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Sample records for pilot randomized controlled

  1. THERAPY: A RANDOMIZED CONTROLLED PILOT STUDY

    Directory of Open Access Journals (Sweden)

    SOFIA VON HUMBOLDT

    2013-01-01

    Full Text Available El objetivo del estudio que se informa fue ex- plorar si una intervención individual de terapia centrada en la persona (TCP en personas adul- tas mayores puede promover su sentido de cohe- rencia, en comparación con un grupo control (lista de espera. Se plantea que los participantes asignados al azar a TCP informarían mejoras en SDC de pre y post-intervención en comparación con el grupo control. Un grupo de 87 participantes de 65 a 86 años (M = 72.4; DE = 5.15 fue evaluado con la Escala de Sentido de Coherencia (ESDC y el cuestio- nario sociodemográfico en tres momentos dife- rentes: al inicio del estudio (t1, post-tratamiento (t2 y a los 12 meses de seguimiento (t3. Los resultados indicaron que los participan- tes en TCP evidenciaron un aumento significa- tivo en cuanto a su SDC (16.7%, mientras que en el grupo control se encontró una disminu- ción significativa (-2.7%, entre el inicio del es- tudio y el momento de seguimiento. El tamaño del efecto en el grupo TCP fue alto (η2p = .776. En concreto, tanto en la post-intervención como en el momento del seguimiento, los participan- tes que se sometieron a TCP tenían un SDC sig- nificativamente mayor (M = 3.84, DE = .219 Se encontraron diferencias significativas entre el grupo de intervención y el grupo control en la post-intervención y en el seguimiento. Se concluye que los cambios en SDC fueron positivos y mantenidos, por lo tanto, los resul- tados sugieren que la TCP es favorable a la me- jora de SDC. Por otra parte, ya que la SDC se asocia con el bienestar relacionado con la salud de las poblaciones de mayor edad, hay que en- fatizar el desarrollo de SDC en la vejez.

  2. 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...... increase in balancing performance (DGI score: 21.3) after short-term playful training with the modular interactive tiles, whereas the control group remained with a score indicating balancing problems and risk of falling (DGI score: 16.6). The small pilot randomized controlled trial suggests...

  3. Working on asymmetry in Parkinson's disease: randomized, controlled pilot study.

    Science.gov (United States)

    Ricciardi, Lucia; Ricciardi, Diego; Lena, Francesco; Plotnik, Meir; Petracca, Martina; Barricella, Simona; Bentivoglio, Anna Rita; Modugno, Nicola; Bernabei, Roberto; Fasano, Alfonso

    2015-08-01

    Posture, gait and balance problems are very disabling symptoms in Parkinson's disease (PD). An increased stride-to-stri de variability, reduction of automaticity and asymmetry of lower limbs function characterize parkinsonian gait. These features predispose to freezing of gait (FOG), which often leads to falls. The aim of this study was to evaluate how the modulation of asymmetry through physiotherapy might improve gait and reduce FOG, thus preventing falls. Twenty-eight PD patients entered a double-blind pilot feasibility controlled study and were evaluated at baseline and after 3 months of a rehabilitative program (performed twice a week) by means of the motor part of the Unified Parkinson's Disease Rating Scale (UPDRS-III), Gait and Falls Questionnaire, Tinetti balance and gait scale, Short Physical Performance Battery (SPPB), European Quality of Life questionnaire. Patients were randomly assigned to three treatment arms: (1) worst side improvement; (2) best side improvement; (3) standard therapy. All study arms showed a significant improvement of the Tinetti and SPPB scores. BSI led to a greater improvement than ST in terms of UPDRS-III (p = 0.01); Tinetti total score (p = 0.05) and Tinetti gait subscore (p = 0.01). Our study confirms the efficacy of physical therapy in the treatment of PD and, more importantly, suggests that specific intervention tailored on individual feature (e.g., asymmetry of motor condition) might be even more effective than standard rehabilitative programs.

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

    Science.gov (United States)

    Van Sciver, Angela; Mahnken, Jonathan D.; Honea, Robyn A.; Brooks, William M.; Billinger, Sandra A.; Swerdlow, Russell H.; Burns, Jeffrey M.

    2017-01-01

    Background 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. Methods and findings 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. Conclusions 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. Trial registration ClinicalTrials.gov NCT01128361 PMID:28187125

  5. 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…

  6. Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

    2010-01-01

    Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7…

  7. Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

    2010-01-01

    Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7…

  8. Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

    Science.gov (United States)

    Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

    2015-01-01

    This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study.

  9. Training Significantly Improves Fetoscopy Performance: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Mietzsch, Stefan; Boettcher, Johannes; Yang, Sisi; Chantereau, Pierre; Romero, Philip; Bergholz, Robert; Reinshagen, Konrad; Boettcher, Michael

    2016-10-01

    Background Implementation of complex fetoscopic procedures that included intracorporeal suturing has been limited due to technical difficulties that might be surmounted with adequate training. Evaluating the impact of laparoscopic or fetoscopic training on fetoscopic performance was the aim of this study. Methods To evaluate fetoscopic performance after either laparoscopic or fetoscopic training, subjects were asked to perform four surgeon's square knots fetoscopically prior and post 2 hours of hands-on training. All subjects were medical students and novice in laparoscopic and fetoscopic interventions. Total time, knot stability (evaluated via tensiometer), suture accuracy, knot quality, and fetoscopic performance were assessed. Results Forty-six subjects were included in the study; after simple randomization, 24 were trained fetoscopically and 22 laparoscopically. Both groups had comparable baseline characteristics and improved after training significantly regarding all aspects assessed in this study. Subjects who trained fetoscopically were superior in terms of suturing and knot-tying performance. Conclusion Training significantly improves fetoscopic performance and may indeed be the keystone for future complex fetoscopic interventions. It seems advisable to train rather fetoscopically than laparoscopically resulting in higher suture and knot-tying quality. Georg Thieme Verlag KG Stuttgart · New York.

  10. Pilates in heart failure patients: a randomized controlled pilot trial.

    Science.gov (United States)

    Guimarães, Guilherme Veiga; Carvalho, Vitor Oliveira; Bocchi, Edimar Alcides; d'Avila, Veridiana Moraes

    2012-12-01

    Conventional cardiac rehabilitation program consist of 15 min of warm-up, 30 min of aerobic exercise and followed by 15 min calisthenics exercise. The Pilates method has been increasingly applied for its therapeutic benefits, however little scientific evidence supports or rebukes its use as a treatment in patients with heart failure (HF). Investigate the effects of Pilates on exercise capacity variables in HF. Sixteen pts with HF, left ventricular ejection fraction 27 ± 14%, NYHA class I-II were randomly assigned to conventional cardiac rehabilitation program (n = 8) or mat Pilates training (n = 8) for 16 weeks of 30 min of aerobic exercise followed by 20 min of the specific program. At 16 weeks, pts in the mat Pilates group and conventional group showed significantly increase on exercise time 11.9 ± 2.5 to 17.8 ± 4 and 11.7 ± 3.9 to 14.2 ± 4 min, respectively. However, only the Pilates group increased significantly the ventilation (from 56 ± 20 to 69 ± 17 L/min, P = 0.02), peak VO(2) (from 20.9 ± 6 to 24.8 ± 6 mL/kg/min, P = 0.01), and O(2) pulse (from 11.9 ± 2 to 13.8 ± 3 mL/bpm, P = 0.003). The Pilates group showed significantly increase in peak VO(2) when compared with conventional group (24.8 ± 6 vs. 18.3 ± 4, P = 0.02). The result suggests that the Pilates method may be a beneficial adjunctive treatment that enhances functional capacity in patients with HF who are already receiving standard medical therapy. © 2011 Blackwell Publishing Ltd.

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

    OpenAIRE

    Cristina Cavaiuolo; Anna Casani; Gaetano Di Manso; Luigi Orfeo

    2015-01-01

    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 ...

  12. 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 Netherland

  13. 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

  14. A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Preconditioning in Major Vascular Surgery.

    Science.gov (United States)

    Healy, D A; Boyle, E; McCartan, D; Bourke, M; Medani, M; Ferguson, J; Yagoub, H; Bashar, K; O'Donnell, M; Newell, J; Canning, C; McMonagle, M; Dowdall, J; Cross, S; O'Daly, S; Manning, B; Fulton, G; Kavanagh, E G; Burke, P; Grace, P A; Moloney, M Clarke; Walsh, S R

    2015-11-01

    A pilot randomized controlled trial that evaluated the effect of remote ischemic preconditioning (RIPC) on clinical outcomes following major vascular surgery was performed. Eligible patients were those scheduled to undergo open abdominal aortic aneurysm repair, endovascular aortic aneurysm repair, carotid endarterectomy, and lower limb revascularization procedures. Patients were randomized to RIPC or to control groups. The primary outcome was a composite clinical end point comprising any of cardiovascular death, myocardial infarction, new-onset arrhythmia, cardiac arrest, congestive cardiac failure, cerebrovascular accident, renal failure requiring renal replacement therapy, mesenteric ischemia, and urgent cardiac revascularization. Secondary outcomes were components of the primary outcome and myocardial injury as assessed by serum troponin values. The primary outcome occurred in 19 (19.2%) of 99 controls and 14 (14.1%) of 99 RIPC group patients (P = .446). There were no significant differences in secondary outcomes. Our trial generated data that will guide future trials. Further trials are urgently needed. © The Author(s) 2015.

  15. A randomized, controlled pilot trial of hormone therapy for menopausal insomnia.

    Science.gov (United States)

    Silva, Betania Huber; Martinez, Denis; Wender, Maria Celeste Osório

    2011-12-01

    Insomnia is a frequent climacteric symptom. This pilot, double-blind, randomized placebo-controlled trial compared estradiol associated with trimegestone or placebo in 12 women with perimenopausal insomnia. The Pittsburgh Sleep Quality Index (PSQI) was administered, and polysomnography was performed at baseline and after 28 days. Sleep efficiency and median score of the PSQI improved significantly in the hormone therapy group (HT) (p=0.041 and p=0.027, respectively) and not in placebo group. Perimenopausal insomnia improved after short-term HT.

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

    OpenAIRE

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

    2010-01-01

    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 (±4.8) points in the omega-3 group compared to 0.3 (±7.2) points in the placebo group (p = 0.40; effect size = 0.38). Correlations were found between decreases in f...

  17. 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.

  18. Assertive Community Treatment For People With Alcohol Dependence: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Gilburt, Helen; Burns, Tom; Copello, Alex; Crawford, Michael; Day, Ed; Deluca, Paolo; Godfrey, Christine; Parrott, Steve; Rose, Abigail; Sinclair, Julia; Coulton, Simon

    2017-01-01

    Abstract Aims A pilot randomized controlled trial (RCT) to assess the feasibility and potential efficacy of assertive community treatment (ACT) in adults with alcohol dependence. Methods Single blind, individually randomized, pilot RCT of 12 months of ACT plus treatment as usual (TAU) versus TAU alone in adults (age 18+ years) with alcohol dependence and a history of previous unsuccessful alcohol treatment attending specialist community alcohol treatment services. ACT aimed to actively engage participants for 12 months with assertive, regular, minimum weekly contact. ACT was combined with TAU. TAU comprised access to the full range of services provided by the community teams. Primary outcome is mean drinks per drinking day and percent days abstinent at 12 months follow up. Analysis of covariance was conducted using 80% confidence intervals, appropriate in the context of a pilot trial. Results A total of 94 participants were randomized, 45 in ACT and 49 in TAU. Follow-up was achieved with 98 and 88%, respectively at 12 months. Those in ACT had better treatment engagement, and were more often seen in their homes or local community than TAU participants. At 12 months the ACT group had more problems related to drinking and lower quality of life than TAU but no differences in drinking measures. The ACT group had a higher percentage of days abstinent but lower quality of life at 6 months. The ACT group had less unplanned healthcare use than TAU. Conclusions An trial of ACT was feasible to implement in an alcohol dependent treatment population. Trial registration ISRCTN22775534 PMID:27940571

  19. Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Shawn D Aaron

    Full Text Available BACKGROUND: Many patients with cystic fibrosis develop persistent airway infection/colonization with Aspergillus fumigatus, however the impact of A. fumigatus on clinical outcomes remains unclear. The objective of this study was to determine whether treatment directed against Aspergillus fumigatus improves pulmonary function and clinical outcomes in patients with cystic fibrosis (CF. METHODS: We performed a double-blind randomized placebo-controlled pilot clinical trial involving 35 patients with CF whose sputum cultures were chronically positive for A. fumigatus. Participants were centrally randomized to receive either oral itraconazole 5 mg/kg/d (N = 18 or placebo (N = 17 for 24 weeks. The primary outcome was the proportion of patients who experienced a respiratory exacerbation requiring intravenous antibiotics over the 24 week treatment period. Secondary outcomes included changes in FEV(1 and quality of life. RESULTS: Over the 24 week treatment period, 4 of 18 (22% patients randomized to itraconazole experienced a respiratory exacerbation requiring intravenous antibiotics, compared to 5 of 16 (31% placebo treated patients, P = 0.70. FEV(1 declined by 4.62% over 24 weeks in the patients randomized to itraconazole, compared to a 0.32% improvement in the placebo group (between group difference = -4.94%, 95% CI: -15.33 to 5.45, P = 0.34. Quality of life did not differ between the 2 treatment groups throughout the study. Therapeutic itraconazole blood levels were not achieved in 43% of patients randomized to itraconazole. CONCLUSION: We did not identify clinical benefit from itraconazole treatment for CF patients whose sputum was chronically colonized with A. fumigatus. Limitations of this pilot study were its small sample size, and failure to achieve therapeutic levels of itraconazole in many patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT00528190.

  20. 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.

  1. 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

  2. A pilot cluster randomized controlled trial of structured goal-setting following stroke.

    Science.gov (United States)

    Taylor, William J; Brown, Melanie; William, Levack; McPherson, Kathryn M; Reed, Kirk; Dean, Sarah G; Weatherall, Mark

    2012-04-01

    To determine the feasibility, the cluster design effect and the variance and minimal clinical importance difference in the primary outcome in a pilot study of a structured approach to goal-setting. A cluster randomized controlled trial. Inpatient rehabilitation facilities. People who were admitted to inpatient rehabilitation following stroke who had sufficient cognition to engage in structured goal-setting and complete the primary outcome measure. Structured goal elicitation using the Canadian Occupational Performance Measure. Quality of life at 12 weeks using the Schedule for Individualised Quality of Life (SEIQOL-DW), Functional Independence Measure, Short Form 36 and Patient Perception of Rehabilitation (measuring satisfaction with rehabilitation). Assessors were blinded to the intervention. Four rehabilitation services and 41 patients were randomized. We found high values of the intraclass correlation for the outcome measures (ranging from 0.03 to 0.40) and high variance of the SEIQOL-DW (SD 19.6) in relation to the minimally importance difference of 2.1, leading to impractically large sample size requirements for a cluster randomized design. A cluster randomized design is not a practical means of avoiding contamination effects in studies of inpatient rehabilitation goal-setting. Other techniques for coping with contamination effects are necessary.

  3. 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.

  4. 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.

  5. 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), Ptherapy alone, this study demonstrates the feasibility of VR training in early stroke. © The Author(s) 2014.

  6. Congruence Couple Therapy for Pathological Gambling: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Bonnie K; Awosoga, Olu

    2015-09-01

    A multi-site pilot randomized controlled trial of Congruence Couple Therapy (CCT) for problem gambling was conducted in Ontario and Alberta, Canada from 2009 to 2011. The purpose was to assess the feasibility of a full trial and to identify methodological modifications to enhance future trials. The sample (N = 30; 15 couples) consisted of 66% male gamblers and 34% female. Mean age of sample was 49.1 years. Baseline mean DSM-IV gambling score was 8.7/10. Retention of the treatment couples was 89% at 2-month follow-up. Retention of control couples was 78%. A randomized controlled design compared the status of couples in treatment condition to control condition. Treatment couples received 12-week CCT while control couples received three brief check-ins over 12 weeks. No significant difference was found between treatment and control group at baseline on all measures. At (1) week 12 post-treatment, and (2) week 20 follow-up, significant treatment effects were found for gambling symptoms (p = 0.008; p = 0.041), mental distress (p = 0.001; p = 0.035), and family systems function (p = 0.023; p = 0.054) between treatment and control group. Within group changes for treatment couples over time were significant for mental distress (p = 0.000), dyadic adjustment (p = 0.002), and family systems function (p = 0.000). On similar measures, control group showed non-significant improvement. Future methodological changes, advantages and disadvantages of multi-site partnerships with community treatment agencies are discussed. Of interest is that control participants showed unintended improvement. CCT as a treatment was favourably accepted by counselors, problem gamblers and their spouses. Positive outcome trends ranging from small to large effect size on key measures indicate that a full-scaled trial will require approximately 140 couples and is an investment worth pursuing.

  7. Mirror therapy for distal radial fractures: A pilot randomized controlled study.

    Science.gov (United States)

    Bayon-Calatayud, Manuel; Benavente-Valdepeñas, Ana Maria; Del Prado Vazquez-Muñoz, Maria

    2016-10-12

    To investigate the efficacy of mirror therapy in reducing pain and disability in patients with distal radial fractures. Pilot randomized controlled study. Twenty-two patients with closed distal radial fracture. Patients were randomly assigned to experimental (= 11) or control (= 11) groups. Researchers were blinded to group allocation. Both groups received conventional physiotherapy. In addition, the experimental group had 15 sessions of mirror therapy (a daily session, 30 min). The control group received the same amount of conventional occupational therapy. Assessment was made from baseline to post-treatment. Pain was measured on a visual analogue scale (VAS). Active wrist extension and Quick-DASH (Disabilities of Arm, Shoulder and Hand) were used to assess functional recovery. Pain, disability, and range of motion improved for both groups after intervention. No significant post-treatment differences were found between groups in Quick-DASH (= 0.409), active wrist extension (= 0.191) and VAS scores (= 0.807). There was no significant difference in active wrist extension between groups. Mirror therapy was not superior to conventional occupational therapy in reducing pain and disability.

