Sudha Prathikanti

    Full Text Available Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression.Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI. At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72, and mean BDI score 22.4 (SD = 4.5. Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES and Rosenberg Self-Esteem Scale (RSES at baseline and at 8 weeks.In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034. In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018. Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or

  11. Breathing retraining for African-American adolescents with asthma: a pilot study of a school-based randomized controlled trial.

    Science.gov (United States)

    Bignall, Whitney Janee Raglin; Luberto, Christina Marie; Cornette, Adrianne Falkenberg; Haj-Hamed, Monzer; Cotton, Sian

    2015-01-01

    Asthma affects approximately seven million children/adolescents in the USA, with African-American children disproportionately affected. Breathing retraining techniques have been shown to improve asthma outcomes in adults, though research in youth is limited. The purpose of this pilot study was to test the feasibility and preliminary efficacy of a school-based randomized controlled trial of breathing retraining for asthma outcomes and anxiety symptoms in a sample of urban, African-American adolescents. Adolescents were randomized into either the intervention group (20-min breathing retraining plus education) or control group (20-min standard education). Participants completed two study visits, one month apart. Asthma control, asthma quality of life and lung functioning (FEV1 and peak flow) were the primary outcomes, and state anxiety (pre-post the intervention) and trait anxiety (over the one-month period) were the secondary outcomes. Thirty-three African-American adolescents participated in the study, with a 90% retention rate between visit 1 and visit 2. Asthma control and asthma quality of life, significantly improved over time (p ≤ 0.01) with no differences between intervention and control groups. State anxiety significantly decreased (p ≤ 0.01) immediately post intervention at both time points with no differences between groups. There were no significant differences found in lung functioning or trait anxiety over the one-month time period. These preliminary results suggest that breathing retraining is a feasible, acceptable and potentially efficacious intervention (although no significant differences between groups were found) for improving asthma symptoms in urban adolescents with asthma in a school-based setting.

  12. Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial.

    Directory of Open Access Journals (Sweden)

    Anuja P Shah

    Full Text Available We tested minocycline as an anti-proteinuric adjunct to renin-angiotensin-aldosterone system inhibitors (RAASi in diabetic nephropathy (DN and measured urinary biomarkers to evaluate minocycline's biological effects.Prospective, single center, randomized, placebo-controlled, intention-to-treat pilot trial. Inclusion. Type 2 diabetes/DN; Baseline creatinine clearance >30 mL/min; proteinuria ≥1.0 g/day; Age ≥30 years; BP <150/95 mm Hg; intolerant of/at maximum RAASi dose. Protocol. 3-wk screening; Baseline randomization; Urine and blood measures at months 1, 2, 4, and Month 6 study completion. Urine interleukin-6 (IL-6 and osteoprotegerin were measured in a subset. Primary outcome. Natural log of urine protein/creatinine (ln U P:Cr ratio at Month 6 vs Baseline.30 patients completed the study. The 15% decline in U P: Cr in minocycline patients (6 month P:Cr ÷ Baseline P:Cr, 0.85 vs. 0.92 was not significant (p = 0.27. Creatinine clearance did not differ in the 2 groups. Urine IL-6:Cr (p = 0.03 and osteoprotegerin/Cr (p = 0.046 decrements were significant. Minocycline modified the relationship between urine IL-6 and proteinuria, suggesting a protective biological effect.Although the decline in U P:Cr in minocycline patients was not statistically significant, the significant differences in urine IL-6 and osteoprotegerin suggest that minocycline may confer cytoprotection in patients with DN, providing a rationale for further study.Clinicaltrials.gov NCT01779089.

  13. Feasibility of Pilates exercise to decrease falls risk: a pilot randomized controlled trial in community-dwelling older people.

    Science.gov (United States)

    Barker, Anna L; Talevski, Jason; Bohensky, Megan A; Brand, Caroline A; Cameron, Peter A; Morello, Renata T

    2016-10-01

    To evaluate the feasibility of Pilates exercise in older people to decrease falls risk and inform a larger trial. Pilot Randomized controlled trial. Community physiotherapy clinic. A total of 53 community-dwelling people aged ⩾60 years (mean age, 69.3 years; age range, 61-84). A 60-minute Pilates class incorporating best practice guidelines for exercise to prevent falls, performed twice weekly for 12 weeks. All participants received a letter to their general practitioner with falls risk information, fall and fracture prevention education and home exercises. Indicators of feasibility included: acceptability (recruitment, retention, intervention adherence and participant experience survey); safety (adverse events); and potential effectiveness (fall, fall injury and injurious fall rates; standing balance; lower limb strength; and flexibility) measured at 12 and 24 weeks. Recruitment was achievable but control group drop-outs were high (23%). Of the 20 participants who completed the intervention, 19 (95%) attended ⩾75% of the classes and reported classes were enjoyable and would recommend them to others. The rate of fall injuries at 24 weeks was 42% lower and injurious fall rates 64% lower in the Pilates group, however, was not statistically significant (P = 0.347 and P = 0.136). Standing balance, lower-limb strength and flexibility improved in the Pilates group relative to the control group (P fall injury rates. A definitive randomized controlled trial analysing the effect of Pilates in older people would be feasible and is warranted given the acceptability and potential positive effects of Pilates on fall injuries and fall risk factors. The protocol for this study is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1262000224820). © The Author(s) 2015.

  14. Using the Vibrance Kegel Device With Pelvic Floor Muscle Exercise for Stress Urinary Incontinence: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Ong, Teng Aik; Khong, Su Yen; Ng, Keng Lim; Ting, Jesse Ron Swire; Kamal, Norlia; Yeoh, Wei Sien; Yap, Ning Yi; Razack, Azad Hassan

    2015-09-01

    To evaluate the effectiveness of pelvic floor muscle exercises (PFMEs) performed with the new biofeedback Vibrance Kegel Device (VKD), compared to PFMEs alone, in treating stress urinary incontinence (SUI). This was a pilot prospective, randomized trial of women aged ≥18 years with SUI symptoms who underwent PFMEs at University Malaya Medical Centre from October 2011 to October 2013. The patients were randomly divided into two groups: control (PFMEs alone) and VKD (PFMEs with VKD biofeedback). The patients underwent 16 weeks of pelvic floor training, during which they were assessed using Australian pelvic floor questionnaires and modified Oxford scales for pelvic floor muscle strength at week 0, 4, and 16. Forty patients were recruited (control 19, VKD 21). Three patients in the control group dropped out during week 16 training, whereas the VKD group had no dropouts. The VKD group reported significantly earlier improvement in SUI scores, as assessed by the Australian pelvic floor questionnaires (P = .035) at week 4. However, there was no significant difference between the groups' SUI scores at week 16. Pelvic floor muscle strength was significantly better in the VKD group at week 4 (P = .025) and week 16 (P = 0.001). The subjective cure rate was similar in both groups at week 16 (62.5% for control and 61.9% for VKD) (P = 0.742). Using the VKD resulted in significant early improvement in SUI scores, and pelvic muscle strength had improved significantly by the end of the study. The VKD proved useful as an adjunct for pelvic floor training. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  15. Supporting Parents of Premature Infants Transitioning from the NICU to Home: A Pilot Randomized Control Trial of a Smartphone Application.

    Science.gov (United States)

    Garfield, Craig F; Lee, Young Seok; Kim, Hyung Nam; Rutsohn, Joshua; Kahn, Janine Yasmin; Mustanski, Brian; Mohr, David C

    2016-05-01

    To determine whether parents of Very Low Birth Weight (VLBW) infants in the Neonatal Intensive Care Unit (NICU) transitioning home with the NICU-2-Home smartphone application have greater parenting self-efficacy, are better prepared for discharge and have shorter length of stay (LOS) than control parents. A four-week pilot randomized controlled trial during the transition home with 90 VLBW parents randomized to usual care (n=44) or usual care plus NICU-2-Home (n=46), a smartphone application designed for VLBW parents. Parenting Sense of Competence Scale (PSOC) was assessed at baseline, day after discharge, and two weeks post-discharge. Preparedness for discharge and length of stay (LOS) were secondary outcomes. Analyses by usage were also included. While parents of VLBW infants in the intervention group did not show an improvement in PSOC during the transition when compared directly to controls, after accounting for actual mean app usage, PSOC improved 7% (2.71 points/time greater; 95%CI = 1.45, 6.27) for intervention versus controls. Compared to controls, above-average users increased their PSOC score by 14% (6.84 points/time; 95%CL = 5.02, 8.67), average users by 11% (4.58 points/time; 95%CL = 2.89, 6.27) and below-average users by 6% (2.41 points/time; 95%CL = 0.04, 4.79). Moderate evidence showed LOS was shorter for above-average users compared to the control group (β = 12.2. SE = 6.9, p = 0.085). A smartphone application used by parents of VLBW infants during the transition home from the NICU can improve parenting self-efficacy, discharge preparedness, and LOS with improved benefits based on usage.

  16. Preliminary efficacy and feasibility of embedding high intensity interval training into the school day: A pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    S.A. Costigan

    2015-01-01

    Full Text Available Current physical activity and fitness levels among adolescents are low, increasing the risk of chronic disease. Although the efficacy of high intensity interval training (HIIT for improving metabolic health is now well established, it is not known if this type of activity can be effective to improve adolescent health. The primary aim of this study is to assess the effectiveness and feasibility of embedding HIIT into the school day. A 3-arm pilot randomized controlled trial was conducted in one secondary school in Newcastle, Australia. Participants (n = 65; mean age = 15.8(0.6 years were randomized into one of three conditions: aerobic exercise program (AEP (n = 21, resistance and aerobic exercise program (RAP (n = 22 and control (n = 22. The 8-week intervention consisted of three HIIT sessions per week (8–10 min/session, delivered during physical education (PE lessons or at lunchtime. Assessments were conducted at baseline and post-intervention to detect changes in cardiorespiratory fitness (multi-stage shuttle-run, muscular fitness (push-up, standing long jump tests, body composition (Body Mass Index (BMI, BMI-z scores, waist circumference and physical activity motivation (questionnaire, by researchers blinded to treatment allocation. Intervention effects for outcomes were examined using linear mixed models, and Cohen's d effect sizes were reported. Participants in the AEP and RAP groups had moderate intervention effects for waist circumference (p = 0.024, BMI-z (p = 0.037 and BMI (not significant in comparison to the control group. A small intervention effect was also evident for cardiorespiratory fitness in the RAP group.

  17. Manual Therapy With Cryotherapy Versus Manual Therapy With Kinesio Taping for Males With Lumbar Discopathy: A Pilot Randomized Trial.

    Science.gov (United States)

    Lizis, Pawel; Kobza, Wojciech

    2017-06-23

    Context • Numerous modalities of therapeutic interventions exist for lumbar discopathy. Manual therapy is one option, although its effectiveness remains controversial. The addition of cryotherapy to manual therapy may enhance the health benefits in patients with lumbar discopathy.  Objective • The study intended to evaluate the efficacy of manual therapy combined with cryotherapy vs manual therapy combined with Kinesio taping for males with lumbar discopathy. Design • The research team designed a pilot randomized trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Setting • The study occurred in the Physiotherapy Outpatient Department of the Regional Hospital (Zywiec, Poland). Participants • The participants were 40 males with lumbar discopathy, aged 30-75 y, who were patients in the department at the hospital. Intervention • The participants were randomly assigned to an intervention group that received Kaltenborn-Evjenth orthopedic manual therapy (KEOMT) combined with cryotherapy, the KEOMT-C group (n = 20), or to a control group that received KEOMT combined with Kinesio taping, the KEOMT-K group (n = 20). The participants in both groups received 10 treatments, 2 per wk for 5 wk. Outcome Measures • The primary outcome was measured using a visual analog scale and the Laitinen scale pain ratings. The secondary outcome measured the quality of life using the short form-36 questionnaire. The participants completed the tests at baseline and postintervention. Results • After the treatments, the intervention group had significantly lower scores than the control group for pain as well as significantly higher scores for quality of life. Conclusions • Patients achieved better health benefits from manual therapy when it was combined with cryotherapy.

  18. Home-based balance training using the Wii balance board: a randomized, crossover pilot study in multiple sclerosis.

    Science.gov (United States)

    Prosperini, Luca; Fortuna, Deborah; Giannì, Costanza; Leonardi, Laura; Marchetti, Maria Rita; Pozzilli, Carlo

    2013-01-01

    To evaluate the effectiveness of a home-based rehabilitation of balance using the Nintendo Wii Balance Board System (WBBS) in patients affected by multiple sclerosis (MS). In this 24-week, randomized, 2-period crossover pilot study, 36 patients having an objective balance disorder were randomly assigned in a 1:1 ratio to 2 counterbalanced arms. Group A started a 12-week period of home-based WBBS training followed by a 12-week period without any intervention; group B received the treatment in reverse order. As endpoints, we considered the mean difference (compared with baseline) in force platform measures (i.e., the displacement of body center of pressure in 30 seconds), 4-step square test (FSST), 25-foot timed walking test (25-FWT), and 29-item MS Impact Scale (MSIS-29), as evaluated after 12 weeks and at the end of the 24-week study period. The 2 groups did not differ in baseline characteristics. Repeated-measures analyses of variance showed significant time × treatment effects, indicating that WBBS was effective in ameliorating force platform measures (F = 4.608, P = .016), FSST (F = 3.745, P = .034), 25-FWT (F = 3.339, P = .048), and MSIS-29 (F = 4.282, P = .023). Five adverse events attributable to the WBSS training (knee or low back pain) were recorded, but only 1 patient had to retire from the study. A home-based WBBS training might potentially provide an effective, engaging, balance rehabilitation solution for people with MS. However, the risk of WBBS training-related injuries should be carefully balanced with benefits. Further studies, including cost-effectiveness analyses, are warranted to establish whether WBBS may be useful in the home setting.

  19. Use of EMG biofeedback for basic activities of daily living training in stroke patients. Pilot randomized clinical trial

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    Maricel Garrido-Montenegro

    2016-07-01

    Full Text Available Introduction: Sequels in stroke patients include hemiparesis and dependency for performing basic activities of daily living (BADL. EMG biofeedback has yielded some benefits but has been limited to repetitive movement, therefore, it is insufficient for current task-oriented neurorehabilitation paradigms. Objective: To assess whether the application of EMG biofeedback in upper limbs during BADL training improves motor, occupational and satisfaction performances compared to BADL training without this feedback. Materials and methods: A pilot randomized clinical trial was conducted with stroke patients of more than six months of evolution, who showed hemiparesis and no cognitive deterioration. These patients were randomly classified into two groups: control group, who underwent conventional occupational therapy (COT, and experimental group, who underwent COT+EMG-BF. Patients were given 10 therapy sessions. Entry, evaluation and data analysis were masked. Results: Seven patients were included in each group, showing the same initial clinical and demographic characteristics (p>0.05. The group that underwent COT+EMG-BF showed a significantly better performance in all assessments. For example, the Barthel scale obtained a median of 100 points [85-100] for the COT+EMG-BF group versus 85 [80-90] for the control group (p<0.05, whereas ARAT score was 42 [40-47] points versus 20 [15-38] (p=0.03, respectively. Conclusion: The combination of COT+EMG-BF for BADL may be considered as an alternative for treatment of stroke patients.

  20. The effect of electroacupuncture on opioid-like medication consumption by chronic pain patients: a pilot randomized controlled clinical trial.

    Science.gov (United States)

    Zheng, Zhen; Guo, Runxiang J; Helme, Robert D; Muir, Andrew; Da Costa, Cliff; Xue, Charlie C L

    2008-07-01

    Opioid-like medications (OLM) are commonly used by patients with various types of chronic pain, but their long-term benefit is questionable. Electroacupuncture (EA) has been previously shown beneficial in reducing post-operative acute OLM consumption. In this pilot randomized controlled trial, the effect of EA on OLM usage and associated side effects in chronic pain patients was evaluated. After a two-week baseline assessment, participants using OLM for their non-malignant chronic pain were randomly assigned to receive either real EA (REA, n=17) or sham EA (SEA, n=18) treatment twice weekly for 6 weeks before entering a 12-week follow-up. Pain, OLM consumption and their side effects were recorded daily. Participants also completed the McGill Pain Questionnaire (MPQ), SF-36 and Beck Depression Inventory (BDI) at baseline, and at the 5th, 8th, 12th, 16th and 20th week. Nine participants withdrew during the treatment period with another three during the follow-up period. Intention to treat analysis was applied. At the end of treatment period, reductions of OLM consumption in REA and SEA were 39% and 25%, respectively (p=0.056), but this effect did not last more than 8 weeks after treatment. There was no difference between the two groups with respect to reduction of side effects and pain and the improvement of depression and quality of life. In conclusion, REA demonstrates promising short-term reduction of OLM for participants with chronic non-malignant pain, but such effect needs to be confirmed by trials with adequate sample sizes.

  1. Impact of newer self-monitoring technology and brief phone-based intervention on weight loss: A randomized pilot study.

    Science.gov (United States)

    Ross, Kathryn M; Wing, Rena R

    2016-08-01

    Despite the proliferation of newer self-monitoring technology (e.g., activity monitors and smartphone apps), their impact on weight loss outside of structured in-person behavioral intervention is unknown. A randomized, controlled pilot study was conducted to examine efficacy of self-monitoring technology, with and without phone-based intervention, on 6-month weight loss in adults with overweight and obesity. Eighty participants were randomized to receive standard self-monitoring tools (ST, n = 26), technology-based self-monitoring tools (TECH, n = 27), or technology-based tools combined with phone-based intervention (TECH + PHONE, n = 27). All participants attended one introductory weight loss session and completed assessments at baseline, 3 months, and 6 months. Weight loss from baseline to 6 months differed significantly between groups P = 0.042; there was a trend for TECH + PHONE (-6.4 ± 1.2 kg) to lose more weight than ST (-1.3 ± 1.2 kg); weight loss in TECH (-4.1 ± 1.4 kg) was between ST and TECH + PHONE. Fewer ST (15%) achieved ≥5% weight losses compared with TECH and TECH + PHONE (44%), P = 0.039. Adherence to self-monitoring caloric intake was higher in TECH + PHONE than TECH or ST, Ps self-monitoring technology plus brief phone-based intervention improves adherence and weight loss compared with traditional self-monitoring tools. Further research should determine cost-effectiveness of adding phone-based intervention when providing self-monitoring technology. © 2016 The Obesity Society.

  2. Postoperative pain after conventional laparoscopic versus single-port sleeve gastrectomy: a prospective, randomized, controlled pilot study.

    Science.gov (United States)

    Morales-Conde, Salvador; Del Agua, Isaías Alarcón; Moreno, Antonio Barranco; Macías, María Socas

    2017-04-01

    Laparoscopic approach is the gold standard for surgical treatment of morbid obesity. The single-port (SP) approach has been demonstrated to be a safe and effective technique for the treatment of morbid obesity in several case control studies. Compare conventional multiport laparoscopy (LAP) with an SP approach for the treatment of morbid obesity using sleeve gastrectomy in terms of postoperative pain using a visual analog scale (VAS) 0-100, surgical outcome, weight loss, and aesthetical satisfaction at 6 months after surgery. University Hospital, Spain. Randomized, controlled pilot study. The trial enrolled patients suitable for bariatric surgery, with a body mass index lower than 50 kg/m 2 and xiphoumbilical distance lower than 25 cm. Patients were randomly assigned to receive LAP or SP sleeve gastrectomy. A total of 30 patients were enrolled; 15 were assigned to LAP group and 15 to SP group. No patients were lost during follow-up. Baseline characteristics were similar in both groups. A significantly higher level of pain during movement was noted for the patients in the LAP group on the first (mean VAS 49.3±12.2 versus 34.1±8.9, P = .046) and second days (mean VAS 35.9±10.2 versus 22.1±7.9, P = .044) but not the third day (mean VAS 20.1±5.2 versus 34.12.9 ±4.3, P = .620). No differences regarding pain at rest, operative time, complications, or weight loss at 6 months were observed. Higher aesthetical satisfaction was noticed in SP group. In selected patients, SP surgery presented less postoperative pain in sleeve gastrectomy compared with the conventional laparoscopic approach with similar surgical results. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  3. Inflammation and psychosocial factors mediate exercise effects on sleep quality in breast cancer survivors: pilot randomized controlled trial.

    Science.gov (United States)

    Rogers, Laura Q; Fogleman, Amanda; Trammell, Rita; Hopkins-Price, Patricia; Spenner, Allison; Vicari, Sandra; Rao, Krishna; Courneya, Kerry S; Hoelzer, Karen; Robbs, Randall; Verhulst, Steven

    2015-03-01

    To improve mechanistic understanding, this pilot randomized controlled trial examined mediators of an exercise intervention effects on sleep in breast cancer survivors (BCS). Forty-six postmenopausal BCS (≤Stage II, off primary treatment) were randomized to a 3-month exercise intervention or control group. Intervention included 160 min/week of moderate intensity aerobic walking, twice weekly resistance training (resistance bands), and six discussion groups (to improve adherence). Blinded assessments at baseline and post-intervention included sleep disturbance (PSQI and PROMIS®), objective sleep quality (accelerometer), serum cytokines, accelerometer physical activity, cardiorespiratory fitness, body composition, fatigue, and psychosocial factors. Mediation was tested using Freedman-Schatzkin difference-in-coefficients tests. When compared with control, the intervention group demonstrated a significant increase in PSQI sleep duration (i.e., fewer hours of sleep/night) (d = 0.73, p = .03). Medium to large but non-significant standardized effect sizes were noted for PSQI daytime somnolence (d = -0.63, p = .05) and accelerometer latency (d = -0.49, p = .14). No statistically significant mediators were detected for PSQI sleep duration score or accelerometer latency. Daytime somnolence was mediated by tumor necrosis factor-alpha (mediated 23% of intervention effect, p sleep outcomes were noted for accelerometer physical activity, PROMIS® fatigue, exercise social support, and/or physical activity enjoyment. Inflammation and psychosocial factors may mediate or enhance sleep response to our exercise intervention. Further study is warranted to confirm our results and translate our findings into more effective interventions aimed at improving sleep quality in BCS. Copyright © 2014 John Wiley & Sons, Ltd.

  4. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial.

    Science.gov (United States)

    Busch, Andrew M; Tooley, Erin M; Dunsiger, Shira; Chattillion, Elizabeth A; Srour, John Fani; Pagoto, Sherry L; Kahler, Christopher W; Borrelli, Belinda

    2017-04-17

    Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS) significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS). The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC). Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up. Fifty-nine participants (28 BAT-CS, 31 SC) were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41-3.93) for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42-3.82) for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03). At 24-weeks, effect sizes for mood and stress outcomes ranged from η(2)partial of.07-.11, with significant between treatment effects for positive affect, negative affect, and stress. The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted. NCT01964898 . First received by clinicaltrials.gov October 15, 2013.

  5. The Effect of Spirulina platensis versus Soybean on Insulin Resistance in HIV-Infected Patients: A Randomized Pilot Study

    Directory of Open Access Journals (Sweden)

    Jeanne Ngogang

    2011-07-01

    Full Text Available HIV-infected patients develop abnormalities of glucose metabolism due to the virus and antiretroviral drugs. Spirulina and soybean are nutritional supplements that are cheap, accessible in our community and affect glucose metabolism. We carried out a randomized study to assess the effect of Spirulina platensis versus soybean as a food supplement on HIV/HAART-associated insulin resistance (IR in 33 insulin-resistant HIV-infected patients. The study lasted for two months at the National Obesity Centre of Cameroon. Insulin resistance was measured using the short insulin tolerance test. Physical activity and diet did not change over the study duration. On-treatment analysis was used to analyze data. The Mann-Whitney U test, the Students T test and the Chi square test were used as appropriate. Curve gradients were analyzed using ANCOVA. Seventeen subjects were randomized to spirulina and 16 to soybean. Each received 19 g of supplement daily. The follow up rate was 65% vs. 100% for spirulina and soybean groups, respectively, and both groups were comparable at baseline. After eight weeks, insulin sensitivity (IS increased by 224.7% vs. 60% in the spirulina and soybean groups respectively (p < 0.001. One hundred per cent vs. 69% of subjects on spirulina versus soybean, respectively, improved their IS (p = 0.049 with a 1.45 (1.05–2.02 chance of improving insulin sensitivity on spirulina. This pilot study suggests that insulin sensitivity in HIV patients improves more when spirulina rather than soybean is used as a nutritional supplement. Trial registration: ClinicalTrials.gov identifier NCT01141777.

  6. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle.

    Science.gov (United States)

    Saposnik, Gustavo; Teasell, Robert; Mamdani, Muhammad; Hall, Judith; McIlroy, William; Cheung, Donna; Thorpe, Kevin E; Cohen, Leonardo G; Bayley, Mark

    2010-07-01

    Hemiparesis resulting in functional limitation of an upper extremity is common among stroke survivors. Although existing evidence suggests that increasing intensity of stroke rehabilitation therapy results in better motor recovery, limited evidence is available on the efficacy of virtual reality for stroke rehabilitation. In this pilot, randomized, single-blinded clinical trial with 2 parallel groups involving stroke patients within 2 months, we compared the feasibility, safety, and efficacy of virtual reality using the Nintendo Wii gaming system (VRWii) versus recreational therapy (playing cards, bingo, or "Jenga") among those receiving standard rehabilitation to evaluate arm motor improvement. The primary feasibility outcome was the total time receiving the intervention. The primary safety outcome was the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, was evaluated with the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at 4 weeks after intervention. Overall, 22 of 110 (20%) of screened patients were randomized. The mean age (range) was 61.3 (41 to 83) years. Two participants dropped out after a training session. The interventions were successfully delivered in 9 of 10 participants in the VRWii and 8 of 10 in the recreational therapy arm. The mean total session time was 388 minutes in the recreational therapy group compared with 364 minutes in the VRWii group (P=0.75). There were no serious adverse events in any group. Relative to the recreational therapy group, participants in the VRWii arm had a significant improvement in mean motor function of 7 seconds (Wolf Motor Function Test, 7.4 seconds; 95% CI, -14.5, -0.2) after adjustment for age, baseline functional status (Wolf Motor Function Test), and stroke severity. VRWii gaming technology represents a safe, feasible, and potentially effective alternative to facilitate rehabilitation therapy and promote

  7. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    Science.gov (United States)

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P videogames were equally effective as traditional therapy for overall ROM gains and resulted in quicker recovery of motion with less pain experienced. Such videogames are a useful adjunct to therapy and should be considered as part of a holistic approach to rehabilitation within the hospital and at home after discharge in pediatric patients recovering from burn injury.

  8. A Randomized Controlled Pilot Intervention Study of a Mindfulness-Based Self-Leadership Training (MBSLT) on Stress and Performance.

    Science.gov (United States)

    Sampl, Juliane; Maran, Thomas; Furtner, Marco R

    2017-01-01

    The present randomized pilot intervention study examines the effects of a mindfulness-based self-leadership training (MBSLT) specifically developed for academic achievement situations. Both mindfulness and self-leadership have a strong self-regulatory focus and are helpful in terms of stress resilience and performance enhancements. Based on several theoretical points of contact and a specific interplay between mindfulness and self-leadership, the authors developed an innovative intervention program that improves mood as well as performance in a real academic setting. The intervention was conducted as a randomized controlled study over 10 weeks. The purpose was to analyze the effects on perceived stress, test anxiety, academic self-efficacy, and the performance of students by comparing an intervention and control group ( n  = 109). Findings demonstrated significant effects on mindfulness, self-leadership, academic self-efficacy, and academic performance improvements in the intervention group. Results showed that the intervention group reached significantly better grade point averages than the control group. Moreover, the MBSLT over time led to a reduction of test anxiety in the intervention group compared to the control group. Furthermore, while participants of the control group showed an increase in stress over time, participants of the intervention group maintained constant stress levels over time. The combination of mindfulness and self-leadership addressed both positive effects on moods and on objective academic performance. The effects demonstrate the great potential of combining mindfulness with self-leadership to develop a healthy self-regulatory way of attaining achievement-related goals and succeeding in high-stress academic environments.

  9. Mindfulness-and body-psychotherapy-based group treatment of chronic tinnitus: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Kreuzer Peter M

    2012-11-01

    Full Text Available Abstract Background Tinnitus, the perception of sound in absence of an external acoustic source, impairs the quality of life in 2% of the population. Since in most cases causal treatment is not possible, the majority of therapeutic attempts aim at developing and strengthening individual coping and habituation strategies. Therapeutic interventions that incorporate training in mindfulness meditation have become increasingly popular in the treatment of stress-related disorders. Here we conducted a randomized, controlled clinical study to investigate the efficacy of a specific mindfulness- and body-psychotherapy based program in patients suffering from chronic tinnitus. Methods Thirty-six patients were enrolled in this pilot study. The treatment was specifically developed for tinnitus patients and is based on mindfulness and body psychotherapy. Treatment was performed as group therapy at two training weekends that were separated by an interval of 7 weeks (eleven hours/weekend and in four further two-hour sessions (week 2, 9, 18 and 22. Patients were randomized to receive treatment either immediately or after waiting time, which served as a control condition. The primary study outcome was the change in tinnitus complaints as measured by the German Version of the Tinnitus Questionnaire (TQ. Results ANOVA testing for the primary outcome showed a significant interaction effect time by group (F = 7.4; df = 1,33; p = 0.010. Post hoc t-tests indicated an amelioration of TQ scores from baseline to week 9 in both groups (intervention group: t = 6.2; df = 17; p  Conclusions Our results suggest that this mindfulness- and body-psychotherapy-based approach is feasible in the treatment of tinnitus and merits further evaluation in clinical studies with larger sample sizes. The study is registered with clinicaltrials.gov (NCT01540357.

  10. Xenon anaesthesia for patients undergoing off-pump coronary artery bypass graft surgery: a prospective randomized controlled pilot trial.

    Science.gov (United States)

    Al Tmimi, L; Van Hemelrijck, J; Van de Velde, M; Sergeant, P; Meyns, B; Missant, C; Jochmans, I; Poesen, K; Coburn, M; Rex, S

    2015-10-01

    Off-pump coronary artery bypass (OPCAB) surgery carries a high risk for haemodynamic instability and perioperative organ injury. Favourable haemodynamic effects and organ-protective properties could render xenon an attractive anaesthetic for OPCAB surgery. The primary aim of this study was to assess whether xenon anaesthesia for OPCAB surgery is non-inferior to sevoflurane anaesthesia with regard to intraoperative vasopressor requirements. Forty-two patients undergoing elective OPCAB surgery were enrolled in this prospective, single-blind, randomized controlled pilot trial. Patients were randomized to either xenon (50-60 vol%) or sevoflurane (1.1-1.4 vol%) anaesthesia. Primary outcome was intraoperative noradrenaline requirements necessary to achieve predefined haemodynamic goals. Secondary outcomes included safety variables such as the occurrence of adverse events (intraoperatively and during a 6-month follow-up after surgery) and the perioperative cardiorespiratory and inflammatory profile. Baseline and intraoperative data did not differ between groups. Xenon was non-inferior to sevoflurane, as xenon patients required significantly less noradrenaline intraoperatively to achieve the predefined haemodynamic goals {geometric mean 428 [95% confidence interval (CI) 312, 588] vs 1702 [1267, 2285] µg, Pxenon anaesthesia allows a significant reduction in vasopressor administration in OPCAB surgery. Moreover, xenon anaesthesia was associated with a lower risk for POD, a finding that has to be confirmed in larger studies. ClinicalTrials.gov (NCT01757106) and EudraCT (2012-002316-12). © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  11. A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.