  8. Diabetes telemonitoring reduces the risk of hypoglycaemia during Ramadan: a pilot randomized controlled study.

    Science.gov (United States)

    Lee, J Y; Lee, S W H; Nasir, N H; How, S; Tan, C S S; Wong, C P

    2015-12-01

    This pilot study evaluated the short-term benefits of a telemonitoring-supplemented focused diabetic education compared with education alone in participants with Type 2 diabetes who were fasting during Ramadan. In this pilot mixed-method study, we identified 37 participants and randomly allocated them to either a telemonitoring group (n = 18) or a group receiving Ramadan-focused pre-education only (usual care; n = 19). The telemonitoring group received goal-setting and personalized feedback. The telemonitoring group was less likely to experience hypoglycaemia than the usual care group (odds ratio: 0.1273; 95% confidence interval: 0.0267-0.6059). No significant differences were noted in glycaemic control at the end of study. Participants viewed telemedicine as a more convenient alternative although technological barriers remain a concern. The results of this study reinforce the need for monitoring as well as educational initiatives for Muslims with diabetes who fast during Ramadan. Telemonitoring offers an attractive option requiring further research. (Clinical Trial Registry No. NCT02189135). © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

  9. Fructus Mume Formula in the Treatment of Type 2 Diabetes Mellitus: A Randomized Controlled Pilot Trial

    Directory of Open Access Journals (Sweden)

    Xiang Tu

    2013-01-01

    Full Text Available Background. “Fructus Mume or Dark Plum” (pilule form has been used for many years in Traditional Chinese Medicine (TCM and may be a valid treatment for type 2 diabetes mellitus (T2DM. Aim. One aspect toward efficacy validation is the evaluation of the blood glucose-lowering effect of Fructus Mume (FM with T2DM patients in a randomized controlled trial (RCT. Methods. This pilot study uses a RCT procedure to assess efficacy of FM and Metformin. The trial was for 12 weeks, with 80 T2DM subjects. Both groups were standardized in their diet and exercise routine. Comparisons of several variables were analyzed. Results. No significant differences were found between groups in the fasting and postprandial glucose levels although both had significant decreases. The values of glycosylated hemoglobin were significantly reduced in both groups. For patients whose body mass index (BMI was 25, both FM and Metformin significantly reduce the BMI. Conclusions. In this pilot study, it was demonstrated that Fructus Mume formula may reduce the levels of blood glucose in patients with type 2 diabetes.

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

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    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.

  11. A pilot randomized controlled trial testing a minimal intervention to prepare breast cancer survivors for recovery

    Science.gov (United States)

    Sterba, Katherine Regan; Armeson, Kent; Franco, Regina; Harper, Jennifer; Patten, Rebecca; Kindall, Stacey; Bearden, James; Zapka, Jane

    2015-01-01

    Background Interventions addressing cancer survivors’ post-treatment concerns can be time-intensive and require specialized staff. Research is needed to identify feasible minimal intervention strategies to improve survivors’ quality of life after treatment. Objectives The objectives of this study were to evaluate the feasibility and short-term impact of a minimal clinic intervention on breast cancer survivors’ quality of life, unmet needs, distress and cancer worry. Interventions/Methods In this randomized controlled pilot trial, we enrolled breast cancer survivors at the end of treatment and administered baseline surveys. Participants were randomized to study arm (4-week video plus educational booklet intervention group and usual care group) and completed follow-up surveys at 10 weeks. Linear regression was used to examine intervention effects on quality of life outcomes controlling for clinical and demographic factors. Open-ended questions were used to examine program satisfaction and obtain feedback to improve the intervention. Results We enrolled 92 survivors in the trial. Participants rated the intervention highly and reported feeling less isolated and having more realistic expectations about their recovery after completing the program. Despite positive qualitative findings, no significant intervention effects were observed for quality of life, unmet needs, distress or cancer worry in unadjusted or adjusted analyses. Conclusions Future research is needed to define optimal intervention elements to prepare breast cancer survivors for the post-treatment period. Implications for Practice Effective survivorship interventions may require more intensive components such as clinical input and longer follow-up periods. PMID:24831043

  12. 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.

  13. Hypnosis as a treatment of chronic widespread pain in general practice: A randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Grøndahl Jan

    2008-09-01

    Full Text Available Abstract Background Hypnosis treatment in general practice is a rather new concept. This pilot study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP. Methods The study was designed as a randomized control group-controlled study. Sixteen patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions. The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy. A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering. Data were analyzed by means of T-tests. Results The treatment group improved from their symptoms, (change from 62.5 to 55.4, while the control group deteriorated, (change from 37.2 to 45.1, (p = 0,045. The 12 patients who completed the treatment showed a mean improvement from 51.5 to 41.6. (p = 0,046. One year later the corresponding result was 41.3, indicating a persisting improvement. Conclusion The study indicates that hypnosis treatment may have a positive effect on pain and quality of life for patients with chronic muscular pain. Considering the limited number of patients, more studies should be conducted to confirm the results. Trial Registration The study was registered in ClinicalTrials.gov and released 27.08.07 Reg nr NCT00521807 Approval Number: 05032001.

  14. Group Singing as a Therapy during Diabetes Training--A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Groener, J B; Neus, I; Kopf, S; Hartmann, M; Schanz, J; Kliemank, E; Wetekam, B; Kihm, L; Fleming, T; Herzog, W; Nawroth, P P

    2015-11-01

    Comprehensive diabetes treatment has been shown to reduce quality of life in diabetic patients. However, there is evidence to suggest that group singing can have positive effects on quality of life in various clinical settings. In this randomized controlled pilot study, the effect of singing as a therapy to reduce stress and improve quality of life was investigated in insulin-dependent diabetic patients, undergoing a lifestyle intervention program. Patients from the singing group felt less discontented following treatment. This effect, however, was lost after 3 months. No effect on serum cortisol and plasma adrenocorticotropic hormone (ACTH) levels could be seen when comparing the singing group with the control group, although reduced levels of ACTH and cortisol 3 days after treatment could be found and were still present after 3 months within the group of patients who undertook singing as a therapy. Singing led to an increase in bodyweight, which interestingly had no effect on glucose control or methylglyoxal levels. Therefore, singing during a lifestyle intervention program for insulin-dependent diabetic patients had a short lasting and weak effect on patients' mood without affecting glucose control, but no significant effect on stress related hormones. © Georg Thieme Verlag KG Stuttgart · New York.

  15. Effects of errorless skill learning in people with mild-to-moderate or severe dementia: A randomized controlled pilot study

    NARCIS (Netherlands)

    Kessels, R.P.C.; Olde Hensken, L.M.G.

    2009-01-01

    This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with m

  16. Effects of errorless skill learning in people with mild-to-moderate or severe dementia: a randomized controlled pilot study.

    NARCIS (Netherlands)

    Kessels, R.P.C.; Hensken, L.M.

    2009-01-01

    This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with m

  17. Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Chuan Zou

    Full Text Available To assess the feasibility and acceptability of a randomized controlled trial compared auricular acupressure (AA on specific acupoints with AA on non-specific acupoints for treating maintenance hemodialysis (MHD patients with insomnia.Sixty three (63 eligible subjects were randomly assigned into either AA group received AA on specific acupoints (n=32, or sham AA (SAA group received AA on points irrelevant to insomnia treatment (n=31 for eight weeks. All participants were followed up for 12 weeks after treatments. The primary outcome was clinical response at eight weeks after randomization, defined as a reduction of Pittsburgh Sleep Quality Index (PSQI global score by 3 points and more.Fifty-eight (58 participants completed the trial and five dropped out. Twenty participants in AA group (62.5% and ten in SAA group (32.3% responded to the eight-week interventions (χ2 = 5.77, P = 0.02. PSQI global score declined 3.75 ± 4.36 (95%CI -5.32, -2.18 and 2.26 ± 3.89 (95%CI -3.68, -0.83 in AA group and SAA group respectively. Three participants died during the follow-up period. No evidence supported their deaths were related to the AA intervention. No other adverse event was observed.Feasibility and logistics of patient recruitment, randomization procedure, blinding approach, interventions application and outcome assessment had been tested in this pilot trial. The preliminary data appeared to show a favorable result on AA treatment. A full-scale trial is warranted.Chinese Clinical Trial Registry ChiCTR-TRC-12002272.

  18. Interpersonal psychotherapy (IPT) for major depression following perinatal loss: a pilot randomized controlled trial.

    Science.gov (United States)

    Johnson, Jennifer E; Price, Ann Back; Kao, Jennifer Chienwen; Fernandes, Karen; Stout, Robert; Gobin, Robyn L; Zlotnick, Caron

    2016-10-01

    This randomized controlled pilot trial examined the feasibility, acceptability, and preliminary efficacy of an adapted interpersonal psychotherapy (IPT) for major depressive disorder (MDD) following perinatal loss (miscarriage, stillbirth, or early neonatal death). Fifty women who experienced a perinatal loss within the past 18 months, whose current depressive episode onset occurred during or after the loss, were randomized to the group IPT adapted for perinatal loss (the Group IPT for Major Depression Following Perinatal Loss manual developed for this study is available at no cost by contacting either of the first two authors) or to the group Coping with Depression (CWD), a cognitive behavioral treatment which did not focus on perinatal loss nor social support. Assessments occurred at baseline, treatment weeks 4 and 8, post-treatment, and 3 and 6 months after the end of treatment. IPT was feasible and acceptable in this population. Although some participants were initially hesitant to discuss their losses in a group (as occurred in IPT but not CWD), end of treatment satisfaction scores were significantly (p = 0.001) higher in IPT than in CWD. Confidence intervals around between-groups effect sizes favored IPT for reductions in depressive symptoms during treatment as well as for improvement in mode-specific targets (social support, grief symptoms) and recovery from a post-traumatic stress disorder over follow-up. This group IPT treatment adapted for MDD after perinatal loss is feasible, acceptable, and possibly efficacious.

  19. 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

  20. Mixed methods evaluation of a randomized control pilot trial targeting sugar-sweetened beverage behaviors.

    Science.gov (United States)

    Zoellner, Jamie; Cook, Emily; Chen, Yvonnes; You, Wen; Davy, Brenda; Estabrooks, Paul

    2013-02-01

    This Excessive sugar-sweetened beverage (SSB) consumption and low health literacy skills have emerged as two public health concerns in the United States (US); however, there is limited research on how to effectively address these issues among adults. As guided by health literacy concepts and the Theory of Planned Behavior (TPB), this randomized controlled pilot trial applied the RE-AIM framework and a mixed methods approach to examine a sugar-sweetened beverage (SSB) intervention (SipSmartER), as compared to a matched-contact control intervention targeting physical activity (MoveMore). Both 5-week interventions included two interactive group sessions and three support telephone calls. Executing a patient-centered developmental process, the primary aim of this paper was to evaluate patient feedback on intervention content and structure. The secondary aim was to understand the potential reach (i.e., proportion enrolled, representativeness) and effectiveness (i.e. health behaviors, theorized mediating variables, quality of life) of SipSmartER. Twenty-five participants were randomized to SipSmartER (n=14) or MoveMore (n=11). Participants' intervention feedback was positive, ranging from 4.2-5.0 on a 5-point scale. Qualitative assessments reavealed several opportunties to improve clarity of learning materials, enhance instructions and communication, and refine research protocols. Although SSB consumption decreased more among the SipSmartER participants (-256.9 ± 622.6 kcals), there were no significant group differences when compared to control participants (-199.7 ± 404.6 kcals). Across both groups, there were significant improvements for SSB attitudes, SSB behavioral intentions, and two media literacy constructs. The value of using a patient-centered approach in the developmental phases of this intervention was apparent, and pilot findings suggest decreased SSB may be achieved through targeted health literacy and TPB strategies. Future efforts are needed to examine

  1. How Should Surgical Residents Be Educated About Patient Safety: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Putnam, Luke R; Pham, Dean H; Ostovar-Kermani, Tiffany G; Alawadi, Zeinab M; Etchegaray, Jason M; Ottosen, Madelene J; Thomas, Eric J; Lesslie, Donald P; Kao, Lillian S; Lally, Kevin P; Tsao, KuoJen

    2016-01-01

    The Accreditation Council for Graduate Medical Education mandates patient safety education without specific curricular guidelines. We hypothesized that a dedicated, adjunctive resident safety workshop (SW) led by surgical faculty compared with an online curriculum (OC) for hospital personnel alone would improve residents' patient safety perceptions and behaviors. A pilot randomized controlled trial was performed from 2014 to 2015 within a university-based general surgery residency. Control and intervention groups, stratified by postgraduate year, participated in a hospital-based OC; the intervention group participated in an additional SW. Primary outcomes were perceptions of safety culture, teamwork, and speaking up as per the validated safety attitudes questionnaire (SAQ) at 6 and 12 months postintervention. Secondary outcomes included behavioral scores from blinded surgical faculty using the Oxford NonTechnical Skills scale. A total of 51 residents were enrolled (control = 25, intervention = 26). SAQ response rates were 100%, 100%, and 76% at baseline, 6 months, and 12 months, respectively. SAQ scores were similar at baseline between groups and did not change significantly at 6 or 12 months, independent of postgraduate year (PGY) level. Overall NonTechnical Skills scores were similar between groups, but senior residents (≥PGY 4) in the OC + SW group scored significantly higher in teamwork, decision-making, and situation awareness (all p < 0.05). An adjunctive, dedicated resident SW compared with a hospital-based OC alone did not significantly improve overall perceptions of patient safety. However, senior residents participating in the SW demonstrated improved patient safety perceptions and had significantly better intraoperative safety behaviors than senior residents in the OC group. Future curricular enhancements should include PGY-level specific education, iterative reviews, and increased faculty involvement. A larger randomized trial may be warranted

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

    Science.gov (United States)

    Sharma, Neena K; Robbins, Kristin; Wagner, Kathleen; Colgrove, Yvonne M

    2015-01-01

    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. This randomized controlled pilot study investigated the effectiveness of yoga intervention on physiological and health-related QOL measures in people with PD. 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. 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. 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.

  3. 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

  4. Randomized, placebo-controlled pilot trial of gabapentin during an outpatient, buprenorphine-assisted detoxification procedure.

    Science.gov (United States)

    Sanders, Nichole C; Mancino, Michael J; Gentry, W Brooks; Guise, J Benjamin; Bickel, Warren K; Thostenson, Jeff; Oliveto, Alison H

    2013-08-01

    This pilot study examined the efficacy of the N-type calcium channel blocker gabapentin to improve outcomes during a brief detoxification protocol with buprenorphine. Treatment-seeking opioid-dependent individuals were enrolled in a 5-week, double-blind, placebo-controlled trial examining the effects of gabapentin during a 10-day outpatient detoxification from buprenorphine. Participants were inducted onto buprenorphine sublingual tablets during Week 1, were randomized and inducted onto gabapentin or placebo during Week 2, underwent a 10-day buprenorphine taper during Weeks 3 and 4, and then were tapered off gabapentin/placebo during Week 5. Assessments included thrice-weekly opioid withdrawal scales, vitals, and urine drug screens. Twenty-four individuals (13 male; 17 Caucasian, 3 African American, 4 Latino; mean age 29.7 years) participated in the detoxification portion of the study (gabapentin, n = 11; placebo, n = 13). Baseline characteristics did not differ significantly between groups. Self-reported and observer-rated opioid withdrawal ratings were relatively low and did not differ between groups during the buprenorphine taper. Urine results showed a Drug × Time interaction, such that the probability of opioid-positive urines significantly decreased over time in the gabapentin versus placebo groups during Weeks 3 and 4 (OR = 0.73, p = .004). These results suggest that gabapentin reduces opioid use during a 10-day buprenorphine detoxification procedure.

  5. Reactivating addiction-related memories under propranolol to reduce craving: A pilot randomized controlled trial.

    Science.gov (United States)

    Lonergan, Michelle; Saumier, Daniel; Tremblay, Jacques; Kieffer, Brigitte; Brown, Thomas G; Brunet, Alain

    2016-03-01

    The reconsolidation blocker propranolol abolishes alcohol and drug-seeking behavior in rodents and attenuates conditioned emotional responses to drug-cues in humans in experimental settings. This suggests a role for its use in the treatment of substance dependence. In this translational pilot study, we explored the feasibility and efficacy of this procedure as an adjunct treatment for addiction. We hypothesized that guided addiction-related memory reactivation under propranolol would significantly attenuate tonic craving, a central element in relapse following addiction treatment. Seventeen treatment-seeking adults diagnosed with substance dependence were randomized to receive double-blind propranolol (n = 9) or placebo (n = 8) on six occasions prior to reading a personalized script detailing a drug-using experience. The primary outcome measure was self-reported craving intensity. After controlling for baseline craving scores, intent-to-treat analysis revealed a time by group interaction, F(1, 14) = 5.68, p = .03, η(2) = 0.29; craving was reduced in the propranolol-treated group (Cohen's d = 1.40, p craving among substance-dependent individuals. Considering the relapse rate among individuals treated for substance dependence, our study highlights the feasibility of, and need for, more comprehensive trials of this treatment approach. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Randomized Controlled Pilot Study Testing Use of Smartphone Technology for Obesity Treatment

    OpenAIRE

    Allen, Jerilyn K.; Janna Stephens; Dennison Himmelfarb, Cheryl R.; Stewart, Kerry J.; Sara Hauck

    2013-01-01

    Background. The established interventions for weight loss are resource intensive which can create barriers for full participation and ultimate translation. The major goal of this pilot study was to evaluate the feasibility, acceptability, and preliminary efficacy of theoretically based behavioral interventions delivered by smartphone technology. Methods. The study randomized 68 obese adults to receive one of four interventions for six months: (1) intensive counseling intervention, (2) intensi...

  7. 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.

  8. Mindfulness meditation for the treatment of chronic low back pain in older adults: A randomized controlled pilot study

    OpenAIRE

    Morone, Natalia E.; Greco, Carol M.; Weiner, Debra K.

    2007-01-01

    The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were ra...

  9. Randomized, Placebo-Controlled Pilot Trial of Gabapentin During an Outpatient, Buprenorphine-Assisted Detoxification Procedure1

    OpenAIRE

    Sanders, Nichole C.; Mancino, Michael J.; Gentry, W Brooks; Guise, J. Benjamin; Bickel, Warren K.; Thostenson, Jeff; Oliveto, Alison H.

    2013-01-01

    This pilot study examined the efficacy of the N-type calcium channel blocker gabapentin to improve outcomes during a brief detoxification protocol with buprenorphine. Treatment-seeking opioid-dependent individuals were enrolled in a 5-wk, double blind, placebo-controlled trial examining the effects of gabapentin during a 10-day outpatient detoxification from buprenorphine. Participants were inducted onto buprenorphine sublingual tablets during week 1, were randomized and inducted onto gabapen...

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

    OpenAIRE

    Costigan, S.A.; Eather, N.; Plotnikoff, R.C.; Taaffe, D R; E. Pollock; S.G. Kennedy; Lubans, D. R.

    2015-01-01

    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 o...

  11. 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...... aimed to: 1) develop an instrument to assess practitioner-patient interactions; 2) determine the equivalence of a chiropractor's verbal interactions and treatment delivery for participants allocated to active or sham chiropractic groups; and 3) describe the perceptions of a treatment-masked evaluator...

  12. 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......-report and verified by measurement of exhaled carbon monoxide (CO). Fewer patients than expected were recruited, which renders this report a pilot study. RESULTS: 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...... 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...

  13. 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

  14. 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.

  15. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

    Science.gov (United States)

    Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

    2016-10-01

    This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Randomized Controlled Pilot Study Testing Use of Smartphone Technology for Obesity Treatment

    Directory of Open Access Journals (Sweden)

    Jerilyn K. Allen

    2013-01-01

    Full Text Available Background. The established interventions for weight loss are resource intensive which can create barriers for full participation and ultimate translation. The major goal of this pilot study was to evaluate the feasibility, acceptability, and preliminary efficacy of theoretically based behavioral interventions delivered by smartphone technology. Methods. The study randomized 68 obese adults to receive one of four interventions for six months: (1 intensive counseling intervention, (2 intensive counseling plus smartphone intervention, (3 a less intensive counseling plus smartphone intervention, and (4 smartphone intervention only. The outcome measures of weight, BMI, waist circumference, and self-reported dietary intake and physical activity were assessed at baseline and six months. Results. The sample was 78% female and 49% African American, with an average age of 45 years, and average BMI of 34.3 kg/m2. There were trends for differences in weight loss among the four intervention groups. Participants in the intensive counseling plus self-monitoring smartphone group and less intensive counseling plus self-monitoring smartphone group tended to lose more weight than other groups (5.4 kg and 3.3 kg, resp.. Conclusions. The results of this pilot trial of a weight loss intervention provide preliminary support for using a smartphone application for self-monitoring as an adjunct to behavioral counseling.

  17. Erythromycin infusion prior to endoscopy for acute nonvariceal upper gastrointestinal bleeding: a pilot randomized controlled trial.

    Science.gov (United States)

    Na, Hee Kyong; Jung, Hwoon-Yong; Seo, Dong Woo; Lim, Hyun; Ahn, Ji Yong; Lee, Jeong Hoon; Kim, Do Hoon; Choi, Kee Don; Song, Ho June; Lee, Gin Hyug; Kim, Jin-Ho

    2017-03-28

    The aim of this study was to compare the effects of erythromycin infusion and gastric lavage in order to improve the quality of visualization during emergency upper endoscopy. We performed a prospective randomized pilot study. Patients presented with hematemesis or melena within 12 hours and were randomly assigned to the erythromycin group (intravenous infusion of erythromycin), gastric lavage group (nasogastric tube placement with gastric lavage), or erythromycin + gastric lavage group (both erythromycin infusion and gastric lavage). The primary outcome was satisfactory visualization. Secondary outcomes included identification of a bleeding source, the success rate of hemostasis, duration of endoscopy, complications related to erythromycin infusion or gastric lavage, number of transfused blood units, rebleeding rate, and bleeding-related mortality. A total of 43 patients were randomly assigned: 14 patients in the erythromycin group; 15 patients in the gastric lavage group; and 14 patients in the erythromycin + gastric lavage group. Overall satisfactory visualization was achieved in 81% of patients: 92.8% in the erythromycin group; 60.0% in the gastric lavage group; and 92.9% in the erythromycin + gastric lavage group, respectively (p = 0.055). The identification of a bleeding source was possible in all cases. The success rate of hemostasis, duration of endoscopy, and number of transfused blood units did not significantly differ between groups. There were no complications. Rebleeding occurred in three patients (7.0%). Bleeding-related mortality was not reported. Intravenous erythromycin infusion prior to emergency endoscopy for acute nonvariceal upper gastrointestinal bleeding seems to provide satisfactory endoscopic visualization.

  18. Feasibility and preliminary effectiveness of ice therapy in patients with an acute tear in the gastrocnemius muscle: A pilot randomized controlled trial

    NARCIS (Netherlands)

    Prins, J.C.M.; Stubbe, J.H.; Meeteren, N.L.U. van; Scheffers, F.A.; Dongen, M.C.J.M. van

    2011-01-01

    Objective: To investigate the feasibility of a randomized controlled trial and the preliminary effectiveness of ice therapy in the acute phase of a gastrocnemius tear for the quality of functional recovery. Design: A pilot version of an intended prospective randomized controlled clinical trial was

  19. Infant skin-cleansing product versus water: A pilot randomized, assessor-blinded controlled trial

    Directory of Open Access Journals (Sweden)

    Cork Michael J

    2011-05-01

    Full Text Available Abstract Background The vulnerability of newborn babies' skin creates the potential for a number of skin problems. Despite this, there remains a dearth of good quality evidence to inform practice. Published studies comparing water with a skin-cleansing product have not provided adequate data to inform an adequately powered trial. Nor have they distinguished between babies with and without a predisposition to atopic eczema. We conducted a pilot study as a prequel to designing an optimum trial to investigate whether bathing with a specific cleansing product is superior to bathing with water alone. The aims were to produce baseline data which would inform decisions for the main trial design (i.e. population, primary outcome, sample size calculation and to optimize the robustness of trial processes within the study setting. Methods 100 healthy, full term neonates aged Results Forty nine babies were randomized to cleansing product, 51 to water. The 95% confidence intervals (CI for the average TEWL measurement at each time point were: whole sample at baseline: 10.8 g/m2/h to 11.7 g/m2/h; CP group 4 weeks: 10.9 g/m2/h to 13.3 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h; W group 4 weeks:10.9 g/m2/h to 12.2 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h. Conclusion This pilot study provided valuable baseline data and important information on trial processes. The decision to proceed with a superiority trial, for example, was inconsistent with our data; therefore a non-inferiority trial is recommended. Trial registration ISRCTN72285670

  20. Acupuncture in Patients with a Vertebral Compression Fracture: A Protocol for a Randomized, Controlled, Pilot Clinical Trial

    Directory of Open Access Journals (Sweden)

    Hyun-jong Lee

    2015-03-01

    Full Text Available Objectives: A vertebral compression fracture (VCF is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total. The primary outcomes will be the pain intensity (visual analogue scale and PainVisionTM system. The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article

  1. 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.

    2016-01-01

    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). INTERVENTI

  2. 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.

    2016-01-01

    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). Interventi

  3. Short cognitive behavioral therapy and cognitive training for adults with ADHD - a randomized controlled pilot study.

    Science.gov (United States)

    Virta, Maarit; Salakari, Anita; Antila, Mervi; Chydenius, Esa; Partinen, Markku; Kaski, Markus; Vataja, Risto; Kalska, Hely; Iivanainen, Matti

    2010-09-07

    In clinical practice, a growing need exists for effective non-pharmacological treatments of adult attention-deficit/hyperactivity disorder (ADHD). Here, we present the results of a pilot study of 10 adults with ADHD participating in short-term individual cognitive- behavioral therapy (CBT), 9 adults participating in cognitive training (CT), and 10 controls. Self-report questionnaires, independent evaluations, and computerized neurocognitive testing were collected before and after the treatments to evaluate change. There were distinctive pre-hypotheses regarding the treatments, and therefore the statistical comparisons were conducted in pairs: CBT vs control, CT vs control, and CBT vs CT. In a combined ADHD symptom score based on self-reports, 6 participants in CBT, 2 in CT and 2 controls improved. Using independent evaluations, improvement was found in 7 of the CBT participants, 2 of CT participants and 3 controls. There was no treatment-related improvement in cognitive performance. Thus, in the CBT group, some encouraging improvement was seen, although not as clearly as in previous research with longer interventions. In the CT group, there was improvement in the trained tasks but no generalization of the improvement to the tasks of the neurocognitive testing, the self- report questionnaires, or the independent evaluations. These preliminary results warrant further studies with more participants and with more elaborate cognitive testing.

  4. TEACCH-based group social skills training for children with high-functioning autism: a pilot randomized controlled trial.

    Science.gov (United States)

    Ichikawa, Kayoko; Takahashi, Yoshimitsu; Ando, Masahiko; Anme, Tokie; Ishizaki, Tatsuro; Yamaguchi, Hinako; Nakayama, Takeo

    2013-10-01

    Although social skills training programs for people with high-functioning autism (HFA) are widely practiced, the standardization of curricula, the examination of clinical effectiveness, and the evaluation of the feasibility of future trials have yet to be done in Asian countries. To compensate for this problem, a Japanese pilot randomized controlled trial (RCT) of the Treatment and Education of Autistic and Related Communication Handicapped Children (TEACCH)-based group social skills training for children with HFA and their mothers was conducted. Eleven children with HFA, aged 5-6 years, and their mothers were randomly assigned to the TEACCH program (n=5) or a waiting-list control group (n=6). The program involved comprehensive group intervention and featured weekly 2-hour sessions, totaling 20 sessions over six months. The adaptive behaviors and social reciprocity of the children, parenting stress, and parent-child interactions were assessed using the Strengths and Difficulties Questionnaire (SDQ), Parenting Stress Index (PSI), Beck depression inventory-II (BDI-II), and Interaction Rating Scale (IRS). Through this pilot trial, the intervention and evaluation of the program has been shaped. There were no dropouts from the program and the mothers' satisfaction was high. The outcome measurements improved more in the program group than in the control group, with moderate effect sizes (SDQ, 0.71; PSI, 0.58; BDI-II, 0.40; and IRS, 0.69). This pilot trial also implied that this program is more beneficial for high IQ children and mothers with low stress than for those who are not. We have standardized the TEACCH program, confirmed the feasibility of a future trial, and successfully estimated the positive effect size. These findings will contribute to a larger trial in the future and to forthcoming systematic reviews with meta-analyses. UMIN000004560.

  5. 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.

  6. Interferential light therapy in the treatment of shoulder tendinopathies: a randomized controlled pilot study.

    Science.gov (United States)

    Montes-Molina, Ramón; Martínez-Rodríguez, Maria Elena; Rodríguez, Ana Belén Romojaro; Martínez-Ruiz, Fidel; Prieto-Baquero, Almudena

    2012-12-01

    To test the safety of the diode light therapy and evaluate the advantages of the interferential effect of two light probes versus a conventional light probe in the relief of shoulder pain and disability caused by shoulder tendinopathies. Randomized single-blind pilot study. Clinical electrotherapy unit. A total of 30 patients with shoulder pain from tendinopathies. The patients were randomly assigned into two groups. Group 1 (n = 15) received interferential light therapy generated by two independent and identical cluster probes composed of light emitting and superluminescent diodes. Similarly, two applicators were applied in group 2 (n = 15), but only one was active, as in conventional clinical therapy. Each multi-diode cluster probe was composed of seven light-emitting diodes at 600 nm and 12 superluminescent diodes at 950 nm. Pain was evaluated by visual analogue scale (VAS) at day, at night and during several shoulder movements. Shoulder functional status was measured by means of the University California Los Angeles scale (UCLA). Comparison between both treatments using the Mann-Whitney U-test showed better results for the interferential treatment. There were significant differences in pain reduction during abduction (P < 0.05) and external rotation (P < 0.05), with pain reductions in abduction and external rotation of 1.5 (± 1.3) and 0.5 (± 1.0) respectively. Interferential light therapy was safe and effective regarding the shoulder pain reduction during abduction and external rotation movements. The estimated size sample needed for future two-treatment parallel-design studies will require about 60 patients.

  7. A Pilot Randomized Controlled Trial Using Prophylactic Dressings to Minimize Sacral Pressure Injuries in High-Risk Hospitalized Patients.

    Science.gov (United States)

    Walker, Rachel; Huxley, Leisa; Juttner, Melanie; Burmeister, Elizabeth; Scott, Justin; Aitken, Leanne M

    2016-02-12

    This pilot randomized controlled trial examined the effect of prophylactic dressings to minimize sacral pressure injuries (PIs) in high-risk hospitalized patients and assessed feasibility criteria to inform a larger study. Eighty patients were recruited at admission points (the emergency department and surgical care unit) or directly from participating wards in the general medical-surgical setting following the assessment of high risk of sacral PI. Participants were randomized into either the routine care or routine care and silicone foam border dressing group. Outcome assessment comprised digital photographs of each participant's sacrum every 72 hr for evaluation by a blind-to-intervention assessor. Sixty-seven participants had at least one sacral photograph taken and assessed by a blind-to-intervention assessor. Three participants were assessed as having a Stage I PI. Although the use of photography was effective, feasibility criteria identified challenges related to bias, blinding, weight assessment, preparation of nursing staff, and sample size estimation.

  8. Effects of far-infrared irradiation on myofascial neck pain: a randomized, double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Lai, Chien-Hung; Leung, Ting-Kai; Peng, Chih-Wei; Chang, Kwang-Hwa; Lai, Ming-Jun; Lai, Wen-Fu; Chen, Shih-Ching

    2014-02-01

    The objective of this study was to determine the relative efficacy of irradiation using a device containing a far-infrared emitting ceramic powder (cFIR) for the management of chronic myofascial neck pain compared with a control treatment. This was a randomized, double-blind, placebo-controlled pilot study. The study comprised 48 patients with chronic, myofascial neck pain. Patients were randomly assigned to the experimental group or the control (sham-treatment) group. The patients in the experimental group wore a cFIR neck device for 1 week, and the control group wore an inert neck device for 1 week. Quantitative measurements based on a visual analogue scale (VAS) scoring of pain, a sleep quality assessment, pressure-pain threshold (PPT) testing, muscle tone and compliance analysis, and skin temperature analysis were obtained. Both the experimental and control groups demonstrated significant improvement in pain scores. However, no statistically significant difference in the pain scores was observed between the experimental and control groups. Significant decreases in muscle stiffness in the upper regions of the trapezius muscles were reported in the experimental group after 1 week of treatment. Short-term treatment using the cFIR neck device partly reduced muscle stiffness. Although the differences in the VAS and PPT scores for the experimental and control groups were not statistically significant, the improvement in muscle stiffness in the experimental group warrants further investigation of the long-term effects of cFIR treatment for pain management.

  9. 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

  10. Metformin in Amnestic Mild Cognitive Impairment: Results of a Pilot Randomized Placebo Controlled Clinical Trial.

    Science.gov (United States)

    Luchsinger, José A; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Davangere P; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (aMCI) with the goal of collecting preliminary data on feasibility, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with aMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake in the posterior cingulate-precuneus in brain fluorodeoxyglucose positron emission tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty percent of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7±8.5 versus 5.3±8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD.

  11. A natural mineral supplement provides relief from knee osteoarthritis symptoms: a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Kuskowski Michael A

    2008-02-01

    Full Text Available Abstract Background This small, pilot study evaluated the impact of treatment with a natural multi-mineral supplement from seaweed (Aquamin on walking distance, pain and joint mobility in subjects with moderate to severe osteoarthritis of the knee. Methods Subjects (n = 70 with moderate to severe osteoarthritis of the knee were randomized to four double-blinded treatments for 12 weeks: (a Glucosamine sulfate (1500 mg/d; (b Aquamin (2400 mg/d; (c Combined treatment composed of Glucosamine sulfate (1500 mg/d plus Aquamin (2400 mg/d and (d Placebo. Primary outcome measures were WOMAC scores and 6 Minute Walking Distances (6 MWD. Laboratory based blood tests were used as safety measures. Results Fifty subjects completed the study and analysis of the data showed significant differences between the groups for changes in WOMAC pain scores over time (p = 0.009 ANCOVA; however, these data must be reviewed with caution since significant differences were found between the groups at baseline for WOMAC pain and stiffness scores (p = 0.0039 and p = 0.013, respectively, ANOVA. Only the Aquamin and Glucosamine groups demonstrated significant improvements in symptoms over the course of the study. The combination group (like the placebo group did not show any significant improvements in OA symptoms in this trial. Within group analysis demonstrated significant improvements over time on treatment for the WOMAC pain, activity, composite and stiffness (Aquamin only scores as well as the 6 minute walking distances for subjects in the Aquamin and Glucosamine treatment groups. The Aquamin and Glucosamine groups walked 101 feet (+7% and 56 feet (+3.5% extra respectively. All treatments were well tolerated and the adverse events profiles were not significantly different between the groups. Conclusion This small preliminary study suggested that a multi mineral supplement (Aquamin may reduce the pain and stiffness of osteoarthritis of the knee over 12 weeks of treatment and

  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. Myoelectrically driven functional electrical stimulation may increase motor recovery of upper limb in poststroke subjects: A randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Rune Thorsen, PhD, MScee

    2013-08-01

    Full Text Available The objective of this randomized controlled pilot study was to assess the feasibility and effectiveness of myoelectrically controlled functional electrical stimulation (MeCFES for rehabilitation of the upper limb in poststroke subjects. Eleven poststroke hemiparetic subjects with residual proximal control of the arm, but impaired volitional opening of the paretic hand, were enrolled and randomized into a treated and a control group. Subjects received 3 to 5 treatment sessions per week until totaling 25 sessions. In the experimental group, myoelectric activity from wrist and finger extensors was used to control stimulation of the same muscles. Patients treated with MeCFES (n = 5 had a significant (p = 0.04 and clinically important improvement in Action Research Arm Test score (median change 9 points, confirmed by an Individually Prioritized Problem Assessment self-evaluation score. This improvement was maintained at follow-up. The control group did not show a significant improvement (p = 0.13. The reduced sample size of participants, together with confounding factors such as spontaneous recovery, calls for larger studies to draw definite conclusions. However, the large and persistent treatment effect seen in our results indicate that MeCFES could play an important role as a clinical tool for stroke rehabilitation.

  14. A pilot randomized control trial: testing a transitional care model for acute psychiatric conditions.

    Science.gov (United States)

    Hanrahan, Nancy P; Solomon, Phyllis; Hurford, Matthew O

    2014-01-01

    People with multiple and persistent mental and physical health problems have high rates of transition failures when transferring from a hospital level of care to home. The transitional care model (TCM) is evidence-based and demonstrated to improve posthospital outcomes for elderly with physical health conditions, but it has not been studied in the population with serious mental illness. Using a randomized controlled design, 40 inpatients from two general hospital psychiatric units were recruited and randomly assigned to an intervention group (n = 20) that received the TCM intervention that was delivered by a psychiatric nurse practitioner for 90 days posthospitalization, or a control group (n = 20) that received usual care. Outcomes were as follows: service utilization, health-related quality of life, and continuity of care. The intervention group showed higher medical and psychiatric rehospitalization than the control group (p = .054). Emergency room use was lower for intervention group but not statistically significant. Continuity of care with primary care appointments were significantly higher for the intervention group (p = .023). The intervention group's general health improved but was not statistically significant compared with controls. A transitional care intervention is recommended; however, the model needs to be modified from a single nurse to a multidisciplinary team with expertise from a psychiatric nurse practitioner, a social worker, and a peer support specialist. A team approach can best manage the complex physical/mental health conditions and complicated social needs of the population with serious mental illness. © The Author(s) 2014.