    Science.gov (United States)

    Rivara, Matthew B; Mehrotra, Rajnish; Linke, Lori; Ruzinski, John; Ikizler, T Alp; Himmelfarb, Jonathan

    2015-01-01

    Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure. Prospective, randomized, crossover, pilot clinical trial (NCT01562340). The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period. Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure. Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production. Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress

  12. A randomized controlled pilot study of the therapeutic effects of yoga in people with Parkinson′s disease

    Directory of Open Access Journals (Sweden)

    Neena K Sharma

    2015-01-01

    Full Text Available Background: Exercise can be beneficial for cardiopulmonary, musculoskeletal or neurological systems, and other factors including mood, and may be beneficial in reducing fall risks, dementia and variables associated with quality of life (QOL. Parkinson′s disease (PD produces progressive motor and cognitive deterioration that may leave those inflicted unable to participate in standard exercise programs. Alternative forms of exercise such as yoga may be successful in improving physical function, QOL and physiological variables for overall well-being. Aim: This randomized controlled pilot study investigated the effectiveness of yoga intervention on physiological and health-related QOL measures in people with PD. Methods and Materials: Thirteen people with stage 1-2 PD were randomized to either a yoga (n = 8 or a control group (n = 5. The yoga group participated in twice-weekly yoga sessions for 12 weeks. Participants were tested at baseline, and at 6 and 12 weeks using the Unified Parkinson′s Disease Rating Scale (UPDRS, clinical measures of health-related QOL and physiological measures. Results: Significant improvement in UPDRS scores (P = .006, diastolic blood pressure (P = 0.036 and average forced vital capacity (P = 0.03 was noted in the yoga group over time. Changes between groups were also noted in two SF-36 subscales. Positive trends of improvement were noted in depression scores (P = 0.056, body weight (P = 0.056 and forced expiratory volume (P = 0.059. Yoga participants reported more positive symptom changes including immediate tremor reduction. Conclusions: The results suggest that yoga may improve aspects of QOL and physiological functions in stages 1-2 PD. Future larger studies are needed to confirm and extend our findings of the effects of yoga in PD.

  13. Guided Internet-delivered cognitive behavioural therapy in patients with non-cardiac chest pain - a pilot randomized controlled study.

    Science.gov (United States)

    Mourad, Ghassan; Strömberg, Anna; Jonsbu, Egil; Gustafsson, Mikael; Johansson, Peter; Jaarsma, Tiny

    2016-07-26

    Patients with recurrent episodes of non-cardiac chest pain may experience cardiac anxiety and avoidance behavior, leading to increased healthcare utilization. These patients might benefit from help and support to evaluate the perception and management of their chest pain. The purpose of this study was to test the feasibility of a short guided Internet-delivered cognitive behavioural therapy (CBT) program and explore the effects on cardiac anxiety, fear of body sensations, depressive symptoms, and chest pain in patients with non-cardiac chest pain, compared with usual care. A pilot randomized controlled study was conducted. Fifteen patients with non-cardiac chest pain with cardiac anxiety or fear of body sensations, aged 22-76 years, were randomized to intervention (n = 7) or control (n = 8) groups. The four-session CBT program contained psychoeducation, physical activity, and relaxation. The control group received usual care. Data were collected before and after intervention. Five of seven patients in the intervention group completed the program, which was perceived as user-friendly with comprehensible language, adequate and varied content, and manageable homework assignments. Being guided and supported, patients were empowered and motivated to be active and complete the program. Patients in both intervention and control groups improved with regard to cardiac anxiety, fear of body sensations, and depressive symptoms, but no significant differences were found between the groups. The Internet-delivered CBT program seems feasible for patients with non-cardiac chest pain, but needs to be evaluated in larger groups and with a longer follow-up period. Clinicaltrials.gov NCT02336880 . Registered on 8 January 2015.

  14. Cognitive processing therapy versus supportive counseling for acute stress disorder following assault: a randomized pilot trial.

    Science.gov (United States)

    Nixon, Reginald D V

    2012-12-01

    The study tested the efficacy and tolerability of cognitive processing therapy (CPT) for survivors of assault with acute stress disorder. Participants (N=30) were randomly allocated to CPT or supportive counseling. Therapy comprised six individual weekly sessions of 90-min duration. Independent diagnostic assessment for PTSD was conducted at posttreatment. Participants completed self-report measures of posttraumatic stress, depression, and negative trauma-related beliefs at pre-, posttreatment, and 6-month follow-up. Results indicated that both interventions were successful in reducing symptoms at posttreatment with no statistical difference between the two; within and between-group effect sizes and the proportion of participants not meeting PTSD criteria was greater in CPT. Treatment gains were maintained for both groups at 6-month follow-up. Copyright © 2012. Published by Elsevier Ltd.

  15. Cognitive behaviour therapy for specific phobia of vomiting (Emetophobia): A pilot randomized controlled trial.

    Science.gov (United States)

    Riddle-Walker, Lori; Veale, David; Chapman, Cynthia; Ogle, Frank; Rosko, Donna; Najmi, Sadia; Walker, Lana M; Maceachern, Pete; Hicks, Thomas

    2016-10-01

    This is the first randomised controlled trial to evaluate a protocol for cognitive behaviour therapy (CBT) for a Specific Phobia of Vomiting (SPOV) compared with a wait list and to use assessment scales that are specific for a SPOV. 24 participants (23 women and 1 man) were randomly allocated to either 12 sessions of CBT or a wait list. At the end of the treatment, CBT was significantly more efficacious than the wait list with a large effect size (Cohen's d=1.53) on the Specific Phobia of Vomiting Inventory between the two groups after 12 sessions. Six (50%) of the participants receiving CBT achieved clinically significant change compared to 2 (16%) participants in the wait list group. Eight (58.3%) participants receiving CBT achieved reliable improvement compared to 2 (16%) participants in the wait list group. A SPOV is a condition treatable by CBT but further developments are required to increase efficacy. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Group cognitive behavior therapy for chronic posttraumatic stress disorder: an initial randomized pilot study.

    Science.gov (United States)

    Beck, J Gayle; Coffey, Scott F; Foy, David W; Keane, Terence M; Blanchard, Edward B

    2009-03-01

    Individuals with posttraumatic stress disorder (PTSD) related to a serious motor vehicle accident were randomly assigned to either group cognitive behavioral treatment(GCBT) or a minimum contact comparison group (MCC).Compared to the MCC participants (n=16), individuals who completed GCBT (n=17) showed significant reductions in PTSD symptoms, whether assessed using clinical interview or a self-report measure. Among treatment completers, 88.3% of GCBT participants did not satisfy criteria for PTSD at posttreatment assessment, relative to31.3% of the MCC participants. Examination of anxiety,depression, and pain measures did not show a unique advantage of GCBT. Treatment-related gains were maintained over a 3-month follow-up interval. Patients reported satisfaction with GCBT, and attrition from this treatment was comparable with individually administered CBTs.Results are discussed in light of modifications necessitated by the group treatment format, with suggestions for future study of this group intervention.

  17. Treadmill training as an augmentation treatment for Alzheimer?s disease: a pilot randomized controlled study

    Directory of Open Access Journals (Sweden)

    Cynthia Arcoverde

    2014-03-01

    Full Text Available Objective To assess the effect of aerobic exercise on the cognition and functional capacity in Alzheimer’s disease (AD patients. Method Elderly (n=20 with mild dementia (NINCDS-ADRDA/CDR1 were randomly assigned to an exercise group (EG on a treadmill (30 minutes, twice a week and moderate intensity of 60% VO2max and control group (GC 10 patients. The primary outcome measure was the cognitive function using Cambridge Cognitive Examination (CAMCOG. Specifics instruments were also applied to evaluate executive function, memory, attention and concentration, cognitive flexibility, inhibitory control and functional capacity. Results After 16 weeks, the EG showed improvement in cognition CAMCOG whereas the CG declined. Compared to the CG, the EG presented significant improvement on the functional capacity. The analysis of the effect size has shown a favorable response to the physical exercise in all dependent variables. Conclusion Walking on treadmill may be recommended as an augmentation treatment for patients with AD.

  18. Effect of Kinesiology Taping on breast cancer-related lymphedema: a randomized single-blind controlled pilot study.

    Science.gov (United States)

    Smykla, A; Walewicz, K; Trybulski, R; Halski, T; Kucharzewski, M; Kucio, C; Mikusek, W; Klakla, K; Taradaj, J

    2013-01-01

    The aim of the study was to assess the efficacy of Kinesiology Taping (KT) for treating breast cancer-related lymphedema. Sixty-five women with unilateral stage II and III lymphedema were randomly grouped into the KT group (K-tapes, n = 20), the Quasi KT group (quasi K-tapes, n = 22), or the MCT group (multilayered compression therapy group, n = 23). Skin care, 45 min pneumatic compression therapy, 1 h manual lymphatic drainage, and application of K-tape/Quasi K-tapes/multilayered short-stretch bandages were given every treatment session, 3 times per week for 1 month. Patient evaluation items included limb size and percentage edema. Comparing the changes in K-tapes with quasi K-tapes changes, there were no significant differences (P > 0.05). The edema reduction of multilayered bandages was much better than in results observed in taping groups. The KT appeared to be ineffective at secondary lymphedema after breast cancer treatment. The single-blind, controlled pilot study results suggest that K-tape could not replace the bandage, and at this moment it must not be an alternative choice for the breast cancer-related lymphedema patient. The trial is registered with ACTRN12613001173785.

  19. Real-time visual biofeedback to improve therapy compliance after total hip arthroplasty: A pilot randomized controlled trial.

    Science.gov (United States)

    Raaben, Marco; Vogely, H Charles; Blokhuis, Taco J

    2018-01-31

    Previous studies have shown limited therapy compliance in weight-bearing in patients following total hip arthroplasty. The purpose of this pilot RCT is to determine the immediate and late effect of real-time, visual biofeedback on weight-bearing during rehabilitation after THA in elderly. 24 participants who underwent THA were randomized to either the control or the intervention group. The intervention group received real-time, visual biofeedback on weight-bearing during training with the physical therapist during hospitalization and at twelve weeks follow up. Without biofeedback, therapy compliance was limited. Significant improvement in peak load was found in the intervention group in the early postoperative phase. In contrast to the control group, the peak load at twelve weeks was significantly higher in the intervention group compared to the pre-operative peak load, indicating a lasting effect of early biofeedback. Other gait parameters were not significantly different in the early postoperative phase. In the intervention group a longer walking distance was observed and the use of walking aids was reduced at twelve weeks. Biofeedback systems could be promising to improve outcomes and reduce costs in future rehabilitation programs after THA. Copyright © 2018 Elsevier B.V. All rights reserved.

  20. The infiltration of the AC joint performed by one specialist: Ultrasound versus palpation a prospective randomized pilot study

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    Sabeti-Aschraf, M., E-mail: manuel.sabeti-aschraf@meduniwien.ac.a [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Ochsner, A. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Schueller-Weidekamm, C. [Vienna Medical School, Department for Radiology, AKH-Wien, Waehringer Guertel 18-20, 1090 Vienna (Austria); Schmidt, M. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Funovics, Ph.T. [Vienna Medical School, Department for Radiology, AKH-Wien, Waehringer Guertel 18-20, 1090 Vienna (Austria); Skrbensky, G. von [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Goll, A. [Vienna Medical School, Core Unit for Medical Statistics and Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Schatz, K.D. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria)

    2010-07-15

    Introduction: The acromio-clavicular (AC) joint is very susceptible to degenerative processes that result in pain and functional impairment. One common modality of treatment has been local infiltration of the joint space. Although this procedure has produced notable positive results, needle misplacement occurs frequently. The aim of this investigation is to evaluate the effects of an intra articular infiltration by comparing precise needle placement into the joint space using high-resolution-ultrasound with the conventional palpation technique. Methods: This prospective and randomized pilot study analysed 20 patients who were assigned either to the 'ultrasound' or the 'palpation' group. Clinical examinations were performed before treatment and at 1 h, 1 week and 3 weeks after a single infiltration of local anaesthetic and corticoid carried out by one specialist. Results: In both groups significant improvement in pain and function was obtained up to one-week post injection. Function remained significantly improved until the last follow-up and did not differ between the two groups. The agent was administered in all patients into the joint space in the ultrasound group. Conclusion: Ultrasound guided infiltration of the AC joint is an easily achieved procedure without any complications. However, clinical follow-up did not differ between free-hand and ultrasound-guided AC joint space infiltration.

  1. Does balneotherapy with low radon concentration in water influence the endocrine system? A controlled non-randomized pilot study.

    Science.gov (United States)

    Nagy, Katalin; Berhés, István; Kovács, Tibor; Kávási, Norbert; Somlai, János; Bender, Tamás

    2009-08-01

    Radon bath is a well-established modality of balneotherapy for the management of degenerative musculoskeletal disorders. The present study was conducted to ascertain whether baths of relatively low (80 Bq/l) radon concentration have any influence on the functioning of the endocrine system. In the study, a non-randomized pilot study, 27 patients with degenerative musculoskeletal disorders received 30-min radon baths (of 31-32 degrees C temperature and 80 Bq/l average radon concentration) daily, for 15 days. Twenty-five patients with matching pathologies were subjected to balneotherapy according to the same protocol, using thermal water with negligible radon content (6 Bq/l). Serum thyroid stimulating hormone, prolactin, cortisol, adrenocorticotropic hormone, and dehydroepiandrosterone levels were measured before and after a balneotherapy course of 15 sessions. Comparison of the accumulated data using the Wilcoxon test did not reveal any significant difference between pre- and post-treatment values or between the two patient groups. It is noted that while the beneficial effects of balneotherapy with radon-containing water on degenerative disorders is widely known, only few data have been published in the literature on its effect on endocrine functions. The present study failed to demonstrate any substantial effect of thermal water with relatively low radon content on the functioning of the endocrine system.

  2. Ketamine versus midazolam in bipolar depression with suicidal thoughts: A pilot midazolam-controlled randomized clinical trial.

    Science.gov (United States)

    Grunebaum, Michael F; Ellis, Steven P; Keilp, John G; Moitra, Vivek K; Cooper, Thomas B; Marver, Julia E; Burke, Ainsley K; Milak, Matthew S; Sublette, M Elizabeth; Oquendo, Maria A; Mann, J John

    2017-05-01

    To evaluate feasibility and effects of a sub-anesthetic infusion dose of ketamine versus midazolam on suicidal ideation in bipolar depression. Neurocognitive, blood and saliva biomarkers were explored. Sixteen participants with bipolar depression and a Scale for Suicidal Ideation (SSI) score of ≥4 were randomized to ketamine (0.5 mg/kg) or midazolam (0.02 mg/kg). Current pharmacotherapy was maintained excluding benzodiazepines within 24 hours. The primary clinical outcome was SSI score on day 1 post-infusion. Results supported feasibility. Mean reduction of SSI after ketamine infusion was almost 6 points greater than after midazolam, although this was not statistically significant (estimate=5.84, SE=3.01, t=1.94, P=.074, 95% confidence interval ([CI)]=-0.65 to 12.31). The number needed to treat for response (SSI ketamine (ρ=-.89, P=.007). Pre- to post-infusion decrease in serum brain derived neurotrophic factor (BDNF) correlated with reduction in SSI from baseline to day 1 after ketamine (n=5, ρ=0.90, P=.037) but not midazolam (P=.087). The study demonstrated feasibility. Suicidal thoughts were lower after ketamine than after midazolam at a trend level of significance, likely due to the small pilot sample. Memory improvement and BDNF are promising biomarkers. Replication is needed in an adequately powered full-scale trial. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  3. Effects of Suspended Moxibustion on Delayed Onset Muscle Soreness: A Randomized Controlled Double-Blind Pilot Study

    Directory of Open Access Journals (Sweden)

    Ding Meng, Dong Xiaosheng, Wang Xuhui, Wang Xu, Zhang Xijin

    2017-06-01

    Full Text Available The objective of this study was to investigate the effects of suspended moxibustion upon tender point on delayed onset muscle soreness. The study was a randomized double-blind controlled trial with 50 subjects in each group. Subjects in moxibustion group received suspended moxibustion upon tender point (by palpation twice. The controls received no treatment. Each subject received treatments twice, 24 hr and 48 hr after the delayed onset muscle soreness induction. The measurements of Pain Visual Analog Scale, maximum isometric muscle strength and circumference were made immediately after delayed onset muscle soreness induction, before and after every treatment session and 72 hr after delayed onset muscle soreness induction. There were no significantly statistical differences between two groups at all measurement time points on maximum isometric muscle strength and circumference. However, the Pain Visual Analog Scale scores after first treatment session and 72 hr after delayed onset muscle soreness induction in moxibustion group was less than the control group, with significant difference (p < 0.05. The suspended moxibustion failed to show the effect on delayed onset muscle soreness. However, results need to be cautiously interpreted because of the pilot character of this study. The suspended moxibustion has a potential effect of pain relief on DOMS from the analysis of the data of this study. A large sample size trial is needed to confirm the effect of the suspended moxibustion on DOMS in the future.

  4. A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Prchal Alice

    2012-01-01

    Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration ClinicalTrials.gov NCT00296907

  5. A Small Randomized Controlled Pilot Trial Comparing Mobile and Traditional Pain Coping Skills Training Protocols for Cancer Patients with Pain

    Directory of Open Access Journals (Sweden)

    Tamara J. Somers

    2016-01-01

    Full Text Available Psychosocial pain management interventions are efficacious for cancer pain but are underutilized. Recent advances in mobile health (mHealth technologies provide new opportunities to decrease barriers to access psychosocial pain management interventions. The objective of this study was to gain information about the accessibility and efficacy of mobile pain coping skills training (mPCST intervention delivered to cancer patients with pain compared to traditional in-person pain coping skills training intervention. This study randomly assigned participants (N=30 to receive either mobile health pain coping skills training intervention delivered via Skype or traditional pain coping skills training delivered face-to-face (PCST-trad. This pilot trial suggests that mPCST is feasible, presents low burden to patients, may lead to high patient engagement, and appears to be acceptable to patients. Cancer patients with pain in the mPCST group reported decreases in pain severity and physical symptoms as well as increases in self-efficacy for pain management that were comparable to changes in the PCST-trad group (p’s < 0.05. These findings suggest that mPCST, which is a highly accessible intervention, may provide benefits similar to an in-person intervention and shows promise for being feasible, acceptable, and engaging to cancer patients with pain.

  6. Effect of Kinesiology Taping on Breast Cancer-Related Lymphedema: A Randomized Single-Blind Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    A. Smykla

    2013-01-01

    Full Text Available The aim of the study was to assess the efficacy of Kinesiology Taping (KT for treating breast cancer-related lymphedema. Sixty-five women with unilateral stage II and III lymphedema were randomly grouped into the KT group (K-tapes, n=20, the Quasi KT group (quasi K-tapes, n=22, or the MCT group (multilayered compression therapy group, n=23. Skin care, 45 min pneumatic compression therapy, 1 h manual lymphatic drainage, and application of K-tape/Quasi K-tapes/multilayered short-stretch bandages were given every treatment session, 3 times per week for 1 month. Patient evaluation items included limb size and percentage edema. Comparing the changes in K-tapes with quasi K-tapes changes, there were no significant differences (P>0.05. The edema reduction of multilayered bandages was much better than in results observed in taping groups. The KT appeared to be ineffective at secondary lymphedema after breast cancer treatment. The single-blind, controlled pilot study results suggest that K-tape could not replace the bandage, and at this moment it must not be an alternative choice for the breast cancer-related lymphedema patient. The trial is registered with ACTRN12613001173785.

  7. A pilot study of a randomized controlled trial of yoga as an intervention for PTSD symptoms in women.

    Science.gov (United States)

    Mitchell, Karen S; Dick, Alexandra M; DiMartino, Dawn M; Smith, Brian N; Niles, Barbara; Koenen, Karestan C; Street, Amy

    2014-04-01

    Posttraumatic stress disorder (PTSD) is a debilitating condition that affects approximately 10% of women in the United States. Although effective psychotherapeutic treatments for PTSD exist, clients with PTSD report additional benefits of complementary and alternative approaches such as yoga. In particular, yoga may downregulate the stress response and positively impact PTSD and comorbid depression and anxiety symptoms. We conducted a pilot study of a randomized controlled trial comparing a 12-session Kripalu-based yoga intervention with an assessment control group. Participants included 38 women with current full or subthreshold PTSD symptoms. During the intervention, yoga participants showed decreases in reexperiencing and hyperarousal symptoms. The assessment control group, however, showed decreases in reexperiencing and anxiety symptoms as well, which may be a result of the positive effect of self-monitoring on PTSD and associated symptoms. Between-groups effect sizes were small to moderate (0.08-0.31). Although more research is needed, yoga may be an effective adjunctive treatment for PTSD. Participants responded positively to the intervention, suggesting that it was tolerable for this sample. Findings underscore the need for future research investigating mechanisms by which yoga may impact mental health symptoms, gender comparisons, and the long-term effects of yoga practice. Published 2014. This article is a US Government work and is in the public domain in the USA.

  8. Red yeast rice induces less muscle fatigue symptom than simvastatin in dyslipidemic patients: a single center randomized pilot trial.

    Science.gov (United States)

    Xue, Yangjing; Tao, Luyuan; Wu, Shaoze; Wang, Guoqiang; Qian, Lu; Li, Jiwu; Liao, Lianming; Tang, Jifei; Ji, Kangting

    2017-05-18

    About 10-15% patients who take statins experience skeletal muscle problems. Red yeast rice has a good safety profile could provide a compromise therapeutic strategy. Therefore, the aim of this study was to evaluate the effects of red yeast rice, when compared to simvastatin, on the muscle fatigue symptom and the serum lipid level in dyslipidemic patients with low to moderate cardiovascular risk. A total of 60 dyslipidemic patients with low to moderate cardiovascular risk were recruited and randomly assigned to receive either simvastatin (n = 33) or red yeast rice (n = 27) for 4 weeks. The muscle fatigue score, the physical activity, the serum lipid profile and the safety profile were then evaluated. At the end of study, the fatigue score was significantly increased in patients treated with simvastatin, whereas no significant change was observed in patients receiving red yeast rice. In addition, the physical activity level was significantly decreased in patients from simvastatin group when compared to those from red yeast rice group. Similar lipid-lowering effects were observed in two groups. The safety profile was not affected after the treatments. Among dyslipidemic patients with low to moderate cardiovascular risk, red yeast rice induced less fatigue side effect and exerted comparable lipid-lowering effects when compared to simvastatin in this pilot primary prevention study. NCT01686451 .

  9. The effect of nasal oxytocin on pregnancy rates following intrauterine insemination: double-blind, randomized, clinical pilot study.

    Science.gov (United States)

    Ochsenkühn, Robert; Pavlik, Roman; Hecht, Stephanie; von Schönfeldt, Viktoria; Rogenhofer, Nina; Thaler, Christian J

    2010-04-01

    We tested the hypothesis that the application of intranasal oxytocin (8 IU) following intrauterine insemination (IUI) would increase pregnancy rates, without causing major side effects. Randomized, double-blind, placebo-controlled pilot study: eighty-six couples with idiopathic infertility, polycystic ovary syndrome and/or male sub-fertility treated with 132 homologous IUI cycles with nasal application of placebo or 8 IU oxytocin following IUI. In 132 IUI cycles of 86 women, 17 pregnancies were achieved, accounting for a pregnancy rate of 12.9% (17/132) per IUI cycle. The pregnancy rates were 13.4% (9/67) per IUI cycle in the placebo group, and 12.3% (8/65) per IUI cycle in the oxytocin group, the difference not being statistically significant. No relevant side effects were observed in both groups. Intranasal application of 8 IU oxytocin has no major side effects but at the same time did not affect pregnancy rates after IUI in our population. This study does not exclude that a larger patient group, a different time interval between oxytocin application and IUI, higher or multiple oxytocin applications or a different mode of application would have achieved different effects on pregnancy rates.

  10. High-dose Oral Ambroxol for Early Treatment of Pulmonary Acute Respiratory Distress Syndrome: an Exploratory, Randomized, Controlled Pilot Trial.

    Science.gov (United States)

    Baranwal, Arun K; Murthy, Aparna S; Singhi, Sunit C

    2015-10-01

    To evaluate efficacy of high-dose oral ambroxol in acute respiratory distress syndrome (ARDS) with respect to ventilator-free days (VFD). Prospective, randomized, placebo-controlled, blinded pilot trial. Sixty-six mechanically ventilated patients (1 month to 12 years) with ARDS who were hand-ventilated for ambroxol (40 mg/kg/day, in four divided doses) (n = 32) or placebo (n = 34) until 10 days, extubation or death whichever is earlier. Majority (91%) had pneumonia and bronchiolitis. Two study groups were similar in baseline characteristics. Mean partial pressure of arterial oxygen/fraction of inspired oxygen and oxygenation index were >175 and ambroxol. Among ventilated pulmonary ARDS patients with oxygenation index of Ambroxol did not improve VFD. Study with higher and more frequently administered doses of ambroxol in larger sample is suggested after having generated relevant pharmacokinetic data among critically ill children. © The Author [2015]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  11. Randomized Controlled Trial of Clozapine and CBT for First-Episode Psychosis with Enduring Positive Symptoms: A Pilot Study

    Directory of Open Access Journals (Sweden)

    J. Edwards

    2011-01-01

    Full Text Available Here we report the results of a pilot study investigating the relative and combined effects of a 12 week course of clozapine and CBT in first-episode psychosis patients with prominent ongoing positive symptoms following their initial treatment. Patients from our early psychosis service who met the inclusion criteria (=48 were randomized to one of four treatment groups: clozapine, clozapine plus CBT, thioridazine, or thioridazine plus CBT. The degree of psychopathology and functionality of all participants was measured at baseline then again at 6, 12 and 24 weeks, and the treatment outcomes for each group determined by statistical analysis. A substantial proportion (52% of those treated with clozapine achieved symptomatic remission, as compared to 35% of those who were treated with thioridazine. Overall, those who received clozapine responded more rapidly to treatment than those receiving the alternative treatments. Interestingly, during the early treatment phase CBT appeared to reduce the intensity of both positive and negative symptoms and thus the time taken to respond to treatment, as well having as a stabilizing effect over time.

  12. Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Shah, Anuja P; Shen, Jenny I; Wang, Ying; Tong, Lili; Pak, Youngju; Andalibi, Ali; LaPage, Janine A; Adler, Sharon G

    2016-01-01

    We tested minocycline as an anti-proteinuric adjunct to renin-angiotensin-aldosterone system inhibitors (RAASi) in diabetic nephropathy (DN) and measured urinary biomarkers to evaluate minocycline's biological effects. Prospective, single center, randomized, placebo-controlled, intention-to-treat pilot trial. Inclusion. Type 2 diabetes/DN; Baseline creatinine clearance >30 mL/min; proteinuria ≥1.0 g/day; Age ≥30 years; BP osteoprotegerin were measured in a subset. Primary outcome. Natural log of urine protein/creatinine (ln U P:Cr) ratio at Month 6 vs Baseline. 30 patients completed the study. The 15% decline in U P: Cr in minocycline patients (6 month P:Cr ÷ Baseline P:Cr, 0.85 vs. 0.92) was not significant (p = 0.27). Creatinine clearance did not differ in the 2 groups. Urine IL-6:Cr (p = 0.03) and osteoprotegerin/Cr (p = 0.046) decrements were significant. Minocycline modified the relationship between urine IL-6 and proteinuria, suggesting a protective biological effect. Although the decline in U P:Cr in minocycline patients was not statistically significant, the significant differences in urine IL-6 and osteoprotegerin suggest that minocycline may confer cytoprotection in patients with DN, providing a rationale for further study. Clinicaltrials.gov NCT01779089.

  13. Fostering Self-Compassion and Loving-Kindness in Patients With Borderline Personality Disorder: A Randomized Pilot Study.

    Science.gov (United States)

    Feliu-Soler, Albert; Pascual, Juan Carlos; Elices, Matilde; Martín-Blanco, Ana; Carmona, Cristina; Cebolla, Ausiàs; Simón, Vicente; Soler, Joaquim

    2017-01-01

    The aim of this randomized pilot study is to investigate the effects of a short training programme in loving-kindness and compassion meditation (LKM/CM) in patients with borderline personality disorder. Patients were allocated to LKM/CM or mindfulness continuation training (control group). Patients in the LKM/CM group showed greater changes in Acceptance compared with the control group. Remarkable changes in borderline symptomatology, self-criticism and self-kindness were also observed in the LKM/CM group. Mechanistic explanations and therapeutic implications of the findings are discussed. Three weeks of loving-kindness and compassion meditations increased acceptance of the present-moment experience in patients with borderline personality disorder. Significant improvements in the severity of borderline symptoms, self-criticism, mindfulness, acceptance and self-kindness were observed after the LKM/CM intervention. LKM/CM is a promising complementary strategy for inclusion in mindfulness-based interventions and Dialectical Behavioural Therapy for treating core symptoms in borderline personality disorder. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  14. A pilot randomized controlled trial on the effectiveness of a 'lung age' intervention on smoking cessation: study protocol.

    Science.gov (United States)

    Muhammad, Imran; Mok, Wenqi; Toh, Hai Moy; Sii, Daniel; Wang, Wenru

    2015-10-01

    To evaluate the effectiveness of the 'lung age' intervention on smoking cessation rates, smoking abstinence self-efficacy, nicotine dependence and behavioural change among the smoking population in Singapore. Tobacco use has been linked to several preventable chronic diseases, such as cardiovascular diseases, stroke, cancers and respiratory diseases. Despite numerous health education attempts to promote smoking cessation, there has been a sustained increase in smoking rates worldwide, including in Singapore. A pilot randomized controlled trial. A convenience sample of 108 smoking individuals will be recruited from population health screenings conducted by a tertiary public hospital in Singapore, with 54 participants in the experimental group and 54 in the control group. Participants in the experimental group will receive a lung age intervention, consisting of lung age determination and education as well as smoking cessation advice, while the researchers will provide those in the control group with the usual smoking education. Outcome measures include smoking cessation rates, smoking abstinence self-efficacy, nicotine dependence and assessment of the stages of behavioural change. Data will be collected at the baseline and again at the 3- and 6-month follow-ups. This study offers an additional intervention to improve smoking cessation rates in Singapore. It aims to reduce or delay the onset of smoking-related chronic diseases such as coronary heart diseases and cancer, which would eventually reduce the healthcare burden in an increasingly ageing society. ISRCTN15839687. © 2015 John Wiley & Sons Ltd.

  15. An oral health optimized diet can reduce gingival and periodontal inflammation in humans - a randomized controlled pilot study.

    Science.gov (United States)

    Woelber, J P; Bremer, K; Vach, K; König, D; Hellwig, E; Ratka-Krüger, P; Al-Ahmad, A; Tennert, C

    2016-07-26

    The aim of this pilot study was to investigate the effects of four weeks of an oral health optimized diet on periodontal clinical parameters in a randomized controlled trial. The experimental group (n = 10) had to change to a diet low in carbohydrates, rich in Omega-3 fatty acids, and rich in vitamins C and D, antioxidants and fiber for four weeks. Participants of the control group (n = 5) did not change their dietary behavior. Plaque index, gingival bleeding, probing depths, and bleeding upon probing were assessed by a dentist with a pressure-sensitive periodontal probe. Measurements were performed after one and two weeks without a dietary change (baseline), followed by a two week transitional period, and finally performed weekly for four weeks. Despite constant plaque values in both groups, all inflammatory parameters decreased in the experimental group to approximately half that of the baseline values (GI: 1.10 ± 0.51 to 0.54 ± 0.30; BOP: 53.57 to 24.17 %; PISA: 638 mm(2) to 284 mm(2)). This reduction was significantly different compared to that of the control group. A diet low in carbohydrates, rich in Omega-3 fatty acids, rich in vitamins C and D, and rich in fibers can significantly reduce gingival and periodontal inflammation. German Clinical Trials Register; https://www.germanctr.de (DRKS00006301). Registered on 2015-02-21.