  15. Pentoxifylline Treatment in Severe Acute Pancreatitis: A Pilot, Double-Blind, Placebo-Controlled, Randomized Trial.

    Science.gov (United States)

    Vege, Santhi Swaroop; Atwal, Tegpal; Bi, Yan; Chari, Suresh T; Clemens, Magdalen A; Enders, Felicity T

    2015-08-01

    In acute pancreatitis (AP) tumor necrosis factor-α mediates multi-organ failure; in animal models its blockade with pentoxifylline ameliorates AP. The efficacy of pentoxifylline in predicted severe AP (pSAP) was tested in a double-blinded, randomized, control trial. Twenty-eight patients with pSAP were randomized within 72 hours of diagnosis to pentoxifylline or placebo. Baseline characteristics were similar in both groups. The pentoxifylline group had fewer intensive care unit admissions and shorter intensive care unit and hospital stays of longer than 4 days (all P < .05). Patients receiving pentoxifylline had no adverse effects. Pentoxifylline within 72 hours of pSAP is safe; a larger study of pentoxifylline in AP is needed to confirm efficacy. ClinicalTrials.gov number: NCT01292005. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

  16. 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

    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 condition

  17. Randomized pilot study to disseminate caries-control services in dentist offices

    Directory of Open Access Journals (Sweden)

    Reynolds Debra

    2006-05-01

    Full Text Available Abstract Background To determine whether education and financial incentives increased dentists' delivery of fluoride varnish and sealants to at risk children covered by capitation dental insurance in Washington state (U.S.. Methods In 1999, 53 dental offices in Washington Dental Service's capitation dental plan were invited to participate in the study, and consenting offices were randomized to intervention (n = 9 and control (n = 10 groups. Offices recruited 689 capitation children aged 6–14 and at risk for caries, who were followed for 2 years. Intervention offices received provider education and fee-for-service reimbursement for delivering fluoride varnish and sealants. Insurance records were used to calculate office service rates for fluoride, sealants, and restorations. Parents completed mail surveys after follow-up to measure their children's dental utilization, dental satisfaction, dental fear and oral health status. Regression models estimated differences in service rates between intervention and control offices, and compared survey measures between groups. Results Nineteen offices (34% consented to participate in the study. Fluoride and sealant rates were greater in the intervention offices than the control offices, but the differences were not statistically significant. Restoration rates were lower in the intervention offices than the control offices. Parents in the intervention group reported their children had less dental fear than control group parents. Conclusion Due to low dentist participation the study lacked power to detect an intervention effect on dentists' delivery of caries-control services. The intervention may have reduced children's dental fear.

  18. 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.

  19. Cognitive remediation for depressed inpatients: Results of a pilot randomized controlled trial.

    Science.gov (United States)

    Trapp, Wolfgang; Engel, Sinha; Hajak, Goeran; Lautenbacher, Stefan; Gallhofer, Bernd

    2016-01-01

    Neurocognitive deficits that persist despite antidepressive treatment and affect social and vocational functioning are well documented in major depressive disorder. Cognitive training approaches have proven successful in ameliorating these deficits in other psychiatric groups, but very few studies have been conducted in unipolar depressive patients by now. In contrast to previous studies solely including outpatients, effects of a cognitive remediation intervention on neurocognitive functioning of depressed inpatients were assessed by the present study. A randomized controlled trial was carried out with 46 depressed inpatients of a psychiatric hospital. Patients were randomly assigned to either a control group that received standard drug and non-drug (cognitive behavioural, occupational, sports, relaxation and music therapy) antidepressive treatment or a remediation group that additionally received 12 sessions of cognitive training for a total of 4 weeks (three sessions per week). An intent to treat analysis and a last observation carried forward method was used for data analyses. Patients of the remediation group demonstrated greater improvements in neurocognitive measures of verbal and nonverbal memory, working memory and executive function (Cohen's d effect sizes between .52 and .98). These results provide preliminary evidence that cognitive remediation interventions can be successfully applied also in psychiatric inpatients experiencing an acute depressive episode. © The Royal Australian and New Zealand College of Psychiatrists 2015.

  20. Ketamine Patient Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active Comparator Controlled, Blinded, Pilot Trial

    Science.gov (United States)

    2017-01-11

    AFRL-SA-WP-SR-2017-0003 Ketamine Patient-Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active Comparator...June 2013 – December 2016 4. TITLE AND SUBTITLE Ketamine Patient-Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active...in trauma patients while reducing opioid consumption in the traumatically injured patient. The objective of this study was to compare differences in

  1. 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.

  2. Exploring the effect of companion robots on emotional expression in older adults with dementia: a pilot randomized controlled trial.

    Science.gov (United States)

    Moyle, Wendy; Cooke, Marie; Beattie, Elizabeth; Jones, Cindy; Klein, Barbara; Cook, Glenda; Gray, Chrystal

    2013-05-01

    This pilot study aimed to compare the effect of companion robots (PARO) to participation in an interactive reading group on emotions in people living with moderate to severe dementia in a residential care setting. A randomized crossover design, with PARO and reading control groups, was used. Eighteen residents with mid- to late-stage dementia from one aged care facility in Queensland, Australia, were recruited. Participants were assessed three times using the Quality of Life in Alzheimer's Disease, Rating Anxiety in Dementia, Apathy Evaluation, Geriatric Depression, and Revised Algase Wandering Scales. PARO had a moderate to large positive influence on participants' quality of life compared to the reading group. The PARO intervention group had higher pleasure scores when compared to the reading group. Findings suggest PARO may be useful as a treatment option for people with dementia; however, the need for a larger trial was identified.

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

    Science.gov (United States)

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

    2017-01-01

    Background 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. Methods 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. Results 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

  4. Problem-solving therapy for adults with diabetic retinopathy and diabetes-specific distress: a pilot randomized controlled trial

    Science.gov (United States)

    Rees, Gwyneth; O'Hare, Fleur; Saeed, Marian; Sudholz, Bronwyn; Sturrock, Bonnie A; Xie, Jing; Speight, Jane; Lamoureux, Ecosse L

    2017-01-01

    Objective To provide preliminary evidence for the impact of problem-solving therapy for diabetes (PST-D) in adults with diabetic retinopathy (DR) and diabetes distress. Research design and methods In a pilot randomized controlled trial, 40 participants with DR and diabetes distress were allocated to the PST-D or control groups. Diabetes distress (DDS), depressive symptoms (PHQ-9), self-care activities (SDSCA), and HbA1c were assessed at baseline, and 3 and 6-month follow-ups. Results At the 6-month follow-up, the PST-D group showed significant improvements relative to the control group, in ‘regimen-related distress’ (PST-D: −1.3±1.4; control: −0.4±1.1), depressive symptoms (PST-D: −4.3±6.1; control: −0.3±4.6), and HbA1c (PST-D: −1.2%±1.01; control: 0.2%±1.2%) (all ppsychological outcomes and glycemic control. A fully powered study is required to confirm these findings and examine mechanisms of change in HbA1c. Trial registration number ACTRN12616001010482; results. PMID:28243448

  5. 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.

  6. Pilot randomized controlled trial of individual meaning-centered psychotherapy for patients with advanced cancer.

    Science.gov (United States)

    Breitbart, William; Poppito, Shannon; Rosenfeld, Barry; Vickers, Andrew J; Li, Yuelin; Abbey, Jennifer; Olden, Megan; Pessin, Hayley; Lichtenthal, Wendy; Sjoberg, Daniel; Cassileth, Barrie R

    2012-04-20

    Spiritual well-being and sense of meaning are important concerns for clinicians who care for patients with cancer. We developed Individual Meaning-Centered Psychotherapy (IMCP) to address the need for brief interventions targeting spiritual well-being and meaning for patients with advanced cancer. Patients with stage III or IV cancer (N = 120) were randomly assigned to seven sessions of either IMCP or therapeutic massage (TM). Patients were assessed before and after completing the intervention and 2 months postintervention. Primary outcome measures assessed spiritual well-being and quality of life; secondary outcomes included anxiety, depression, hopelessness, symptom burden, and symptom-related distress. Of the 120 participants randomly assigned, 78 (65%) completed the post-treatment assessment and 67 (56%) completed the 2-month follow-up. At the post-treatment assessment, IMCP participants demonstrated significantly greater improvement than the control condition for the primary outcomes of spiritual well-being (b = 0.39; P IMCP patients were also observed for the secondary outcomes of symptom burden (b = -6.56; P IMCP group were no longer significantly greater than those observed for the TM group. IMCP has clear short-term benefits for spiritual suffering and quality of life in patients with advanced cancer. Clinicians working with patients who have advanced cancer should consider IMCP as an approach to enhance quality of life and spiritual well-being.

  7. PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids.

    Science.gov (United States)

    Jacoby, Vanessa L; Kohi, Maureen P; Poder, Liina; Jacoby, Alison; Lager, Jeanette; Schembri, Michael; Rieke, Viola; Grady, Deborah; Vittinghoff, Eric; Coakley, Fergus V

    2016-03-01

    To evaluate the feasibility of a full-scale placebo-controlled trial of magnetic resonance-guided focused ultrasound for fibroids (MRgFUS) and obtain estimates of safety and efficacy. Pilot, randomized, placebo-controlled trial. University medical center. Premenopausal women with symptomatic uterine fibroids. Participants randomized in a 2:1 ratio to receive MRgFUS or placebo procedure. change in fibroid symptoms from baseline to 4 and 12 weeks after treatment assessed by the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QOL); secondary outcome: incidence of surgery or procedures for recurrent symptoms at 12 and 24 months. Twenty women with a mean age of 44 years (±standard deviation 5.4 years) were enrolled, and 13 were randomly assigned to MRgFUS and 7 to placebo. Four weeks after treatment, all participants reported improvement in the UFS-QOL: a mean of 10 points in the MRgFUS group and 9 points in the placebo group (for difference in change between groups). By 12 weeks, the MRgFUS group had improved more than the placebo group (mean 31 points and 13 points, respectively). The mean fibroid volume decreased 18% in the MRgFUS group with no decrease in the placebo group at 12 weeks. Two years after MRgFUS, 4 of 12 women who had a follow-up evaluation (30%) had undergone another fibroid surgery or procedure. Women with fibroids were willing to enroll in a randomized, placebo-controlled trial of MRgFUS. A placebo effect may explain some of the improvement in fibroid-related symptoms observed in the first 12 weeks after MRgFUS. NCT01377519. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  8. 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.

  9. 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

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

    Science.gov (United States)

    Hubert, Dominique; Soubeiran, Lucile; Gourmelon, Fabrice; Grenet, Dominique; Serreau, Raphaël; Perrodeau, Elodie; Zegarra-Parodi, Rafael; Boutron, Isabelle

    2014-01-01

    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.

  11. 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.

  12. Interview Skills for Adults with Autism Spectrum Disorder: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Morgan, Lindee; Leatzow, Allison; Clark, Sarah; Siller, Michael

    2014-01-01

    The purpose of this pilot study was to evaluate the efficacy of the interview skills curriculum (ISC), a manualized 12-week group-delivered intervention for young adults with autism spectrum disorder (ASD). This intervention aims to increase social-pragmatic skills essential to a successful job interview. Twenty-eight adults (18-36 years) were…

  13. Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rickard Kristen

    2011-03-01

    Full Text Available Abstract Background Although the connection between ascending infection and preterm birth is undisputed, research focused on finding effective treatments has been disappointing. However evidence that eradication of Candida in pregnancy may reduce the risk of preterm birth is emerging. We conducted a pilot study to assess the feasibility of conducting a large randomized controlled trial to determine whether treatment of asymptomatic candidiasis in early pregnancy reduces the incidence of preterm birth. Methods We used a prospective, randomized, open-label, blinded-endpoint (PROBE study design. Pregnant women presenting at Candida were randomized to 6-days of clotrimazole vaginal pessaries (100mg or usual care (screening result is not revealed, no treatment. The primary outcomes were the rate of asymptomatic vaginal candidiasis, participation and follow-up. The proposed primary trial outcome of spontaneous preterm birth Results Of 779 women approached, 500 (64% participated in candidiasis screening, and 98 (19.6% had asymptomatic vaginal candidiasis and were randomized to clotrimazole or usual care. Women were not inconvenienced by participation in the study, laboratory testing and medication dispensing were problem-free, and the follow-up rate was 99%. There was a tendency towards a reduction in spontaneous preterm birth among women with asymptomatic candidiasis who were treated with clotrimazole RR = 0.33, 95%CI 0.04-3.03. Conclusions A large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12609001052224

  14. 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

  15. 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.

  16. Effects of interactive visual feedback training on post-stroke pusher syndrome: a pilot randomized controlled study.

    Science.gov (United States)

    Yang, Yea-Ru; Chen, Yi-Hua; Chang, Heng-Chih; Chan, Rai-Chi; Wei, Shun-Hwa; Wang, Ray-Yau

    2015-10-01

    We investigated the effects of a computer-generated interactive visual feedback training program on the recovery from pusher syndrome in stroke patients. Assessor-blinded, pilot randomized controlled study. A total of 12 stroke patients with pusher syndrome were randomly assigned to either the experimental group (N = 7, computer-generated interactive visual feedback training) or control group (N = 5, mirror visual feedback training). The scale for contraversive pushing for severity of pusher syndrome, the Berg Balance Scale for balance performance, and the Fugl-Meyer assessment scale for motor control were the outcome measures. Patients were assessed pre- and posttraining. A comparison of pre- and posttraining assessment results revealed that both training programs led to the following significant changes: decreased severity of pusher syndrome scores (decreases of 4.0 ± 1.1 and 1.4 ± 1.0 in the experimental and control groups, respectively); improved balance scores (increases of 14.7 ± 4.3 and 7.2 ± 1.6 in the experimental and control groups, respectively); and higher scores for lower extremity motor control (increases of 8.4 ± 2.2 and 5.6 ± 3.3 in the experimental and control groups, respectively). Furthermore, the computer-generated interactive visual feedback training program produced significantly better outcomes in the improvement of pusher syndrome (p visual feedback training program. Although both training programs were beneficial, the computer-generated interactive visual feedback training program more effectively aided recovery from pusher syndrome compared with mirror visual feedback training. © The Author(s) 2014.

  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.

  18. 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.

  19. 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

  20. Smoking cessation among diabetes patients: results of a pilot randomized controlled trial in Kerala, India

    Directory of Open Access Journals (Sweden)

    Thankappan KR

    2013-01-01

    Full Text Available Abstract Background India has the second largest diabetic population (61 million and tobacco users (275 million in the world. Data on smoking cessation among diabetic patients are limited in low and middle income countries. The objective of the study was to document the effectiveness of diabetic specific smoking cessation counseling by a non-doctor health professional in addition to a cessation advice to quit, delivered by doctors. Methods In our parallel-group randomized controlled trial, we selected 224 adult diabetes patients aged 18 years or older who smoked in the last month, from two diabetes clinics in South India. Using a computer generated random sequence with block size four; the patients were randomized equally into intervention-1 and intervention-2 groups. Patients in both groups were asked and advised to quit smoking by a doctor and distributed diabetes specific education materials. The intervention-2 group received an additional diabetes specific 30 minutes counseling session using the 5As (Ask, Advise, Assess, Assist and Arrange, and 5 Rs (Relevance, Risks, Rewards, Roadblocks and Repetition from a non-doctor health professional. Follow up data were available for 87.5% of patients at six months. The Quit Tobacco International Project is supported by a grant from the Fogarty International Centre of the US National Institutes of Health (RO1TW005969-01. The primary outcomes were quit rate (seven day smoking abstinence and harm reduction (reduction of the number of cigarettes / bidis smoked per day > 50% of baseline use at six months. Results In the intention to treat analysis, the odds for quitting was 8.4 [95% confidence interval (CI: 4.1-17.1] for intervention-2 group compared to intervention-1 group. Even among high level smokers the odds of quitting was similar. The odds of harm reduction was 1.9 (CI: 0.8-4.1 for intervention-2 group compared to intervention-1 group. Conclusions The value addition of culturally sensitive diabetic

  1. 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

  2. Hypertonic fluid administration in patients with septic shock: a prospective randomized controlled pilot study.

    Science.gov (United States)

    van Haren, Frank M P; Sleigh, James; Boerma, E Christiaan; La Pine, Mary; Bahr, Mohamed; Pickkers, Peter; van der Hoeven, Johannes G

    2012-03-01

    We assessed the short-term effects of hypertonic fluid versus isotonic fluid administration in patients with septic shock. This was a double-blind, prospective randomized controlled trial in a 15-bed intensive care unit. Twenty-four patients with septic shock were randomized to receive 250 mL 7.2% NaCl/6% hydroxyethyl starch (HT group) or 500 mL 6% hydroxyethyl starch (IT group). Hemodynamic measurements included mean arterial blood pressure (MAP), central venous pressure, stroke volume index, stroke volume variation, intrathoracic blood volume index, gastric tonometry, and sublingual microcirculatory flow as assessed by sidestream dark field imaging. Systolic tissue Doppler imaging velocities of the medial mitral annulus were measured using echocardiography to assess left ventricular contractility. Log transformation of the ratio MAP divided by the norepinephrine infusion rate (log MAP/NE) quantified the combined effect on both parameters. Compared with the IT group, hypertonic solution treatment resulted in an improvement in log MAP/NE (P = 0.008), as well as an increase in systolic tissue Doppler imaging velocities (P = 0.03) and stroke volume index (P = 0.017). No differences between the groups were found for preload parameters (central venous pressure, stroke volume variation, intrathoracic blood volume index) or for afterload parameters (systemic vascular resistance index, MAP). Hypertonic solution treatment decreased the need for ongoing fluid resuscitation (P = 0.046). No differences between groups were observed regarding tonometry or the sublingual microvascular variables. In patients with septic shock, hypertonic fluid administration did not promote gastrointestinal mucosal perfusion or sublingual microcirculatory blood flow in comparison to isotonic fluid. Independent of changes in preload or afterload, hypertonic fluid administration improved the cardiac contractility and vascular tone compared with isotonic fluid. The need for ongoing fluid

  3. [Postoperative transcutaneous electrical nerve stimulation (TENS) in shoulder surgery (randomized, double blind, placebo controlled pilot trial)].

    Science.gov (United States)

    Likar, R; Molnar, M; Pipam, W; Koppert, W; Quantschnigg, B; Disselhoff, B; Sittl, R

    2001-06-01

    The aim of this study was to determine whether 3 days of TENS therapy postoperatively after shoulder operations would result in better pain relief and/or reduced analgesic intake when compared to placebo. The study was carried out randomized, double-blind and placebo controlled. Thirty patients were randomized to two groups. The verum group received TENS SM1AKS 80 Hz 6 mA and the placebo group received TENS SM1AKS 80 Hz 0 mA. The pain was assessed pre-operatively using the Hamburg Pain Adjective List. Premedication and Anaesthesia were standardized. TENS was applied to the patients immediately postoperatively for 8 hours and then on the following days 5 times daily for 45 minutes. The effectiveness was evaluated postoperatively using a visual analogue scale (rest, activity), the Hamburg Pain Adjective List and postoperative analgesic consumption. The visual analogue scale at rest and on activity showed no significant difference between the groups. Postoperative analgesic consumption of morphine hydrochloride in the first 24 hours was at time 8 hours postoperative significantly and at all other time points markedly less in the verum group compared to the placebo group. The sensory secondary scale score of the "Hamburg Pain Adjective List" was significantly lower postoperatively compared to preoperatively in the verum group. We were able to show in this study that TENS applied postoperatively after shoulder surgery clearly reduced analgesic consumption in the first 72 hours. Furthermore there was a significant difference in the pain scores using the "Hamburg Pain Adjective List" in favour of the verum group. TENS applied postoperatively is a effective, simple modality with few side-effects.

  4. 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.

  5. Tai-chi for residential patients with schizophrenia on movement coordination, negative symptoms, and functioning: a pilot randomized controlled trial.

    Science.gov (United States)

    Ho, Rainbow T H; Au Yeung, Friendly S W; Lo, Phyllis H Y; Law, Kit Ying; Wong, Kelvin O K; Cheung, Irene K M; Ng, Siu Man

    2012-01-01

    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.

  6. 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.

  7. Problem-solving skills training for parents of children with chronic pain: a pilot randomized controlled trial.

    Science.gov (United States)

    Palermo, Tonya M; Law, Emily F; Bromberg, Maggie; Fales, Jessica; Eccleston, Christopher; Wilson, Anna C

    2016-06-01

    This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem-solving skills training (PSST) compared with treatment as usual on improving parental mental health symptoms, physical health and well-being, and parenting behaviors. Effects of parent PSST on child outcomes (pain, emotional, and physical functioning) were also examined. Participants included 61 parents of children aged 10 to 17 years with chronic pain randomized to PSST (n = 31) or treatment as usual (n = 30) groups. Parents receiving PSST participated in 4 to 6 individual sessions of training in problem-solving skills. Outcomes were assessed at pretreatment, immediately after treatment, and at a 3-month follow-up. Feasibility was determined by therapy session attendance, therapist ratings, and parent treatment acceptability ratings. Feasibility of PSST delivery in this population was demonstrated by high compliance with therapy attendance, excellent retention, high therapist ratings of treatment engagement, and high parent ratings of treatment acceptability. PSST was associated with posttreatment improvements in parental depression (d = -0.68), general mental health (d = 0.64), and pain catastrophizing (d = -0.48), as well as in child depression (d = -0.49), child general anxiety (d = -0.56), and child pain-specific anxiety (d = -0.82). Several effects were maintained at the 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youths with chronic pain. Treatment outcome analyses show promising but mixed patterns of effects of PSST on parent and child mental health outcomes. Further rigorous trials of PSST are needed to extend these pilot results.

  8. 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

  9. 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.

  10. Smell and Taste to Improve Nutrition in Very Preterm Infants: A Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Beker, Friederike; Opie, Gillian; Noble, Elizabeth; Jiang, Yannan; Bloomfield, Frank H

    2017-01-01

    The perception of smell and taste, though present early in development, is not routinely considered in the care of preterm infants. Smell and taste are known to increase gut motility, insulin secretion, and the release of appetite, digestive and metabolic hormones. We aimed to investigate the effect of regular smell and taste on the time from birth to full enteral feeds, and the feasibility of the study protocol in very preterm infants. In a randomized controlled trial, infants <29 weeks' postmenstrual age (PA) were assigned to receive either the smell and taste of milk before each feed or to have no exposure to the smell and taste of milk (control). Infants in the treatment group (n = 28) and control group (n = 23) were born at a mean (SD) PA of 26.7 (1.5) and 27.2 (1.4) weeks, respectively. They reached full enteral feeds at a median (IQR) of 13.5 (10.0-19.0) and 15.5 (11.0-22.0) days, respectively. Survival analysis showed an adjusted hazard ratio of 1.63 (95% confidence interval 0.91-2.91; p = 0.10) for the effect on the time to establish full enteral feeds. Repeated-measures analysis indicated significant group differences in weight z scores at 36 weeks' PA and at discharge in favor of the intervention (p < 0.05). These data indicate that the smell and taste of milk may improve milk tolerance and weight in preterm infants. The role of regular smell and taste in promoting enteral nutrition and growth in preterm infants merits a larger trial powered to detect important outcomes. © 2016 S. Karger AG, Basel.

  11. Mindfulness meditation for the treatment of chronic low back pain in older adults: a randomized controlled pilot study.

    Science.gov (United States)

    Morone, Natalia E; Greco, Carol M; Weiner, Debra K

    2008-02-01

    The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were randomized to an 8-week mindfulness-based meditation program or to a wait-list control group. Baseline, 8-week and 3-month follow-up measures of pain, physical function, and quality of life were assessed. Eighty-nine older adults were screened and 37 found to be eligible and randomized within a 6-month period. The mean age of the sample was 74.9 years, 21/37 (57%) of participants were female and 33/37 (89%) were white. At the end of the intervention 30/37 (81%) participants completed 8-week assessments. Average class attendance of the intervention arm was 6.7 out of 8. They meditated an average of 4.3 days a week and the average minutes per day was 31.6. Compared to the control group, the intervention group displayed significant improvement in the Chronic Pain Acceptance Questionnaire Total Score and Activities Engagement subscale (P=.008, P=.004) and SF-36 Physical Function (P=.03). An 8-week mindfulness-based meditation program is feasible for older adults with CLBP. The program may lead to improvement in pain acceptance and physical function.

  12. A neurocognitive approach for recovering upper extremity movement following subacute stroke: a randomized controlled pilot study.

    Science.gov (United States)

    Sallés, Laia; Martín-Casas, Patricia; Gironès, Xavier; Durà, María José; Lafuente, José Vicente; Perfetti, Carlo

    2017-04-01

    [Purpose] This study aims to describe a protocol based on neurocognitive therapeutic exercises and determine its feasibility and usefulness for upper extremity functionality when compared with a conventional protocol. [Subjects and Methods] Eight subacute stroke patients were randomly assigned to a conventional (control group) or neurocognitive (experimental group) treatment protocol. Both lasted 30 minutes, 3 times a week for 10 weeks and assessments were blinded. Outcome measures included: Motor Evaluation Scale for Upper Extremity in Stroke Patients, Motricity Index, Revised Nottingham Sensory Assessment and Kinesthetic and Visual Imagery Questionnaire. Descriptive measures and nonparametric statistical tests were used for analysis. [Results] The results indicate a more favorable clinical progression in the neurocognitive group regarding upper extremity functional capacity with achievement of the minimal detectable change. The functionality results are related with improvements on muscle strength and sensory discrimination (tactile and kinesthetic). [Conclusion] Despite not showing significant group differences between pre and post-treatment, the neurocognitive approach could be a safe and useful strategy for recovering upper extremity movement following stroke, especially regarding affected hands, with better and longer lasting results. Although this work shows this protocol's feasibility with the panel of scales proposed, larger studies are required to demonstrate its effectiveness.

  13. 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.

  14. 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.

  15. Randomized, Placebo-Controlled, Double-Blind Pilot Study of D-Cycloserine in Chronic Stroke

    Science.gov (United States)

    Butler, Andrew J.; Kallos, Justiss; Housley, Stephen N.; LaPlaca, Michelle C.; Traynelis, Stephen F.; Wolf, Steven L.

    2015-01-01

    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. PMID:26587287

  16. 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

  17. 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

  18. 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 Paleolit

  19. Preoperative home-based physical therapy versus usual care to improve functional health of frail older adults scheduled for elective total hip arthroplasty: A pilot randomized controlled trial

    NARCIS (Netherlands)

    Oosting, E.; Jans, M.P.; Dronkers, J.J.; Naber, R.H.; Dronkers-Landman, C.M.; Appelman-De Vries, S.M.; Meeteren, N.L. van

    2012-01-01

    Preoperative home-based physical therapy versus usual care to improve functional health of frail older adults scheduled for elective total hip arthroplasty: a pilot randomized controlled trial. Objective: To investigate the feasibility and preliminary effectiveness of a home-based intensive exercise

  20. 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 Paleolith

  1. 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

  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. 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…

  4. 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…

  5. A pilot randomized control study to evaluate endoscopic resection using a ligation device for rectal carcinoid tumors

    Institute of Scientific and Technical Information of China (English)

    Hiroyuki Sakata; Sadahiro Amemori; Kotaro Mannen; Masanobu Mizuguchi; Kazuma Fujimoto; Ryuichi Iwakiri; Akifumi Ootani; Seiji Tsunada; Shinichi Ogata; Hibiki Ootani; Ryo Shimoda; Kanako Yamaguchi; Yasuhisa Sakata

    2006-01-01

    AIM: Rectal carcinoid tumors smaller than 10 mm can be resected with local excision using endoscopy. In order to remove rectal carcinoid tumors completely, we evaluated endoscopic mucosal resection with a ligation device in this pilot control randomized study.METHODS: Fifteen patients were diagnosed with rectal carcinoid tumor (less than 10 mm) in our hospital from 1993 to 2002. There were 9 males and 6 females,with a mean age 61.5 years (range, 34-77 years).The patientshad no complaints of carcinoid syndrome symptoms. Fifteen patients were randomly divided into 2 groups: 7 carcinoid tumors were treated by conventional endoscopic resection, and 8 carcinoid tumors were treated by endoscopic resection using a ligation device.RESULTS: All rectal carcinoid tumors were located at the middle to distal rectum. The size of the tumors varied from 3 mm to 10 mm and background characteristics of the patients were not different in the two groups.The rate of complete removal of carcinoid tumors using a ligation device (100%, 8/8) was significantly higher than that of conventional endoscopic resection (57.1%,4/7). The three patients had tumor involvement of deep margin, for which additional treatment was performed.No complications occurred during or after endoscopic resection using a ligation device. All patients in the both groups were alive during the 3-year observation period.CONCLUSION: Endoscopic resection using a ligation device is a useful and safe method for resection of small rectal carcinoid tumors.

  6. A pilot randomized control study to evaluate endoscopic resection using a ligation device for rectal carcinoid tumors

    Science.gov (United States)

    Sakata, Hiroyuki; Iwakiri, Ryuichi; Ootani, Akifumi; Tsunada, Seiji; Ogata, Shinichi; Ootani, Hibiki; Shimoda, Ryo; Yamaguchi, Kanako; Sakata, Yasuhisa; Amemori, Sadahiro; Mannen, Kotaro; Mizuguchi, Masanobu; Fujimoto, Kazuma

    2006-01-01

    AIM: Rectal carcinoid tumors smaller than 10 mm can be resected with local excision using endoscopy. In order to remove rectal carcinoid tumors completely, we evaluated endoscopic mucosal resection with a ligation device in this pilot control randomized study. METHODS: Fifteen patients were diagnosed with rectal carcinoid tumor (less than 10 mm) in our hospital from 1993 to 2002. There were 9 males and 6 females, with a mean age 61.5 years (range, 34-77 years). The patients had no complaints of carcinoid syndrome symptoms. Fifteen patients were randomly divided into 2 groups: 7 carcinoid tumors were treated by conventional endoscopic resection, and 8 carcinoid tumors were treated by endoscopic resection using a ligation device. RESULTS: All rectal carcinoid tumors were located at the middle to distal rectum. The size of the tumors varied from 3 mm to 10 mm and background characteristics of the patients were not different in the two groups. The rate of complete removal of carcinoid tumors using a ligation device (100%, 8/8) was significantly higher than that of conventional endoscopic resection (57.1%, 4/7). The three patients had tumor involvement of deep margin, for which additional treatment was performed. No complications occurred during or after endoscopic resection using a ligation device. All patients in the both groups were alive during the 3-year observation period. CONCLUSION: Endoscopic resection using a ligation device is a useful and safe method for resection of small rectal carcinoid tumors. PMID:16810752

  7. 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.

  8. 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 cesarean section. Further studies with larger sample sizes and long-term follow-up are needed to verify these results.

  9. Confronting Fear Using Exposure and Response Prevention for Anorexia Nervosa: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Steinglass, Joanna E; Albano, Anne Marie; Simpson, H Blair; Wang, Yuanjia; Zou, Jingjing; Attia, Evelyn; Walsh, B. Timothy

    2014-01-01

    Objective Anorexia nervosa (AN) is a severe illness with high rates of relapse. Exposure and Response Prevention for AN (AN-EXRP) is a new approach that specifically addresses maladaptive eating behavior by targeting eating-related fear and anxiety. The aim of this study was to evaluate AN-EXRP as an adjunctive strategy to improve eating behavior during weight restoration, at a pivotal moment when treatment goals shift toward relapse prevention. Method A randomized controlled trial was conducted to compare AN-EXRP with a comparison condition, Cognitive Remediation Therapy (CRT). Hospitalized patients with AN (n=32) who had achieved weight restoration to a BMI > 18.5 kg/m2 received 12 sessions of either AN-EXRP or CRT. Outcome was assessed by change in caloric intake in an objective assessment of eating behavior. Results The average test meal caloric intake of participants who received AN-EXRP increased from 352±263 kcal at baseline to 401±215 kcal post-treatment, while that of participants who received CRT decreased from 501±232 kcal at baseline to 424±221 kcal post-treatment (t(28)=2.5, p=0.02). Improvement in intake was significantly associated with improvement in eating-related anxiety (Spearman’s ρ=0.40, p=0.03). Conclusions These data demonstrate that AN-EXRP, compared to a credible comparison intervention, is associated with better caloric intake in a laboratory meal over time in AN. Additional studies are required to determine whether incorporation of these techniques into a longer treatment program leads to enduring and clinically significant change. PMID:24488838

  10. Dexmedetomidine versus propofol in dilatation and curettage: An open-label pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Priyanka Sethi

    2015-01-01

    Full Text Available Background: Traditionally propofol has been used for providing sedation in dilatation and curettage (D and C. Recently, dexmedetomidine has been tried, but very little evidence exists to support its use. Aims: The aim was to compare hemodynamic and recovery profile of both the drugs along with a degree of comfort experienced by patients and the usefulness of the drug to surgeons. Settings and Design: Tertiary care center and open-label randomized controlled trial. Materials and Methods: Patients posted for D and C were enrolled in two groups (25 each. Both groups received fentanyl 1 μg/kg intravenous (IV at the beginning of the procedure. Group P received IV propofol in dose of 1.5 mg/kg over 10-15 min and Group D received dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by 0.5 μg/kg/h infusion until Ramsay sedation score reached 3-4. Hemodynamic vitals were compared during and after the procedure. In the recovery room time to reach modified Aldrete score (MAS of 9-10 and patient′s and surgeon′s satisfaction scores were also recorded and compared. Results: In Group D, patients had statistically significant lower heart rate at 2, 5, 10 and 15 min as compared to Group P. Hypotension was present in 52% in Group P and 4% in Group D (P < 0.05. MAS of 9-10 was achieved in 4.4 min in subjects in Group D in contrast to 16.2 min in Group P (P < 0.05. Group D showed higher patient and surgeon satisfaction scores (P < 0.05. Conclusion: Dexmedetomidine provide better hemodynamic and recovery profile than propofol. It can be a superior alternative for short surgical day care procedures.

  11. The effect of a structured intervention on caregivers of patients with dementia and problem behaviors: a randomized controlled pilot study.

    Science.gov (United States)

    Nobili, Alessandro; Riva, Emma; Tettamanti, Mauro; Lucca, Ugo; Liscio, Mariarosaria; Petrucci, Bianca; Porro, Gabriella Salvini

    2004-01-01

    The objective was to assess the effect of a structured intervention on caregiver stress and the institutionalization rate of patients with dementia and problem behaviors. Caregivers contacting the Federazione Alzheimer Italia (AI) to receive help, advice, or information in relation to problem behaviors of outpatients were enrolled. Eligible caregiver-patient dyads were randomized to receive either a structured intervention or the counseling AI usually provides (control group). After basal assessment, families were reassessed at 6 and 12 months. Problem behavior (particularly agitation) was the only variable significantly correlated (P = 0.006) with the baseline caregivers' stress score. Thirty-nine families completed the 12-month follow-up; the mean problem behavior score was significantly lower in the intervention than the control group (p < 0.03); the time needed for care of the patient increased by 0.5 +/- 9.7 hours/day in the control group and decreased by 0.3 +/- 4.1 in the intervention group (p = 0.4, Wilcoxon test). The main determinant of institutionalization seemed to be the level of caregiver stress (p = 0.03). In patients of the intervention group, there was a significant reduction in the frequency of delusions. This pilot study suggests that caregiver stress is relieved by a structured intervention. The number of families lost to follow-up, the relatively short duration of the study, and the ceiling effect due to the severity of the clinical characteristics of patients probably all partly dilute the observed findings.

  12. 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.

  13. Wean Earlier and Automatically with New technology (the WEAN study: a protocol of a multicentre, pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lessard Martin R

    2009-09-01

    Full Text Available Abstract Background Weaning is the process during which mechanical ventilation is withdrawn and the work of breathing is transferred from the ventilator back to the patient. Prolonged weaning is associated with development of ventilator-related complications and longer stays in the Intensive Care Unit (ICU. Computerized or Automated Weaning is a novel weaning strategy that continuously measures and adapts ventilator support (by frequently measuring and averaging three breathing parameters and automatically conducts Spontaneous Breathing Trials to ascertain whether patients can resume autonomous breathing. Automated Weaning holds promise as a strategy to reduce the time spent on the ventilator, decrease ICU length of stay, and improve clinically important outcomes. Methods/Design A pilot weaning randomized controlled trial (RCT is underway in the ICUs of 8 Canadian hospitals. We will randomize 90 critically ill adults requiring invasive ventilation for at least 24 hours and identified at an early stage of the weaning process to either Automated Weaning (SmartCare™ or Protocolized Weaning. The results of a National Weaning Survey informed the design of the Protocolized Weaning arm. Both weaning protocols are operationalized in Pressure Support mode, include opportunities for Spontaneous Breathing Trials, and share a common sedation protocol, oxygen titration parameters, and extubation and reintubation criteria. The primary outcome of the WEAN study is to evaluate compliance with the proposed weaning and sedation protocols. A key secondary outcome of the pilot RCT is to evaluate clinician acceptance of the weaning and sedation protocols. Prior to initiating the WEAN Study, we conducted a run-in phase, involving two patients per centre (randomizing the first participant to either weaning strategy and assigning the second patient to the alternate strategy to ensure that participating centres could implement the weaning and sedation protocols and

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

    Science.gov (United States)

    Costigan, S.A.; Eather, N.; Plotnikoff, R.C.; Taaffe, D.R.; Pollock, E.; Kennedy, S.G.; Lubans, D.R.

    2015-01-01

    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. PMID:26844177

  15. 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.

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

    Science.gov (United States)

    Costigan, S A; Eather, N; Plotnikoff, R C; Taaffe, D R; Pollock, E; Kennedy, S G; Lubans, D R

    2015-01-01

    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. The Impact of Text Messaging on Medication Adherence and Exercise Among Postmyocardial Infarction Patients: Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Pandey, Avinash; Krumme, Alexis; Patel, Tejal; Choudhry, Niteesh

    2017-08-03

    Adherence to evidence-based therapies such as medications and exercise remains poor among patients after a myocardial infarction (MI). Text message reminders have been shown to improve rates of adherence to medication and exercise, but the existing studies have been of short duration. Two single-center randomized controlled pilot trials were conducted to evaluate the impact of text message reminders over 12 months on adherence to cardiac medications and exercise among patients receiving cardiac rehabilitation after hospitalization for MI. In the medication adherence trial, 34 patients were randomized to receive usual care alone or usual care plus daily text message reminders delivered at the time of day at which medications were to be taken. In the exercise adherence trial, 50 patients were randomized to receive usual care alone or usual care plus 4 daily text messages reminding them to exercise as directed. The text message reminders led to a mean 14.2 percentage point improvement in self-reported medication adherence over usual care (Ptext message reminders resulted in an additional 4.2 days (P=.001, 95% CI 1.9-6.4) and 4.0 hours (PText message reminders significantly increased adherence to medication and exercise among post-MI patients receiving care in a structured cardiac rehabilitation program. This technology represents a simple and scalable method to ensure consistent use of evidence-based cardiovascular therapies. Clinicaltrials.gov NCT02783287; https://clinicaltrials.gov/ct2/show/NCT02783287 (Archived by WebCite at http://www.webcitation.org/6sBnvNb05).