  16. Check it! A randomized pilot of a positive psychology intervention to improve adherence in adolescents with type 1 diabetes.

    Science.gov (United States)

    Jaser, Sarah S; Patel, Niral; Rothman, Russell L; Choi, Leena; Whittemore, Robin

    2014-01-01

    The purpose of the current study was to pilot-test a positive psychology intervention to improve adherence to diabetes management in adolescents with type 1 diabetes. A total of 39 adolescents (ages, 13-17 years) with type 1 diabetes and their caregivers were randomized to a positive psychology intervention (n = 20) or an attention control (education) intervention (n = 19). The intervention condition used positive psychology exercises (eg, gratitude, self-affirmation), small gifts, and parent affirmations to boost positive affect. Outcomes included frequency of blood glucose monitoring, quality of life, and glycemic control. No main effects for treatment were observed at the 6-month follow-up. However, there was a significant association between adolescents' levels of positive affect and measures of adherence, including self-report and meter downloads of glucose monitoring. The results from the current study support the assertion that positive affect in the context of diabetes education is an important factor to consider in adolescents with type 1 diabetes. © 2014 The Author(s).

  17. Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial

    Science.gov (United States)

    Wang, Ying; Tong, Lili; Pak, Youngju; Andalibi, Ali; LaPage, Janine A.; Adler, Sharon G.

    2016-01-01

    Background We tested minocycline as an anti-proteinuric adjunct to renin-angiotensin-aldosterone system inhibitors (RAASi) in diabetic nephropathy (DN) and measured urinary biomarkers to evaluate minocycline’s biological effects. Methods Design: Prospective, single center, randomized, placebo-controlled, intention-to-treat pilot trial. Inclusion. Type 2 diabetes/DN; Baseline creatinine clearance > 30 mL/min; proteinuria ≥ 1.0 g/day; Age ≥30 years; BP minocycline patients (6 month P:Cr ÷ Baseline P:Cr, 0.85 vs. 0.92) was not significant (p = 0.27). Creatinine clearance did not differ in the 2 groups. Urine IL-6:Cr (p = 0.03) and osteoprotegerin/Cr (p = 0.046) decrements were significant. Minocycline modified the relationship between urine IL-6 and proteinuria, suggesting a protective biological effect. Conclusions Although the decline in U P:Cr in minocycline patients was not statistically significant, the significant differences in urine IL-6 and osteoprotegerin suggest that minocycline may confer cytoprotection in patients with DN, providing a rationale for further study. Trial Registration Clinicaltrials.gov NCT01779089 PMID:27019421

  18. Bioimpedance-guided fluid management in maintenance hemodialysis: a pilot randomized controlled trial.

    Science.gov (United States)

    Onofriescu, Mihai; Hogas, Simona; Voroneanu, Luminita; Apetrii, Mugurel; Nistor, Ionut; Kanbay, Mehmet; Covic, Adrian C

    2014-07-01

    Chronic subclinical volume overload happens very frequently in hemodialysis patients and is associated directly with hypertension, increased arterial stiffness, left ventricular hypertrophy, and ultimately higher mortality. Randomized controlled parallel-group trial. 131 patients from one hemodialysis center, randomly assigned into 2 groups. Dry weight prescription using results derived from repeated 3-month bioimpedance measurements to guide ultrafiltration for strict volume control (bioimpedance group; n=62) compared with clinical judgment without bioimpedance measures (clinical-methods group; n=69) for 2.5 years. The primary outcome was all-cause mortality over 2.5 years (the duration of the intervention). Secondary outcomes were change in relative arterial stiffness, fluid overload, and blood pressure (BP) over 2.5 years. Bioimpedance measurements were performed using a Body Composition Monitor device. Pulse wave velocity analysis was performed at baseline, 2.5 years (end of intervention), and 3.5 years (end of study). Relative fluid overload and BP were assessed at 3-month intervals. The unadjusted HR for all-cause death in the bioimpedance group (vs the clinical-methods group) was 0.100 (95% CI, 0.013-0.805; P=0.03). After 2.5 years, we found a greater decline in arterial stiffness, relative fluid overload, and systolic BP in the bioimpedance group than the clinical-methods group. Between-group differences in change from baseline to the end of intervention were -2.78 (95% CI, -3.75 to 1.80)m/s for pulse wave velocity (Pafter strict volume control using bioimpedance to guide dry weight adjustment. These findings need to be confirmed in a larger trial. Copyright © 2014 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  19. Mobile Phone Multilevel and Multimedia Messaging Intervention for Breast Cancer Screening: Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Hee; Ghebre, Rahel; Le, Chap; Jang, Yoo Jeong; Sharratt, Monica; Yee, Douglas

    2017-11-07

    Despite the increasing breast cancer incidence and mortality rates, Korean American immigrant women have one of the lowest rates of breast cancer screening across racial groups in the United States. Mobile health (mHealth), defined as the delivery of health care information or services through mobile communication devices, has been utilized to successfully improve a variety of health outcomes. This study adapted the principles of mHealth to advance breast cancer prevention efforts among Korean American immigrant women, an underserved community. Using a randomized controlled trial design, 120 Korean American women aged 40 to 77 years were recruited and randomly assigned to either the mMammogram intervention group (n=60) to receive culturally and personally tailored multilevel and multimedia messages through a mobile phone app along with health navigator services or the usual care control group (n=60) to receive a printed brochure. Outcome measures included knowledge, attitudes, and beliefs about breast cancer screening, readiness for mammography, and mammogram receipt. The feasibility and acceptability of the mMammogram intervention was also assessed. The intervention group showed significantly greater change on scores of knowledge of breast cancer and screening guidelines (P=.01). The intervention group also showed significantly greater readiness for mammography use after the intervention compared with the control group. A significantly higher proportion of women who received the mMammogram intervention (75%, 45/60) completed mammograms by the 6-month follow-up compared with the control group (30%, 18/60; Phttps://clinicaltrials.gov/show/NCT01972048 (Archived by WebCite at https://clinicaltrials.gov/archive/NCT01972048/2013_10_29).

  20. An Integrated Clinic-Community Partnership for Child Obesity Treatment: A Randomized Pilot Trial.

    Science.gov (United States)

    Hoffman, Jessica; Frerichs, Leah; Story, Mary; Jones, Jason; Gaskin, Kiah; Apple, Annie; Skinner, Asheley; Armstrong, Sarah

    2018-01-01

    Effective treatment of childhood obesity remains elusive. Integration of clinical and community systems may achieve effective and sustainable treatment. However, the feasibility and effectiveness of this integrated model are unknown. We conducted a randomized clinical trial among children aged 5 to 11 presenting for obesity treatment. We randomized participants to clinical care or clinical care plus community-based programming at a local parks and recreation facility. Primary outcomes were the change in child BMI at 6 months and the intensity of the program in treatment hours. Secondary outcomes included health behaviors, fitness, attrition, and quality of life. We enrolled 97 children with obesity, and retention at 6 months was 70%. Participants had a mean age of 9.1 years and a mean baseline BMI z score of 2.28, and 70% were living in poverty. Intervention participants achieved more treatment hours than controls (11.4 vs 4.4, SD: 15.3 and 1.6, respectively). We did not observe differences in child BMI z score or percent of the 95th percentile at 6 months. Intervention participants had significantly greater improvements in physical activity (P = .010) and quality of life (P = .008). An integrated clinic-community model of child obesity treatment is feasible to deliver in a low-income and racially diverse population. As compared with multidisciplinary treatment, the integrated model provides more treatment hours, improves physical activity, and increases quality of life. Parks and recreation departments hold significant promise as a partner agency to deliver child obesity treatment. Copyright © 2018 by the American Academy of Pediatrics.

  1. Dose-Response of Aerobic Exercise on Cognition: A Community-Based, Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Vidoni, Eric D; Johnson, David K; Morris, Jill K; Van Sciver, Angela; Greer, Colby S; Billinger, Sandra A; Donnelly, Joseph E; Burns, Jeffrey M

    2015-01-01

    Epidemiological studies suggest a dose-response relationship exists between physical activity and cognitive outcomes. However, no direct data from randomized trials exists to support these indirect observations. The purpose of this study was to explore the possible relationship of aerobic exercise dose on cognition. Underactive or sedentary participants without cognitive impairment were randomized to one of four groups: no-change control, 75, 150, and 225 minutes per week of moderate-intensity semi-supervised aerobic exercise for 26-weeks in a community setting. Cognitive outcomes were latent residual scores derived from a battery of 16 cognitive tests: Verbal Memory, Visuospatial Processing, Simple Attention, Set Maintenance and Shifting, and Reasoning. Other outcome measures were cardiorespiratory fitness (peak oxygen consumption) and measures of function functional health. In intent-to-treat (ITT) analyses (n = 101), cardiorespiratory fitness increased and perceived disability decreased in a dose-dependent manner across the 4 groups. No other exercise-related effects were observed in ITT analyses. Analyses restricted to individuals who exercised per-protocol (n = 77) demonstrated that Simple Attention improved equivalently across all exercise groups compared to controls and a dose-response relationship was present for Visuospatial Processing. A clear dose-response relationship exists between exercise and cardiorespiratory fitness. Cognitive benefits were apparent at low doses with possible increased benefits in visuospatial function at higher doses but only in those who adhered to the exercise protocol. An individual’s cardiorespiratory fitness response was a better predictor of cognitive gains than exercise dose (i.e., duration) and thus maximizing an individual’s cardiorespiratory fitness may be an important therapeutic target for achieving cognitive benefits. ClinicalTrials.gov NCT01129115.

  2. Effect of text messages to improve health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled pilot trial

    OpenAIRE

    Yamagata, Zentaro; Suzuki,Kohta; Yokomichi, Hiroshi; Shinohara, Ryoji; Sugita, Hideki

    2017-01-01

    ABSTRACT It has been suggested that low health literacy (HL) is associated with poor medication adherence. This study aimed to examine the effect of a text message-based HL intervention to promote medication adherence, compared with text messages that only sent medication reminders, in patients with type 2 diabetes. This was a single-center, open-label, randomized (1:1) controlled pilot study. The study period was 6 months. Intervention group was sent HL related text messages, compared to the...

  3. Favourable effects of consuming a Palaeolithic-type diet on characteristics of the metabolic syndrome: a randomized controlled pilot-study

    OpenAIRE

    Boers, Inge; Muskiet, Frits A. J.; Berkelaar, Evert; Schut, Erik; Penders, Ria; Hoenderdos, Karine; Wichers, Harry J.; Jong, Miek C.

    2014-01-01

    Background The main goal of this randomized controlled single-blinded pilot study was to study whether, independent of weight loss, a Palaeolithic-type diet alters characteristics of the metabolic syndrome. Next we searched for outcome variables that might become favourably influenced by a Paleolithic-type diet and may provide new insights in the pathophysiological mechanisms underlying the metabolic syndrome. In addition, more information on feasibility and designing an innovative dietary re...

  4. Eye Movement Training and Suggested Gaze Strategies in Tunnel Vision - A Randomized and Controlled Pilot Study.

    Directory of Open Access Journals (Sweden)

    Iliya V Ivanov

    Full Text Available Degenerative retinal diseases, especially retinitis pigmentosa (RP, lead to severe peripheral visual field loss (tunnel vision, which impairs mobility. The lack of peripheral information leads to fewer horizontal eye movements and, thus, diminished scanning in RP patients in a natural environment walking task. This randomized controlled study aimed to improve mobility and the dynamic visual field by applying a compensatory Exploratory Saccadic Training (EST.Oculomotor responses during walking and avoiding obstacles in a controlled environment were studied before and after saccade or reading training in 25 RP patients. Eye movements were recorded using a mobile infrared eye tracker (Tobii glasses that measured a range of spatial and temporal variables. Patients were randomly assigned to two training conditions: Saccade (experimental and reading (control training. All subjects who first performed reading training underwent experimental training later (waiting list control group. To assess the effect of training on subjects, we measured performance in the training task and the following outcome variables related to daily life: Response Time (RT during exploratory saccade training, Percent Preferred Walking Speed (PPWS, the number of collisions with obstacles, eye position variability, fixation duration, and the total number of fixations including the ones in the subjects' blind area of the visual field.In the saccade training group, RTs on average decreased, while the PPWS significantly increased. The improvement persisted, as tested 6 weeks after the end of the training. On average, the eye movement range of RP patients before and after training was similar to that of healthy observers. In both, the experimental and reading training groups, we found many fixations outside the subjects' seeing visual field before and after training. The average fixation duration was significantly shorter after the training, but only in the experimental training

  5. Eye Movement Training and Suggested Gaze Strategies in Tunnel Vision - A Randomized and Controlled Pilot Study

    Science.gov (United States)

    Ivanov, Iliya V.; Mackeben, Manfred; Vollmer, Annika; Martus, Peter; Nguyen, Nhung X.; Trauzettel-Klosinski, Susanne

    2016-01-01

    Purpose Degenerative retinal diseases, especially retinitis pigmentosa (RP), lead to severe peripheral visual field loss (tunnel vision), which impairs mobility. The lack of peripheral information leads to fewer horizontal eye movements and, thus, diminished scanning in RP patients in a natural environment walking task. This randomized controlled study aimed to improve mobility and the dynamic visual field by applying a compensatory Exploratory Saccadic Training (EST). Methods Oculomotor responses during walking and avoiding obstacles in a controlled environment were studied before and after saccade or reading training in 25 RP patients. Eye movements were recorded using a mobile infrared eye tracker (Tobii glasses) that measured a range of spatial and temporal variables. Patients were randomly assigned to two training conditions: Saccade (experimental) and reading (control) training. All subjects who first performed reading training underwent experimental training later (waiting list control group). To assess the effect of training on subjects, we measured performance in the training task and the following outcome variables related to daily life: Response Time (RT) during exploratory saccade training, Percent Preferred Walking Speed (PPWS), the number of collisions with obstacles, eye position variability, fixation duration, and the total number of fixations including the ones in the subjects' blind area of the visual field. Results In the saccade training group, RTs on average decreased, while the PPWS significantly increased. The improvement persisted, as tested 6 weeks after the end of the training. On average, the eye movement range of RP patients before and after training was similar to that of healthy observers. In both, the experimental and reading training groups, we found many fixations outside the subjects' seeing visual field before and after training. The average fixation duration was significantly shorter after the training, but only in the

  6. Robotic objective structured assessment of technical skills: a randomized multicenter dry laboratory training pilot study.

    Science.gov (United States)

    Tarr, Megan Elizabeth; Rivard, Colleen; Petzel, Amy E; Summers, Sondra; Mueller, Elizabeth R; Rickey, Leslie M; Denman, Mary A; Harders, Regina; Durazo-Arvizu, Ramon; Kenton, Kimberly

    2014-01-01

    The goal of this study was to determine if a robotic dry laboratory curriculum for gynecology and urology residents improved their basic robotic skills. After the institution-specific institutional review board approval or exemption, 165 residents from 8 gynecology and/or urology programs were enrolled. Residents underwent standardized robotic orientation followed by dry laboratory testing on 4 unique robotic tasks. Residents were block randomized by program to unstructured or structured training programs. Regardless of group, residents were expected to practice for 15 minutes twice monthly over 7 months. Errors, time to completion, and objective structured assessment of technical skills global rating scores were recorded for each task before and after the training period. Statistics were calculated using the Student t tests, Pearson correlation, and analysis of variance with STATA systems (version 11.2). A total of 99 residents completed both the pretraining and posttraining testing. A mean of 4 (range, 0-15) 15-minute training sessions per resident was self-reported. The structured group had faster posttraining times on the transection task, although the unstructured group had higher posttraining scores on the knot-tying task. Overall, the residents' robotic skills improved after participating in a dry laboratory curriculum; however, robotic availability, duty hour restrictions, and clinical responsibilities limit the curriculum implementation.

  7. Noradrenaline vs terlipressin in the treatment of type 2 hepatorenal syndrome: a randomized pilot study.

    Science.gov (United States)

    Ghosh, Saubhik; Choudhary, Narendra S; Sharma, Arun K; Singh, Baljinder; Kumar, Pradeep; Agarwal, Ritesh; Sharma, Navneet; Bhalla, Ashish; Chawla, Yogesh K; Singh, Virendra

    2013-09-01

    Various vasoconstrictors have shown promising results in the management of type 1 hepatorenal syndrome (HRS). However, there are very few studies on vasopressors in the management of type 2 HRS. Terlipressin has been used commonly; however, it is costly and not available in some countries. In this study, we evaluated the safety and efficacy of terlipressin and noradrenaline in the treatment of type 2 HRS. Forty-six patients with type 2 HRS were managed with terlipressin (group A, N = 23) or noradrenaline (Group B, N = 23) with albumin in a randomized controlled trial at a tertiary centre. HRS reversal could be achieved in 17(73.9%) patients in group A as well as in group B (P = 1.0). Univariate analysis showed that the baseline model of end-stage liver disease score, urine output, urinary sodium, serum creatinine and mean arterial pressure were associated with response. However, in multivariate analysis only baseline serum creatinine, urine output and urinary sodium were associated with the response. Eight patients in group A and 9 in group B died within 90 days of follow-up (P > 0.05). Noradrenaline was less expensive than terlipressin (P noradrenaline are safe and effective in the treatment of type 2 HRS and baseline serum creatinine, urine output and urinary sodium are predictive of response. Noradrenaline is less expensive than terlipressin in the treatment of type 2 HRS (ClinicalTrials.gov, Number NCT01637454). © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  8. Interventions for older persons reporting memory difficulties: a randomized controlled pilot study.

    Science.gov (United States)

    Cohen-Mansfield, Jiska; Cohen, Rinat; Buettner, Linda; Eyal, Nitza; Jakobovits, Hanna; Rebok, George; Rotenberg-Shpigelman, Shlomit; Sternberg, Shelley

    2015-05-01

    The objective of this study is to compare three different interventions for persons who report memory difficulties: health promotion, cognitive training, and a participation-centered course, using a single-blind, randomized controlled design. Participants were 44 Israeli adults with memory complaints, aged 65 years or older. The main outcome variable was the Global Cognitive Score assessed using the MindStreams(®) mild cognitive impairment assessment, a computerized cognitive assessment. The Mini-Mental State Examination and the self-report of memory difficulties were also utilized. To assess well-being, the UCLA Loneliness Scale-8 was used. Health was evaluated by self-report instruments. All three interventions resulted in significant improvement in cognitive function as measured by the computerized cognitive assessment. All approaches seemed to decrease loneliness. The only variable which showed a significant difference among the groups is the self-report of memory difficulties, in which the cognitive training group participants reported greater improvement than the other groups. Multiple approaches should be offered to older persons with memory complaints. The availability of diverse options would help fit the needs of a heterogeneous population. An educational media effort to promote the public's understanding of the efficacy of these multiple approaches is needed. Copyright © 2014 John Wiley & Sons, Ltd.

  9. A randomized pilot study of dietary treatments for polycystic ovary syndrome in adolescents.

    Science.gov (United States)

    Wong, J M W; Gallagher, M; Gooding, H; Feldman, H A; Gordon, C M; Ludwig, D S; Ebbeling, C B

    2016-06-01

    Evidence is lacking to recommend one diet over another when treating polycystic ovary syndrome (PCOS). To obtain preliminary data, comparing the impact of a low-glycaemic load (LGL) vs. low-fat (LF) diet on biochemical hyperandrogenism in overweight and obese adolescents with PCOS. To ascertain feasibility of recruiting study participants, in partnership with an adolescent clinic, and implementing dietary interventions. Randomized controlled trial of 19 overweight and obese adolescents with PCOS and not using hormonal contraceptives (HCs). Interventions comprised nutrition education, dietary counselling and cooking workshops to foster adherence to a LGL (45% carbohydrate, 35% fat, 20% protein) or LF (55% carbohydrate, 25% fat, 20% protein) diet over 6 months. Serum bioavailable testosterone was the primary outcome. Sixteen (LGL, n = 7; LF, n = 9) participants completed the study. Body fat percentage decreased (P diets and cooking workshops (≥8 on a 10-cm scale). Dietary interventions were beneficial for weight control but did not attenuate biochemical hyperandrogenism. Innovative strategies are needed to recruit adolescents for studies aimed at assessing independent effects of diet on features of PCOS. © 2015 World Obesity.

  10. Preliminary data from a randomized pilot study of web-based functional analytic psychotherapy therapist training.

    Science.gov (United States)

    Kanter, Jonathan W; Tsai, Mavis; Holman, Gareth; Koerner, Kelly

    2013-06-01

    Therapists of many persuasions emphasize the therapy relationship in their work, a priority backed by strong empirical evidence. Training in how to maximize the power and potential of the therapy relationship, however, has lagged behind. A novel approach to using the therapy relationship and to training therapists in its use is provided by Functional Analytic Psychotherapy (FAP). FAP training involves eight 2-hr weekly training sessions conducted online using web-conferencing technology. The training integrates behavioral principles with a focus on trainee-trainer and trainee-trainee relationships in a highly structured course that evokes the desirable FAP therapist-trainee behaviors and collectively shapes the behaviors through reinforcement by the trainer and other trainees. In a preliminary study, 16 therapist-trainees were randomly assigned to receive either immediate FAP training or training after a waitlist period. Significant and large effects of training were found on both self-reported and observer-assessed measures for the first training group, and the waitlist training group replicated the first training group with significant within-subject change over the course of training. Finally, qualitative feedback from therapists indicated high satisfaction with the primary elements of the training protocol. Several important limitations to this preliminary study are discussed.

  11. Early vibration assisted physiotherapy in toddlers with cerebral palsy - a randomized controlled pilot trial.

    Science.gov (United States)

    Stark, C; Herkenrath, P; Hollmann, H; Waltz, S; Becker, I; Hoebing, L; Semler, O; Hoyer-Kuhn, H; Duran, I; Hero, B; Hadders-Algra, M; Schoenau, E

    2016-09-07

    to investigate feasibility, safety and efficacy of home-based side-alternating whole body vibration (sWBV) to improve motor function in toddlers with cerebral palsy (CP). Randomized controlled trial including 24 toddlers with CP (mean age 19 months (SD±3.1); 13 boys). 14 weeks sWBV with ten 9-minute sessions weekly (non-individualized). Group A started with sWBV, followed by 14 weeks without; in group B this order was reversed. Feasibility (≥70% adherence) and adverse events were recorded; efficacy evaluated with the Gross Motor Function Measure (GMFM-66), Pediatric Evaluation of Disability Inventory (PEDI), at baseline (T0), 14 (T1) and 28 weeks (T2). Developmental change between T0 and T1 was similar in both groups; change scores in group A and B: GMFM-66 2.4 (SD±2.1) and 3.3 (SD±2.9) (p=0.412); PEDI mobility 8.4 (SD±6.6) and 3.5 (SD±9.2) (p=0.148), respectively. In two children muscle tone increased post-sWBV. 24 children received between 67 and 140 sWBV sessions, rate of completed sessions ranged from 48 to 100% and no dropouts were observed. A 14-week home-based sWBV intervention was feasible and safe in toddlers with CP, but was not associated with improvement in gross motor function.

  12. Restriction of meat, fish, and poultry in omnivores improves mood: a pilot randomized controlled trial.

    Science.gov (United States)

    Beezhold, Bonnie L; Johnston, Carol S

    2012-02-14

    Omnivorous diets are high in arachidonic acid (AA) compared to vegetarian diets. Research shows that high intakes of AA promote changes in brain that can disturb mood. Omnivores who eat fish regularly increase their intakes of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), fats that oppose the negative effects of AA in vivo. In a recent cross-sectional study, omnivores reported significantly worse mood than vegetarians despite higher intakes of EPA and DHA. This study investigated the impact of restricting meat, fish, and poultry on mood. Thirty-nine omnivores were randomly assigned to a control group consuming meat, fish, and poultry daily (OMN); a group consuming fish 3-4 times weekly but avoiding meat and poultry (FISH), or a vegetarian group avoiding meat, fish, and poultry (VEG). At baseline and after two weeks, participants completed a food frequency questionnaire, the Profile of Mood States questionnaire and the Depression Anxiety and Stress Scales. After the diet intervention, VEG participants reduced their EPA, DHA, and AA intakes, while FISH participants increased their EPA and DHA intakes. Mood scores were unchanged for OMN or FISH participants, but several mood scores for VEG participants improved significantly after two weeks. Restricting meat, fish, and poultry improved some domains of short-term mood state in modern omnivores. To our knowledge, this is the first trial to examine the impact of restricting meat, fish, and poultry on mood state in omnivores.

  13. Restriction of meat, fish, and poultry in omnivores improves mood: A pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Beezhold Bonnie L

    2012-02-01

    Full Text Available Abstract Background Omnivorous diets are high in arachidonic acid (AA compared to vegetarian diets. Research shows that high intakes of AA promote changes in brain that can disturb mood. Omnivores who eat fish regularly increase their intakes of eicosapentaenoic acid (EPA and docosahexaenoic acid (DHA, fats that oppose the negative effects of AA in vivo. In a recent cross-sectional study, omnivores reported significantly worse mood than vegetarians despite higher intakes of EPA and DHA. This study investigated the impact of restricting meat, fish, and poultry on mood. Findings Thirty-nine omnivores were randomly assigned to a control group consuming meat, fish, and poultry daily (OMN; a group consuming fish 3-4 times weekly but avoiding meat and poultry (FISH, or a vegetarian group avoiding meat, fish, and poultry (VEG. At baseline and after two weeks, participants completed a food frequency questionnaire, the Profile of Mood States questionnaire and the Depression Anxiety and Stress Scales. After the diet intervention, VEG participants reduced their EPA, DHA, and AA intakes, while FISH participants increased their EPA and DHA intakes. Mood scores were unchanged for OMN or FISH participants, but several mood scores for VEG participants improved significantly after two weeks. Conclusions Restricting meat, fish, and poultry improved some domains of short-term mood state in modern omnivores. To our knowledge, this is the first trial to examine the impact of restricting meat, fish, and poultry on mood state in omnivores.

  14. Flaxseed supplementation in non-alcoholic fatty liver disease: a pilot randomized, open labeled, controlled study.

    Science.gov (United States)

    Yari, Zahra; Rahimlou, Mehran; Eslamparast, Tannaz; Ebrahimi-Daryani, Naser; Poustchi, Hossein; Hekmatdoost, Azita

    2016-06-01

    A two-arm randomized open labeled controlled clinical trial was conducted on 50 patients with non-alcoholic fatty liver disease (NAFLD). Participants were assigned to take either a lifestyle modification (LM), or LM +30 g/day brown milled flaxseed for 12 weeks. At the end of the study, body weight, liver enzymes, insulin resistance and hepatic fibrosis and steatosis decreased significantly in both groups (p< 0.05); however, this reduction was significantly greater in those who took flaxseed supplementation (p < 0.05). The significant mean differences were reached in hepatic markers between flaxseed and control group, respectively: ALT [-11.12 compared with -3.7 U/L; P< 0.001], AST [-8.29 compared with -4 U/L; p < 0.001], GGT [-15.7 compared with -2.62 U/L; p < 0.001], fibrosis score [-1.26 compared with -0.77 kPa; p = 0.013] and steatosis score [-47 compared with -15.45 dB/m; p = 0.022]. In conclusion, flaxseed supplementation plus lifestyle modification is more effective than lifestyle modification alone for NAFLD management.

  15. The spaced learning concept significantly improves training for laparoscopic suturing: a pilot randomized controlled study.

    Science.gov (United States)

    Boettcher, Michael; Boettcher, Johannes; Mietzsch, Stefan; Krebs, Thomas; Bergholz, Robert; Reinshagen, Konrad

    2018-01-01

    Spaced learning has been shown to be effective in various areas like traditional knowledge or motor skill acquisition. To evaluate the impact of implementation of the spaced learning concept in laparoscopic training was the aim of this study. To evaluate the effectiveness of spaced learning, subjects were asked to perform four surgeon's square knots on a bowel model prior and post 3 h of hands-on training. All subjects were medical students and novice in laparoscopic suturing. Total time, knot stability (evaluated via tensiometer), suture accuracy, knot quality (Muresan score), and laparoscopic performance (Munz checklist) were assessed. Moreover, motivation was accessed using Questionnaire on Current Motivation. Twenty students were included in the study; after simple randomization, ten were trained using "spaced learning" concept and ten conservatively. Both groups had comparable baseline characteristics and improved after training significantly regarding all aspects assessed in this study. Subjects that trained via spaced learning were superior in terms of suture performance, knot quality, and suture strength. Ultimately, spaced learning significantly decreased anxiety and impression of challenge compared to controls. The spaced learning concept is very suitable for complex motor skill acquisition like laparoscopic suturing and knot tying. It significantly improves laparoscopic performance and knot quality as shown by the knot score and suture strength. Thus, we recommend to incorporate spaced learning into training courses and surgical programs.

  16. Neurofeedback reduces overeating episodes in female restrained eaters: a randomized controlled pilot-study.

    Science.gov (United States)

    Schmidt, Jennifer; Martin, Alexandra

    2015-12-01

    Overeating episodes, despite of intentions to control weight, are a common problem among women. Recurring episodes of overeating and dietary failure have been reported to result in higher Body Mass Indexes and to induce severe distress even in non-clinical groups. Based on findings from physiological research on eating behavior and craving, as well as previous biofeedback studies, we derived a cue exposure based EEG neurofeedback protocol to target overeating episodes. The treatment was evaluated in a randomized controlled trial, comparing a neurofeedback group (NFG; n = 14) with a waiting list control group (WLG; n = 13) in a sub-clinical sample of female restrained eaters. At post-treatment, the number of weekly overeating episodes and subsequent distress were significantly reduced in the NFG compared to the WLG (p  .50). In a 3 month follow-up, effects in the NFG remained stable. As secondary outcomes, perceived dieting success was enhanced after the treatment. At follow-up, additional beneficial effects on trait food craving were observed. Altogether, we found preliminary evidence for the cue exposure neurofeedback against overeating episodes in female restrained eaters, although specific effects and underlying mechanisms still have to be explored in future research.

  17. Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study

    Science.gov (United States)

    Degli Stefani, Mario; Biasutti, Michele

    2016-01-01

    Objective: Framed in the patients’ engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed. PMID:27774073

  18. Effect of core strength and endurance training on performance in college students: randomized pilot study.

    Science.gov (United States)

    Schilling, Jim F; Murphy, Jeff C; Bonney, John R; Thich, Jacob L

    2013-07-01

    Core training continues to be emphasized with the proposed intent of improving athletic performance. The purpose of this investigation was to discover if core isometric endurance exercises were superior to core isotonic strengthening exercises and if either influenced specific endurance, strength, and performance measures. Ten untrained students were randomly assigned to core isometric endurance (n = 5) and core isotonic strength training (n = 5). Each performed three exercises, two times per week for six weeks. A repeated measures ANOVA was used to compare the measurements for the dependent variables and significance by bonferroni post-hoc testing. The training protocols were compared using a 2 × 3 mixed model ANOVA. Improvement in trunk flexor and extensor endurance (p strength (p strength group. Improvement in trunk flexor and right lateral endurance (p strength in the squat (p < 0.05) were found with the endurance group. Neither training protocol claimed superiority and both were ineffective in improving performance. Published by Elsevier Ltd.

  19. Telemonitoring Adherence to Medications in Heart Failure Patients (TEAM-HF): A Pilot Randomized Clinical Trial.

    Science.gov (United States)

    Gallagher, Benjamin D; Moise, Nathalie; Haerizadeh, Mytra; Ye, Siqin; Medina, Vivian; Kronish, Ian M

    2017-04-01

    Medication nonadherence contributes to hospitalizations in recently discharged patients with heart failure (HF). We aimed to test the feasibility of telemonitoring medication adherence in patients with HF. We randomized 40 patients (1:1) hospitalized for HF to 30 days of loop diuretic adherence monitoring with telephonic support or to passive adherence monitoring alone. Eighty-three percent of eligible patients agreed to participate. The median age of patients was 64 years, 25% were female, and 45% were Hispanic. Overall, 67% of patients were nonadherent (percentage of days that the correct number of doses were taken patients, respectively, in adherence (median correct dosing adherence 82% vs 73%; P = .41) or in the proportion readmitted within 30 days (30% vs 20%; P = .72). Eighty-eight percent of patients rated the wireless electronic adherence device as somewhat or very easy to use, and 88% agreed to use it again. Adherence telemonitoring was acceptable to most patients with HF. Diuretic nonadherence was common even when patients knew they were being monitored. Future studies should assess whether adherence telemonitoring can improve adherence and reduce readmissions among patients with HF. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Effects of adjunctive exercise on physiological and psychological parameters in depression: a randomized pilot trial.

    Science.gov (United States)

    Kerling, Arno; Tegtbur, Uwe; Gützlaff, Elke; Kück, Momme; Borchert, Luise; Ates, Zeynep; von Bohlen, Anne; Frieling, Helge; Hüper, Katja; Hartung, Dagmar; Schweiger, Ulrich; Kahl, Kai G

    2015-05-15

    Major depressive disorder (MDD) is associated with decreased physical activity and increased rates of the metabolic syndrome (MetS), a risk factor for the development of type 2 diabetes and cardiovascular disorders. Exercise training has been shown to improve cardiorespiratory fitness and metabolic syndrome factors. Therefore, our study aimed at examining whether patients receiving an exercise program as an adjunct to inpatient treatment will benefit in terms of physiological and psychological factors. Fourty-two inpatients with moderate to severe depression were included. Twenty-two patients were randomized to additional 3x weekly exercise training (EXERCISE) and compared to treatment as usual (TAU). Exercise capacity was assessed as peak oxygen uptake (VO2peak), ventilatory anaerobic threshold (VAT) and workload expressed as Watts (W). Metabolic syndrome was defined according to NCEP ATPIII panel criteria. After 6 weeks of treatment, cardiorespiratory fitness (VO2peak, VAT, Watt), waist circumference and HDL cholesterol were significantly improved in EXERCISE participants. Treatment response expressed as ≥50% MADRS reduction was more frequent in the EXERCISE group. Adjunctive exercise training in depressed inpatients improves physical fitness, MetS factors, and psychological outcome. Given the association of depression with cardiometablic disorders, exercise training is recommended as an adjunct to standard antidepressant treatment. Copyright © 2015 Elsevier B.V. All rights reserved.

  1. Controlling memory impairment in elderly adults using virtual reality memory training: a randomized controlled pilot study.

    Science.gov (United States)

    Optale, Gabriele; Urgesi, Cosimo; Busato, Valentina; Marin, Silvia; Piron, Lamberto; Priftis, Konstantinos; Gamberini, Luciano; Capodieci, Salvatore; Bordin, Adalberto

    2010-05-01

    Memory decline is a prevalent aspect of aging but may also be the first sign of cognitive pathology. Virtual reality (VR) using immersion and interaction may provide new approaches to the treatment of memory deficits in elderly individuals. The authors implemented a VR training intervention to try to lessen cognitive decline and improve memory functions. The authors randomly assigned 36 elderly residents of a rest care facility (median age 80 years) who were impaired on the Verbal Story Recall Test either to the experimental group (EG) or the control group (CG). The EG underwent 6 months of VR memory training (VRMT) that involved auditory stimulation and VR experiences in path finding. The initial training phase lasted 3 months (3 auditory and 3 VR sessions every 2 weeks), and there was a booster training phase during the following 3 months (1 auditory and 1 VR session per week). The CG underwent equivalent face-to-face training sessions using music therapy. Both groups participated in social and creative and assisted-mobility activities. Neuropsychological and functional evaluations were performed at baseline, after the initial training phase, and after the booster training phase. The EG showed significant improvements in memory tests, especially in long-term recall with an effect size of 0.7 and in several other aspects of cognition. In contrast, the CG showed progressive decline. The authors suggest that VRMT may improve memory function in elderly adults by enhancing focused attention.

  2. Oral language supports early literacy: a pilot cluster randomized trial in disadvantaged schools.

    Science.gov (United States)

    Snow, Pamela C; Eadie, Patricia A; Connell, Judy; Dalheim, Brenda; McCusker, Hugh J; Munro, John K

    2014-10-01

    This study examined the impact of teacher professional development aimed at improving the capacity of primary teachers in disadvantaged schools to strengthen children's expressive and receptive oral language skills and early literacy success in the first 2 years of school. Fourteen low-SES schools in Victoria, Australia were randomly allocated to a research (n = 8) or control arm (n = 6), resulting in an initial sample of 1254 students, (n = 602 in research arm and n = 652 in control arm). The intervention comprised 6 days of teacher and principal professional development (delivered by language and literacy experts), school-based continuing contact with the research team and completion by one staff member of each research school of a postgraduate unit on early language and literacy. Schools in the control arm received standard teaching according to state auspiced curriculum guidelines. Full data were available on 979 students at follow-up (time 2). Students in the research arm performed significantly better on Test of Language Development: Primary (Fourth Edition) sub-tests (p ≤ .002) and the Reading Progress Test (F = 10.4(1); p = .001) than students in the control arm at time 2. Narrative scores were not significantly different at time 2, although students in research schools showed greater gains. Findings provide "proof of concept" for this approach, and are discussed with respect to implications for teacher professional development and pre-service education concerning the psycholinguistic competencies that underpin the transition to literacy.

  3. Individual Placement and Support (IPS) for Methadone Maintenance Therapy Patients: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Lones, Carrie E; Bond, Gary R; McGovern, Mark P; Carr, Kathryn; Leckron-Myers, Teresa; Hartnett, Tim; Becker, Deborah R

    2017-05-01

    Individual Placement and Support (IPS) is an evidence-based employment model for people with severe mental illness, but it has not been evaluated for clients enrolled in substance abuse treatment programs. This study evaluated the effectiveness of IPS for people with opioid use disorders enrolled in an opioid treatment program. Within a randomized controlled experiment, 45 patients receiving methadone maintenance therapy were assigned to either IPS or a 6-month waitlist. The waitlist group received IPS after 6 months. The primary outcome assessed over 1 year compared the attainment of a job for the IPS condition to the waitlist comparison group. During the first 6 months after enrollment, 11 (50%) active IPS participants gained competitive employment compared to 1 (5%) waitlist participant (Χ (2) = 12.0, p IPS participants gained competitive employment compared to 5 (22%) waitlist participants (Χ (2) = 3.92, p = 0.07). We conclude that IPS holds promise as an employment intervention for people with opioid use disorders in methadone maintenance treatment, but larger trials with longer follow-up are needed.

  4. A video-based educational pilot for basal cell carcinoma (BCC) treatment: A randomized controlled trial.

    Science.gov (United States)

    Love, Elyse M; Manalo, Iviensan F; Chen, Suephy C; Chen, Kuang-Ho; Stoff, Benjamin K

    2016-03-01

    Several treatment options exist for uncomplicated basal cell carcinoma. Standardized and effective informed consent is difficult in busy dermatology clinics. We investigated whether an educational video depicting 3 treatment options for uncomplicated basal cell carcinoma-excision, electrodessication and curettage, and topical therapy-before standard in-office informed consent affected patient knowledge and consent time compared with standard in-office consent alone. Patients were randomized to receive video education plus verbal discussion (video) or standard verbal discussion alone (control). Both groups completed baseline and final knowledge assessments. The primary outcome measure was change in knowledge scores between groups. Secondary outcomes were patient satisfaction, physician satisfaction, and informed consent time. In all, 32 eligible patients (16 control, 16 video) from an academic institution and affiliate Department of Veterans Affairs Medical Center dermatology clinics participated. The video group had significantly greater gains in knowledge compared with the control group (mean ± SD: 9 ± 3.6 vs 2.9 ± 2.2) (P = .0048). There was no significant difference in total consent time between groups. Patients and physicians were highly satisfied with the video. Small sample size and slight methodological difference between recruitment sites are limitations. Video-based education for basal cell carcinoma improved patient knowledge with no additional physician time when compared with standard communication. Published by Elsevier Inc.

  5. Randomized Controlled Pilot Study of Mindfulness-Based Stress Reduction for Persistently Fatigued Cancer Survivors

    Science.gov (United States)

    Johns, Shelley A.; Brown, Linda F.; Beck-Coon, Kathleen; Monahan, Patrick O.; Tong, Yan; Kroenke, Kurt

    2014-01-01

    Objective Cancer-related fatigue (CRF) is one of the most common, persistent, and disabling symptoms associated with cancer and its treatment. Evidence-based treatments that are acceptable to patients are critically needed. This study examined the efficacy of Mindfulness-Based Stress Reduction (MBSR) for CRF and related symptoms. Method A sample of 35 cancer survivors with clinically-significant CRF was randomly assigned to a 7-week MBSR-based intervention or wait-list control group. The intervention group received training in mindfulness meditation, yoga, and self-regulatory responses to stress. Fatigue interference (primary outcome) and a variety of secondary outcomes (e.g., fatigue severity, vitality, disability, depression, anxiety, sleep disturbance) were assessed at baseline, post-intervention, and 1-month follow-up. Bonferroni correction was employed to account for multiple comparisons. Controls received the intervention after the 1-month follow-up. Participants in both groups were followed for 6 months after completing their respective MBSR courses to assess maintenance of effects. Results Compared to controls, the MBSR group reported large post-intervention reductions as assessed by effect sizes (d) in the primary outcome, fatigue interference (d= −1.43, pMBSR adherence was high, with 90% attendance across groups and high rates of participant-reported home practice of mindfulness. Conclusions MBSR is a promising treatment for CRF and associated symptoms. PMID:25132206

  6. Parent-child interactions during traditional and interactive media settings: A pilot randomized control study.

    Science.gov (United States)

    Skaug, Silje; Englund, Kjellrun T; Saksvik-Lehouillier, Ingvild; Lydersen, Stian; Wichstrøm, Lars

    2017-12-15

    Parent-child interactions are pivotal for children's socioemotional development, yet might suffer with increased attention to screen media, as research has suggested. In response, we hypothesized that parent-child play on a tablet computer, as representative of interactive media, would generate higher-quality parent-child interactions than toy play or watching TV. We examined the emotional availability of mothers and their 2-year-old child during the previous three contexts using a randomized crossover design (n = 22) in a laboratory room. Among other results, mothers were more sensitive and structuring during joint gaming on a tablet than when engaged in toy play or watching TV. In addition, mothers were more hostile toward their children during play with traditional toys than during joint tablet gaming and television co-viewing. Such findings provide new insights into the impact of new media on parent-child interactions, chiefly by demonstrating that interactive media devices such as tablets can afford growth-enhancing parent-child interactions. © 2017 Scandinavian Psychological Associations and John Wiley & Sons Ltd.

  7. Teaching Parents About Responsive Feeding Through a Vicarious Learning Video: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Ledoux, Tracey; Robinson, Jessica; Baranowski, Tom; O'Connor, Daniel P

    2017-06-01

    The American Academy of Pediatrics and World Health Organization recommend responsive feeding (RF) to promote healthy eating behaviors in early childhood. This project developed and tested a vicarious learning video to teach parents RF practices. A RF vicarious learning video was developed using community-based participatory research methods. Fifty parents of preschoolers were randomly assigned to watch Happier Meals or a control video about education. Knowledge and beliefs about RF practices were measured 1 week before and immediately after intervention. Experimental group participants also completed measures of narrative engagement and video acceptability. Seventy-four percent of the sample was White, 90% had at least a college degree, 96% were married, and 88% made >$50,000/year. RF knowledge increased ( p = .03) and positive beliefs about some unresponsive feeding practices decreased ( ps < .05) more among experimental than control parents. Knowledge and belief changes were associated with video engagement ( ps < .05). Parents perceived Happier Meals as highly relevant, applicable, and informative. Community-based participatory research methods were instrumental in developing this vicarious learning video, with preliminary evidence of effectiveness in teaching parents about RF. Happier Meals is freely available for parents or community health workers to use when working with families to promote healthy eating behaviors in early childhood.

  8. Prospective randomized pilot study of Y90+/-sorafenib as bridge to transplantation in hepatocellular carcinoma.

    Science.gov (United States)

    Kulik, Laura; Vouche, Michael; Koppe, Sean; Lewandowski, Robert J; Mulcahy, Mary F; Ganger, Daniel; Habib, Ali; Karp, Jennifer; Al-Saden, Patrice; Lacouture, Mario; Cotliar, Jonathan; Abecassis, Michael; Baker, Talia; Salem, Riad

    2014-08-01

    To investigate the safety and adverse event profile of sorafenib plus radioembolization (Y90) compared to Y90 alone in patients awaiting liver transplantation. 20 patients with HCC were randomized to Y90 alone (Group A) or Y90+sorafenib (Group B). Adverse events, dose reductions, and peri-transplant complications were assessed. All patients in the sorafenib group necessitated dose reductions. Seventeen of 20 patients underwent liver transplantation; median time-to-transplant was 7.8 months (range: 4.2-20.3) and similar between groups (p = 0.35). In the sorafenib group, there were 4/8 peri-transplant (<30 days) biliary complications (p = 0.029) and 3/8 acute rejections (p = 0.082); there were none in the Y90-only group. Survival rates were 70% (Group A) and 72% (Group B) at 3 years (p = 0.57). The addition of sorafenib to Y90 necessitated dose reductions in all patients awaiting transplantation. Preliminary data suggest that the combination was associated with more peri-transplant biliary complications and potentially trended towards more acute rejections. Caution should be exercised when considering sorafenib in the transplant setting. Further investigation is warranted. Copyright © 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

  9. Action observation training for functional activities after stroke: a pilot randomized controlled trial.

    Science.gov (United States)

    Kim, Jung-Hee; Lee, Byoung-Hee

    2013-01-01

    The objective of this study was to compare the effects of action observation training and motor imagery training on recovery from chronic stroke. Thirty patients who were more than six months post stroke participated in this study and were randomly allocated to three groups. The action observation training group practiced additional action observation training for five 30-minute sessions over a four-week period. The motor imagery training group practiced additional motor imagery training for five 30-minute sessions over a four-week period. The following clinical measures were used for assessment of dynamic balance and gait abilities: Timed Up and Go Test, Functional Reaching Test, Walking Ability Questionnaire, and Functional Ambulation Category. Spatiotemporal gait parameters were also collected using a GAITRite system. Compared with the physical training group, the action observation training group showed significant improvement in the Timed Up and Go test, gait speed, cadence, and single limb support of the affected side. No significant differences in any of the outcome measures were observed between the action observation training group and the motor imagery training group. Action observation training and motor imagery training results in improvement of dynamic balance and gait ability. These results suggest the feasibility and suitability of action observation training for patients with chronic stroke.

  10. Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study.

    Science.gov (United States)

    Degli Stefani, Mario; Biasutti, Michele

    2016-01-01

    Objective: Framed in the patients' engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants ( n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed.

  11. Meaning-centered group psychotherapy for patients with advanced cancer: a pilot randomized controlled trial.

    Science.gov (United States)

    Breitbart, William; Rosenfeld, Barry; Gibson, Christopher; Pessin, Hayley; Poppito, Shannon; Nelson, Christian; Tomarken, Alexis; Timm, Anne Kosinski; Berg, Amy; Jacobson, Colleen; Sorger, Brooke; Abbey, Jennifer; Olden, Megan

    2010-01-01

    An increasingly important concern for clinicians who care for patients at the end of life is their spiritual well-being and sense of meaning and purpose in life. In response to the need for short-term interventions to address spiritual well-being, we developed Meaning Centered Group Psychotherapy (MCGP) to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives, even as they approach the end of life. Patients with advanced (stage III or IV) solid tumor cancers (N=90) were randomly assigned to either MCGP or a supportive group psychotherapy (SGP). Patients were assessed before and after completing the 8-week intervention, and again 2 months after completion. Outcome assessment included measures of spiritual well-being, meaning, hopelessness, desire for death, optimism/pessimism, anxiety, depression and overall quality of life. MCGP resulted in significantly greater improvements in spiritual well-being and a sense of meaning. Treatment gains were even more substantial (based on effect size estimates) at the second follow-up assessment. Improvements in anxiety and desire for death were also significant (and increased over time). There was no significant improvement on any of these variables for patients participating in SGP. MCGP appears to be a potentially beneficial intervention for patients' emotional and spiritual suffering at the end of life. Further research, with larger samples, is clearly needed to better understand the potential benefits of this novel intervention. (c) 2009 John Wiley & Sons, Ltd.

  12. Pilot randomized trial of therapeutic hypothermia with serial cranial ultrasound and 18-22 month follow-up for neonatal encephalopathy in a low resource hospital setting in Uganda: study protocol

    National Research Council Canada - National Science Library

    Robertson, Nicola J; Hagmann, Cornelia F; Acolet, Dominique; Allen, Elizabeth; Nyombi, Natasha; Elbourne, Diana; Costello, Anthony; Jacobs, Ian; Nakakeeto, Margaret; Cowan, Frances

    2011-01-01

    .... Under the UCL Uganda Women's Health Initiative, a pilot randomized controlled trial in infants with perinatal asphyxia was set up in the special care baby unit in Mulago Hospital, a large public hospital...

  13. The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Ahmed, Sara; Ernst, Pierre; Bartlett, Susan J; Valois, Marie-France; Zaihra, Tasneem; Paré, Guy; Grad, Roland; Eilayyan, Owis; Perreault, Robert; Tamblyn, Robyn

    2016-12-01

    Whether Web-based technologies can improve disease self-management is uncertain. My Asthma Portal (MAP) is a Web-based self-management support system that couples evidence-based behavioral change components (self-monitoring of symptoms, physical activity, and medication adherence) with real-time monitoring, feedback, and support from a nurse case manager. The aim of this study was to compare the impact of access to a Web-based asthma self-management patient portal linked to a case-management system (MAP) over 6 months compared with usual care on asthma control and quality of life. A multicenter, parallel, 2-arm, pilot, randomized controlled trial was conducted with 100 adults with confirmed diagnosis of asthma from 2 specialty clinics. Asthma control was measured using an algorithm based on overuse of fast-acting bronchodilators and emergency department visits, and asthma-related quality of life was assessed using the Mini-Asthma Quality of Life Questionnaire (MAQLQ). Secondary mediating outcomes included asthma symptoms, depressive symptoms, self-efficacy, and beliefs about medication. Process evaluations were also included. A total of 49 individuals were randomized to MAP and 51 to usual care. Compared with usual care, participants in the intervention group reported significantly higher asthma quality of life (mean change 0.61, 95% CI 0.03 to 1.19), and the change in asthma quality of life for the intervention group between baseline and 3 months (mean change 0.66, 95% CI 0.35 to 0.98) was not seen in the control group. No significant differences in asthma quality of life were found between the intervention and control groups at 6 (mean change 0.46, 95% CI -0.12 to 1.05) and 9 months (mean change 0.39, 95% CI -0.2 to 0.98). For poor control status, there was no significant effect of group, time, or group by time. For all self-reported measures, the intervention group had a significantly higher proportion of individuals, demonstrating a minimal clinically

  14. Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

    Science.gov (United States)

    Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

    2017-01-01

    Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible

  15. The effectiveness of moxibustion for the treatment of functional constipation: a randomized, sham-controlled, patient blinded, pilot clinical trial

    Directory of Open Access Journals (Sweden)

    Park Ji-Eun

    2011-12-01

    Full Text Available Abstract Background Moxibustion is an ancient traditional medicine using burning mugworts to stimulate acupuncture points. The aim of this study was to investigate the safety and efficacy of moxibustion for the treatment of constipation using a randomized, sham-controlled, participant-blinded, pilot trial. Methods Twenty-six participants (identified with either qi (vital energy deficiency or qi excess syndrome were randomly divided into either a moxibustion or sham group. Participants were treated with real or sham moxibustion at 4 acupuncture points, ST23 and ST27, bilaterally, 3 times per week for four weeks. The primary outcome was the frequency of defecations; secondary outcomes were the Bristol stool form scale (BSS and the constipation assessment scale (CAS. Results Of the 26 participants that were randomized, 24 completed the study. Defecation frequency, BSS, and CAS showed no difference between the moxibustion and sham groups. The differences were -0.25 (95% CI: -2.08, 1.58, p = 0.78, -1.22 (95% CI: -2.7, 0.26, p = 0.1, 0.91 (95% CI: -1.46, 3.28, p = 0.44 in defecation frequency, BSS, CAS, respectively. The defecation frequency increased from an average of 3.3 to 4.6 times per week in the moxibustion group (1.5[-0.5, 2], p = 0.06 and from 2.7 to 3.7 stools per week in the sham group (1[-1, 2], p = 0.15 after four weeks of treatment. The difference between participants with a deficiency or an excess syndrome, determined based on assessment of sweat, facial features, pain, body energy, and pulse type, was significant in only defecation frequency. The difference was 3.3 (95% CI: 0.41, 6.19, p = 0.03. Conclusion Moxibustion treatment appears safe, but showed no positive effect on constipation. The effectiveness of moxibustion treatment may depend on the syndrome pattern, and further long-term studies with a larger number of subjects are warranted. Trial registration Clinical Research Information Service, KCT0000168

  16. Internet-Based Guided Self-Help for Vaginal Penetration Difficulties: Results of a Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Zarski, Anna-Carlotta; Berking, Matthias; Fackiner, Christina; Rosenau, Christian; Ebert, David Daniel

    2017-02-01

    Difficulties with vaginal penetration can severely affect a woman's desire to have sexual intercourse, her sexual and general well-being, or her partnership. However, treatment opportunities for vaginismus are scarce. To evaluate the efficacy of an internet-based guided self-help intervention for vaginismus in a randomized controlled pilot trial. Seventy-seven women with vaginismus (primary inclusion criterion = no intercourse ≥ 6 months) were randomly assigned to an intervention group (IG) and a waitlist control group (WCG). The intervention consisted of 10 sessions involving psychoeducation, relaxation exercises, sensate focus, and gradual exposure with dilators. Participants received written feedback on completed sessions from an eCoach. The primary outcome was successful sexual intercourse. Secondary outcomes were non-intercourse penetration, fear of coitus, sexual functioning, and dyadic coping. Self-reported assessments were scheduled at baseline, 10 weeks, and 6 months. More participants (10 of 40, 34.48%) in the IG had intercourse compared with those in the WCG (6 of 37, 20.69%) at least once at 10 weeks or 6 months (odds ratio = 2.02). The difference was not significant (χ21 = 1.38, P = .38), but in the IG, there was a significant increase in intercourse penetration from baseline to 6 months (d = 0.65). No such increase was found in the WCG (d = 0.21). There were significant between-group effects concerning non-intercourse penetration (self-insertion of a finger or dilator or insertion by the partner) in favor of the IG. Fear of coitus and dyadic coping significantly decreased in the IG. Overall satisfaction with the training was high. This randomized controlled trial showed promising effects of an internet-based intervention by increasing participants' ability to have intercourse and non-intercourse penetration while experiencing high treatment satisfaction. The WCG also showed improvement, although participants had vaginismus for an average

  17. Yoga and exercise for symptoms of depression and anxiety in people with poststroke disability: a randomized, controlled pilot trial.

    Science.gov (United States)

    Chan, Weili; Immink, Maarten A; Hillier, Susan

    2012-01-01

    Mood disorders are prevalent in people after stroke, and a disorder's onset can exacerbate stroke-related disabilities. While evidence supports the mental-health benefits of participation in exercise and yoga, it is unknown whether such benefits extend to a population with poststroke hemiparesis. The study investigated whether supplementing exercise with participation in a yoga program would provide further improvements in self-reported symptoms of depression and anxiety in a chronic poststroke population, and it also assessed trial feasibility for future studies. The research team designed a randomized, controlled pilot trial that included an exercise-only group (EX, control) and a yoga-and-exercise group (YEX, intervention). The study took place at the Centre for Physical Activity in Ageing an exercise rehabilitation and activity center at the Royal Adelaide Hospital in South Australia. The participants included 14 individuals with chronic poststroke hemiparesis: eight in the intervention group and six in the control group. The YEX group participated in a 6-week standardized program that included yoga in weekly group sessions and home practice in addition to exercise in a weekly group class. The EX group participated only in the group exercise class weekly for 6 weeks. The research team assessed self-reported symptoms of depression using the Geriatric Depression Scale (GDS15) and symptoms of anxiety and negative affect using the State Trait Anxiety Inventory (STAI). The team based the feasibility evaluation on recruitment outcomes, retention of participants, participants' compliance with the intervention program, and the safety of the intervention. Changes in depression and state and trait anxiety did not significantly differ between intervention groups (GDS15 P=.749, STAI-Y1, P=.595, STAI-Y2, P=.407). Comparison of individuals' case results indicated clinically relevant improvements in both groups, although members of the intervention group had greater

  18. Penile vibratory stimulation in the treatment of post-prostatectomy incontinence: a randomized pilot study.

    Science.gov (United States)

    Fode, Mikkel; Sønksen, Jens

    2015-02-01

    To examine penile vibratory stimulation (PVS) in the treatment of post-prostatectomy urinary incontinence (UI). Patients with post-prostatectomy UI were included in a 12-week trial. A 24-hr pad test and a 72-hr voiding diary were collected at baseline. Participants were randomized to receive PVS for the first 6 weeks (group 1) or for the final 6 weeks (group 2) of the study. The primary outcome was the difference in leakage between groups 1 and 2 at 6 weeks as measured by changes in the pad test. The trial was registered at www.clinicaltrials.org (NCT01540656). Data from 31 men were available for analyses. The difference in the change on the pad test between the groups did not reach statistical significance at 6 weeks (P = 0.13) while the change in incontinence episodes between groups approached statistical significance (P = 0.052). However, there was a median reduction of -33 g (P = 0.021) on the pad test and a median reduction in daily incontinence episodes of -1 (P = 0.023) in group 1 at 6 weeks. At 12 weeks, group 2 had a median decrease on the pad test of -8 g (P = 0.10) and no change in incontinence episodes. A pooled analysis showed a decline on the pad test of -13.5 g (P = 0.004) after PVS. Small improvements were seen in subjective symptom scores and 58% stated to be satisfied with PVS. Self-limiting side effects were experienced by 15% of patients. PVS is feasible in the treatment of post-prostatectomy UI. Larger trials are needed to document the clinical efficacy. © 2013 Wiley Periodicals, Inc.

  19. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study.

    Science.gov (United States)

    Forrester, Larry W; Roy, Anindo; Krywonis, Amanda; Kehs, Glenn; Krebs, Hermano Igo; Macko, Richard F

    2014-09-01

    BACKGROUND. Modular lower extremity robotics may offer a valuable avenue for restoring neuromotor control after hemiparetic stroke. Prior studies show that visually guided and visually evoked practice with an ankle robot (anklebot) improves paretic ankle motor control that translates into improved overground walking. To assess the feasibility and efficacy of daily anklebot training during early subacute hospitalization poststroke. Thirty-four inpatients from a stroke unit were randomly assigned to anklebot (n = 18) or passive manual stretching (n = 16) treatments. All suffered a first stroke with residual hemiparesis (ankle manual muscle test grade 1/5 to 4/5), and at least trace muscle activation in plantar- or dorsiflexion. Anklebot training employed an "assist-as-needed" approach during >200 volitional targeted paretic ankle movements, with difficulty adjusted to active range of motion and success rate. Stretching included >200 daily mobilizations in these same ranges. All sessions lasted 1 hour and assessments were not blinded. Both groups walked faster at discharge; however, the robot group improved more in percentage change of temporal symmetry (P = .032) and also of step length symmetry (P = .038), with longer nonparetic step lengths in the robot (133%) versus stretching (31%) groups. Paretic ankle control improved in the robot group, with increased peak (P ≤ .001) and mean (P ≤ .01) angular speeds, and increased movement smoothness (P ≤ .01). There were no adverse events. Though limited by small sample size and restricted entry criteria, our findings suggest that modular lower extremity robotics during early subacute hospitalization is well tolerated and improves ankle motor control and gait patterning. © The Author(s) 2014.

  20. Modular Ankle Robotics Training in Early Sub-Acute Stroke: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Forrester, Larry W.; Roy, Anindo; Krywonis, Amanda; Kehs, Glenn; Krebs, Hermano Igo; Macko, Richard F.

    2014-01-01

    Background Modular lower extremity (LE) robotics may offer a valuable avenue for restoring neuromotor control after hemiparetic stroke. Prior studies show that visually-guided and visually-evoked practice with an ankle robot (anklebot) improves paretic ankle motor control that translates into improved overground walking. Objective Assess the feasibility and efficacy of daily anklebot training during early sub-acute hospitalization post-stroke. Methods Thirty-four inpatients from a stroke unit were randomly assigned to anklebot (N=18) or passive manual stretching (N=16) treatments. All suffered a first stroke with residual hemiparesis (ankle manual muscle test grade 1/5 to 4/5), and at least trace muscle activation in plantar- or dorsiflexion. Anklebot training employed an “assist-as-needed” approach during > 200 volitional targeted paretic ankle movements, with difficulty adjusted to active range of motion and success rate. Stretching included >200 daily mobilizations in these same ranges. All sessions lasted 1 hour and assessments were not blinded. Results Both groups walked faster at discharge, however the robot group improved more in percent change of temporal symmetry (p=0.032) and also of step length symmetry (p=0.038), with longer nonparetic step lengths in the robot (133%) vs. stretching (31%) groups. Paretic ankle control improved in the robot group, with increased peak (p≤ 0.001) and mean (p≤ 0.01) angular speeds, and increased movement smoothness (p≤ 0.01). There were no adverse events. Conclusion Though limited by small sample size and restricted entry criteria, our findings suggest that modular lower extremity robotics during early sub-acute hospitalization is well tolerated and improves ankle motor control and gait patterning. PMID:24515923

  1. Effectiveness of Cognitive-Behavioral Therapy and Physical Therapy for Provoked Vestibulodynia: A Randomized Pilot Study.