  18. Early versus delayed umbilical cord clamping in infants with congenital heart disease: a pilot, randomized, controlled trial.

    Science.gov (United States)

    Backes, C H; Huang, H; Cua, C L; Garg, V; Smith, C V; Yin, H; Galantowicz, M; Bauer, J A; Hoffman, T M

    2015-10-01

    Delayed umbilical cord clamping (DCC) at birth may provide a better neonatal health status than early umbilical cord clamping (ECC). However, the safety and feasibility of DCC in infants with congenital heart disease (CHD) have not been tested. This was a pilot, randomized, controlled trial to establish the safety and feasibility of DCC in neonates with CHD. Pregnant women admitted >37 weeks gestational age with prenatal diagnosis of critical CHD were enrolled and randomized to ECC or DCC. For ECC, the umbilical cord was clamped cord was clamped ~120 s after delivery. Thirty infants were randomized at birth. No differences between the DCC and ECC groups were observed in gestational age at birth or time of surgery. No differences were observed across all safety measures, although a trend for higher peak serum bilirubin levels (9.2±2.2 vs 7.3±3.2 mg dl(-1), P=0.08) in the DCC group than in the ECC group was noted. Although similar at later time points, hematocrits were higher in the DCC than in the ECC infants during the first 72 h of life. The proportion of infants not receiving blood transfusions throughout hospitalization was higher in the DCC than in the ECC infants (43 vs 7%, log-rank test P=0.02). DCC in infants with critical CHD appears both safe and feasible, with fewer infants exposed to red blood cell transfusions than with ECC. A more comprehensive appraisal of this practice is warranted.

  19. 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.

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

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    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.

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

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    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.

  2. Continence promotion for older hospital patients following surgery for fractured neck of femur: Pilot of a randomized controlled trial

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    Lynne Parkinson

    2008-01-01

    Full Text Available Lynne Parkinson1,2, Pauline Chiarelli3, Jennifer Byrne1, Richard Gibson1, Suzanne McNeill4, Gillian Lloyd5, Wendy Watts6, Julie Byles11Research Centre for Gender, Health and Ageing, Faculty of Health, The University of Newcastle, NSW, Australia; 2Hunter Ageing Research, Faculty of Health, The University of Newcastle, NSW, Australia; 3Faculty of Health, The University of Newcastle, NSW, Australia; 4NC Trauma Orthopedics, John Hunter Hospital, New Lambton Heights, NSW, Australia; 5Hunter New England Health, Wallsend Community Health Centre, Wallsend, NSW, Australia; 6Royal Newcastle Centre, John Hunter Hospital, New Lambton Heights, NSW, AustraliaAbstract: Evidence suggests that bladder control problems develop or worsen as a result of fractured neck of femur (#NOF and its subsequent management. The primary aim of this study was to reduce the prevalence and severity of post surgery continence problems among patients, aged from 60-years, undergoing surgery for #NOF, using a best practice “case-management model” multifactorial intervention. Eligible consenting patients admitted with #NOF were randomized to intervention or control group. Self-report questionnaires compared pre-surgery, post surgery, and follow-up continence status between groups.This pilot randomized controlled trial, which included 45 eligible patients aged 60 to 93-years, found no evidence that the intervention was effective in reducing prevalence of post-surgery incontinence in this acute setting. Staff surveys highlighted the need for open communication between the research team and hospital staff. Unclear results were attributed to the small sample size.A central outcome was evidence that intervention to improve continence management for older people post-surgery is imperative. Focused assessment and treatment for those most at risk of incontinence after #NOF would be more acceptable to staff and a more efficient use of resources. A simple screening tool would ensure that

  3. A randomized, controlled, pilot study of dialectical behavior therapy skills in a psychoeducational group for individuals with bipolar disorder.

    Science.gov (United States)

    Van Dijk, Sheri; Jeffrey, Janet; Katz, Mark R

    2013-03-05

    Bipolar disorder (BD) is a chronic and disabling psychiatric disorder characterized by recurrent episodes of mania/hypomania and depression. Dialectical behavior therapy (DBT) techniques have been shown to effectively treat borderline personality disorder, a condition also marked by prominent affective disturbances. The utility of DBT techniques in treating BD has been largely unexplored. The purpose of this research was to conduct a pilot study of a DBT-based psychoeducational group (BDG) in treating euthymic, depressed, or hypomanic Bipolar I or II patients. In this experiment, 26 adults with bipolar I or II were randomized to intervention or wait-list control groups and completed the Beck depression inventory II, mindfulness-based self-efficacy scale, and affective control scale at baseline and 12 weeks. The BDG intervention consisted of 12 weekly 90-min sessions which taught DBT skills, mindfulness techniques, and general BD psychoeducation. Using RM-ANOVA, subjects in BDG demonstrated a trend toward reduced depressive symptoms, and significant improvement in several MSES subscales indicating greater mindful awareness, and less fear toward and more control of emotional states (ACS). These findings were supported with a larger sample of patients who completed the BDG. Furthermore, group attendees had reduced emergency room visits and mental health related admissions in the six months following BDG. The small sample size in RCT affects power to detect between group differences. How well improvements after the12-week BDG were maintained is unknown. There is preliminary evidence that DBT skills reduce depressive symptoms, improve affective control, and improve mindfulness self-efficacy in BD. Its application warrants further evaluation in larger studies. Copyright © 2012 Elsevier B.V. All rights reserved.

  4. Lee Silverman voice treatment versus standard NHS speech and language therapy versus control in Parkinson's disease (PD COMM pilot): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Sackley, Catherine M; Smith, Christina H; Rick, Caroline; Brady, Marian C; Ives, Natalie; Patel, Ramilla; Roberts, Helen; Dowling, Francis; Jowett, Sue; Wheatley, Keith; Patel, Smitaa; Kelly, Debbie; Sands, Gina; Clarke, Carl

    2014-06-07

    Parkinson's disease is a common movement disorder affecting approximately 127,000 people in the UK, with an estimated two thirds having speech-related problems. Currently there is no preferred approach to speech and language therapy within the NHS and there is little evidence for the effectiveness of standard NHS therapy or Lee Silverman voice treatment. This trial aims to investigate the feasibility and acceptability of randomizing people with Parkinson's disease-related speech or voice problems to Lee Silverman voice treatment or standard speech and language therapy compared to a no-intervention control. The PD COMM pilot is a three arm, assessor-blinded, randomized controlled trial. Randomization will be computer-generated with participants randomized at a ratio of 1:1:1. Participants randomized to intervention arms will be immediately referred to the appropriate speech and language therapist. The target population are patients with a confirmed diagnosis of idiopathic Parkinson's disease who have problems with their speech or voice. The Lee Silverman voice treatment intervention group will receive the standard regime of 16 sessions between 50 and 60 minutes in length over four weeks, with extra home practice. The standard speech and language therapy intervention group will receive a dose determined by patients' individual needs, but not exceeding eight weeks of treatment. The control group will receive standard care with no speech and language therapy input for at least six months post-randomization. Outcomes will be assessed at baseline (pre-randomization) and post- randomization at three, six, and 12 months. The outcome measures include patient-reported voice measures, quality of life, resource use, and assessor-rated speech recordings. The recruitment aim is at least 60 participants over 21 months from 11 sites, equating to at least 20 participants in each arm of the trial. This trial is ongoing and recruitment commenced in May 2012. This study will

  5. Compensatory cognitive training for people with first-episode schizophrenia: results from a pilot randomized controlled trial.

    Science.gov (United States)

    Mendella, Paul D; Burton, Cynthia Z; Tasca, Giorgio A; Roy, Paul; St Louis, Lea; Twamley, Elizabeth W

    2015-03-01

    Cognitive training or remediation now has multiple studies and meta-analyses supporting its efficacy in improving cognition and functioning in people with schizophrenia. However, relatively little is known about cognitive training outcomes in early psychosis. We conducted a pilot randomized controlled trial of Compensatory Cognitive Training (CCT) compared to Treatment as Usual (TAU) in 27 participants with first-episode psychosis who had received treatment for psychosis for less than six months. Assessments of cognition (MATRICS Consensus Cognitive Battery; MCCB) and functional capacity (UCSD Performance-Based Skills Assessment-Brief; UPSA-B) were administered at baseline and following the 12-week treatment. The CCT condition, compared to TAU, was associated with significant improvements on the MCCB composite score, as well as MCCB subtests measuring processing speed (Trail Making) and social cognition (Mayer-Salovey-Caruso Emotional Intelligence Test), with large effects on these three outcome measures. There were no significant CCT-associated effects on the UPSA-B or on positive, negative, or depressive symptoms. CCT treatment of cognitive impairments in first-episode schizophrenia is feasible and can result in large effect size improvements in global cognition, processing speed, and social cognition.

  6. Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

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    Brodmann, Marianne, E-mail: marianne.brodmann@medunigraz.at; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz [Medical University of Graz, Division of Angiology (Austria); Deutschmann, Hannes [Medical University Graz, Division of Interventional Radiology (Austria); Seinost, Gerald; Pilger, Ernst [Medical University of Graz, Division of Angiology (Austria)

    2013-02-15

    Due to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate. We conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia. In a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178 mm vs. IMT PTA 0.1 mm, p = 0.001) with a spike at month 5 (max IMT SH 0.206 mm vs. IMT PTA 0.145 mm, p = 0.003) and a decline once again at month 6 (max IMT SH 0.177 mm vs. IMT PTA 0.121 mm, p = 0.02). The values for mean IMT performed the same way. Although Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

  7. 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.

  8. The effect of aquatic therapy on postural balance and muscle strength in stroke survivors--a randomized controlled pilot trial.

    Science.gov (United States)

    Noh, Dong Koog; Lim, Jae-Young; Shin, Hyung-Ik; Paik, Nam-Jong

    2008-01-01

    To evaluate the effect of an aquatic therapy programme designed to increase balance in stroke survivors. A randomized, controlled pilot trial. Rehabilitation department of a university hospital. Ambulatory chronic stroke patients (n = 25):13 in an aquatic therapy group and 12 in a conventional therapy group. The aquatic therapy group participated in a programme consisting of Ai Chi and Halliwick methods, which focused on balance and weight-bearing exercises. The conventional therapy group performed gym exercises. In both groups, the interventions occurred for 1 hour, three times per week, for eight weeks. The primary outcome measures were Berg Balance Scale score and weight-bearing ability, as measured by vertical ground reaction force during four standing tasks (rising from a chair and weight-shifting forward, backward and laterally). Secondary measures were muscle strength and gait. Compared with the conventional therapy group, the aquatic therapy group attained significant improvements in Berg Balance Scale scores, forward and backward weight-bearing abilities of the affected limbs, and knee flexor strength (P aquatic therapy based on the Halliwick and Ai Chi methods in stroke survivors. Because of limited power and a small population base, further studies with larger sample sizes are required.

  9. 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.

  10. 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

  11. A pilot randomized controlled clinical trial to improve antiepileptic drug adherence in young children with epilepsy.

    Science.gov (United States)

    Modi, Avani C; Guilfoyle, Shanna M; Mann, Krista A; Rausch, Joseph R

    2016-03-01

    The primary aim was to examine the preliminary efficacy of a family tailored problem-solving intervention to improve antiepileptic drug (AED) adherence in families of children with new-onset epilepsy. Secondary aims were to assess changes in targeted mechanisms and treatment feasibility and acceptability. Fifty families (M(age) = 7.6 ± 3.0; 80% Caucasian; 42% idiopathic localization related) completed baseline questionnaires and were given an electronic monitor to observe daily AED adherence. If adherence was ≤ 95% in the first 7 months of the study, families were randomized (Supporting Treatment Adherence Regimens (STAR): n = 11; Treatment as Usual (TAU): n = 12). Twenty-one families were not randomized due to adherence being ≥95%. The STAR intervention included four face-to-face and two telephone problem-solving sessions over 8 weeks. Significant group differences in adherence were found during active intervention (weeks 4-6; TAU = -12.0 vs. STAR = 18.1, p < 0.01; and weeks session 6-8: TAU = -9.7 vs. STAR = 15.3, p < 0.05). Children who received the STAR intervention exhibited improved adherence compared to children in the TAU group during active treatment. Significant changes in epilepsy knowledge and management were noted for the STAR group. Families expressed benefitting from the STAR intervention. Future studies should include a larger sample size and booster intervention sessions to maintain treatment effects over time.

  12. 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

  13. Warming Intravenous Fluids for Improved Patient Comfort in the Emergency Department: A Pilot Crossover Randomized Controlled Trial

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    Wesley H Self

    2013-09-01

    Full Text Available Introduction: The purpose of this study was to test if intravenous (IV fluids warmed to body temperature are associated with greater patient comfort than room temperature IV fluids in adult emergency department (ED patients.Methods: This was a pilot double-blind, crossover, randomized controlled trial. Enrolled subjects sequentially received boluses of body temperature (36ºC and room temperature (22 ºC IV fluid, with the order of boluses randomized. Each subject’s level of discomfort was assessed prior to and after each bolus, using a 10 cm visual analog scale (Discomfort VAS, with higher scores indicating greater discomfort. We calculated the change in Discomfort VAS score associated with body temperature IV fluid (ΔVASbody and room temperature IV fluid (ΔVASroom by subtracting the score reported before the bolus from the score reported after that bolus. We compared changes in Discomfort VAS score with body temperature and room temperature IV fluid using the Wilcoxon matched-pairs signed-rank test.Results: Twenty-seven subjects were included. Treatment with body temperature IV fluid was associated with a significant decrease in discomfort (median ΔVASbody: -0.7 cm; interquartile range (IQR: -4.5 cm to +0.4 cm compared to room temperature IV fluid (median ΔVASroom: +1.2 cm; interquartile range: -0.1 cm to + 3.6 cm (P = 0.001.Conclusion: In this small trial of adult ED patients, infusing IV fluids warmed to body temperature was associated with improved comfort compared to standard, room temperature IV fluids. [West J Emerg Med. 2013;14(5:542–546.

  14. 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 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.

  15. A Randomized Controlled Pilot Trial of Different Mobile Messaging Interventions for Problem Drinking Compared to Weekly Drink Tracking.

    Science.gov (United States)

    Muench, Frederick; van Stolk-Cooke, Katherine; Kuerbis, Alexis; Stadler, Gertraud; Baumel, Amit; Shao, Sijing; McKay, James R; Morgenstern, Jon

    2017-01-01

    Recent evidence suggests that text messaging may help to reduce problem drinking as an extension to in-person services, but very little is known about the effectiveness of remote messaging on problem drinking as a stand-alone intervention, or how different types of messages may improve drinking outcomes in those seeking to moderate their alcohol consumption. We conducted an exploratory, single-blind randomized controlled pilot study comparing four different types of alcohol reduction-themed text messages sent daily to weekly drink self-tracking texts in order to determine their impact on drinking outcomes over a 12-week period in 152 participants (≈ 30 per group) seeking to reduce their drinking on the internet. Messaging interventions included: weekly drink self-tracking mobile assessment texts (MA), loss-framed texts (LF), gain-framed texts (GF), static tailored texts (ST), and adaptive tailored texts (TA). Poisson and least squares regressions were used to compare differences between each active messaging group and the MA control. When adjusting for baseline drinking, participants in all messaging groups except GF significantly reduced the number of drinks consumed per week and the number of heavy drinking days compared to MA. Only the TA and GF groups were significantly different from MA in reducing the number of drinking days. While the TA group yielded the largest effect sizes on all outcome measures, there were no significant differences between active messaging groups on any outcome measure. 79.6% of individuals enrolled in the study wanted to continue receiving messages for an additional 12 weeks at the end of the study. Results of this pilot study indicate that remote automated text messages delivered daily can help adult problem drinkers reduce drinking frequency and quantity significantly more than once-a-week self-tracking messages only, and that tailored adaptive texts yield the largest effect sizes across outcomes compared to MA. Larger samples are

  16. Needling versus liquid nitrogen cryotherapy for the treatment of pedal warts a randomized controlled pilot study.

    Science.gov (United States)

    Cunningham, Daniel J; Brimage, Jessica T; Naraghi, Reza N; Bower, Virginia M

    2014-07-01

    We hypothesized that needling of a pedal wart creates local inflammation and a subsequent cell-mediated immune response (CMIR) against human papillomavirus. The primary objective of this study was to investigate whether needling to induce a CMIR against human papillomavirus is an effective treatment for pedal warts compared with liquid nitrogen cryotherapy. A secondary objective was to investigate whether the CMIR induced by needling is effective against satellite pedal warts. Eligible patients with pedal warts were randomly allocated to receive either needling or liquid nitrogen cryotherapy. Only the primary pedal wart was treated during the study. Follow-up was 12 weeks, with outcome assessments made independently under blinded circumstances. Of 37 patients enrolled in the study, 18 were allocated to receive needling and 19 to receive liquid nitrogen cryotherapy. Regression of the primary pedal wart occurred in 64.7% of the needling group (11 of 17) and in 6.2% of the liquid nitrogen cryotherapy group (1 of 16) (P =  .001). No significant relationship was found between needling of the primary pedal wart and regression of satellite pedal warts (P = .615) or complete pedal wart regression (P = .175). There was no significant difference in pain, satisfaction, or cosmesis between the two groups. The regression rate of the primary pedal wart was significantly higher in the needling group compared with the liquid nitrogen cryotherapy group.

  17. Treadmill training improves overground walking economy in Parkinson's disease: a randomized, controlled pilot study.

    Science.gov (United States)

    Fernández-Del-Olmo, Miguel Angel; Sanchez, Jose Andres; Bello, Olalla; Lopez-Alonso, Virginia; Márquez, Gonzalo; Morenilla, Luis; Castro, Xabier; Giraldez, Manolo; Santos-García, Diego

    2014-01-01

    Gait disturbances are one of the principal and most incapacitating symptoms of Parkinson's disease (PD). In addition, walking economy is impaired in PD patients and could contribute to excess fatigue in this population. An important number of studies have shown that treadmill training can improve kinematic parameters in PD patients. However, the effects of treadmill and overground walking on the walking economy remain unknown. The goal of this study was to explore the walking economy changes in response to a treadmill and an overground training program, as well as the differences in the walking economy during treadmill and overground walking. Twenty-two mild PD patients were randomly assigned to a treadmill or overground training group. The training program consisted of 5 weeks (3 sessions/week). We evaluated the energy expenditure of overground walking, before and after each of the training programs. The energy expenditure of treadmill walking (before the program) was also evaluated. The treadmill, but not the overground training program, lead to an improvement in the walking economy (the rate of oxygen consumed per distance during overground walking at a preferred speed) in PD patients. In addition, walking on a treadmill required more energy expenditure compared with overground walking at the same speed. This study provides evidence that in mild PD patients, treadmill training is more beneficial compared with that of walking overground, leading to a greater improvement in the walking economy. This finding is of clinical importance for the therapeutic administration of exercise in PD.