    Science.gov (United States)

    Goldfinger, Corrie; Pukall, Caroline F; Thibault-Gagnon, Stephanie; McLean, Linda; Chamberlain, Susan

    2016-01-01

    Non-medical and non-surgical treatments for provoked vestibulodynia target psychological, sexual, and pelvic floor muscle factors that maintain the condition. The goal of the study was to compare the effects of cognitive-behavioral therapy (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked vestibulodynia. In a clinical trial, 20 women with provoked vestibulodynia were randomly assigned to receive CBT or comprehensive PT. Participants were assessed before treatment, after treatment, and at 6-month follow-up by gynecologic examination, structured interviews, and standardized questionnaires measuring pain, psychological, and sexual variables. Outcome measurements were based on an adaptation of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations. The primary outcome was change in intercourse pain intensity. Secondary outcomes included pain during the cotton swab test, pain with various sexual and non-sexual activities, and sexual functioning and negative pain cognitions. The two treatment groups demonstrated significant decreases in vulvar pain during sexual intercourse, with 70% and 80% of participants in the CBT and PT groups demonstrating a moderate clinically important decrease in pain (≥30%) after treatment. Participants in the two groups also had significant improvements in pain during the gynecologic examination, the percentage of painful intercourse attempts, the percentage of activities resulting in pain, and the ability to continue intercourse without stopping because of pain. Psychological outcomes, including pain catastrophizing and perceived control over pain, also showed improvement in the two groups. Significant improvements in sexual functioning were observed only in participants who completed CBT. Few between-group differences were identified other than the PT group showing earlier improvements in some outcomes. Nearly all improvements were maintained at the 6-month

  2. Dynamic Balance Training Improves Physical Function in Individuals With Knee Osteoarthritis: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Takacs, Judit; Krowchuk, Natasha M; Garland, S Jayne; Carpenter, Mark G; Hunt, Michael A

    2017-08-01

    To examine the effect of a targeted balance training program on dynamic balance and self-reported physical function in people with medial tibiofemoral osteoarthritis (OA). Single-blind randomized controlled trial. Exercise gymnasium and community dwellings. Individuals with medial compartment knee OA (N=40). Ten weeks of partially supervised exercises targeting dynamic balance and strength performed 4 times per week or no intervention (nonintervention group). Dynamic balance was measured using the Community Balance and Mobility Scale (CB&M), and self-reported physical function was measured using the Western Ontario and McMaster Universities Arthritis Index physical function subscale. Secondary outcomes included knee pain, fear of movement, knee joint proprioception, and muscle strength. Forty individuals underwent baseline testing, with 36 participants completing follow-up testing. Adherence to exercise in the training group was high, with 82.2% of all home-based exercise sessions completed. No significant changes were observed in any outcome in the nonintervention group at follow-up. Significant improvements in self-reported pain, physical function, and fear of movement were observed in the training group when compared with the nonintervention group. No other within- or between-group differences were observed. A 10-week dynamic balance training program for people with knee OA significantly improved self-reported knee pain, physical function, and fear of movement; however, there was no change in dynamic balance as quantified by the CB&M. Further research is needed to investigate how exercise may result in improvement on objective measures of dynamic balance. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  3. Randomized controlled trial of neurofeedback on chemotherapy-induced peripheral neuropathy: A pilot study.

    Science.gov (United States)

    Prinsloo, Sarah; Novy, Diane; Driver, Larry; Lyle, Randall; Ramondetta, Lois; Eng, Cathy; McQuade, Jennifer; Lopez, Gabriel; Cohen, Lorenzo

    2017-06-01

    Chemotherapy-induced peripheral neuropathy (CIPN) is a significant problem for cancer patients, and there are limited treatment options for this often debilitating condition. Neuromodulatory interventions could be a novel modality for patients trying to manage CIPN symptoms; however, they are not yet the standard of care. This study examined whether electroencephalogram (EEG) neurofeedback (NFB) could alleviate CIPN symptoms in survivors. This was a randomized controlled trial with survivors assigned to an NFB group or a wait-list control (WLC) group. The NFB group underwent 20 sessions of NFB, in which visual and auditory rewards were given for voluntary changes in EEGs. The Brief Pain Inventory (BPI) worst-pain item was the primary outcome. The BPI, the Pain Quality Assessment Scale, and EEGs were collected before NFB and again after treatment. Outcomes were assessed with general linear modeling. Cancer survivors with CIPN (average duration of symptoms, 25.3 mo), who were mostly female and had a mean age of 62.5 years, were recruited between April 2011 and September 2014. One hundred percent of the participants starting the NFB program completed it (30 in the NFB group and 32 in the WLC group). The NFB group demonstrated greater improvement than the controls on the BPI worst-pain item (mean change score, -2.43 [95% confidence interval, -3.58 to -1.28] vs 0.09 [95% confidence interval, -0.72 to -0.90]; P =·.001; effect size, 0.83). NFB appears to be effective at reducing CIPN symptoms. There was evidence of neurological changes in the cortical location and in the bandwidth targeted by the intervention, and changes in EEG activity were predictive of symptom reduction. Cancer 2017;123:1989-1997. © 2017 American Cancer Society. © 2017 American Cancer Society.

  4. Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

    Directory of Open Access Journals (Sweden)

    Andrew J. Butler

    2015-01-01

    Full Text Available Stroke is a leading cause of death and disability in the USA. Up to 60% of patients do not fully recover despite intensive physical therapy treatment. N-Methyl-D-aspartate receptors (NMDA-R have been shown to play a role in synaptic plasticity when activated. D-Cycloserine promotes NMDA receptor function by binding to receptors with unoccupied glycine sites. These receptors are involved in learning and memory. We hypothesized that D-cycloserine, when combined with robotic-assisted physiotherapy (RAP, would result in greater gains compared with placebo + RAP in stroke survivors. Participants (n=14 were randomized to D-cycloserine plus RAP or placebo plus RAP. Functional, cognitive, and quality-of-life measures were used to assess recovery. There was significant improvement in grip strength of the affected hand within both groups from baseline to 3 weeks (95% confidence interval for mean change, 3.95 ± 2.96 to 4.90 ± 3.56 N for D-cycloserine and 5.72 ± 3.98 to 8.44 ± 4.90 N for control. SIS mood domain showed improvement for both groups (95% confidence interval for mean change, 72.6 ± 16.3 to 82.9 ± 10.9 for D-cycloserine and 82.9 ± 13.5 to 90.3 ± 9.9 for control. This preliminary study does not provide evidence that D-cycloserine can provide greater gains in learning compared with placebo for stroke survivors.

  5. Working memory training in survivors of pediatric cancer: a randomized pilot study.

    Science.gov (United States)

    Hardy, Kristina K; Willard, Victoria W; Allen, Taryn M; Bonner, Melanie J

    2013-08-01

    Survivors of pediatric brain tumors and acute lymphoblastic leukemia (ALL) are at increased risk for neurocognitive deficits, but few empirically supported treatment options exist. We examined the feasibility and preliminary efficacy of a home-based, computerized working memory training program, CogmedRM, with survivors of childhood cancer. Survivors of brain tumors or ALL (n = 20) with identified deficits in attention and/or working memory were randomized to either the success-adapted computer intervention or a non-adaptive, active control condition. Specifically, children in the adaptive condition completed exercises that became more challenging with each correct trial, whereas those in the non-adaptive version trained with exercises that never increased in difficulty. All participants were asked to complete 25 training sessions at home, with weekly, phone-based coaching support. Brief assessments were completed pre-intervention and post-intervention; outcome measures included both performance-based and parent-report measures of working memory and attention. Eighty-five percent of survivors were compliant with the intervention, with no adverse events reported. After controlling for baseline intellectual functioning, survivors who completed the intervention program evidenced significant post-training improvements in their visual working memory and in parent-rated learning problems compared with those in the active control group. No differences in verbal working memory functioning were evident between groups, however. Home-based, computerized cognitive training demonstrates good feasibility and acceptability in our sample. Children with higher intellectual functioning at baseline appeared to benefit more from the training, although further study is needed to clarify the strength, scope, and particularly the generalizability of potential treatment effects. Copyright © 2012 John Wiley & Sons, Ltd.

  6. A randomized prospective pilot trial of Web-delivered epilepsy stigma reduction communications in young adults.

    Science.gov (United States)

    Sajatovic, Martha; Herrmann, Lynn K; Van Doren, Jamie R; Tatsuoka, Curtis; Welter, Elisabeth; Perzynski, Adam T; Bukach, Ashley; Needham, Kelley; Liu, Hongyan; Berg, Anne T

    2017-11-01

    Epilepsy is a common neurological condition that is often associated with stigmatizing attitudes and negative stereotypes among the general public. This randomized controlled trial (RCT) tested two new communication approaches targeting epilepsy stigma versus an education-alone approach. Two brief stigma-reduction videos were developed, informed by community stakeholder input; one highlighted role competency in people with epilepsy; the other highlighted social inclusion of people with epilepsy. A control video was also developed. A Web-based survey using a prospective RCT design compared effects of experimental videos and control on acceptability, perceived impact, epilepsy knowledge, and epilepsy stigma. Epilepsy knowledge and stigma were measured with the Epilepsy Knowledge Questionnaire (EKQ) and Attitudes and Beliefs about Living with Epilepsy (ABLE), respectively. A total of 295 participants completed the study. Mean age was 23.1 (standard deviation = 3.27) years; 59.0% were male, and 71.4% were white. Overall, respondents felt videos impacted their epilepsy attitudes. EKQ scores were similar across videos, with a trend for higher knowledge in experimental videos versus control (p = 0.06). The role competency and control videos were associated with slightly better perceived impact on attitudes. There were no differences between videos on ABLE scores (p = 0.568). There were subgroup differences suggesting that men, younger individuals, whites, and those with personal epilepsy experience had more stigmatizing attitudes. This RCT tested communication strategies to improve knowledge and attitudes about epilepsy. Although this initial effort will require follow-up, we have demonstrated the acceptability, feasibility, and potential of novel communication strategies to target epilepsy stigma, and a Web-based approach for assessing them. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  7. Randomized pilot trial comparing tolvaptan with furosemide on renal and neurohumoral effects in acute heart failure.

    Science.gov (United States)

    Jujo, Kentaro; Saito, Katsumi; Ishida, Issei; Furuki, Yuho; Kim, Ahsung; Suzuki, Yuki; Sekiguchi, Haruki; Yamaguchi, Junichi; Ogawa, Hiroshi; Hagiwara, Nobuhisa

    2016-09-01

    Loop diuretics are first-line medications for congestive heart failure (CHF); however, they are associated with serious adverse effects, including decreased renal function, and sympathetic nervous and renin-angiotensin system activation. We tested whether tolvaptan, a vasopressin V2-receptor antagonist, could reduce unfavourable furosemide-induced effects during CHF treatment. Sixty patients emergently hospitalized owing to CHF-induced dyspnea were randomly assigned to receive either 40 mg intravenous furosemide daily or 7.5 mg oral tolvaptan for 5 days after admission. Both groups also received intravenous carperitide and canrenoate potassium. As results, baseline patient characteristics were similar between the furosemide (n = 30) and the tolvaptan (n = 30) groups, with no significant difference in 5 day urine volume or fluid balance. Brain natriuretic peptide and body weight improvements were similar between groups. However, serum creatinine (Cr) level did not increase, and the incidence of worsening renal function was significantly lower in the tolvaptan group. Consequently, the Cr increase to gain 1000 mL urine was 2.5-fold lower in the tolvaptan group. Furthermore, the blood urea nitrogen (BUN)/Cr ratio significantly decreased in the tolvaptan group, suggesting that renal perfusion was preserved, and urea reuptake and passive water reabsorption were suppressed following tolvaptan treatment. Although catecholamine improvements after treatment were not significantly different, plasma renin activity was enhanced in the furosemide group. As compared with furosemide, tolvaptan in patients with acute heart failure is associated with comparable decongestion, better preservation of renal function and less activation of renin-angiotensin system. (UMIN 000014134).

  8. The effect of acupuncture on psychosocial outcomes for women experiencing infertility: a pilot randomized controlled trial.

    Science.gov (United States)

    Smith, Caroline A; Ussher, Jane M; Perz, Janette; Carmady, Bridget; de Lacey, Sheryl

    2011-10-01

    The study objectives were to examine the effectiveness of acupuncture for reducing infertility-related stress. The study design was a randomized controlled trial of acupuncture compared with a wait-list control. The study was conducted at The University of Western Sydney. Thirty-two (32) women aged 20-45 years, with a diagnosis of infertility, or a history of unsuccessfully trying to conceive for 12 months or more, were the subjects of the study. Women received six sessions of acupuncture over 8 weeks. The primary outcomes were infertility self-efficacy, anxiety, and infertility-related stress. The women's experience of infertility and acupuncture is also reported. At the end of the 8-week intervention, women in the acupuncture group reported significant changes on two domains on the Fertility Problem Inventory with less social concern (mean difference [MD] -3.75, 95% confidence interval [CI] -7.58 to 0.84, p=0.05), and less relationship concern (MD -3.66, 95% CI -6.80 to -0.052, p=0.02). There were also trends toward a reduction of infertility stress on other domains, and a trend toward improved self-efficacy (MD 11.9, 95% CI -2.20 to 26.0, p=0.09) and less anxiety (MD -2.54, 95% CI -5.95 to 0.86, p=0.08) in the acupuncture group compared with the wait-list control. Women described the experience and impact of acupuncture as positive relating to a sense of relaxation and time out, the engagement with the practitioner, and an intervention that had very few negative side-effects. Changes were also perceived after treatment with women describing a physical and psychologic sense of relaxation and calmness, and a changed perspective in relation to coping. Acupuncture may be a useful intervention to assist with the reduction of infertility-related stress. Further research is justified.

  9. Laparoscopic Sleeve Gastrectomy versus Laparoscopic Banded Sleeve Gastrectomy: First Prospective Pilot Randomized Study

    Directory of Open Access Journals (Sweden)

    Valeria Tognoni

    2016-01-01

    Full Text Available Introduction. The placement of ring or band around the gastric tube might prevent the dilation after Laparoscopic Sleeve Gastrectomy (LSG. We describe the first randomized study comparing LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG. Material and Method. Fifty obese patients were enrolled in the study between January 2014 and January 2015. We analysed differences in operative time, complication rate, mortality, and BMI between the two groups over a period of 12 months. Results. Twenty-five patients received LSG (group A and 25 LBSG (group B. The mean preoperative BMI was 47.3±6.58 kg/m2 and 44.95±5.85 kg/m2, respectively, in the two groups. There was no statistical relevant difference in operative time. No intraoperative complications occurred. Mean BMI registered after 3, 6, and 12 months in groups A and B, respectively, were 37.86±5.72 kg/m2 and 37.58±6.21 kg/m2 (p=0.869, 33.64±6.08 kg/m2 and 32.03±5.24 kg/m2 (p=0.325, and 29.72±4.40 kg/m2 and 27.42±4.47 kg/m2 (p=0.186; no statistical relevant difference was registered between the two groups. Conclusion. LBSG is a safe and feasible procedure. The time required for the device positioning did not influence significantly the surgical time. The results of bodyweight loss did not document any statistically significant differences among the two groups, even though LBSG group showed a mean BMI slightly lower than that of the control group.

  10. Yoga for managing knee osteoarthritis in older women: a pilot randomized controlled trial.

    Science.gov (United States)

    Cheung, Corjena; Wyman, Jean F; Resnick, Barbara; Savik, Kay

    2014-05-18

    Osteoarthritis (OA) is a common problem in older women that is associated with pain and disabilities. Although yoga is recommended as an exercise intervention to manage arthritis, there is limited evidence documenting its effectiveness, with little known about its long term benefits. This study's aims were to assess the feasibility and potential efficacy of a Hatha yoga exercise program in managing OA-related symptoms in older women with knee OA. Eligible participants (N=36; mean age 72 years) were randomly assigned to 8-week yoga program involving group and home-based sessions or wait-list control. The yoga intervention program was developed by a group of yoga experts (N=5). The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score that measures knee OA pain, stiffness, and function at 8 weeks. The secondary outcomes, physical function of the lower extremities, body mass index (BMI), quality of sleep (QOS), and quality of life (QOL), were measured using weight, height, the short physical performance battery (SPPB), the Pittsburgh Sleep Quality Index (PSQI), the Cantril Self-Anchoring Ladder, and the SF12v2 Health Survey. Data were collected at baseline, 4 weeks and 8 weeks, and 20 weeks. The recruitment target was met, with study retention at 95%. Based on ANCOVAs, participants in the treatment group exhibited significantly greater improvement in WOMAC pain (adjusted means [SE]) (8.3 [.67], 5.8 [.67]; p=.01), stiffness (4.7 [.28], 3.4 [.28]; p=.002) and SPPB (repeated chair stands) (2.0 [.23], 2.8 [.23]; p=.03) at 8 weeks. Significant treatment and time effects were seen in WOMAC pain (7.0 [.46], 5.4 [.54]; p=.03), function (24.5 [1.8], 19.9 [1.6]; p=.01) and total scores (35.4 [2.3], 28.6 [2.1]; p=.01) from 4 to 20 weeks. Sleep disturbance was improved but the PSQI total score declined significantly at 20 weeks. Changes in BMI and QOL were not significant. No yoga related adverse events were observed. A weekly

  11. Efficient leadership and staff motivation in a chosen firm

    OpenAIRE

    VLÁŠKOVÁ, Dagmar

    2010-01-01

    This bachelor work deals with the leadership and staff motivation. The main object was a detection of the mistakes which the managers in a chosen firm make in this sphere. The alternate targets were to analyse the staff satisfaction with their leaders and to detect the managers´ style of leading. The close of my work contains my own suggestions and recommendations how to eliminate the detected mistakes and how to improve current situation in a firm.

  12. Early enteral nutrition therapy in congenital cardiac repair postoperatively: A randomized, controlled pilot study

    Directory of Open Access Journals (Sweden)

    Manoj Kumar Sahu

    2016-01-01

    Full Text Available Background and Objectives: Adequate nutritional supplementation in infants with cardiac malformations after surgical repair is a challenge. Critically ill infants in the early postoperative period are in a catabolic stress. The mismatch between estimated energy requirement (EER and the intake in the postoperative period is multifactorial, predisposing them to complications such as immune deficiency, more infection, and growth failure. This study aimed to assess the feasibility and efficacy of enriched breast milk feed on postoperative recovery and growth of infants after open heart surgery. Methodology: Fifty infants <6 months of age were prospectively randomized in the trial for enteral nutrition (EN postoperatively from day 1 to 10, after obtaining the Institute Ethics Committee's approval. They were equally divided into two groups on the basis of the feed they received: Control group was fed with expressed breast milk (EBM; 0.65 kcal/ml and intervention group was fed with EBM + energy supplementation/fortification with human milk fortifier (7.5 kcal/2 g/Simyl medium-chain triglyceride oil (7.8 kcal/ml. Energy need for each infant was calculated as per EER at 90 kcal/kg/day, as the target requirement. The intra- and post-operative variables such as cardiopulmonary bypass and aortic cross-clamp times, ventilation duration, Intensive Care Unit (ICU, and hospital length of stay and mortality were recorded. Anthropometric and hematological parameters and infection control data were recorded in a predesigned pro forma. Data were analyzed using Stata 14.1 software. Results: The duration of mechanical ventilation, length of ICU stay (LOIS, length of hospital stay (LOHS, infection rate, and mortality rate were lower in the intervention group compared to the control group although none of the differences were statistically significant. Infants in control group needed mechanical ventilation for about a day more (i.e., 153.6 ± 149.0 h vs. 123.2 ± 107

  13. Web-based nursing intervention for self-management of pain after cardiac surgery: pilot randomized controlled trial.

    Science.gov (United States)

    Martorella, Géraldine; Côté, José; Racine, Mélanie; Choinière, Manon

    2012-12-14

    Most adults undergoing cardiac surgery suffer from moderate to severe pain for up to 6 days after surgery. Individual barriers and attitudes regarding pain and its relief make patients reluctant to report their pain and ask for analgesic medication, which results in inadequate pain management. More innovative educational interventions for postoperative pain relief are needed. We developed a Web-based nursing intervention to influence patient's involvement in postoperative pain management. The intervention (SOULAGE-TAVIE) includes a preoperative 30-minute Web-based session and 2 brief face-to-face postoperative booster sessions. The Web application generates reflective activities and tailored educational messages according to patients' beliefs and attitudes. The messages are transmitted through videos of a virtual nurse, animations, stories, and texts. The aim of this single-blinded pilot randomized trial was to investigate the preliminary effects of a virtual nursing intervention (SOULAGE-TAVIE) to improve pain relief in patients undergoing cardiac surgery. Participants (N = 60) were adults scheduled for their first cardiac surgery. They were randomly assigned to the experimental group using SOULAGE-TAVIE (n = 30) or the control group using usual care, including an educational pamphlet and postoperative follow-up (n = 30). Data were collected through questionnaires at the time of admission and from day 1 to day 7 after surgery with the help of a blinded research assistant. Outcomes were pain intensity, pain interference with daily activities, patients' pain barriers, tendency to catastrophize in face of pain, and analgesic consumption. The two groups were comparable at baseline across all demographic measures. Results revealed that patients in the experimental group did not experience less intense pain, but they reported significantly less pain interference when breathing/coughing (P = .04). A severe pain interference with breathing/coughing (pain ranked ≥ 7

  14. Chosen-Prefix Collisions for MD5 and Colliding X.509 Certificates for Different Identities

    Science.gov (United States)

    Stevens, Marc; Lenstra, Arjen; de Weger, Benne

    We present a novel, automated way to find differential paths for MD5. As an application we have shown how, at an approximate expected cost of 250 calls to the MD5 compression function, for any two chosen message prefixes P and P', suffixes S and S' can be constructed such that the concatenated values P||S and P'||S' collide under MD5. Although the practical attack potential of this construction of chosen-prefix collisions is limited, it is of greater concern than random collisions for MD5. To illustrate the practicality of our method, we constructed two MD5 based X.509 certificates with identical signatures but different public keys and different Distinguished Name fields, whereas our previous construction of colliding X.509 certificates required identical name fields. We speculate on other possibilities for abusing chosen-prefix collisions. More details than can be included here can be found on www.win.tue.nl/hashclash/ChosenPrefixCollisions/.

  15. A pilot randomized study of a gratitude journaling intervention on HRV and inflammatory biomarkers in Stage B heart failure patients

    Science.gov (United States)

    Redwine, Laura; Henry, Brook L.; Pung, Meredith A.; Wilson, Kathleen; Chinh, Kelly; Knight, Brian; Jain, Shamini; Rutledge, Thomas; Greenberg, Barry; Maisel, Alan; Mills, Paul J

    2016-01-01

    Objective Stage B, asymptomatic heart failure (HF) presents a therapeutic window for attenuating disease progression and development of HF symptoms, and improving quality of life. Gratitude, the practice of appreciating positive life features, is highly related to quality of life, leading to development of promising clinical interventions. However, few gratitude studies have investigated objective measures of physical health; most relied on self-report measures. We conducted a pilot study in Stage B HF patients to examine whether gratitude journaling improved biomarkers related to HF prognosis. Methods Patients (N = 70; mean age = 66.2 years, SD = 7.6) were randomized to an 8-week gratitude journaling intervention or treatment as usual (TAU). Baseline (T1) assessments included 6-item Gratitude Questionnaire (GQ-6), resting heart rate variability (HRV), and an inflammatory biomarker index. At T2 (mid-intervention) GQ6 was measured. At T3 (post-intervention), T1 measures were repeated but also included a gratitude journaling task. Results The gratitude intervention was associated with improved trait gratitude scores (F = 6.0, p = .017, η2 = .10), reduced inflammatory biomarker index score over time (F = 9.7, p = .004, η2 = .21) and increased parasympathetic HRV responses during the gratitude journaling task (F = 4.2, p = .036, η2 = .15), compared with TAU. However, there were no resting pre- to post-intervention group differences in HRV (p's > .10). Conclusions Gratitude journaling may improve biomarkers related to HF morbidity, such as reduced inflammation; large-scale studies with active control conditions are needed to confirm these findings. PMID:27187845

  16. Internet-delivered physical activity intervention for college students with mental health disorders: a randomized pilot trial.

    Science.gov (United States)

    Mailey, Emily L; Wójcicki, Thomas R; Motl, Robert W; Hu, Liang; Strauser, David R; Collins, Kimberly D; McAuley, Edward

    2010-12-01

    The prevalence of mental health disorders among college students is rising and the increasing rates of anxiety and depression have important societal implications. Physical activity has been proposed as an adjuvant to traditional treatment approaches (i.e. psychotherapy or pharmacotherapy), and the internet is a potentially useful means of delivering physical activity information to the college-aged population. This randomized pilot trial examined the effects of an internet-based physical activity intervention on physical activity, self-efficacy, depression, and anxiety in college students (n = 47) receiving mental health counseling. Physical activity, depression, anxiety, exercise self-efficacy, and barriers self-efficacy were assessed at baseline and post-intervention. There was a significant time effect for physical activity, with both groups increasing their physical activity levels across the 10-week intervention but with a larger increase in the intervention condition (d = 0.68) than the control condition (d = 0.05). Exercise and barriers self-efficacy declined across the intervention, but more so in the control than intervention condition. Effects on depression and anxiety were nonsignificant. Finally, correlation analyses showed increases in physical activity were associated with increases in exercise self-efficacy (r = 0.62) and barriers self-efficacy (r = 0.63) and decreases in depression (r = -0.44) in the intervention condition, but not in the control condition. These results suggest that an internet-delivered physical activity intervention may be a promising approach to promoting physical activity among college students undergoing mental health counseling.

  17. Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Jose M Trigo

    Full Text Available The current lack of pharmacological treatments for cannabis use disorder (CUD warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC/ 25 mg/ml cannabidiol (CBD, Sativex® can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants.Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT. Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time.Medication was well tolerated and no serious adverse events (SAEs were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS. There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS. Cannabis use was reduced in the nabiximols (70.5% and placebo groups (42.6%. Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores.Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.

  18. RECAST (Remote Ischemic Conditioning After Stroke Trial): A Pilot Randomized Placebo Controlled Phase II Trial in Acute Ischemic Stroke.

    Science.gov (United States)

    England, Timothy J; Hedstrom, Amanda; O'Sullivan, Saoirse; Donnelly, Richard; Barrett, David A; Sarmad, Sarir; Sprigg, Nikola; Bath, Philip M

    2017-05-01

    Repeated episodes of limb ischemia and reperfusion (remote ischemic conditioning [RIC]) may improve outcome after acute stroke. We performed a pilot blinded placebo-controlled trial in patients with acute ischemic stroke, randomized 1:1 to receive 4 cycles of RIC within 24 hours of ictus. The primary outcome was tolerability and feasibility. Secondary outcomes included safety, clinical efficacy (day 90), putative biomarkers (pre- and post-intervention, day 4), and exploratory hemodynamic measures. Twenty-six patients (13 RIC and 13 sham) were recruited 15.8 hours (SD 6.2) post-onset, age 76.2 years (SD 10.5), blood pressure 159/83 mm Hg (SD 25/11), and National Institutes of Health Stroke Scale (NIHSS) score 5 (interquartile range, 3.75-9.25). RIC was well tolerated with 49 out of 52 cycles completed in full. Three patients experienced vascular events in the sham group: 2 ischemic strokes and 2 myocardial infarcts versus none in the RIC group ( P =0.076, log-rank test). Compared with sham, there was a significant decrease in day 90 NIHSS score in the RIC group, median NIHSS score 1 (interquartile range, 0.5-5) versus 3 (interquartile range, 2-9.5; P =0.04); RIC augmented plasma HSP27 (heat shock protein 27; P stroke is well tolerated and appears safe and feasible. RIC may improve neurological outcome, and protective mechanisms may be mediated through HSP27. A larger trial is warranted. URL: http://www.isrctn.com. Unique identifier: ISRCTN86672015. © 2017 American Heart Association, Inc.

  19. Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study.

    Science.gov (United States)

    Vanoglio, Fabio; Bernocchi, Palmira; Mulè, Chiara; Garofali, Francesca; Mora, Chiara; Taveggia, Giovanni; Scalvini, Simonetta; Luisa, Alberto

    2017-03-01

    The purpose of the study was to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation in improving arm function abilities in sub-acute hemiplegic patients. Randomized controlled pilot study. Inpatient rehabilitation centers. Thirty hemiplegic stroke patients (Ashworth spasticity index hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the CG received the same amount of time in terms of conventional hand rehabilitation. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences, (Δ) mean(standard deviation), compared between groups. Results Twenty-seven patients concluded the program: 14 in the TG and 13 in the CG. None of the patients refused the device and only one adverse event of rheumatoid arthritis reactivation was reported. Baseline data did not differ significantly between the two groups. In TG, ΔMI 23(16.4), ΔNHPT 0.16(0.16), ΔGRIP 0.27(0.23) and ΔPINCH 0.07(0.07) were significantly greater than in CG, ΔMI 5.2(9.2), ΔNHPT 0.02(0.07), ΔGRIP 0.03(0.06) and ΔPINCH 0.02(0.03)] ( p=0.002, p=0.009, p=0.003 and p=0.038, respectively). Gloreha Professional is feasible and effective in recovering fine manual dexterity and strength and reducing arm disability in sub-acute hemiplegic patients.

  20. Effects of omega-3 fatty acids on arterial stiffness in patients with hypertension: a randomized pilot study.

    Science.gov (United States)

    Krantz, Mori J; Havranek, Edward P; Pereira, Rocio I; Beaty, Brenda; Mehler, Philip S; Long, Carlin S

    2015-12-02

    Omega-3 fatty acids prevent cardiovascular disease (CVD) events in patients with myocardial infarction or heart failure. Benefits in patients without overt CVD have not been demonstrated, though most studies did not use treatment doses (3.36 g) of omega-3 fatty acids. Arterial stiffness measured by pulse wave velocity (PWV) predicts CVD events independent of standard risk factors. However, no therapy has been shown to reduce PWV in a blood pressure-independent manner. We assessed the effects of esterified omega-3 fatty acids on PWV and serum markers of inflammation among patients with hypertension. We performed a prospective, randomized; double-blinded pilot study of omega-3 fatty acids among 62 patients in an urban, safety net hospital. Patients received 3.36 g of omega-3 fatty acids vs. matched placebo daily for 3-months. The principal outcome measure was change in brachial-ankle PWV. Serum inflammatory markers associated with CVD risk were also assessed. The majority (71 %) were of Latino ethnicity. After 3-months, mean change in arterial PWV among omega-3 and placebo groups was -97 cm/s vs. -33 cm/s respectively (p = 0.36 for difference, after multivariate adjustment for baseline age, systolic blood pressure, and serum adiponectin). Non-significant reductions in lipoprotein-associated phospholipase A2 (LpPLA2) mass and high sensitivity C-reactive protein (hsCRP) relative to placebo were also observed (p = 0.08, and 0.21, respectively). High-dose omega-3 fatty acids did not reduce arterial PWV or markers of inflammation among patients within a Latino-predominant population with hypertension. NCT00935766 , registered July 8 2009.

  1. Improvement of insulin sensitivity by isoenergy high carbohydrate traditional Asian diet: a randomized controlled pilot feasibility study.

    Directory of Open Access Journals (Sweden)

    William C Hsu

    Full Text Available The prevalence of diabetes is rising dramatically among Asians, with increased consumption of the typical Western diet as one possible cause. We explored the metabolic responses in East Asian Americans (AA and Caucasian Americans (CA when transitioning from a traditional Asian diet (TAD to a typical Western diet (TWD, which has not been reported before. This 16-week randomized control pilot feasibility study, included 28AA and 22CA who were at risk of developing type 2 diabetes. Eight weeks of TAD were provided to all participants, followed by 8 weeks of isoenergy TWD (intervention or TAD (control. Anthropometric measures, lipid profile, insulin resistance and inflammatory markers were assessed. While on TAD, both AA and CA improved in insulin AUC (-960.2 µU/mL × h, P = 0.001 and reduced in weight (-1.6 kg; P<0.001, body fat (-1.7%, P<0.001 and trunk fat (-2.2%, P<0.001. Comparing changes from TAD to TWD, AA had a smaller weight gain (-1.8 to 0.3 kg, P<0.001 than CA (-1.4 to 0.9 kg, P = 0.001, but a greater increase in insulin AUC (AA: -1402.4 to 606.2 µU/mL × h, P = 0.015 vs CA: -466.0 to 223.5 µU/mL × h, P = 0.034 and homeostatic static model assessment-insulin resistance (HOMA-IR (AA: -0.3 to 0.2, P = 0.042 vs CA: -0.1 to 0.0, P = 0.221. Despite efforts to maintain isoenergy state and consumption of similar energy, TAD induced weight loss and improved insulin sensitivity in both groups, while TWD worsened the metabolic profile.ClinicalTrials.gov NCT00379548.

  2. Individualized Cognition-Action intervention to prevent behavioral disturbances and functional decline in institutionalized older adults: a randomized pilot trial.

    Science.gov (United States)

    Dechamps, Arnaud; Alban, Rigier; Jen, Joanne; Decamps, Arnaud; Traissac, Thalie; Dehail, Patrick

    2010-08-01

    To evaluate the effectiveness of an individualized Cognition-Action (CA) intervention to reduce behavioral disturbances in severely deconditioned institutionalized old adults. 12 weeks randomized pilot trial of either individualized Cognition-Action program (n = 24) or routine medical care as control (C, n = 25). Long-term care (LTC) of the Geriatric Department from the University State Hospital in Bordeaux, France. 49 institutionalized old patients with at least one Neuropsychiatric symptoms > or =4. The CA rationale was a non-preconceived ideas approach over the patient's abilities and discourse. Patients received short bouts of 5-15 min and accumulated 50 min of interaction per week. CA intervention used five standardized exercises as tools to enhance communication and social interactions. CA was compared to usual care. Primary outcomes were the Neuropsychiatric inventory (NPI) total and symptoms scores. Secondary outcomes were the BERG balance scale, the Geriatric Depression Scale (GDS), Quality of life AM-PAC-CAT and Muscle strength. The CA group had a clinically significant NPI total score reduction compared to C, -7, 95%CI [-10.8 to -3], eta2 = 0.24. CA group showed a risk reduction of NPI total score worsening, OR = 0.09, 95%CI [0.02-0.37]. BERG total score was clinically improved in the CA group compared to C, 4.9 95%CI [0.7-9.2], eta2(p)= 0.11. CA patients reduced their GDS score and improved their Quality of life and Strength. The combination of tailored guidance and simple standardized exercises was an effective behavioral management approach for behavioral disturbances reduction and functional autonomy improvement in institutionalized old adult populations.

  3. Acupuncture for Chemotherapy-Induced Neutropenia in Patients with Gynecologic Malignancies: A Pilot Randomized, Sham-Controlled Clinical Trial

    Science.gov (United States)

    Lu, Weidong; Matulonis, Ursula A.; Doherty-Gilman, Anne; Lee, Hang; Dean-Clower, Elizabeth; Rosulek, Andrew; Gibson, Carolyn; Goodman, Annekathryn; Davis, Roger B.; Buring, Julie E.; Wayne, Peter M.; Rosenthal, David S.; Penson, Richard T.

    2009-01-01

    Abstract Objectives The objective of this study was to investigate the effect of acupuncture administered during myelosuppressive chemotherapy on white blood cell (WBC) count and absolute neutrophil count (ANC) in patients with ovarian cancer. Design This study is a pilot, randomized, sham-controlled clinical trial. Patients received active acupuncture versus sham acupuncture while undergoing chemotherapy. A standardized acupuncture protocol was employed with manual and electrostimulation. The frequency of treatment was 2–3 times per week for a total of 10 sessions, starting 1 week before the second cycle of chemotherapy. Setting The setting was two outpatient academic centers for patients with cancer. Subjects Twenty-one (21) newly diagnosed and recurrent ovarian cancer patients were the subjects. Outcome measures WBC count, ANC, and plasma granulocyte colony-stimulating factor (G-CSF) were assessed weekly. Results The median leukocyte value in the acupuncture arm at the first day of the third cycle of chemotherapy was significantly higher than in the control arm after adjusting for baseline value (8600 cells/μL, range: 4800–12,000 versus 4400 cell/μL, range: 2300–10,000) (p = 0.046). The incidence of grade 2–4 leukopenia was less in the acupuncture arm than in the sham arm (30% versus 90%; p = 0.02). However, the median leukocyte nadir, neutrophil nadir, and recovering ANC were all higher but not statistically significantly different (p = 0.116–0.16), after adjusting for baseline differences. There were no statistically significant differences in plasma G-CSF between the two groups. Conclusions We observed clinically relevant trends of higher WBC values during one cycle of chemotherapy in patients with ovarian cancer, which suggests a potential myeloprotective effect of acupuncture. A larger trial is warranted to more definitively determine the efficacy of acupuncture on clinically important outcomes of chemotherapy-induced neutropenia. PMID:19552597

  4. Parents and Tots Together: Pilot randomized controlled trial of a family-based obesity prevention intervention in Canada.

    Science.gov (United States)

    Walton, Kathryn; Filion, A Jordan; Gross, Deborah; Morrongiello, Barbara; Darlington, Gerarda; Randall Simpson, Janis; Hou, Sharon; Haines, Jess

    2016-03-16

    To test the feasibility, acceptability and preliminary impact of Parents and Tots Together (PTT), a family-based obesity prevention intervention, in Canada. Canadian parents of preschoolers (aged 2-5 years). Ontario Early Years centres in southwestern Ontario. A pilot randomized controlled trial involving 48 parents who received either the PTT intervention (n = 27) or an attention-matched control home safety intervention (n = 21). To evaluate the feasibility of PTT, we assessed participant retention and outcome evaluation completion rates. To evaluate acceptability, we assessed program attendance and parents' responses to program satisfaction surveys. To evaluate preliminary impact, we assessed children's body mass index (BMI) at baseline, after intervention (end of 9-week intervention) and at 9-month follow-up. As well, at each time point, parents completed surveys assessing stress and self-efficacy related to parenting, children's sleep, activity, TV viewing and diet. Retention rates were high in the intervention (93%) and control (84%) study arms, and 87% of parents reported that they would highly recommend PTT to a friend. At 9-month follow-up, intervention parents reported lower parenting stress (β^ = 15.83, 95% confidence interval [CI] -29.57, -2.07, p = 0.02) and greater self-efficacy in managing their child's behaviour (β^ = 0.16, 95% CI 0.002, 0.33, p = 0.05) than control parents. PTT had minimal influence on children's weight-related behaviours and BMI. The results suggest that PTT can feasibly be implemented and tested in the Canadian context. Preliminary impact results suggest that the program may be effective in changing general parenting; however, program content should be modified to adequately address children's weight-related behaviours.

  5. The Happy Older Latinos are Active (HOLA) health promotion and prevention study: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Jimenez, Daniel E; Reynolds, Charles F; Alegría, Margarita; Harvey, Philip; Bartels, Stephen J

    2015-12-18

    Results of previous studies attest to the greater illness burden of common mental disorders (anxiety and depression) in older Latinos and the need for developing preventive interventions that are effective, acceptable, and scalable. Happy Older Latinos are Active (HOLA) is a newly developed intervention that uses a community health worker (CHW) to lead a health promotion program in order to prevent common mental disorders among at-risk older Latinos. This pilot study tests the feasibility and acceptability of delivering HOLA to older, at-risk Latinos. HOLA is a multi-component, health promotion intervention funded by the National Institute of Mental Health (NIMH). This prevention approach will be tested against a fotonovela, an enhanced psychoeducation control condition, in a sample of Latino elderly with minor or subthreshold depression or anxiety. A total of 60 older Latinos (aged 60+) will be randomized to receive HOLA or the fotonovela. The primary outcomes of interest are recruitment, adherence, retention, and acceptability. Data will also be collected on: preemption of incident and recurrent major depression, generalized anxiety, and social phobia; reduction in depression and anxiety symptom severity; physical functioning; sedentary behaviors; social engagement; and self-efficacy. The results of this study could have implications for other high-risk, highly disadvantaged populations. The development of a health promotion intervention designed to prevent common mental disorders could be a means of addressing multiple disparities (for example, mental health outcomes, mental health service use, stigma) among racial/ethnic minority elderly. CLINICALTRIALS. NCT02371954 . Date of registration: 21 January 2015.

  6. Changes in Hepatic Venous Pressure Gradient Induced by Physical Exercise in Cirrhosis: Results of a Pilot Randomized Open Clinical Trial.

    Science.gov (United States)

    Macías-Rodríguez, Ricardo U; Ilarraza-Lomelí, Hermes; Ruiz-Margáin, Astrid; Ponce-de-León-Rosales, Sergio; Vargas-Vorácková, Florencia; García-Flores, Octavio; Torre, Aldo; Duarte-Rojo, Andrés

    2016-07-14

    Exercise has been scarcely studied in patients with cirrhosis, and prior evidence showed hepatic venous pressure gradient (HVPG) to be increased in response to exercise. The aim of this study was to investigate the effects of a supervised physical exercise program (PEP) in patients with cirrhosis. In an open-label, pilot clinical trial, patients with cirrhosis were randomized to PEP (cycloergometry/kinesiotherapy plus nutritional therapy, n=14) or control (nutritional therapy, n=15); for 14 weeks. Primary outcomes were: the effect of PEP in HVPG, and quality of life (chronic liver disease questionnaire, CLDQ). As secondary outcomes we investigated changes in physical fitness (cardiopulmonary exercise testing), nutritional status (phase angle-bioelectrical impedance), ammonia levels, and safety. Twenty-two patients completed the study (11 each). HVPG decreased in subjects allocated to PEP (-2.5 mm Hg (interquartile range: -5.25 to 2); P=0.05), and increased in controls (4 mm Hg (0-5); P=0.039), with a significant between-groups difference (P=0.009). No major changes were noted in CLDQ in both groups. There was significant improvement in ventilatory efficiency (VE/VCO2) in PEP group (-1.9 (-3.12 to -0.1); P=0.033), but not in controls (-0.4 (-5.7 to 1.4); P=0.467). Phase angle improvement and a less-pronounced exercise-induced hyperammonemia were noted only in PEP group. No episodes of variceal bleeding or hepatic encephalopathy were observed. A supervised PEP in patients with cirrhosis decreases the HVPG and improves nutritional status with no changes in quality of life. Further studies evaluating physical training in cirrhosis are eagerly awaited in order to better define the benefits of sustained exercise. ClinicalTrials.gov:NCT00517738.

  7. Addressing behavioral impacts of childhood leukemia: A feasibility pilot randomized controlled trial of a group videoconferencing parenting intervention.

    Science.gov (United States)

    Williams, Lauren K; McCarthy, Maria C; Burke, Kylie; Anderson, Vicki; Rinehart, Nicole

    2016-10-01

    Child emotional and behavioral problems constitute significant sequelae of acute lymphoblastic leukemia (ALL) treatment. The aims of this study were to a) examine the feasibility, acceptability and satisfaction of a parenting intervention amongst parents of children with ALL and b) explore whether participation in a parenting intervention shows promise for improvements in child behavior. 12 parents with a child aged between 2 and 8 years receiving maintenance phase treatment for ALL participated in a phase 2 randomized controlled trial comparing eight weeks of group online participation in Triple P: Positive Parenting Program with no intervention. The number of eligible parents who completed the intervention was low (31.6%). Main reasons for non-consent or dropout were program time commitment too high or content not relevant. For parents who completed the intervention, satisfaction and acceptability was high. Parents reported the intervention as highly relevant and topical, feasible, helpful and a positive experience. Results indicated a non-significant trend towards improved total child behavioral and emotional difficulties following the intervention. Qualitative results indicated that intervention group parents reported improvements in parenting skills and competence, and decreased child behavioral problems. These pilot data highlight the difficulties of engaging and retaining parents in an 8-week parenting intervention in this context. For parents who completed the intervention, results indicated high feasibility, acceptability and satisfaction. Suggestions for further research and intervention modifications are provided to enhance uptake and strengthen efforts to assist parents in addressing child behavioral and emotional challenges during ALL treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

  8. Cellular pharmacodynamic effects of Pycnogenol® in patients with severe osteoarthritis: a randomized controlled pilot study.

    Science.gov (United States)

    Jessberger, Steffen; Högger, Petra; Genest, Franca; Salter, Donald M; Seefried, Lothar

    2017-12-16

    The standardized maritime pine bark extract (Pycnogenol®) has previously shown symptom alleviating effects in patients suffering from moderate forms of knee osteoarthritis (OA). The cellular mechanisms for this positive impact are so far unknown. The purpose of the present randomized pilot controlled study was to span the knowledge gap between the reported clinical effects of Pycnogenol® and its in vivo mechanism of action in OA patients. Thirty three patients with severe OA scheduled for a knee arthroplasty either received 100 mg of Pycnogenol® twice daily or no treatment (control group) three weeks before surgery. Cartilage, synovial fluid and serum samples were collected during surgical intervention. Relative gene expression of cartilage homeostasis markers were analyzed in the patients' chondrocytes. Inflammatory and cartilage metabolism mediators were investigated in serum and synovial fluid samples. The oral intake of Pycnogenol® downregulated the gene expression of various cartilage degradation markers in the patients' chondrocytes, the decrease of MMP3, MMP13 and the pro-inflammatory cytokine IL1B were statistically significant (p ≤ 0.05). Additionally, protein concentrations of ADAMTS-5 in serum were reduced significantly (p ≤ 0.05) after three weeks intake of the pine bark extract. This is the first report about positive cellular effects of a dietary supplement on key catabolic and inflammatory markers in patients with severe OA. The results provide a rational basis for understanding previously reported clinical effects of Pycnogenol® on symptom scores of patients suffering from OA. ISRCTN10754119 . Retrospectively registered 08/10/2015.

  9. Early education and counselling of patients with acute coronary syndrome. A pilot study for a randomized controlled trial.

    Science.gov (United States)

    Weibel, Lukas; Massarotto, Paola; Hediger, Hannele; Mahrer-Imhof, Romy

    2016-06-01

    At time of discharge, patients with acute coronary syndrome often have a knowledge deficit regarding their disease, further treatment and necessary behavioural changes. It is well known that self-efficacy as a prerequisite for behavioural changes can be influenced by patient education. This study investigated whether an individualized education programme starting early in the cardiac care unit enhanced self-efficacy and rehabilitation programme attendance, and was feasible and satisfying for patients. In a pilot randomized controlled trial, 40 patients with acute coronary syndrome were enrolled. The intervention group received in addition to standard care an early individual needs-oriented educational session in the cardiac care unit and subsequently one on the ward addressing risk factors, medication and self-management as well as referral to a rehabilitation programme by a nurse. Self-efficacy was assessed twice, at attendance in a rehabilitation programme six weeks after discharge. The participants' satisfaction with the intervention was assessed qualitatively. When controlling for anxiety and depression, the intervention group showed significant better self-efficacy scores on the ability to control the symptoms (p=0.034). When controlling additionally for age, no significant differences could be detected. The attendance of a rehabilitation programme was higher in the intervention group. The participants in the intervention group reported high satisfaction with the early education. Early education seems to benefit patients with acute coronary syndrome. In light of increased confidence to control one's symptoms and the higher attendance in rehabilitation programmes, as well as a high satisfaction with the intervention, a full powered study will be pursued. © The European Society of Cardiology 2014.

  10. Robot-assisted reaching exercise promotes arm movement recovery in chronic hemiparetic stroke: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Rymer W Zev

    2006-06-01

    Full Text Available Abstract Background and purpose Providing active assistance to complete desired arm movements is a common technique in upper extremity rehabilitation after stroke. Such active assistance may improve recovery by affecting somatosensory input, motor planning, spasticity or soft tissue properties, but it is labor intensive and has not been validated in controlled trials. The purpose of this study was to investigate the effects of robotically administered active-assistive exercise and compare those with free reaching voluntary exercise in improving arm movement ability after chronic stroke. Methods Nineteen individuals at least one year post-stroke were randomized into one of two groups. One group performed 24 sessions of active-assistive reaching exercise with a simple robotic device, while a second group performed a task-matched amount of unassisted reaching. The main outcome measures were range and speed of supported arm movement, range, straightness and smoothness of unsupported reaching, and the Rancho Los Amigos Functional Test of Upper Extremity Function. Results and discussion There were significant improvements with training for range of motion and velocity of supported reaching, straightness of unsupported reaching, and functional movement ability. These improvements were not significantly different between the two training groups. The group that performed unassisted reaching exercise improved the smoothness of their reaching movements more than the robot-assisted group. Conclusion Improvements with both forms of exercise confirmed that repeated, task-related voluntary activation of the damaged motor system is a key stimulus to motor recovery following chronic stroke. Robotically assisting in reaching successfully improved arm movement ability, although it did not provide any detectable, additional value beyond the movement practice that occurred concurrently with it. The inability to detect any additional value of robot-assisted reaching

  11. Dyadic psychosocial intervention for advanced lung cancer patients and their family caregivers: results of a randomized pilot trial.

    Science.gov (United States)

    Badr, Hoda; Smith, Cardinale B; Goldstein, Nathan E; Gomez, Jorge E; Redd, William H

    2015-01-01

    Advanced lung cancer (LC) patients and their families have reported low self-efficacy for self-care/caregiving and high rates of distress, yet few programs exist to address their supportive care needs during treatment. This pilot study examined the feasibility, acceptability, and preliminary efficacy of a 6-session, telephone-based dyadic psychosocial intervention that was developed for advanced LC patients and their caregivers. The program was grounded in self-determination theory (SDT), which emphasizes the importance of competence (self-efficacy), autonomy (sense of choice/volition), and relatedness (sense of belonging/connection) for psychological functioning. The primary outcomes were patient and caregiver psychological functioning (depression/anxiety) and caregiver burden. The secondary outcomes were the SDT constructs of competence, autonomy, and relatedness. Thirty-nine advanced LC patients who were within 1 month of treatment initiation (baseline) and their caregivers (51% spouses/partners) completed surveys and were randomized to the intervention or usual medical care. Eight weeks after baseline, they completed follow-up surveys. Solid recruitment (60%) and low attrition rates demonstrated feasibility. Strong program evaluations (mean, 8.6/10) and homework completion rates (88%) supported acceptability. Participants receiving the intervention evidenced significant improvements (P < .0001) in depression, anxiety, and caregiver burden in comparison with usual medical care. Large effect sizes (d ≥ 1.2) favoring the intervention were also found for patient and caregiver competence and relatedness and for caregiver autonomous motivation for providing care. These findings support intervention feasibility, acceptability, and preliminary efficacy. By empowering families with the skills to coordinate care and meet the challenges of LC together, this intervention holds great promise for improving palliative/supportive care services in cancer. © 2014

  12. A randomized placebo-controlled pilot trial of omega-3 fatty acids and alpha lipoic acid in Alzheimer's disease.

    Science.gov (United States)

    Shinto, Lynne; Quinn, Joseph; Montine, Thomas; Dodge, Hiroko H; Woodward, William; Baldauf-Wagner, Sara; Waichunas, Dana; Bumgarner, Lauren; Bourdette, Dennis; Silbert, Lisa; Kaye, Jeffrey

    2014-01-01

    Oxidative stress, inflammation, and increased cholesterol levels are all mechanisms that have been associated with Alzheimer's disease (AD) pathology. Several epidemiologic studies have reported a decreased risk of AD with fish consumption. This pilot study was designed to evaluate the effects of supplementation with omega-3 fatty acids alone (ω-3) or omega-3 plus alpha lipoic acid (ω-3 + LA) compared to placebo on oxidative stress biomarkers in AD. The primary outcome measure was peripheral F2-isoprostane levels (oxidative stress measure). Secondary outcome measures included performance on: Mini-Mental State Examination (MMSE), Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL), and Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog). Thirty-nine AD subjects were randomized to one of three groups: 1) placebo, 2) ω-3, or 3) ω-3 + LA for a treatment duration of 12 months. Eighty seven percent (34/39) of the subjects completed the 12-month intervention. There was no difference between groups at 12 months in peripheral F2-isoprostane levels (p = 0.83). The ω-3 + LA and ω-3 were not significantly different than the placebo group in ADAS-cog (p = 0.98, p = 0.86) and in ADL (p = 0.15, p = 0.82). Compared to placebo, the ω-3 + LA showed less decline in MMSE (p < 0.01) and IADL (p = 0.01) and the ω-3 group showed less decline in IADL (p < 0.01). The combination of ω-3 + LA slowed cognitive and functional decline in AD over 12 months. Because the results were generated from a small sample size, further evaluation of the combination of omega-3 fatty acids plus alpha-lipoic acid as a potential treatment in AD is warranted.

  13. Novel physical activity interventions for older patients with prostate cancer on hormone therapy: A pilot randomized study.

    Science.gov (United States)

    Sajid, Saleha; Dale, William; Mustian, Karen; Kotwal, Ashwin; Heckler, Charles; Porto, Michelle; Fung, Chunkit; Mohile, Supriya G

    2016-03-01

    Androgen deprivation therapy (ADT) can decrease the physical performance (PP) of older men with prostate cancer (PC). We conducted a three-arm randomized pilot study (n=19) comparing a home-based walking and resistance intervention (EXCAP) and a technology-mediated walking and resistance intervention using Wii-Fit to a usual-care arm in men ≥70 years with PC receiving ADT. The intervention lasted for 6 weeks, with follow-up at 12 weeks. The primary pre-specified outcome was change in Short Physical Performance Battery (SPPB) score. Mixed effects regression models were used to assess change in outcomes over time. Mean participant age was 70 years (range: 67-93). Eight patients were randomized to the Wii-Fit arm, 6 to the EXCAP arm, and 5 to the usual-care arm. SPPB scores remained nearly constant in the usual-care arm (β=-0.12; p=0.79), while individuals in the EXCAP arm had on average a 1.2 point increase at each follow-up (β=1.20; 95% CI: 0.36, 2.06). The Wii-fit arm had a non-significant increase in SPPB score over time relative to usual-care (β=0.32; 95% CI -0.43, 1.06; p=0.46). Individuals in the EXCAP arm had an increase in steps per day over time compared to the usual-care arm (p-value=0.006); the EXCAP arm had an increase of 2720 steps (95% CI: 1313, 4128) while the usual-care arm had an increase of 97 steps (95% CI: -1140, 1333). Participants in the Wii-Fit arm had an increase of 1020 steps (95% CI: -474, 1238, p=0.710). Other outcomes (i.e., handgrip strength, lean muscle mass, and chest press repetitions) were not statistically significant. A home-based aerobic and resistance exercise program, EXCAP, shows promise for improving PP in older men with PC on ADT. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. How should the impact of different presentations of treatment effects on patient choice be evaluated? A pilot randomized trial.

    Directory of Open Access Journals (Sweden)

    Cheryl Carling

    Full Text Available BACKGROUND: Different presentations of treatment effects can affect decisions. However, previous studies have not evaluated which presentations best help people make decisions that are consistent with their own values. We undertook a pilot study to compare different methods for doing this. METHODS AND FINDINGS: We conducted an Internet-based randomized trial comparing summary statistics for communicating the effects of statins on the risk of coronary heart disease (CHD. Participants rated the relative importance of treatment consequences using visual analogue scales (VAS and category rating scales (CRS with five response options. We randomized participants to either VAS or CRS first and to one of six summary statistics: relative risk reduction (RRR and five absolute measures of effect: absolute risk reduction, number needed to treat, event rates, tablets needed to take, and natural frequencies (whole numbers. We used logistic regression to determine the association between participants' elicited values and treatment choices. 770 participants age 18 or over and literate in English completed the study. In all, 13% in the VAS-first group failed to complete their VAS rating, while 9% of the CRS-first group failed to complete their scoring (p = 0.03. Different ways of weighting the elicited values had little impact on the analyses comparing the different presentations. Most (51% preferred the RRR compared to the other five summary statistics (1% to 25%, p = 0.074. However, decisions in the group presented the RRR deviated substantially from those made in the other five groups. The odds of participants in the RRR group deciding to take statins were 3.1 to 5.8 times that of those in the other groups across a wide range of values (p = 0.0007. Participants with a scientific background, who were more numerate or had more years of education were more likely to decide not to take statins. CONCLUSIONS: Internet-based trials comparing different presentations

  15. A Randomized Controlled Comparison of Emotional Freedom Technique and Cognitive-Behavioral Therapy to Reduce Adolescent Anxiety: A Pilot Study.

    Science.gov (United States)

    Gaesser, Amy H; Karan, Orv C

    2017-02-01

    The objective of this pilot study was to compare the efficacy of Emotional Freedom Techniques (EFT) with that of Cognitive-Behavioral Therapy (CBT) in reducing adolescent anxiety. Randomized controlled study. This study took place in 10 schools (8 public/2 private; 4 high schools/6 middle schools) in 2 northeastern states in the United States. Sixty-three high-ability students in grades 6-12, ages 10-18 years, who scored in the moderate to high ranges for anxiety on the Revised Children's Manifest Anxiety Scale-2 (RCMAS-2) were randomly assigned to CBT (n = 21), EFT (n = 21), or waitlist control (n = 21) intervention groups. CBT is the gold standard of anxiety treatment for adolescent anxiety. EFT is an evidence-based treatment for anxiety that incorporates acupoint stimulation. Students assigned to the CBT or EFT treatment groups received three individual sessions of the identified protocols from trained graduate counseling, psychology, or social work students enrolled at a large northeastern research university. The RCMAS-2 was used to assess preintervention and postintervention anxiety levels in participants. EFT participants (n = 20; M = 52.16, SD = 9.23) showed significant reduction in anxiety levels compared with the waitlist control group (n = 21; M = 57.93, SD = 6.02) (p = 0.005, d = 0.74, 95% CI [-9.76, -1.77]) with a moderate to large effect size. CBT participants (n = 21; M = 54.82, SD = 5.81) showed reduction in anxiety but did not differ significantly from the EFT (p = 0.18, d = 0.34; 95% CI [-6.61, 1.30]) or control (p = 0.12, d = 0.53, 95% CI [-7.06, .84]). EFT is an efficacious intervention to significantly reduce anxiety for high-ability adolescents.

  16. Mindfulness-and body-psychotherapy-based group treatment of chronic tinnitus: a randomized controlled pilot study.

    Science.gov (United States)

    Kreuzer, Peter M; Goetz, Monika; Holl, Maria; Schecklmann, Martin; Landgrebe, Michael; Staudinger, Susanne; Langguth, Berthold

    2012-11-28

    Tinnitus, the perception of sound in absence of an external acoustic source, impairs the quality of life in 2% of the population. Since in most cases causal treatment is not possible, the majority of therapeutic attempts aim at developing and strengthening individual coping and habituation strategies. Therapeutic interventions that incorporate training in mindfulness meditation have become increasingly popular in the treatment of stress-related disorders. Here we conducted a randomized, controlled clinical study to investigate the efficacy of a specific mindfulness- and body-psychotherapy based program in patients suffering from chronic tinnitus. Thirty-six patients were enrolled in this pilot study. The treatment was specifically developed for tinnitus patients and is based on mindfulness and body psychotherapy. Treatment was performed as group therapy at two training weekends that were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22). Patients were randomized to receive treatment either immediately or after waiting time, which served as a control condition. The primary study outcome was the change in tinnitus complaints as measured by the German Version of the Tinnitus Questionnaire (TQ). ANOVA testing for the primary outcome showed a significant interaction effect time by group (F = 7.4; df = 1,33; p = 0.010). Post hoc t-tests indicated an amelioration of TQ scores from baseline to week 9 in both groups (intervention group: t = 6.2; df = 17; p < 0.001; control group: t = 2.5; df = 16; p = 0.023), but the intervention group improved more than the control group. Groups differed at week 7 and 9, but not at week 24 as far as the TQ score was concerned. Our results suggest that this mindfulness- and body-psychotherapy-based approach is feasible in the treatment of tinnitus and merits further evaluation in clinical studies with larger sample sizes.The study is

  17. Effects of low-intensity endurance and resistance training on mobility in chronic stroke survivors: a pilot randomized controlled study.

    Science.gov (United States)

    Lamberti, Nicola; Straudi, Sofia; Malagoni, Anna Maria; Argirò, Matteo; Felisatti, Michele; Nardini, Eleonora; Zambon, Christel; Basaglia, Nino; Manfredini, Fabio

    2017-04-01

    Chronic stroke survivors are exposed to long-term disability and physical deconditioning, effects that may impact their independence and quality of life. Community-based programs optimizing the dose of exercise therapy that are simultaneously low risk and able to achieve high adherence should be identified. We tested the hypothesis that an 8-week, community-based, progressive mixed endurance-resistance exercise program at lower cardiovascular and muscular load yielded more mobility benefits than a higher-intensity program in chronic stroke survivors. A two-arm, parallel-group, pilot randomized, controlled clinical trial. Hospital (recruitment); community-based adapted physical activity center (training). Thirty-five chronic stroke patients (mean age: 68.4±10.4 years; 27 males). Participants were randomized to a low-intensity experimental (LI-E; N.=18) or a high-intensity active control group (HI-C; N.=17). Patients in the LI-E group performed over-ground intermittent walking (weeks 1-8) and muscle power training with portable tools (weeks 5-8); patients in the HI-C group executed treadmill walking (weeks 1-8) and strength training with gym machines (weeks 5-8). Changes in mobility, assessed using the 6-Minute Walking Distance test, were the primary outcome. Secondary outcomes included quality of life (Short-Form-36 Questionnaire), gait speed (10-Meter Walking Test), balance (Berg Balance Scale) and muscle performance of the lower limbs (strength and power of the quadriceps and femoral biceps). After 8 weeks, the 6MWD revealed more improvement for the LI-E group than the HI-C group (P=0.009). The SF36 physical activity domain (P=0.012) and peak power of the femoral quadriceps and biceps were also significantly improved for the LI-E group (P=0.008 and Ptrial. The effectiveness, low-intensity and possible implementation in poorly equipped community-based settings make the LI-E program potentially suitable for stroke survivors and frail individuals.

  18. Can sedentary behavior be made more active? A randomized pilot study of TV commercial stepping versus walking

    Directory of Open Access Journals (Sweden)

    Steeves Jeremy A

    2012-08-01

    Full Text Available Abstract Background There is a growing problem of physical inactivity in America, and approximately a quarter of the population report being completely sedentary during their leisure time. In the U.S., TV viewing is the most common leisure-time activity. Stepping in place during TV commercials (TV Commercial Stepping could increase physical activity. The purpose of this study was to examine the feasibility of incorporating physical activity (PA into a traditionally sedentary activity, by comparing TV Commercial Stepping during 90 min/d of TV programming to traditional exercise (Walking. Methods A randomized controlled pilot study of the impact of 6 months of TV Commercial Stepping versus Walking 30 min/day in adults was conducted. 58 sedentary, overweight (body mass index 33.5 ± 4.8 kg/m2 adults (age 52.0 ± 8.6 y were randomly assigned to one of two 6-mo behavioral PA programs: 1 TV Commercial Stepping; or 2 Walking 30 min/day. To help facilitate behavior changes participants received 6 monthly phone calls, attended monthly meetings for the first 3 months, and received monthly newsletters for the last 3 months. Using intent-to-treat analysis, changes in daily steps, TV viewing, diet, body weight, waist and hip circumference, and percent fat were compared at baseline, 3, and 6 mo. Data were collected in 2010–2011, and analyzed in 2011. Results Of the 58 subjects, 47 (81% were retained for follow-up at the completion of the 6-mo program. From baseline to 6-mo, both groups significantly increased their daily steps [4611 ± 1553 steps/d vs. 7605 ± 2471 steps/d (TV Commercial Stepping; 4909 ± 1335 steps/d vs. 7865 ± 1939 steps/d (Walking; P  Conclusions Participants in both the TV Commercial Stepping and Walking groups had favorable changes in daily steps, TV viewing, diet, and anthropometrics. PA can be performed while viewing TV commercials and this may be a feasible alternative to traditional approaches for

  19. A Randomized Controlled Pilot Study on Mindfulness-Based Cognitive Therapy for Unipolar Depression in Patients With Chronic Pain.