  18. 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.

  19. The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Ernst, Pierre; Bartlett, Susan J; Valois, Marie-France; Zaihra, Tasneem; Paré, Guy; Grad, Roland; Eilayyan, Owis; Perreault, Robert; Tamblyn, Robyn

    2016-01-01

    Background 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. Objective 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. Methods 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. Results 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

  20. Guided and Unguided Internet-Based Treatment for Problematic Alcohol Use - A Randomized Controlled Pilot Trial.

    Directory of Open Access Journals (Sweden)

    Christopher Sundström

    Full Text Available The Internet has increasingly been studied as mode of delivery for interventions targeting problematic alcohol use. Most interventions have been fully automated, but some research suggests that adding counselor guidance may improve alcohol consumption outcomes.An eight-module Internet-based self-help program based on cognitive behavioral therapy (CBT was tested among Internet help-seekers. Eighty participants with problematic alcohol use according to the Alcohol Use Disorders Identification Test (AUDIT; scores of ≥ 6 for women and ≥ 8 for men were recruited online from an open access website and randomized into three different groups. All groups were offered the same self-help program, but participants in two of the three groups received Internet-based counselor guidance in addition to the self-help program. One of the guidance groups was given a choice between guidance via asynchronous text messages or synchronous text-based chat, while the other guidance group received counselor guidance via asynchronous text messages only.In the choice group, 65% (13 of 20 participants chose guidance via asynchronous text messages. At the 10-week post-treatment follow-up, an intention-to-treat (ITT analysis showed that participants in the two guidance groups (choice and messages reported significantly lower past week alcohol consumption compared to the group without guidance; 10.8 (SD = 12.1 versus 22.6 (SD = 18.4; p = 0.001; Cohen's d = 0.77. Participants in both guidance groups reported significantly lower scores on the AUDIT at follow-up compared to the group without guidance, with a mean score of 14.4 (SD = 5.2 versus 18.2 (SD = 5.9; p = 0.003; Cohen's d = 0.68. A higher proportion of participants in the guidance groups said that they would recommend the program compared to the group without guidance (81% for choice; 93% for messages versus 47% for self-help.Self-help programs for problematic alcohol use can be more effective in reducing alcohol

  1. 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

  2. A randomized controlled pilot trial of classroom-based mindfulness meditation compared to an active control condition in sixth-grade children.

    Science.gov (United States)

    Britton, Willoughby B; Lepp, Nathaniel E; Niles, Halsey F; Rocha, Tomas; Fisher, Nathan E; Gold, Jonathan S

    2014-06-01

    The current study is a pilot trial to examine the effects of a nonelective, classroom-based, teacher-implemented, mindfulness meditation intervention on standard clinical measures of mental health and affect in middle school children. A total of 101 healthy sixth-grade students (55 boys, 46 girls) were randomized to either an Asian history course with daily mindfulness meditation practice (intervention group) or an African history course with a matched experiential activity (active control group). Self-reported measures included the Youth Self Report (YSR), a modified Spielberger State-Trait Anxiety Inventory, and the Cognitive and Affective Mindfulness Measure -Revised. Both groups decreased significantly on clinical syndrome subscales and affect but did not differ in the extent of their improvements. Meditators were significantly less likely to develop suicidal ideation or thoughts of self-harm than controls. These results suggest that mindfulness training may yield both unique and non-specific benefits that are shared by other novel activities.

  3. 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

  4. Treatment of Idiopathic Parkinson's Disease with Traditional Chinese Herbal Medicine: A Randomized Placebo-Controlled Pilot Clinical Study

    Directory of Open Access Journals (Sweden)

    Wan Fung Kum

    2011-01-01

    Full Text Available The objective of this clinical study is to examine the effects of a Chinese herbal medicine formula (Jia Wei Liu Jun Zi Tang: JWLJZT on motor and non-motor symptoms, and on complications of conventional therapy in idiopathic Parkinson's disease (PD, using an add-on design. Fifty-five patients with PD were randomly allocated to receive either Chinese herbal medicine or placebo for 24 weeks. Primary outcome measure was the 39-item Parkinson's Disease Questionnaire (PDQ-39. Secondary outcome measures included the Unified Parkinson's Disease Rating Scale (UPDRS, Short-Form-36 Health Survey (SF-36, Geriatric Depression Scale (GDS, home diaries, and a range of category rating scales. JWLJZT resulted in a significant improvement in the UPDRS IVC when compared with placebo at 12 weeks (P = .039 and 24 weeks (P = .034. In addition, patients in the Chinese herbal medicine group also showed significant improvement in PDQ-39 communication scores at 12 weeks (P = .024 and 24 weeks (P = .047 when compared with the placebo group. There were no significant differences between treatment and control groups for SF-36 variables, GDS score or the mean daily “on-off” time. One case of mild diarrhea was noted in the treatment group. The findings suggest that JWLJZT can relieve some non-motor complications of conventional therapy and improve the communication ability in patients with PD. The results of this pilot study warrant larger multi-center clinical studies to assess long-term efficacy and tolerability of JWLJZT, and to elucidate the mechanisms by which it affects PD function.

  5. 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

  6. Falls prevention advice and visual feedback to those at risk of falling: study protocol for a pilot randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Studies have shown that functional strength and balance exercises can reduce the risk of falling in older people if they are done on a regular basis. However, the repetitive nature of these exercises; combined with the inherent lack of feedback of progress may discourage seniors from exercising in the home, thereby rendering such an intervention ineffective. This study hypothesizes that the use of visual feedback and multimodal games will be more effective in encouraging adherence to home rehabilitation than standard care; thereby promoting independence and improving the quality of life in older adults at risk of falling. Methods A pllel-group pilot randomized controlled trial with 3 groups of participants will be conducted in the home for 12 weeks. Participants will include older adults who have been identified as at risk of falling (n = 48), over the age of 65, living in the community, and suitable for a home exercise intervention. The primary outcome is adherence to exercise. Secondary outcomes include: variability in stride length, stride time and double support time (DST); walking speed; Timed up and go test (TUG); Falls Efficacy Scale International (FES-I); CONFbal scale; Romberg’s test; and quality of life measures (SF-12 and EuroQol EQ-5D). Qualitative assessments on personal experiences with rehabilitation tools will be done before and after the trial. Discussion This study will investigate the use of visual feedback and engaging multimodal activities to address the problem of non-compliance to home exercises for falls rehabilitation. One of the unique qualities of this study is the adaptation of special participatory design methods through which the end users (fallers) will be involved in the design of the proposed rehabilitation tools at various stages of the design process. Trial registration ISRCTN79967470 PMID:23510162

  7. 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; Pacute 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.

  8. 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 < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects

  9. 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 BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: High intensity exercise improved disease activity and reduced CV risk factors in

  10. Efficacy of high intensity exercise on disease activity and cardiovascular risk in active axial spondyloarthritis: a randomized controlled pilot study.

    Science.gov (United States)

    Sveaas, Silje Halvorsen; Berg, Inger Jorid; Provan, Sella Aarrestad; Semb, Anne Grete; Hagen, Kåre Birger; Vøllestad, Nina; Fongen, Camilla; Olsen, Inge C; Michelsen, Annika; Ueland, Thor; Aukrust, Pål; Kvien, Tore K; Dagfinrud, Hanne

    2014-01-01

    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

  11. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background The Pre-Consultation Educational Group Intervention pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. Methods/design This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. Setting: The University Health Network, a tertiary care cancer center in Toronto, Canada. Participants: Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction. Intervention: We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. Control: Usual care includes access to an informational booklet, website, and patient volunteer if desired. Outcomes: Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. Discussion Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been

  12. Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

    Science.gov (United States)

    Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

    2007-01-01

    We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

  13. The Meaning-Making intervention (MMi) appears to increase meaning in life in advanced ovarian cancer: a randomized controlled pilot study.

    Science.gov (United States)

    Henry, Melissa; Cohen, S Robin; Lee, Virginia; Sauthier, Philippe; Provencher, Diane; Drouin, Pierre; Gauthier, Philippe; Gotlieb, Walter; Lau, Susie; Drummond, Nancy; Gilbert, Lucy; Stanimir, Gerald; Sturgeon, Jeremy; Chasen, Martin; Mitchell, Julie; Huang, Lina Nuoxin; Ferland, Mira-Klode; Mayo, Nancy

    2010-12-01

    This pilot study aimed to provide supportive evidence for the acceptability and usefulness of the Meaning-Making intervention (MMi) in patients newly diagnosed with Stage III or IV ovarian cancer, and to provide estimates of parameters needed to design a full-scale study. A randomized controlled trial with 24 patients (12 experimental and 12 control) was conducted. Existential well-being (primary outcome), overall quality of life, distress, anxiety, depression and self-efficacy were measured. Compared to the control group, patients in the experimental group had a better sense of meaning in life at one and three months post-intervention. The MMi seems a promising intervention for advanced cancer patients, and a full randomized controlled trial is warranted to further investigate its efficacy.

  14. A Novel Behavioral Intervention in Adolescents with Type 1 Diabetes Mellitus Improves Glycemic Control: Preliminary Results from a Pilot Randomized Control Trial

    Science.gov (United States)

    Maranda, Louise; Lau, May; Stewart, Sunita M; Gupta, Olga T

    2015-01-01

    Purpose The purpose of this study is to develop and pilot an innovative behavioral intervention in adolescents with type 1 diabetes mellitus (T1DM) incorporating structured care of a pet to improve glycemic control. Methods Twenty-eight adolescents with A1C > 8.5% (69 mmol/mol) were randomly assigned to either the intervention group (care of a Betta splendens pet fish) or the control group (usual care). Adolescents in the intervention group were given instructions to associate daily and weekly fish care duties with diabetes self-management tasks including blood glucose testing and parent-adolescent communication. Results After 3 months the participants in the intervention group exhibited a statistically significant decrease in A1C levels (−0.5%) compared to their peers in the control group who had an increase in A1C levels (0.8%)(p = 0.04). The younger adolescents (ages 10–13) demonstrated a greater response to the intervention which was statistically significant (−1.5% vs. 0.6%, p = 0.04) compared with the older adolescents (ages 14–17). Conclusions Structured care of a pet fish can improve glycemic control in adolescents with T1DM, likely by providing cues to perform diabetes self-management behaviors. PMID:25614529

  15. 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.

  16. Mindfulness training and stress reactivity in substance abuse: results from a randomized, controlled stage I pilot study.

    Science.gov (United States)

    Brewer, Judson A; Sinha, Rajita; Chen, Justin A; Michalsen, Ravenna N; Babuscio, Theresa A; Nich, Charla; Grier, Aleesha; Bergquist, Keri L; Reis, Deidre L; Potenza, Marc N; Carroll, Kathleen M; Rounsaville, Bruce J

    2009-01-01

    Stress is important in substance use disorders (SUDs). Mindfulness training (MT) has shown promise for stress-related maladies. No studies have compared MT to empirically validated treatments for SUDs. The goals of this study were to assess MT compared to cognitive behavioral therapy (CBT) in substance use and treatment acceptability, and specificity of MT compared to CBT in targeting stress reactivity. Thirty-six individuals with alcohol and/or cocaine use disorders were randomly assigned to receive group MT or CBT in an outpatient setting. Drug use was assessed weekly. After treatment, responses to personalized stress provocation were measured. Fourteen individuals completed treatment. There were no differences in treatment satisfaction or drug use between groups. The laboratory paradigm suggested reduced psychological and physiological indices of stress during provocation in MT compared to CBT. This pilot study provides evidence of the feasibility of MT in treating SUDs and suggests that MT may be efficacious in targeting stress.

  17. Adherence to a smartphone application for weight loss compared to website and paper diary: pilot randomized controlled trial.

    Science.gov (United States)

    Carter, Michelle Clare; Burley, Victoria Jane; Nykjaer, Camilla; Cade, Janet Elizabeth

    2013-04-15

    There is growing interest in the use of information communication technologies to treat obesity. An intervention delivered by smartphone could be a convenient, potentially cost-effective, and wide-reaching weight management strategy. Although there have been studies of texting-based interventions and smartphone applications (apps) used as adjuncts to other treatments, there are currently no randomized controlled trials (RCT) of a stand-alone smartphone application for weight loss that focuses primarily on self-monitoring of diet and physical activity. The aim of this pilot study was to collect acceptability and feasibility outcomes of a self-monitoring weight management intervention delivered by a smartphone app, compared to a website and paper diary. A sample of 128 overweight volunteers were randomized to receive a weight management intervention delivered by smartphone app, website, or paper diary. The smartphone app intervention, My Meal Mate (MMM), was developed by the research team using an evidence-based behavioral approach. The app incorporates goal setting, self-monitoring of diet and activity, and feedback via weekly text message. The website group used an existing commercially available slimming website from a company called Weight Loss Resources who also provided the paper diaries. The comparator groups delivered a similar self-monitoring intervention to the app, but by different modes of delivery. Participants were recruited by email, intranet, newsletters, and posters from large local employers. Trial duration was 6 months. The intervention and comparator groups were self-directed with no ongoing human input from the research team. The only face-to-face components were at baseline enrollment and brief follow-up sessions at 6 weeks and 6 months to take anthropometric measures and administer questionnaires. Trial retention was 40/43 (93%) in the smartphone group, 19/42 (55%) in the website group, and 20/43 (53%) in the diary group at 6 months. Adherence

  18. 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.

  19. Social Skills Training for Young Adults with High-Functioning Autism Spectrum Disorders: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Gantman, Alexander; Kapp, Steven K.; Orenski, Kaely; Laugeson, Elizabeth A.

    2012-01-01

    Despite the psychosocial difficulties common among young adults with autism spectrum disorders (ASD), little to no evidence-based social skills interventions exist for this population. Using a randomized controlled trial (RCT) design, the current study tested the effectiveness of an evidence-based, caregiver-assisted social skills intervention…

  20. A Parent-Directed Language Intervention for Children of Low Socioeconomic Status: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Suskind, Dana L.; Leffel, Kristin R.; Graf, Eileen; Hernandez, Marc W.; Gunderson, Elizabeth A.; Sapolich, Shannon G.; Suskind, Elizabeth; Leininger, Lindsey; Goldin-Meadow, Susan; Levine, Susan C.

    2016-01-01

    We designed a parent-directed home-visiting intervention targeting socioeconomic status (SES) disparities in children's early language environments. A randomized controlled trial was used to evaluate whether the intervention improved parents' knowledge of child language development and increased the amount and diversity of parent talk.…

  1. 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.

  2. Vitamin D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial

    Science.gov (United States)

    Steenhoff, Andrew P.; Schall, Joan I.; Samuel, Julia; Seme, Boitshepo; Marape, Marape; Ratshaa, Bakgaki; Goercke, Irene; Tolle, Michael; Nnyepi, Maria S.; Mazhani, Loeto; Zemel, Babette S.; Rutstein, Richard M.; Stallings, Virginia A.

    2015-01-01

    Objectives 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). Design Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years. Methods Sixty subjects randomized within five age groups to either 4000 or 7000IU 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) ≥32ng/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. Results 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±9ng/ml to 56±18ng/ml (p<0.0001) and 68% and 90% had 25D ≥32ng/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 7000IU/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±11ng/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). Conclusions 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. Trial Registration ClinicalTrials.gov NCT02189902 PMID:25706751

  3. Transdermal diclofenac patches for control of post-extraction pain. Pilot randomized controlled double-blind study.

    Science.gov (United States)

    Krishnan, Sriram; Sharma, Pankaj; Sharma, Rakesh; Kumar, Suman; Verma, Mahesh; Chaudhary, Zainab

    2015-03-01

    The scope of transdermal analgesics have been limited to pain control following local trauma, muscle spasm, minor esthetic surgeries, or sports-related injuries. Its scope of application can be extended in the field of dentistry and minor oral surgical procedures. A total of 40 healthy patients between the age of 18 and 50 years with deeply carious, nontender mandibular molar tooth deemed unsalvageable which was indicated for extraction were taken into study of which subjects were divided into cases and controls. The data were analyzed with chi-square test and Mann-Whitney U test; the chi-square test showed significant association with expected outcome in visual analog scale pain scores, the two groups at 6th and 12th hour. A Mann-Whitney U test was performed to identify strength of association between two groups where there were significant association between all parameters except for pain interference with routine activities and dental health status(0.022, 0.001); the differences between two groups in these parameters were significant (Transdermal route seems to be comparable to oral diclofenac in post-extraction pain relief; further studies are required to confirm the results and safety for its use in various other dental situations.

  4. Short cognitive behavioral therapy and cognitive training for adults with ADHD – a randomized controlled pilot study

    Science.gov (United States)

    Virta, Maarit; Salakari, Anita; Antila, Mervi; Chydenius, Esa; Partinen, Markku; Kaski, Markus; Vataja, Risto; Kalska, Hely; Iivanainen, Matti

    2010-01-01

    In clinical practice, a growing need exists for effective non-pharmacological treatments of adult attention-deficit/hyperactivity disorder (ADHD). Here, we present the results of a pilot study of 10 adults with ADHD participating in short-term individual cognitive- behavioral therapy (CBT), 9 adults participating in cognitive training (CT), and 10 controls. Self-report questionnaires, independent evaluations, and computerized neurocognitive testing were collected before and after the treatments to evaluate change. There were distinctive pre-hypotheses regarding the treatments, and therefore the statistical comparisons were conducted in pairs: CBT vs control, CT vs control, and CBT vs CT. In a combined ADHD symptom score based on self-reports, 6 participants in CBT, 2 in CT and 2 controls improved. Using independent evaluations, improvement was found in 7 of the CBT participants, 2 of CT participants and 3 controls. There was no treatment-related improvement in cognitive performance. Thus, in the CBT group, some encouraging improvement was seen, although not as clearly as in previous research with longer interventions. In the CT group, there was improvement in the trained tasks but no generalization of the improvement to the tasks of the neurocognitive testing, the self- report questionnaires, or the independent evaluations. These preliminary results warrant further studies with more participants and with more elaborate cognitive testing. PMID:20856608

  5. Whole-body vibration training improves balance control and sit-to-stand performance among middle-aged and older adults: a pilot randomized controlled trial.