    Science.gov (United States)

    de Jong, Marasha; Peeters, Frenk; Gard, Tim; Ashih, Heidi; Doorley, Jim; Walker, Rosemary; Rhoades, Laurie; Kulich, Ronald J; Kueppenbender, Karsten D; Alpert, Jonathan E; Hoge, Elizabeth A; Britton, Willoughby B; Lazar, Sara W; Fava, Maurizio; Mischoulon, David

    2017-02-28

    Chronic pain is a disabling illness, often comorbid with depression. We performed a randomized controlled pilot study on mindfulness-based cognitive therapy (MBCT) targeting depression in a chronic pain population. Participants with chronic pain lasting ≥ 3 months; DSM-IV major depressive disorder (MDD), dysthymic disorder, or depressive disorder not otherwise specified; and a 16-item Quick Inventory of Depressive Symptomatology-Clinician Rated (QIDS-C₁₆) score ≥ 6 were randomly assigned to MBCT (n = 26) or waitlist (n = 14). We adapted the original MBCT intervention for depression relapse prevention by modifying the psychoeducation and cognitive-behavioral therapy elements to an actively depressed chronic pain population. We analyzed an intent-to-treat (ITT) and a per-protocol sample; the per-protocol sample included participants in the MBCT group who completed at least 4 of 8 sessions. Changes in scores on the QIDS-C₁₆ and 17-item Hamilton Depression Rating Sale (HDRS₁₇) were the primary outcome measures. Pain, quality of life, and anxiety were secondary outcome measures. Data collection took place between January 2012 and July 2013. Nineteen participants (73%) completed the MBCT program. No significant adverse events were reported in either treatment group. ITT analysis (n = 40) revealed no significant differences. Repeated-measures analyses of variance for the per-protocol sample (n = 33) revealed a significant treatment × time interaction (F₁,₃₁ = 4.67, P = .039, η²p = 0.13) for QIDS-C₁₆ score, driven by a significant decrease in the MBCT group (t₁₈ = 5.15, P 1.6), but not in the control group (t₁₃ = 2.01, P = .066). The HDRS₁₇ scores did not differ significantly between groups. The study ended before the projected sample size was obtained, which might have prevented effect detection in some outcome measures. MBCT shows potential as a treatment for depression in individuals with chronic pain, but larger controlled

  20. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Andrew M. Busch

    2017-04-01

    Full Text Available Abstract Background Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS. The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC. Methods Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up. Results Fifty-nine participants (28 BAT-CS, 31 SC were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41–3.93 for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42–3.82 for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03. At 24-weeks, effect sizes for mood and stress outcomes ranged from η2 partial of.07–.11, with significant between treatment effects for positive affect, negative affect, and stress. Conclusions The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted. Trial registration NCT01964898 . First received by clinicaltrials.gov October 15, 2013.

  1. Off-pump Versus On-pump Coronary Artery Bypass Surgery: Graft Patency Assessment With Coronary Computed Tomographic Angiography: A Prospective Multicenter Randomized Controlled Pilot Study.

    Science.gov (United States)

    Noiseux, Nicolas; Stevens, Louis-Mathieu; Chartrand-Lefebvre, Carl; Soulez, Gilles; Prieto, Ignacio; Basile, Fadi; Mansour, Samer; Dyub, Adel M; Kieser, Teresa M; Lamy, André

    2017-11-01

    A large multicenter randomized trial (RCT) is needed to assess off-pump coronary artery bypass graft (CABG) patency when performed by skilled surgeons. This prospective multicenter randomized pilot study compares graft patency after on-pump and off-pump techniques and addresses the feasibility of such an RCT. Consecutive patients were prospectively recruited for ≥64-slice computed tomography angiography graft patency assessment 1 year after randomization to off-pump or on-pump CABG. Blinded assessment of graft patency was performed, and the results were categorized as normal, ≥50% stenosis, or occlusion. A multilevel model with random effects on the patient was used to account for correlation of results in patients with multiple grafts. A total of 157 patients (3 centers, 84 off-pump and 73 on-pump patients, 512 grafts, assessability rate 98.4%) were included. Patency index (% nonoccluded grafts) was 89% for the off-pump technique and 95% for the on-pump technique (P=0.09). Patency was similar for arterial and vein grafts (both 92%; P=0.88), as well as between target territories (89% to 94%; P=0.53). In this pilot study, 1-year graft patency results after off-pump and on-pump surgery were similar. This feasibility trial demonstrates that a large multicenter RCT to compare CABG patency after on-pump with that after off-pump techniques is feasible and can be reliably undertaken using computed tomography angiography.

  2. Vulnerability to chosen-plaintext attack of optoelectronic information encryption with phase-shifting interferometry.

    Science.gov (United States)

    Qin, Wan; Peng, Xiang; Meng, Xiangfeng; Gao, Bruce Z

    2011-06-13

    The optical cryptosystem based on phase-shifting interferometry (PSI) is one of the most interesting optical cryptographic schemes in recent years. However, we find that the PSI technique provides an attractive method to record the ciphertext, but contributes little to the security level of the cryptosystem. From the cryptanalysis point of view, in a certain simplified case, an attacker is only required to crack two equivalent decryption keys instead of the original random phase keys and geometric key. Moreover, a chosen-plaintext attack method is proposed, in which an impulse function is chosen as a known plaintext. By using this attack, the attacker can effectively recover any plaintext from the corresponding ciphertext. The validity of the attack is verified by computer simulations.

  3. DEVELOPMENT OF SPA AND WELLNESS SERVICES IN A CHOSEN HOTEL

    OpenAIRE

    MARHOUNOVÁ, Iveta

    2017-01-01

    This work deals with the development of spas and wellness services in the chosen company called Wellness hotel Diamant. This company is one of the key ones, because it makes South Bohemia more attractive. This work proposes complementary services which can lead to improvement of the present ones and to filling up the current market needs. The aim of this work is to analyse economic conditions of the specific hotel, which is its situation on the economy market and what its competitiveness is l...

  4. Freely chosen cadence during a covert manipulation of ambient temperature.

    Science.gov (United States)

    Hartley, Geoffrey L; Cheung, Stephen S

    2013-01-01

    The present study investigated relationships between changes in power output (PO) to torque (TOR) or freely chosen cadence (FCC) during thermal loading. Twenty participants cycled at a constant rating of perceived exertion while ambient temperature (Ta) was covertly manipulated at 20-min intervals of 20 °C, 35 °C, and 20 °C. The magnitude responses of PO, FCC and TOR were analyzed using repeated-measures ANOVA, while the temporal correlations were analyzed using Auto-Regressive Integrated Moving Averages (ARIMA). Increases in Ta caused significant thermal strain (p stressors.

  5. High dose vitamin D administration in ventilated intensive care unit patients: A pilot double blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jenny E. Han

    2016-06-01

    Conclusions: In this pilot study, high-dose vitamin D3 safely increased plasma 25(OHD concentrations into the sufficient range and was associated with decreased hospital length of stay without altering other clinical outcomes.

  6. Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

    Science.gov (United States)

    Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

    2011-01-01

    Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

  7. Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder.

    Science.gov (United States)

    Schneider, Kristin L; Pagoto, Sherry L; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S; Ma, Yunsheng

    2011-06-01

    BACKGROUND: The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. METHODS/DESIGN: Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. DISCUSSION: A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. TRIAL REGISTRATION: NCT01024790.

  8. The Smartphone Peer Physical Activity Counseling (SPPAC) Program for Manual Wheelchair Users: Protocol of a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Best, Krista L; Routhier, François; Sweet, Shane N; Arbour-Nicitopoulos, Kelly P; Borisoff, Jaimie F; Noreau, Luc; Martin Ginis, Kathleen A

    2017-04-26

    Physical activity (PA) must be performed regularly to accrue health benefits. However, the majority of manual wheelchair users do not meet PA recommendations. Existing community-based PA programs for manual wheelchair users appear to work, but effect sizes are small and retention is low. Existing PA programs may not fully implement some psychosocial factors that are strongly linked with PA (eg, autonomy). The use of peers and mobile phone technology in the Smartphone Peer PA Counseling (SPPAC) program represents a novel approach to cultivating a PA-supportive environment for manual wheelchair users. The primary objective is to compare change in objective PA between the experimental (SPPAC) and control groups from baseline to postintervention (10 weeks) and follow-up (3 months). Changes in and relationships between subjective PA, wheelchair skills, motivation, self-efficacy (for overcoming barriers to PA for manual wheelchair use), satisfaction of psychological needs for PA, and satisfaction with PA participation will be explored (secondary outcome). Program implementation will be explored (tertiary objective). A total of 38 community-living manual wheelchair users (≥18 years) will be recruited in a randomized controlled trial (RCT). Participants in both the control and experimental groups will receive existing PA guidelines. Participants in the experimental group will also receive the SPPAC program: 14 sessions (~30 min) over a 10-week period delivered by a peer trainer using a mobile phone. PA activities will be based on individuals' preferences and goals. Implementation of important theoretical variables will be enforced through a peer-trainer checklist. Outcomes for objective PA (primary) and subjective PA, wheelchair skills, motivation, self-efficacy, satisfaction of psychological needs, and satisfaction with participation will be collected at three time points (baseline, postintervention, follow-up). Multiple imputations will be used to treat missing data. A

  9. Whole body and local cryotherapy in restless legs syndrome: A randomized, single-blind, controlled parallel group pilot study.

    Science.gov (United States)

    Happe, Svenja; Evers, Stefan; Thiedemann, Christian; Bunten, Sabine; Siegert, Rudolf

    2016-11-15

    Treatment of restless legs syndrome (RLS) is primarily based on drugs. Since many patients report improvement of symptoms due to cooling their legs, we examined the efficacy of cryotherapy in RLS. 35 patients (28 women, 60.9±12.5years) with idiopathic RLS and symptoms starting not later than 6pm were randomized into three groups: cold air chamber at -60°C (n=12); cold air chamber at -10°C (n=12); local cryotherapy at -17°C (n=11). After a two week baseline, the different therapies were applied three minutes daily at 6pm over two weeks, followed by a four week observation period. The patients completed several questionnaires regarding RLS symptoms, sleep, and quality of life on a weekly basis (IRLS, ESS), VAS and sleep/morning protocol were completed daily, MOSS/RLS-QLI were completed once in each period. Additionally, the PLM index was measured by a mobile device at the end of baseline, intervention, and follow-up. The IRLS score was chosen as primary efficacy parameter. At the end of follow-up, significant improvement of RLS symptoms and quality of life could be observed only in the -60°C group as compared to baseline (IRLS: p=0.009; RLS-QLI: p=0.006; ESS: p=0.020). Local cryotherapy led to improvement in quality of life (VAS4: p=0.028; RLS-QLI: p=0.014) and sleep quality (MOSS: p=0.020; MOSS2: p=0.022) but not in IRLS and ESS. In the -10°C group, the only significant effect was shortening of number of wake phases per night. Serious side-effects were not reported. Whole body cryotherapy at -60°C and, to a less extent, local cryotherapy seem to be a treatment option for RLS in addition to conventional pharmacological treatment. However, the exact mode of cryotherapy needs to be established. Copyright © 2016. Published by Elsevier B.V.

  10. Specific exercise training for reducing neck and shoulder pain among military helicopter pilots and crew members: a randomized controlled trial protocol.

    Science.gov (United States)

    Murray, Mike; Lange, Britt; Nørnberg, Bo Riebeling; Søgaard, Karen; Sjøgaard, Gisela

    2015-08-19

    Flight-related neck/shoulder pain is frequent among military helicopter pilots and crew members. With a lifetime prevalence of 81% for pilots and 84% for crew members, the prevalence of neck pain is considered high compared to the general population. The aim of this study was to investigate whether a specifically tailored exercise intervention would reduce the prevalence and incidence rate of neck/shoulder pain among helicopter pilots and crew members. This study used a prospective, parallel group, single blinded, randomized controlled design. Participants were military helicopter pilots and crew members recruited from the Royal Danish Air Force. Inclusion criteria were: 1) employed within the Royal Danish Air Force as a helicopter pilot or onboard crew member (technician, systems-operator, tactical helicopter observer and/or navigator), 2) maintaining operational flight status at enrollment, and 3) operational flying within the previous 6 months. Primary outcome was change in neck and shoulder pain assessed by 1) a modified version of the "Standardized Nordic questionnaire for the analysis of musculoskeletal symptoms" and by 2) pressure pain threshold measurements. Secondary outcomes included: postural balance, strength, stability, and rate of force development for neck and shoulder muscles. Measurements at baseline and follow-up were conducted at four air force bases in Denmark. Sixty-nine participants were individually randomized to either a training group (TG) or a reference group (RG). Participants in the TG performed 20-weeks of physical exercise training divided into sessions of 3 × 20 min per week. Training was completed within working hours and consisted of specific exercise training for the neck and shoulder muscles based on the principles of "Intelligent Physical Exercise Training". The RG received no training. In spite of the high prevalence of flight related neck/shoulder pain among military helicopter pilots and crew members there are currently no

  11. Effects of hyperthermic baths on depression, sleep and heart rate variability in patients with depressive disorder: a randomized clinical pilot trial.

    Science.gov (United States)

    Naumann, Johannes; Grebe, Julian; Kaifel, Sonja; Weinert, Tomas; Sadaghiani, Catharina; Huber, Roman

    2017-03-28

    Despite advances in the treatment of depression, one-third of depressed patients fail to respond to conventional antidepressant medication. There is a need for more effective treatments with fewer side effects. The primary aim of this study was to determine whether hyperthermic baths reduce depressive symptoms in adults with depressive disorder. Randomized, two-arm placebo-controlled, 8-week pilot trial. Medically stable outpatients with confirmed depressive disorder (ICD-10: F32/F33) who were moderately depressed as determined by the 17-item Hamilton Scale for Depression (HAM-D) score ≥18 were randomly assigned to 2 hyperthermic baths (40 °C) per week for 4 weeks or a sham intervention with green light and follow-up after 4 weeks. Main outcome measure was the change in HAM-D total score from baseline (T0) to the 2-week time point (T1). A total of 36 patients were randomized (hyperthermic baths, n = 17; sham condition, n = 19). The intention-to-treat analysis showed a significant (P = .037) difference in the change in HAM-D total score with 3.14 points after 4 interventions (T1) in favour of the hyperthermic bath group compared to the placebo group. This pilot study suggests that hyperthermic baths do have generalized efficacy in depressed patients. DRKS00004803 at drks-neu.uniklinik-freiburg.de, German Clinical Trials Register (registration date 2016-02-02), retrospectively registered.

  12. Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.

    Science.gov (United States)

    Cambron, Jerrilyn A; Dexheimer, Jennifer M; Chang, Mabel; Cramer, Gregory D

    2010-01-01

    The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis. This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives. Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization). Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  13. A Pilot Randomized, Single Blind, Placebo-Controlled Trial of Traditional Acupuncture for Vasomotor Symptoms and Mechanistic Pathways of Menopause

    Science.gov (United States)

    Painovich, Jeannette M.; Shufelt, Chrisandra L.; Azziz, Ricardo; Yang, Yuching; Goodarzi, Mark O.; Braunstein, Glenn D.; Karlan, Beth Y.; Stewart, Paul M.; Merz, C. Noel Bairey

    2011-01-01

    Objective To conduct a pilot study for feasibility of planning a definitive clinical trial comparing traditional acupuncture (TA) to sham acupuncture (SA) and waiting control (WC) on menopause related vasomotor symptoms (VMS), quality of life (QOL), and the hypothalamic-pituitary-adrenal (HPA) axis in peri and post-menopausal women. Methods Thirty-three peri and post-menopausal women with at least 7 VMS daily were randomized to TA, SA or WC. The TA and SA groups were given three treatments per week for 12 weeks. Outcomes included the number and severity of VMS, MENQOL questionnaire, Beck Depression Inventory, Spielberg State-Trait Anxiety Instrument, Pittsburgh Quality Sleep Index, 24 hour urine cortisol and metabolites, and ACTH stimulation testing. Results Both TA and SA groups demonstrated improved VMS trends compared to WC (Δ −3.5±3.00 vs. −4.1±3.79 vs. −1.2±2.4, respectively, p=.20), and significantly improved MENQOL vasomotor scores (Δ − 1.5±2.02 vs. −1.8±1.52 vs. 0.3±0.64, respectively, p=.04). There were no psychosocial group differences. Exit 24-hour urinary measures were lower in the TA vs the SA or WC in total cortisol metabolites (4,658.9±1,670.9 vs 7,735.8±3,747.9 vs 5,166.0±2,234.5, p=0.03, respectively) and DHEA (41.4±27.46, 161.2±222.77, 252.4±385.40, respectively, p=0.05). The ACTH stimulation cortisol response data also trended in the hypothesized direction (p=0.17). Conclusion Both TA and SA reduce VMS frequency and severity and improve VMS-related quality of life compared to WC; however, TA alone may impact the HPA axis. This association is viewed as preliminary and hypothesis-generating and should be explored in a large clinical trial. PMID:21968279

  14. Role of Rifampin in Reducing Inflammation and Neuronal Damage in Childhood Bacterial Meningitis: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Uppal, Lipi; Singhi, Sunit; Singhi, Pratibha; Aggarwal, Ritu

    2017-06-01

    Treatment of acute bacterial meningitis in children with bactericidal antibiotics causes cell wall lysis and a surge in inflammatory cascade, which in turn contributes to neuronal damage and morbidity. Pretreatment with a nonbacteriolytic antibiotic, such as rifampin, has been shown to attenuate the inflammatory response in experimental models of bacterial meningitis. In a pilot study, in children with bacterial meningitis, we have studied markers of inflammatory response and neuronal damage in 2 groups of children with bacterial meningitis; one group received rifampin pretreatment with ceftriaxone and the other group received ceftriaxone alone. Forty children with bacterial meningitis, who were 3 months to 12 years of age, were randomly assigned to receive either a single dose rifampin (20 mg/kg) 30 minutes before ceftriaxone or ceftriaxone alone was given. The primary outcome variables were cerebrospinal fluid (CSF) concentrations of tumor necrosis factor alpha (TNFα), S100B and neuron-specific enolase on day 1 and day 5, and secondary outcome variables were the values of TNFα and interleukin 6 in serum on day 1 and day 5; hearing and neurologic sequelae at 3 months after recovery from the illness. Children in rifampin pretreatment group had significantly lower CSF TNFα concentrations [median (interquartile range [IQR]): 15.5 (7.2-22.0) vs. 53.0 (9.0-87.5) pg/mL, P = 0.019] and S100B [median (IQR): 145.0 (54.7-450.0) vs. 447.5 (221.0-804.6) pg/mL, P = 0.033] on day 1 and S100B [median (IQR): 109.7 (64.0-287.0) vs. 322 (106.7-578.0) pg/mL, P = 0.048] and neuron-specific enolase [median (IQR): 8.6 (5-14.75) vs. 18.2 (7.0-28.75) ng/mL, P = 0.035] on day 5 when compared with ceftriaxone alone group. The rifampin-treated group also had reduced morbidity and neurologic sequelae; however, these were not statistically significant. Pretreatment with single dose rifampin 30 minutes before ceftriaxone administration reduced the CSF concentrations of markers of

  15. Efficacy of high intensity exercise on disease activity and cardiovascular risk in active axial spondyloarthritis: a randomized controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Silje Halvorsen Sveaas

    Full Text Available Physical therapy is recommended for the management of axial spondyloarthritis (axSpA and flexibility exercises have traditionally been the main focus. Cardiovascular (CV diseases are considered as a major health concern in axSpA and there is strong evidence that endurance and strength exercise protects against CV diseases. Therefore, the aim of this study was to investigate the efficacy of high intensity endurance and strength exercise on disease activity and CV health in patients with active axSpA.In a single blinded randomized controlled pilot study the exercise group (EG performed 12 weeks of endurance and strength exercise while the control group (CG received treatment as usual. The primary outcome was the Ankylosing Spondylitis (AS Disease Activity Score (ASDAS. Secondary outcomes included patient reported disease activity (Bath AS Disease Activity Index [BASDAI], physical function (Bath AS Functional Index [BASFI], and CV risk factors measured by arterial stiffness (Augmentation Index [Alx] and Pulse Wave Velocity [PWV], cardiorespiratory fitness (VO2 peak and body composition. ANCOVA on the post intervention values with baseline values as covariates was used to assess group differences, and Mann Whitney U-test was used for outcomes with skewed residuals.Twenty-eight patients were included and 24 (EG, n = 10, CG, n = 14 completed the study. A mean treatment effect of -0.7 (95%CI: -1.4, 0.1 was seen in ASDAS score. Treatment effects were also observed in secondary outcomes (mean group difference [95%CI]: BASDAI: -2.0 (-3.6, -0.4, BASFI: -1.4 (-2.6, -0.3, arterial stiffness (estimated median group differences [95% CI]: AIx (%: -5.3 (-11.0, -0.5, and for PVW (m/s: -0.3 (-0.7, 0.0, VO2 peak (ml/kg/min (mean group difference [95%CI]: 3.7 (2.1, 5.2 and trunk fat (%: -1.8 (-3.0, -0.6. No adverse events occurred.High intensity exercise improved disease activity and reduced CV risk factors in patients with active axSpA. These effects will

  16. Effects of Standardized Home Training in Patients with Cognitive Impairment following Geriatric Rehabilitation: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Hauer, Klaus; Ullrich, Phoebe; Dutzi, Ilona; Beurskens, Rainer; Kern, Sylvia; Bauer, Jürgen; Schwenk, Michael

    2017-01-01

    Post-ward geriatric rehabilitation programs have hardly been developed and validated, which leaves a substantial gap in rehabilitative care in older adults and hinders full exploitation of maintained, but often unrecognized rehabilitation potentials. Geriatric rehabilitation patients with cognitive impairment represent a highly vulnerable population which is often affected by a lack of an ongoing support at the intersection between ward-based and post-ward rehabilitation. To determine the effect of a standardized home-based training program in geriatric patients with cognitive impairment following ward-based rehabilitation. A randomized controlled, single-blinded intervention trial (RCT) with wait list control design was used. Geriatric patients (n = 34; age: 81.9 ± 5.7 years) with cognitive impairment (MMSE: 18.8 ± 4.7), identified by predefined in- and exclusion criteria, were consecutively recruited from a geriatric rehab ward. Patients in the intervention group (IG, n = 17) performed a 6-week strength and functional home training. The control group (CG, n = 17) started an identical training 6 weeks later with an initial usual care period during the intervention for the IG. Functional performance (Short Physical Performance Battery; SPPB), clinically relevant functional deficits (Performance Oriented Assessment; POMA), and physical activity (Assessment of Physical Activity For Older Persons questionnaire; APAFOP) represented primary outcome measurements complemented by additional secondary outcome parameters. The IG significantly increased functional performances in SPPB (total score: p = 0.012; chair rise: p = 0.007, balance: p = 0.066), reduced gait and balance deficits in POMA (total score: p = 0.006; balance: p = 0.034; gait: p = 0.019), and increased physical activity (APAFOP; p = 0.05) compared to the CG. Effect sizes showed medium to large effects for significant parameters (eta2 = 0.14-0.45). Training benefits and adherence were more pronounced

  17. Behavioral intervention to reduce opioid overdose among high-risk persons with opioid use disorder: A pilot randomized controlled trial.

    Science.gov (United States)

    Coffin, Phillip Oliver; Santos, Glenn-Milo; Matheson, Tim; Behar, Emily; Rowe, Chris; Rubin, Talia; Silvis, Janelle; Vittinghoff, Eric

    2017-01-01

    The United States is amidst an opioid epidemic, including synthetic opioids that may result in rapid death, leaving minimal opportunity for bystander rescue. We pilot tested a behavioral intervention to reduce the occurrence of opioid overdose among opioid dependent persons at high-risk for subsequent overdose. We conducted a single-blinded randomized-controlled trial of a repeated dose motivational interviewing intervention (REBOOT) to reduce overdose versus treatment as usual, defined as information and referrals, over 16 months at the San Francisco Department of Public Health from 2014-2016. Participants were 18-65 years of age, had opioid use disorder by Structured Clinical Interview, active opioid use, opioid overdose within 5 years, and prior receipt of naloxone kits. The intervention was administered at months 0, 4, 8, and 12, preceded by the assessment which was also administered at month 16. Dual primary outcomes were any overdose event and number of events, collected by computer-assisted personal interview, as well as any fatal overdose events per vital records. A total of 78 persons were screened and 63 enrolled. Mean age was 43 years, 67% were born male, 65% White, 17% African-American, and 14% Latino. Ninety-two percent of visits and 93% of counseling sessions were completed. At baseline, 33.3% of participants had experienced an overdose in the past four months, with a similar mean number of overdoses in both arms (p = 0.95); 29% overdosed during follow-up. By intention-to-treat, participants assigned to REBOOT were less likely to experience any overdose (incidence rate ratio [IRR] 0.62 [95%CI 0.41-0.92, p = 0.019) and experienced fewer overdose events (IRR 0.46, 95%CI 0.24-0.90, p = 0.023), findings that were robust to sensitivity analyses. There were no differences between arms in days of opioid use, substance use treatment, or naloxone carriage. REBOOT reduced the occurrence of any opioid overdose and the number of overdoses. clinicaltrials.gov NCT

  18. A randomized pilot study of L-arginine infusion in severe falciparum malaria: preliminary safety, efficacy and pharmacokinetics.

    Directory of Open Access Journals (Sweden)

    Tsin W Yeo

    Full Text Available Decreased nitric oxide (NO and hypoargininemia are associated with severe falciparum malaria and may contribute to severe disease. Intravenous L-arginine increases endothelial NO in moderately-severe malaria (MSM without adverse effects. The safety, efficacy and pharmacokinetics of L-arginine or other agents to improve NO bioavailability in severe malaria have not been assessed.In an open-label pilot study of L-arginine in adults with severe malaria (ARGISM-1 Study, patients were randomized to 12 g L-arginine hydrochloride or saline over 8 hours together with intravenous artesunate. Vital signs, selected biochemical measures (including blood lactate and L-arginine and endothelial NO bioavailability (using reactive hyperemia peripheral arterial tonometry [RH-PAT] were assessed serially. Pharmacokinetic analyses of L-arginine concentrations were performed using NONMEM.Six patients received L-arginine and two saline infusions. There were no deaths in either group. There were no changes in mean systolic (SBP and diastolic blood pressure (DBP or other vital signs with L-arginine, although a transient but clinically unimportant mean maximal decrease in SBP of 14 mmHg was noted. No significant changes in mean potassium, glucose, bicarbonate, or pH were seen, with transient mean maximal increases in plasma potassium of 0.3 mmol/L, and mean maximal decreases in blood glucose of 0.8 mmol/L and bicarbonate of 2.3 mEq/L following L-arginine administration. There was no effect on lactate clearance or RH-PAT index. Pharmacokinetic modelling (n = 4 showed L-arginine concentrations 40% lower than predicted from models developed in MSM.In the first clinical trial of an adjunctive treatment aimed at increasing NO bioavailability in severe malaria, L-arginine infused at 12 g over 8 hours was safe, but did not improve lactate clearance or endothelial NO bioavailability. Future studies may require increased doses of L-arginine.ClinicalTrials.gov NCT00616304.

  19. Effects and feasibility of an Integrative Medicine program for geriatric patients– a cluster-randomized pilot study

    Directory of Open Access Journals (Sweden)

    Teut M

    2013-07-01

    Full Text Available Michael Teut, Katharina Schnabel, Roland Baur, Annette Kerckhoff, Frauke Reese, Niels Pilgram, Franziska Berger, Rainer Luedtke, Claudia M Witt Institute for Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, Berlin, Germany Background: Older adults often use complementary medicine; however, very few interventional studies have focused on them. The aim of this study was to evaluate the feasibility and to obtain preliminary data on effectiveness of an Integrative Medicine (IM program compared to usual medical care. Methods: The study consisted of older adults living in shared apartment communities including caregiving. The shared apartments were cluster-randomized to the IM program or Usual Care (UC. IM consisted of additional lifestyle modification (exercise and diet, external naturopathic applications, homeopathic treatment, and modification of conventional drug therapy for 12 months. The UC group received conventional care alone. The following outcomes were used: Nurses Observation Scale for Geriatric Patients (NOSGER; Assessment of Motor and Process Skills; Barthel Index; Qualidem; Profile of Wellbeing; and Mini-mental State Examination. Exploratory effect sizes (Cohen’s d, means adjusted for differences of baseline values were calculated to analyze group differences. Results: A total of eight shared apartment communities were included; four were allocated to IM (29 patients, median seven patients; [mean ± standard deviation] 82.7 ± 8.6 years and four to UC (29 patients, median eight patients; 76.0 ± 12.8 years of age. After 12 months, effect sizes ≥0.3 were observed for activities of daily living on the NOSGER-Activities of Daily Living subscale (0.53, Barthel Index (0.30, Qualidem total sum score (0.39, Profile of Wellbeing (0.36, NOSGER-Impaired Social Behavior (0.47, and NOSGER-Depressed Mood subscales (0.40. Smaller or no effects were observed for all other outcomes. The intervention

  20. Effect of chiropractic manipulation on vertical jump height in young female athletes with talocrural joint dysfunction: a single-blind randomized clinical pilot trial.

    Science.gov (United States)

    Hedlund, Sofia; Nilsson, Hans; Lenz, Markus; Sundberg, Tobias

    2014-02-01

    The main objective of this pilot study was to explore the effect of chiropractic high-velocity, low-amplitude (HVLA) manipulation on vertical jump height in young female athletes with talocrural joint dysfunction. This was a randomized assessor-blind clinical pilot trial. Twenty-two female handball players with talocrural joint dysfunction were randomized to receive either HVLA manipulation (n = 11) or sham treatment (n = 11) once a week during a 3-week period. The main outcome was change in vertical jump height from baseline to follow-up within and between groups after 3 weeks. Nineteen athletes completed the study. After 3 weeks, the group receiving HVLA manipulation (n = 11) had a statistically significant mean (SD) improvement in vertical jump height of 1.07 (1.23) cm (P = .017). The sham treatment group (n = 8) improved their vertical jump height by 0.59 (2.03) cm (P = .436). The between groups' change was 0.47 cm (95% confidence interval, -1.31 to 2.26; P = .571) in favor of the group receiving HVLA manipulation. Blinding and sham procedures were feasible, and there were no reported adverse events. The results of this pilot study show that a larger-scale study is feasible. Preliminary results suggest that chiropractic HVLA manipulation may increase vertical jump height in young female athletes with talocrural joint dysfunction. However, the clinical result in favor of HVLA manipulation compared with sham treatment needs statistical confirmation in a larger randomized clinical trial. Copyright © 2014 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  1. [Pilot results of using tamsulone-FS in patients with prostatic adenoma according to the results of a randomized multicenter comparative trial].

    Science.gov (United States)

    Lopatkin, N A; Petrov, S B; Sivkov, A V; Markov, A V; Oshchepkov, N N; Bolokhanov, Iu N

    2006-01-01

    Tamsulone-FS--a novel Russian alpha1A/D-adrenoblocker (Farm-Syntez)--was studied in a randomized multicenter comparative trial in patients with prostatic adenoma. Pilot results agreed with other trials published in the literature and demonstrated tamsulone-FS efficacy and safety for management of lower urinary tract symptoms caused by prostatic adenoma. The efficacy and safety of tamsulone-FS was comparable to those of omnik. This drug can be recommended for wide clinical practice in prostatic adenoma. It is registered by Roszdravnadzor (certificate N LC-000859 of 03.11.2005) and allowed for production and sale.

  2. Randomized and double-blinded pilot clinical study of the safety and anti-diabetic efficacy of the Rauvolfia-Citrus tea, as used in Nigerian Traditional Medicine

    DEFF Research Database (Denmark)

    Campbell-Tofte, Joan I A; Mølgaard, Per; Josefsen, Knud

    2011-01-01

    resulted in the normalization of blood sugar, reduction in lipid accumulated in the mice eyes and prevention of the degeneration of the otherwise brittle BKS-db pancreas. The tea is made by boiling foliage of Rauvolfia vomitoria and fruits of Citrus aurantium and is used to treat diabetes in Nigerian folk......The aim of this randomized and double blinded pilot clinical trial was to investigate the anti-diabetic efficacy of the Rauvolfia-Citrus (RC) tea in humans. We have earlier shown that a combination of calorie-restriction and chronic administration of the RC tea to the genetic diabetic (BKS-db) mice...

  3. A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study.

    Science.gov (United States)

    Hale, Timothy M; Jethwani, Kamal; Kandola, Manjinder Singh; Saldana, Fidencio; Kvedar, Joseph C

    2016-04-17

    Heart failure (HF) is a chronic condition affecting nearly 5.7 million Americans and is a leading cause of morbidity and mortality. With an aging population, the cost associated with managing HF is expected to more than double from US $31 billion in 2012 to US $70 billion by 2030. Readmission rates for HF patients are high-25% are readmitted at 30 days and nearly 50% at 6 months. Low medication adherence contributes to poor HF management and higher readmission rates. Remote telehealth monitoring programs aimed at improved medication management and adherence may improve HF management and reduce readmissions. The primary goal of this randomized controlled pilot study is to compare the MedSentry remote medication monitoring system versus usual care in older HF adult patients who recently completed a HF telemonitoring program. We hypothesized that remote medication monitoring would be associated with fewer unplanned hospitalizations and emergency department (ED) visits, increased medication adherence, and improved health-related quality of life (HRQoL) compared to usual care. Participants were randomized to usual care or use of the remote medication monitoring system for 90 days. Twenty-nine participants were enrolled and the final analytic sample consisted of 25 participants. Participants completed questionnaires at enrollment and closeout to gather data on medication adherence, health status, and HRQoL. Electronic medical records were reviewed for data on baseline classification of heart function and the number of unplanned hospitalizations and ED visits during the study period. Use of the medication monitoring system was associated with an 80% reduction in the risk of all-cause hospitalization and a significant decrease in the number of all-cause hospitalization length of stay in the intervention arm compared to usual care. Objective device data indicated high adherence rates (95%-99%) among intervention group participants despite finding no significant difference

  4. A web-based psychoeducational program for informal caregivers of patients with Alzheimer's disease: a pilot randomized controlled trial.

    Science.gov (United States)

    Cristancho-Lacroix, Victoria; Wrobel, Jérémy; Cantegreil-Kallen, Inge; Dub, Timothée; Rouquette, Alexandra; Rigaud, Anne-Sophie

    2015-05-12

    Although several face-to-face programs are dedicated to informal caregivers of persons with dementia, they are not always accessible to overburdened or isolated caregivers. Based on a face-to-face intervention program, we adapted and designed a Web-based fully automated psychoeducational program (called Diapason) inspired by a cognitive approach. This study aimed to evaluate through a pilot unblinded randomized controlled trial the efficacy and acceptability of a Web-based psychoeducational program for informal caregivers of persons with Alzheimer's disease (PWAD) based on a mixed methods research design. We recruited and randomized offline 49 informal caregivers of a PWAD in a day care center in Paris, France. They either received the Web-based intervention and usual care for 3 months (experimental group, n=25) or only usual care (control group, n=24). Caregivers' perceived stress (PSS-14, primary outcome), self-efficacy, burden, perceived health status, and depression (secondary outcomes) were measured during 3 face-to-face on-site visits: at baseline, at the end of the program (month 3), and after follow-up (month 6). Additionally, semistructured interviews were conducted with experimental group caregivers at month 6 and examined with thematic analysis. Intention-to-treat analysis did not show significant differences in self-perceived stress between the experimental and control groups (P=.98). The experimental group significantly improved their knowledge of the illness (d=.79, P=.008) from baseline to month 3. Of the 25 participants allocated to the experimental group, 17 (71%) finished the protocol and entirely viewed at least 10 of 12 online sessions. On average, participants used the website 19.72 times (SD 12.88) and were connected for 262.20 minutes (SD 270.74). The results of the satisfaction questionnaire showed that most participants considered the program to be useful (95%, 19/20), clear (100%, 20/20), and comprehensive (85%, 17/20). Significant

  5. Cultural differences in music chosen for pain relief.

    Science.gov (United States)

    Good, M; Picot, B L; Salem, S G; Chin, C C; Picot, S F; Lane, D

    2000-09-01

    Nurses use music therapeutically but often assume that all patients will equally appreciate the same type of music. Cultural differences in music preferences are compared across five pain studies. Music preferences for pain relief are described as the most frequently chosen type of music for each culture. Findings indicate that in four studies, musical choices were related to cultural background (p = .002 to .049). Although the majority in each group chose among the other types of music, Caucasians most frequently chose orchestra music, African Americans chose jazz, and Taiwanese chose harp music. For culturally congruent care, nurses should become aware of cultural differences in music preference and provide culturally specific selections among other music expected to have a therapeutic effect.

  6. Dopamine neurons learn relative chosen value from probabilistic rewards.

    Science.gov (United States)

    Lak, Armin; Stauffer, William R; Schultz, Wolfram

    2016-10-27

    Economic theories posit reward probability as one of the factors defining reward value. Individuals learn the value of cues that predict probabilistic rewards from experienced reward frequencies. Building on the notion that responses of dopamine neurons increase with reward probability and expected value, we asked how dopamine neurons in monkeys acquire this value signal that may represent an economic decision variable. We found in a Pavlovian learning task that reward probability-dependent value signals arose from experienced reward frequencies. We then assessed neuronal response acquisition during choices among probabilistic rewards. Here, dopamine responses became sensitive to the value of both chosen and unchosen options. Both experiments showed also the novelty responses of dopamine neurones that decreased as learning advanced. These results show that dopamine neurons acquire predictive value signals from the frequency of experienced rewards. This flexible and fast signal reflects a specific decision variable and could update neuronal decision mechanisms.

  7. Effect of the chosen incision on corneal astigmatism after implantable collamer lens surgery

    Directory of Open Access Journals (Sweden)

    Xia Jiang

    2014-06-01

    Full Text Available AIM: To evaluate the effect of the chosen incision on corneal astigmatism after implantable collamer lens(ICLsurgery.METHODS: The study included 195 eyes of 102 patients, and all eyes were randomly divided into two groups: the chosen incision group(Group A, 97 eyesand temporal corneal incision(Group B, 98 eyes. Before the operation, and 1wk,1mo and 3mo after the operation, each patient was examined with corneal topography to observe the changes of corneal astigmatism. RESULTS: Preoperative corneal astigmatisms were(1.26±0.35D in group A and(1.28±0.38D in group B, thus there was no statistically significant difference(P>0.05. One week postoperatively, the astigmatism were(0.93±0.29D in group A and(1.32±0.33D in group B. One month postoperatively, the astigmatism were(0.85±0.16D in group A and(1.27±0.18D in group B. Three months postoperatively, the astigmatism were(0.80±0.13D in group A and(1.25±0.20D in group B. The differences between the two groups were statistically significant(PCONCLUSION: The chosen incision can reduce postoperative astigmatism to a certain extent after ICL surgery.

  8. Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

    Science.gov (United States)

    Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

    2014-09-06

    This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

  9. A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol.

    Science.gov (United States)

    Samaan, Zainab; Litke, Kathryn; McCabe, Kathleen; Dennis, Brittany; Whattam, Jeff; Garrick, Laura; O'Neill, Laura; Tabak, Terri Ann; Simons, Scott; Chalmers, Sandra; Key, Brenda; Vanstone, Meredith; Xie, Feng; Guyatt, Gordon; Thabane, Lehana

    2015-01-01

    Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants' feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants' feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions

  10. The ExStroke Pilot Trial: rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke

    DEFF Research Database (Denmark)

    Krarup, L.H.; Gluud, C.; Truelsen, T.

    2008-01-01

    of increasing stroke patients' level of physical activity and secondarily to associate the level of physical activity to the risk of recurrent stroke, myocardial infarction, and all-cause mortality in the two groups. We describe the rationale, design, and baseline data of the ExStroke Pilot Trial. METHODS....... Physical activity is assessed in both groups seven times during follow-up using the Physical Activity Scale for the Elderly (PASE) questionnaire, which quantifies the amount of physical activity done in the last seven days prior to interview. The PASE score constitutes the primary outcome measure....... The secondary outcome is the time from randomization to recurrent stroke, myocardial infarction, or all-cause mortality. Further outcome measures include: time from randomization to recurrent stroke, myocardial infarction, and vascular death; recurrent stroke; modified Rankin Scale; quality of life; occurrence...

  11. Results From a European Multicenter Randomized Trial of Physical Activity and/or Healthy Eating to Reduce the Risk of Gestational Diabetes Mellitus: The DALI Lifestyle Pilot.

    Science.gov (United States)

    Simmons, David; Jelsma, Judith G M; Galjaard, Sander; Devlieger, Roland; van Assche, Andre; Jans, Goele; Corcoy, Rosa; Adelantado, Juan M; Dunne, Fidelma; Desoye, Gernot; Harreiter, Jürgen; Kautzky-Willer, Alexandra; Damm, Peter; Mathiesen, Elisabeth R; Jensen, Dorte M; Andersen, Lise Lotte; Lapolla, Annunziata; Dalfra, Maria; Bertolotto, Alessandra; Wender-Ozegowska, Ewa; Zawiejska, Agnieszka; Hill, David; Rebollo, Pablo; Snoek, Frank J; van Poppel, Mireille N M

    2015-09-01

    Ways to prevent gestational diabetes mellitus (GDM) remain unproven. We compared the impact of three lifestyle interventions (healthy eating [HE], physical activity [PA], and both HE and PA [HE+PA]) on GDM risk in a pilot multicenter randomized trial. Pregnant women at risk for GDM (BMI ≥29 kg/m2) from nine European countries were invited to undertake a 75-g oral glucose tolerance test before 20 weeks' gestation. Those without GDM were randomized to HE, PA, or HE+PA. Women received five face-to-face and four optional telephone coaching sessions, based on the principles of motivational interviewing. A gestational weight gain (GWG) Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  12. Comparison of Deep Tissue Massage and Therapeutic Massage for Lower Back Pain, Disease Activity, and Functional Capacity of Ankylosing Spondylitis Patients: A Randomized Clinical Pilot Study

    Directory of Open Access Journals (Sweden)

    Mateusz Wojciech Romanowski

    2017-01-01

    Full Text Available Objectives. This study aims to compare the effectiveness of deep tissue massage (DTM and therapeutic massage (TM in the management of ankylosing spondylitis (AS patients. Materials and Methods. This was a small, randomized clinical pilot study. Subjects were 27 men with diagnosed AS, randomly assigned to DTM group or TM group. Subjects in each group had 10 sessions of massage. Outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI, Modified Schober Test, Finger to Floor Test, chest expansion, and pain intensity of lower back. Results. There are no statistical significant differences between groups, except for BASDAI and pain intensity of lower back. Conclusions. This study suggests that massage may have clinical benefits for treating ankylosing spondylitis patients. Additional scientific research in this area is warranted.

  13. The Mothers and Toddlers Program, an attachment-based parenting intervention for substance using women: post-treatment results from a randomized clinical pilot.

    Science.gov (United States)

    Suchman, Nancy E; DeCoste, Cindy; Castiglioni, Nicole; McMahon, Thomas J; Rounsaville, Bruce; Mayes, Linda

    2010-09-01

    This is a report of post-treatment findings from a completed randomized pilot study testing the preliminary efficacy of the Mothers and Toddlers Program (MTP), a 12 week attachment-based individual parenting therapy for mothers enrolled in substance abuse treatment and caring for children ages birth to 36 months. Forty-seven mothers were randomized to MTP versus the Parent Education Program (PE), a comparison intervention providing individual case management and child guidance brochures. At post-treatment, MTP mothers demonstrated better reflective functioning in the Parent Development Interview, representational coherence and sensitivity, and caregiving behavior than PE mothers. Partial support was also found for proposed mechanisms of change in the MTP model. Together, preliminary findings suggest that attachment-based interventions may be more effective than traditional parent training for enhancing relationships between substance using women and their young children.

  14. Increasing Access to Mental Health Care With Breathe, an Internet-Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Newton, Amanda S; Wozney, Lori; Bagnell, Alexa; Fitzpatrick, Eleanor; Curtis, Sarah; Jabbour, Mona; Johnson, David; Rosychuk, Rhonda J; Young, Michael; Ohinmaa, Arto; Joyce, Anthony; McGrath, Patrick

    2016-01-29

    There is a demand to make first-line treatments, including cognitive behavioural therapy (CBT) for adolescent anxiety disorders, more widely available. Internet-based CBT is proposed to circumvent access and availability barriers and reduce health care system costs. Recent reviews suggest more evidence is needed to establish the treatment effects of Internet-based CBT in children and adolescents and to determine related economic impacts. This pilot trial aims to collect the necessary data to inform the planning of a full-scale RCT to test the effectiveness of the Internet-based CBT program Breathe (Being Real, Easing Anxiety: Tools Helping Electronically). We are conducting a 27-month, 2-arm parallel-group, pilot randomized controlled trial (RCT). Outcomes will inform the planning of a full-scale RCT aimed to test the effectiveness of Internet-based CBT with a population of adolescents with moderate to mild anxiety problems. In the pilot RCT we will: (1) define a minimal clinically important difference (MCID) for the primary outcome measure (total anxiety score using the Multidimensional Anxiety Scale for Children); (2) determine a sample size for the full-scale RCT; (3) estimate recruitment and retention rates; (4) measure intervention acceptability to inform critical intervention changes; (5) determine the use of co-interventions; and (6) conduct a cost-consequence analysis to inform a cost-effectiveness analysis in the full-scale RCT. Adolescents aged 13-17 years seeking care for an anxiety complaint from a participating emergency department, mobile or school-based crisis team, or primary care clinic are being screened for interest and eligibility. Enrolled adolescents are being randomly allocated to either 8 weeks of Internet-based CBT with limited telephone and e-mail support, or a control group with access to a static webpage listing anxiety resources. Adolescents are randomly assigned using a computer generated allocation sequence. Data are being collected

  15. Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial

    Energy Technology Data Exchange (ETDEWEB)

    Michel, Patrik [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Neurology Service, Lausanne (Switzerland); Centre Hospitalier Universitaire Vaudois and University of Lausanne, Neurology Service, Lausanne (Switzerland); Ntaios, George; Reichhart, Marc [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Neurology Service, Lausanne (Switzerland); Schindler, Christian [Center Hospitalier Universitaire Vaudois and University of Lausanne, Pharmacy Department, Lausanne (Switzerland); Bogousslavsky, Julien [Genolier Swiss Medical Network, Glion (Switzerland); Maeder, Philip; Meuli, Reto [Center Hospitalier Universitaire Vaudois and University of Lausanne, Department of Radiology, Lausanne (Switzerland); Wintermark, Max [University of Virginia, Department of Radiology, Division of Neuroradiology, Charlottesville, VA (United States)

    2012-06-15

    Patients with unknown stroke onset are generally excluded from acute recanalisation treatments. We designed a pilot study to assess feasibility of a trial of perfusion computed tomography (PCT)-guided thrombolysis in patients with ischemic tissue at risk of infarction and unknown stroke onset. Patients with a supratentorial stroke of unknown onset in the middle cerebral artery territory and significant volume of at-risk tissue on PCT were randomized to intravenous thrombolysis with alteplase (0.9 mg/kg) or placebo. Feasibility endpoints were randomization and blinded treatment of patients within 2 h after hospital arrival, and the correct application (estimation) of the perfusion imaging criteria. At baseline, there was a trend towards older age [69.5 (57-78) vs. 49 (44-78) years] in the thrombolysis group (n = 6) compared to placebo (n = 6). Regarding feasibility, hospital arrival to treatment delay was above the allowed 2 h in three patients (25%). There were two protocol violations (17%) regarding PCT, both underestimating the predicted infarct in patients randomized in the placebo group. No symptomatic hemorrhage or death occurred during the first 7 days. Three of the four (75%) and one of the five (20%) patients were recanalized in the thrombolysis and placebo group respectively. The volume of non-infarcted at-risk tissue was 84 (44-206) cm{sup 3} in the treatment arm and 29 (8-105) cm{sup 3} in the placebo arm. This pilot study shows that a randomized PCT-guided thrombolysis trial in patients with stroke of unknown onset may be feasible if issues such as treatment delays and reliable identification of tissue at risk of infarction tissue are resolved. Safety and efficiency of such an approach need to be established. (orig.)

  16. A group intervention to reduce intimate partner violence among female drug users. Results from a randomized controlled pilot trial in a community substance-abuse center.

    Science.gov (United States)

    Tirado-Muñoz, Judit; Gilchrist, Gail; Lligoña, Eva; Gilbert, Louisa; Torrens, Marta

    2015-09-15

    A greater proportion of drug dependent women are victims of intimate partner violence (IPV) than women in the general population; however, few interventions have been developed to reduce IPV among drug dependent women. An adapted version of the Women's Wellness Treatment, to address IPV and depressive symptoms, was piloted in a randomized controlled trial conducted in outpatient treatment program in Barcelona, Spain among 14 women receiving outpatient treatment for a drug use disorder who screened positive for IPV in the previous month. Participants were randomly assigned to receive the 10 session cognitive behavioral therapy (IPaViT-CBT) group intervention or treatment as usual. The frequency of IPV, depressive symptoms, substance use, quality of life and health status were assessed at baseline and 1, 3 and 12 months post intervention. Intention to treat analysis was performed. Moderate effects for the intervention were found in reducing psychological maltreatment, increasing assertiveness of IPV and reducing aggressiveness in the partner relationship, and in reducing the frequency of drinking up to 3 months post intervention. The intervention did not significantly reduce the likelihood of any IPV, depressive symptoms, quality of life or self-reported health status, up to 12-months post intervention. This pilot trial suggests some initial support for the 10-session CBT group intervention among IPV victims who received treatment for drug use. Study findings indicate that it is feasible to deliver the intervention in a community substance abuse center. An adequately powered trial is required to replicate these results.

  17. Promoting Healthy Transition to College through Mindfulness Training with First-Year College Students: Pilot Randomized Controlled Trial

    Science.gov (United States)

    Dvoráková, Kamila; Kishida, Moé; Li, Jacinda; Elavsky, Steriani; Broderick, Patricia C.; Agrusti, Mark R.; Greenberg, Mark T.

    2017-01-01

    Objective: Given the importance of developmental transitions on young adults' lives and the high rates of mental health issues among U.S. college students, first-year college students can be particularly vulnerable to stress and adversity. This pilot study evaluated the effectiveness and feasibility of mindfulness training aiming to promote…

  18. Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Cermak, Sharon A.; Stein Duker, Leah I.; Williams, Marian E.; Dawson, Michael E.; Lane, Christianne J.; Polido, José C.

    2015-01-01

    This pilot and feasibility study examined the impact of a sensory adapted dental environment (SADE) to reduce distress, sensory discomfort, and perception of pain during oral prophylaxis for children with autism spectrum disorder (ASD). Participants were 44 children ages 6-12 (n = 22 typical, n = 22 ASD). In an experimental crossover design, each…

  19. Dopamine neurons learn relative chosen value from probabilistic rewards

    Science.gov (United States)

    Lak, Armin; Stauffer, William R; Schultz, Wolfram

    2016-01-01

    Economic theories posit reward probability as one of the factors defining reward value. Individuals learn the value of cues that predict probabilistic rewards from experienced reward frequencies. Building on the notion that responses of dopamine neurons increase with reward probability and expected value, we asked how dopamine neurons in monkeys acquire this value signal that may represent an economic decision variable. We found in a Pavlovian learning task that reward probability-dependent value signals arose from experienced reward frequencies. We then assessed neuronal response acquisition during choices among probabilistic rewards. Here, dopamine responses became sensitive to the value of both chosen and unchosen options. Both experiments showed also the novelty responses of dopamine neurones that decreased as learning advanced. These results show that dopamine neurons acquire predictive value signals from the frequency of experienced rewards. This flexible and fast signal reflects a specific decision variable and could update neuronal decision mechanisms. DOI: http://dx.doi.org/10.7554/eLife.18044.001 PMID:27787196

  20. Racial disparities in the type of postmastectomy reconstruction chosen.

    Science.gov (United States)

    Offodile, Anaeze C; Tsai, Thomas C; Wenger, Julia B; Guo, Lifei

    2015-05-01

    Racial disparities remain for women undergoing immediate breast reconstruction (IBR) after mastectomy. Understanding patterns of racial disparities in IBR utilization may present opportunities to tailor policies aimed at optimizing care across racial groups. The aim of this study was to determine if racial disparities exist for types of IBR chosen. A national, retrospective cohort study used the 2005-2011 American College of Surgeons National Surgical Quality Improvement Program database. Multivariable logistic regression models were created to detect the odds by race for receiving each subtype of IBR after mastectomy-prosthetic, pedicled-transfer autologous tissue, or free-transfer autologous tissue. Secondary outcome was trends in IBR rates over time. There were 44,597 women identified in the data set who underwent mastectomy. Thirty-seven percent of women (N = 16, 642) were noted to undergo IBR after mastectomy. Prosthetic reconstruction (84.4%, n = 37, 640) was the most common form of IBR compared with pedicled-autologous reconstruction (15.4%, n = 6868) and free transfer autologous reconstruction (4.9%, n = 2185), P Racial disparities persisted from 2005-2011; as minority patients were less likely to undergo IBR than whites (P disparities in access to high-quality care and underlying cultures. Strategies aimed at reducing racial disparities in IBR should be tailored to specific patterns of disparities among Asian, black, and Hispanic women. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. STUDIES OF CHOSEN TOXIC ELEMENTS CONCENTRATION IN MULTIFLOWER BEE HONEY

    Directory of Open Access Journals (Sweden)

    Ewa Popiela

    2011-04-01

    Full Text Available 72 544x376 Normal 0 21 false false false  The aim of the study was to determine the bioaccumulation level of chosen toxic elements (Zn, Cu, Pb, As and Cd in multiflower honey collected from Brzeg area. Biological material (honey was mineralized using the microwave technique at an elevated pressure in the microprocessor station of pressure in the type Mars 5. Quantitative analysis of elements (As, Cd, Cu, Pb and Zn was performed by plasma spectrometry method using a Varian ICP-AES apparatus. The presence of toxic elements was determined in examined biological materials. The elements fallowed the fallowing decreasing order with respect to their content of honey: Zn>Cu>Pb>As>Cd. The average concentrations of studied elements observed in multi-flower honey were as follows: 6.24 mg.kg-1 of zinc, 2.75 mg.kg-1 of copper, 0.53, 0.071, 0.042 mg.kg-1of lead, arsenic and cadmium, respectively. Lead was the most problematic in bee honey because its average content exceeded the maximum acceptable concentration. Additionally, this metal concentration was 60% higher in studied samples than allowable standard of lead content.doi:10.5219/134 

  2. A trial to determine whether septic shock-reversal is quicker in pediatric patients randomized to an early goal-directed fluid-sparing strategy versus usual care (SQUEEZE): study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Parker, Melissa J; Thabane, Lehana; Fox-Robichaud, Alison; Liaw, Patricia; Choong, Karen

    2016-11-22

    Current pediatric septic shock resuscitation guidelines from the American College of Critical Care Medicine focus on the early and goal-directed administration of intravascular fluid followed by vasoactive medication infusions for persistent and fluid-refractory shock. However, accumulating adult and pediatric data suggest that excessive fluid administration is associated with worse patient outcomes and even increased risk of death. The optimal amount of intravascular fluid required in early pediatric septic shock resuscitation prior to the initiation of vasoactive support remains unanswered. The SQUEEZE Pilot Trial is a pragmatic, two-arm, parallel-group, open-label, prospective pilot randomized controlled trial. Participants are children aged 29 days to under 18 years with suspected or confirmed septic shock and a need for ongoing resuscitation. Eligible participants are enrolled under an exception to consent process and randomly assigned via concealed allocation to either the Usual Care (control) or Fluid Sparing (intervention) resuscitation strategy. The primary objective of this pilot trial is to determine feasibility, based on the ability to enroll participants and to adhere to the study protocol. The primary outcome measure by which success will be determined is participant enrollment rate ("pass" defined as at least two participants/site/month, recognizing that enrollment may be slower during the run-in phase). Secondary objectives include assessing (1) appropriateness of eligibility criteria, and (2) completeness of clinical outcomes to inform the endpoints for the planned multisite trial. To support the nested translational study, SQUEEZE-D, we will also evaluate the feasibility of describing cell-free DNA (a procoagulant molecule with prognostic utility) in blood samples obtained from children enrolled into the SQUEEZE Pilot Trial at baseline and at 24 h. The optimal degree of fluid resuscitation and the timing of initiation of vasoactive support in

  3. Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

    Science.gov (United States)

    Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

    2017-11-09

    Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs

  4. Which factors determine the freely chosen cadence during submaximal cycling?

    Science.gov (United States)

    Vercruyssen, Fabrice; Brisswalter, Jeanick

    2010-03-01

    The present review of cycling science focuses on the identification of criteria that affect the freely chosen cadence (FCC) during submaximal exercise of short and prolonged durations. Cadence selection during submaximal cycling constitutes a potential parameter affecting the endurance performance in subjects of varying aerobic fitness level and experience. The activity constraints such as specificity (e.g. cycle bout of triathlon) and exercise duration may play an important role in the selection of cadence and must be taken into consideration in the task description. The 'holistic' approach of this review is based on a multifactorial analysis considering the cycling constraints, and the physiological and biomechanical factors of cadence selection so as to establish any interrelationships between these factors. During cycle bouts of short duration (<15 min), it has been well argued that experienced cyclists, trained runners and triathletes adopt high cadences (80-100 rpm) systematically above the energetically optimal cadence (EOC) at which the oxygen uptake is minimal (55-65 rpm). The choice of a high cadence has been shown to be dependent upon several factors, such as the aerobic fitness level, the reduction in forces applied to the cranks, the lower extremity net joint moments and minimal neuromuscular fatigue. However, with increasing exercise duration the FCC has been reported to be close to the EOC exclusively in endurance athletes practising a variety of activities, suggesting an impact of training mode on the muscular adaptations and the organisation of the movement pattern. Copyright 2009 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  5. How feasible is the attainment of community ambulation after stroke? A pilot randomized controlled trial to evaluate community-based physiotherapy in subacute stroke.

    Science.gov (United States)

    Lord, Susan; McPherson, Kathryn M; McNaughton, Harry K; Rochester, Lynn; Weatherall, Mark

    2008-03-01

    This pilot randomized controlled trial evaluated an assistant-led, community-based intervention to improve community mobility and participation after stroke, and examined the potential for independent community ambulation in people with subacute stroke who present with moderate gait deficit. A multicentre, pilot randomized controlled trial. Three hospitals and three community settings in New Zealand. Thirty post-acute, home-dwelling stroke survivors were randomly allocated to receive intervention in the community (n = 14) or as hospital outpatients (n = 16) twice a week for seven weeks. The community intervention involved practice of functional gait activities in community environments relevant to each participant. Hospital-based physiotherapy was based upon a Motor Relearning approach. The primary outcome measure was gait speed (m/min). Secondary outcomes included endurance (six-minute walk time), Activities-specific Confidence Balance Scale, and the Subjective Index of Physical and Social Outcomes measured at baseline, post intervention and six months. Large gains in gait speed were obtained for participants in both groups: community group mean (SD) 16 (16.1) m/min; physiotherapy group mean (SD) 15.9 (16.1) m/min, maintained at six months. There were no significant differences between groups for primary and secondary outcomes after treatment (P = 0.86 ANOVA) or at six months (P = 0.83 ANOVA). Only 11 participants reported independent community ambulation. Levels of social integration were low to moderate. A community-based gait recovery programme appears a practicable alternative to routine physiotherapy, however independent community ambulation is a challenging rehabilitation goal.

  6. Randomized controlled pilot trial of mindfulness-based stress reduction for breast and colorectal cancer survivors: effects on cancer-related cognitive impairment.

    Science.gov (United States)

    Johns, Shelley A; Von Ah, Diane; Brown, Linda F; Beck-Coon, Kathleen; Talib, Tasneem L; Alyea, Jennifer M; Monahan, Patrick O; Tong, Yan; Wilhelm, Laura; Giesler, R Brian

    2016-06-01

    Cancer-related cognitive impairment (CRCI) is a common, fatigue-related symptom that disrupts cancer survivors' quality of life. Few interventions for CRCI exist. As part of a randomized pilot study targeting cancer-related fatigue, the effects of mindfulness-based stress reduction (MBSR) on survivors' cognitive outcomes were investigated. Breast and colorectal cancer survivors (n = 71) with moderate-to-severe fatigue were randomized to MBSR (n = 35) or a fatigue education and support (ES; n = 36) condition. The Attentional Function Index (AFI) and the Stroop test were used to assess survivors' cognitive function at baseline (T1), after the 8-week intervention period (T2), and 6 months later (T3) using intent-to-treat analysis. Mediation analyses were performed to explore mechanisms of intervention effects on cognitive functioning. MBSR participants reported significantly greater improvement on the AFI total score compared to ES participants at T2 (d = 0.83, p = 0.001) and T3 (d = 0.55, p = 0.021). MBSR also significantly outperformed ES on most AFI subscales, although both groups improved over time. MBSR produced greater Stroop accuracy rates relative to ES at T2 (r = 0.340, p = 0.005) and T3 (r = 0.280, p = 0.030), with improved accuracy over time only for the MBSR group. There were no significant differences in Stroop reaction time between groups. Improvements in mindfulness mediated the effect of group (e.g., MBSR vs. ES) on AFI total score at T2 and T3. Additional randomized trials with more comprehensive cognitive measures are warranted to definitively assess the efficacy of MBSR for CRCI. This pilot study has important implications for all cancer survivors as it is the first published trial to show that MBSR offers robust and durable improvements in CRCI.

  7. Effects of tai chi qigong on psychosocial well-being among hidden elderly, using elderly neighborhood volunteer approach: a pilot randomized controlled trial.

    Science.gov (United States)

    Chan, Aileen Wk; Yu, Doris Sf; Choi, K C

    2017-01-01

    To test the feasibility and preliminary effectiveness of a tai chi qigong program with the assistance of elderly neighborhood volunteers in strengthening social networks and enhancing the psychosocial well-being of hidden elderly. "Hidden elderly" is a term used to describe older adults who are socially isolated and refuse social participation. This pilot randomized controlled trial recruited 48 older adults aged 60 or above who did not engage in any social activity. They were randomized into tai chi qigong (n=24) and standard care control (n=24) groups. The former group underwent a three-month program of two 60-minute sessions each week, with the socially active volunteers paired up with them during practice. Standard care included regular home visits by social wor