    Science.gov (United States)

    Ko, Ming-Chen; Wu, Long-Shan; Lee, Sangwoo; Wang, Chien-Chun; Lee, Po-Fu; Tseng, Ching-Yu; Ho, Chien-Chang

    2017-01-01

    Aging is associated with decreased balance, which increases falling risk. The objective of the current study was to determine the feasibility and effects of whole-body vibration (WBV) training on knee extensor muscle power, limits of stability, and sit-to-stand performance among community-dwelling middle-aged and older adults in the United States. A randomized pilot study with participant blinding was conducted. Feasibility outcomes included recruitment and compliance rate. Twenty-nine community-dwelling older adults were randomly assigned to perform body-weight exercises with either an individualized vibration frequency and amplitude, a fixed vibration frequency and amplitude, or no vibration. Isokinetic knee extensor power, limits of stability, and sit-to-stand tests were conducted before beginning the exercises (baseline) and after 8 weeks of training. With a favorable recruitment rate (58%) and compliance rates (attrition 9%; adherence 85%), the intervention was deemed feasible. The limits of stability endpoint excursion score for the individualized frequency-amplitude group was increased by 8.8 (12.9%; P = 0.025) after training, and that group's maximum excursion score was increased by 9.2 (11.5%; P = 0.006) after training. The average weight transfer time score was significantly decreased by 0.2 s in the fixed group. The participants in the individualized group demonstrated a significant increase (3.2%) in weight rising index score after 8 weeks of WBV training. WBV training is feasible for use with elderly people, and this study achieved good recruitment and compliance. The present paper suggests that 8 weeks of WBV training improves limits of stability and sit-to-stand performance. Future studies must determine whether WBV training improves other factors that affect posture control. This study was registered at the Texas Woman's University Institutional Review Board [TWU IRB 17632] on the 3rd of November 2014.

  6. 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 omega-3 fatty acids plus alpha-lipoic acid as a potential treatment in AD is warranted.

  7. 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.

  8. 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.

  9. A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Betahistine to Counteract Olanzapine-Associated Weight Gain.

    Science.gov (United States)

    Barak, Nir; Beck, Yaffa; Albeck, Joseph H

    2016-06-01

    Patients with schizophrenia experience higher rates of obesity and related morbidity and mortality than the general population does. Given preclinical studies revealing the role of histamine H1 receptor in human eating behavior, and the potential of olanzapine to block with this system, we hypothesized that histamine H1 receptor agonists may be beneficial in reducing antipsychotic-associated weight gain. In the present study, 36 patients with a diagnosis of schizophrenia or schizoaffective disorder and treated with olanzapine were randomized to betahistine (48 mg/d) or matching placebo for 16 weeks. Study outcomes were change in body weight from baseline and effect on antipsychotic efficacy of olanzapine. The patients in the betahistine group had less weight gain (-1.95 kg) compared with placebo group (5.6 + 5.5 kg vs 6.9 + 5.6 kg, respectively). Positive and Negative Syndrome Scale Questionnaire showed improvement within each group and that subjects treated with betahistine enjoyed an improvement (reduction) by a mean of 35.7 points, higher when compared with placebo subjects who had a reduction of 26.6 points (P = 0.233). An almost equal amount of subjects in both groups experienced adverse effects during the course of this study (87.5% of betahistine vs 85.0% of placebo-treated subjects). Overall, there were no clinically marked differences in safety signals between both groups. A larger study addressing the weaknesses of this pilot study is warranted.

  10. Efficacy of Feedback-Controlled Robotics-Assisted Treadmill Exercise to Improve Cardiovascular Fitness Early After Stroke: A Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Stoller, Oliver; de Bruin, Eling D; Schindelholz, Matthias; Schuster-Amft, Corina; de Bie, Rob A; Hunt, Kenneth J

    2015-07-01

    Cardiovascular fitness is greatly reduced after stroke. Although individuals with mild to moderate impairments benefit from conventional cardiovascular exercise interventions, there is a lack of effective approaches for persons with severely impaired physical function. This randomized controlled pilot trial investigated efficacy and feasibility of feedback-controlled robotics-assisted treadmill exercise (FC-RATE) for cardiovascular rehabilitation in persons with severe impairments early after stroke. Twenty individuals (age 61 ± 11 years; 52 ± 31 days poststroke) with severe motor limitations (Functional Ambulation Classification 0-2) were recruited for FC-RATE or conventional robotics-assisted treadmill exercise (RATE) (4 weeks, 3 × 30-minute sessions/wk). Outcome measures focused on peak cardiopulmonary performance parameters, training intensity, and feasibility, with examiners blinded to allocation. All 14 allocated participants (70% of recruited) completed the intervention (7/group, withdrawals unrelated to intervention), without serious adverse events occurring. Cardiovascular fitness increased significantly in both groups, with peak oxygen uptake increasing from 14.6 to 17.7 mL · kg · min (+17.8%) after 4 weeks (45.8%-55.7% of predicted maximal aerobic capacity; time effect P = 0.01; no group-time interaction). Training intensity (% heart rate reserve) was significantly higher for FC-RATE (40% ± 3%) than for conventional RATE (14% ± 2%) (P = 0.001). Substantive overall increases in the main cardiopulmonary performance parameters were observed, but there were no significant between-group differences when comparing FC-RATE and conventional RATE. Feedback-controlled robotics-assisted treadmill exercise significantly increased exercise intensity, but recommended intensity levels for cardiovascular training were not consistently achieved. Future research should focus on appropriate algorithms within advanced robotic systems to promote optimal cardiovascular

  11. Efficacy of Wii-Fit on Static and Dynamic Balance in Community Dwelling Older Veterans: A Randomized Controlled Pilot Trial

    Science.gov (United States)

    Dubbert, Patricia M.

    2017-01-01

    Background/Objectives. Balance problems are well-established modifiable risk factors for falls, which are common in older adults. The objective of this study was to establish the efficacy of a Wii-Fit interactive video-game-led physical exercise program to improve balance in older Veterans. Methods. A prospective randomized controlled parallel-group trial was conducted at Veterans Affairs Medical Center. Thirty community dwelling Veterans aged 68 (±6.7) years were randomized to either the exercise or control groups. The exercise group performed Wii-Fit program while the control group performed a computer-based cognitive program for 45 minutes, three days per week for 8-weeks. The primary (Berg Balance Scale (BBS)) and secondary outcomes (fear of falling, physical activity enjoyment, and quality of life) were measured at baseline, 4 weeks, and 8 weeks. Results. Of 30 randomized subjects, 27 completed all aspects of the study protocol. There were no study-related adverse events. Intent-to-treat analysis showed a significantly greater improvement in BBS in the exercise group (6.0; 95% CI, 5.1–6.9) compared to the control group (0.5; 95% CI, −0.3–1.3) at 8 weeks (average intergroup difference (95% CI), 5.5 (4.3–6.7), p balance in community dwelling older Veterans. This trial is registered with ClinicalTrials.gov Identifier NCT02190045. PMID:28261500

  12. 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, KC

    2017-01-01

    Purpose 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. Patients and methods “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 workers. Primary outcomes were assessed by means of the Lubben social network and De Jong Gieveld loneliness scales, and by a revised social support questionnaire. Secondary outcomes were covered by a mental health inventory and the Rosenberg self-esteem scale, and quality of life by using the 12-Item Short Form Health Survey. Data was collected at baseline, and at three and six months thereafter. Results The generalized estimating equations model revealed general improvement in outcomes among participants on the tai chi qigong program. In particular, participants reported a significantly greater improvement on the loneliness scale (B=−1.32, 95% confidence interval [CI] −2.54 to −0.11, P=0.033) and the satisfaction component of the social support questionnaire (B=3.43, 95% CI 0.10–6.76, P=0.044) than the control group. Conclusion The pilot study confirmed that tai chi qigong with elderly neighborhood volunteers is a safe and feasible social intervention for hidden elderly. Its potential benefits in improving social and psychological health suggest the need for a full-scale randomized controlled trial to reveal its empirical effects. PMID:28115837

  13. 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.

  14. Effects of inspiratory muscle training on exercise capacity and spontaneous physical activity in elderly subjects: a randomized controlled pilot trial

    OpenAIRE

    Aznar Laín, Susana; Webster, A. L., Mrs.; Cañete, Silvia; San Juan, Alejandro F.; López Mojares, Luis Miguel; Pérez Ruiz, Margarita; Lucía Mulas, Alejandro; Chicharro García, Luis Miguel

    2007-01-01

    Inspiratory muscle training (IMT) has been shown to improve exercise capacity in diseased populations. We chose to examine the effects of eight weeks of IMT on exercise capacity and spontaneous physical activity in elderly individuals. Eighteen moderately active elderly subjects (68.1 +/- 6.8 years [mean +/- SD]; range 58 - 78 years) were randomly assigned to either an experimental group (n = 9) or a control group (n = 9) in a double-blind manner. All subjects underwent inspiratory muscle tes...

  15. Evaluation of the preliminary effectiveness of hand massage therapy on postoperative pain of adults in the intensive care unit after cardiac surgery: a pilot randomized controlled trial.

    Science.gov (United States)

    Boitor, Mădălina; Martorella, Géraldine; Arbour, Caroline; Michaud, Cécile; Gélinas, Céline

    2015-06-01

    Although many intensive care unit patients experience significant pain, very few studies explored massage to maximize their pain relief. This study aimed to evaluate the preliminary effects of hand massage on pain after cardiac surgery in the adult intensive care unit. A pilot randomized controlled trial was used for this study. The study was conducted in a Canadian medical-surgical intensive care unit. Forty adults who were admitted to the intensive care unit after undergoing elective cardiac surgery in the previous 24 hours participated in the study. They were randomly assigned to the experimental (n = 21) or control (n = 19) group. The experimental group received a 15-minute hand massage, and the control group received a 15-minute hand-holding without massage. In both groups the intervention was followed by a 30-minute rest period. The interventions were offered on 2-3 occasions within 24 hours after surgery. Pain, muscle tension, and vital signs were assessed. Pain intensity and behavioral scores were decreased for the experimental group. Although hand massage decreased muscle tension, fluctuations in vital signs were not significant. This study supports potential benefits of hand massage for intensive care unit postoperative pain management. Although larger randomized controlled trials are necessary, this low-cost nonpharmacologic intervention can be safely administered.

  16. Short cognitive behavioral therapy and cognitive training for adults with ADHD – a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Maarit Virta

    2010-07-01

    Full Text Available Maarit Virta1,2, Anita Salakari1, Mervi Antila1, Esa Chydenius1, Markku Partinen1, Markus Kaski1, Risto Vataja3, Hely Kalska2, Matti Iivanainen11Rinnekoti Research Centre, Espoo, Finland; 2Department of Psychology, University of Helsinki, Finland; 3Kellokoski Hospital, Kellokoski, FinlandAbstract: In clinical practice, a growing need exists for effective non-pharmacological ­treatments of adult attention-deficit/hyperactivity disorder (ADHD. Here, we present the results of a pilot study of 10 adults with ADHD participating in short-term individual ­cognitive-behavioral therapy (CBT, 9 adults participating in cognitive training (CT, and 10 controls. Self-report ­questionnaires, independent evaluations, and computerized neurocognitive testing were ­collected before and after the treatments to evaluate change. There were distinctive pre-hypotheses regarding the treatments, and therefore the statistical comparisons were conducted in pairs: CBT vs control, CT vs control, and CBT vs CT. In a combined ADHD symptom score based on self-reports, 6 participants in CBT, 2 in CT and 2 controls improved. Using independent evaluations, improvement was found in 7 of the CBT participants, 2 of CT ­participants and 3 controls. There was no treatment-related improvement in cognitive performance. Thus, in the CBT group, some encouraging improvement was seen, although not as clearly as in ­previous research with longer interventions. In the CT group, there was improvement in the trained tasks but no generalization of the improvement to the tasks of the neurocognitive testing, the ­self-report questionnaires, or the independent evaluations. These preliminary results warrant further studies with more participants and with more elaborate cognitive testing.Keywords: CBT, attention-deficit/hyperactivity disorder, cognitive testing, non-­pharmacological treatments

  17. Treatment of functional dyspepsia with sertraline:A double-blind randomized placebo-controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    Victoria PY Tan; Tin K Cheung; Wai M Wong; Roberta Pang; Benjamin CY Wong

    2012-01-01

    AIM:To evaluate sertraline,a selective serotonin reuptake inhibitor in the treatment of patients with functional dyspepsia.METHODS:Consecutive tertiaryhospital patients with a clinical diagnosis of functional dyspepsia (FD) according to the Rome Ⅱ criteria with a Hong Kong dyspepsia index (HKDI) of greater than 16 were recruited.Patients commenced enrolment prior to the inception of the Rome Ⅲ criteria for functional dyspepsia.All patients were ethnic Chinese,had a normal upper endoscopy and were Helicobacterpylori negative prior to enrolment.Study patients were randomized to receive sertraline 50 mg or placebo daily for 8 wk.HKDI symptom scores,quality of life,hospital anxiety and depression (HAD) scale and global symptom relief were evaluated before,during and after treatment.Adverse effects were monitored during and after treatment.RESULTS:A total of 193 patients were randomized in the intention to treat (ITT),and 150 patients were included in the per protocol (PP) analysis.In both the ITT and PP,there was no difference in the primary outcome of global dyspepsia symptoms between the sertraline and placebo groups at week 8.In the ITT analysis,98 and 95 patients were randomized to the sertraline and placebo groups respectively.A total of 43 patients withdrew from the study (22.3%) by week 8,with 23 of the 24 drop-outs in the sertraline group occurring prior to week 4 (95.8%).In contrast,in the placebo arm,11 of 19 patients dropped out by week 4 (57.9%).Utilizing the last response carried forward to account for the drop-outs,there were no differences between the sertraline and placebo groups at baseline in terms of the HKDI,HKDI 26.08 ± 6.19 vs 26.70 ±5.89,P =0.433; and at week 8,HKDI 22.41 ± 6.36 vs 23.25 ± 7.30,P =0.352 respectively.In the PP analysis,74 and 76 patients were randomized to the sertraline and placebo groups respectively.At baseline,there were no statistically significant differences between the sertraline and placebo groups,HKDI 25

  18. Household-based ceramic water filters for the prevention of diarrhea: a randomized, controlled trial of a pilot program in Colombia.

    Science.gov (United States)

    Clasen, Thomas; Garcia Parra, Gloria; Boisson, Sophie; Collin, Simon

    2005-10-01

    Household water treatment is increasingly recognized as an effective means of reducing the burden of diarrheal disease among low-income populations without access to safe water. Oxfam GB undertook a pilot project to explore the use of household-based ceramic water filters in three remote communities in Colombia. In a randomized, controlled trial over a period of six months, the filters were associated with a 75.3% reduction in arithmetic mean thermotolerant coliforms (TTCs) (P filters than among control households (odds ratio = 0.40, 95% confidence interval = 0.25, 0.63, P filters was not uniform throughout the study communities, suggesting the need to consider the circumstances of the particular setting before implementing this intervention.

  19. Effect of Aerobic Training on Cognitive Function and Arterial Stiffness in Sedentary Young Adults: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Samuel Asamoah

    2013-01-01

    Full Text Available This study measured cognitive and vascular responses to aerobic training in sedentary young adults. Ten adults (6 women, 4 men; 18–29 years were randomly assigned to an experimental or no-treatment control group. The experimental group engaged in a 6-week intervention, performed on exercise cycle and treadmill, 3x/week, 50 min/session; intensity was increased over time. Outcome measures included arterial stiffness (augmentation index, AIx, and pulse pressure, cardiorespiratory fitness (, and cognitive function (attention, processing speed, working memory, episodic memory, and executive function. Participants randomized to aerobic training improved processing speed versus control (, ES = 0.55. However, no group × time effects were noted in other domains of cognitive function. AIx was reduced by approximately 16% from before to after intervention in the experimental group; however, the improvement was not statistically significant versus control (, ES = 0.22. Pulse pressure did not change between groups over time (, ES = 0.0. increased by approximately 10% in the experimental group; however, the change was not significant between groups over time (, ES = 0.27. Vascular and cognitive adaptations to aerobic training may move in parallel. Robust trials simultaneously investigating a broad spectrum of aerobic training interventions and vascular and cognitive outcomes are warranted.

  20. The feasibility of progressive resistance training in women with polycystic ovary syndrome: a pilot randomized controlled trial.

    Science.gov (United States)

    Vizza, Lisa; Smith, Caroline A; Swaraj, Soji; Agho, Kingsley; Cheema, Birinder S

    2016-01-01

    To evaluate the feasibility of executing a randomized controlled trial of progressive resistance training (PRT) in women with polycystic ovary syndrome (PCOS). Women with PCOS were randomized to an experimental (PRT) group or a no-exercise (usual care) control group. The PRT group was prescribed two supervised and two unsupervised (home-based) training sessions per week for 12 weeks. Feasibility outcomes included recruitment and attrition, adherence, adverse events, and completion of assessments. Secondary outcomes, collected pre and post intervention, included a range of pertinent physiological, functional and psychological measures. Fifteen participants were randomised into the PRT group (n = 8) or control group (n = 7); five women (n = 2 in PRT group and n = 3 in control group) withdrew from the study. The most successful recruitment sources were Facebook (40 %) and online advertisement (27 %), while least successful methods were referrals by clinicians, colleagues and flyers. In the PRT group, attendance to supervised sessions was higher (95 %; standard deviation ±6 %) compared to unsupervised sessions (51 %; standard deviation ±28 %). No adverse events were attributed to PRT. Change in menstrual cycle status was not significantly different between groups over time (p = 0.503). However, the PRT group significantly increased body weight (p = 0.01), BMI (p = 0.04), lean mass (p = 0.01), fat-free mass (p = 0.005) and lower body strength (p = 0.03), while reducing waist circumference (p = 0.03) and HbA1c (p = 0.033) versus the control group. The PRT group also significantly improved across several domains of disease-specific and general health-related quality of life, depression, anxiety and exercise self-efficacy. A randomized controlled trial of PRT in PCOS would be feasible, and this mode of exercise may elicit a therapeutic effect on clinically important outcomes in this cohort. The success of a large

  1. Postoperative neurocognitive dysfunction in patients undergoing cardiac surgery after remote ischemic preconditioning: a double-blind randomized controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Patrick Meybohm

    Full Text Available BACKGROUND: Remote ischemic preconditioning (RIPC has been shown to enhance the tolerance of remote organs to cope with a subsequent ischemic event. We hypothesized that RIPC reduces postoperative neurocognitive dysfunction (POCD in patients undergoing complex cardiac surgery. METHODS: We conducted a prospective, randomized, double-blind, controlled trial including 180 adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. Patients were randomized either to RIPC or to control group. Primary endpoint was postoperative neurocognitive dysfunction 5-7 days after surgery assessed by a comprehensive test battery. Cognitive change was assumed if the preoperative to postoperative difference in 2 or more tasks assessing different cognitive domains exceeded more than one SD (1 SD criterion or if the combined Z score was 1.96 or greater (Z score criterion. RESULTS: According to 1 SD criterion, 52% of control and 46% of RIPC patients had cognitive deterioration 5-7 days after surgery (p = 0.753. The summarized Z score showed a trend to more cognitive decline in the control group (2.16±5.30 compared to the RIPC group (1.14±4.02; p = 0.228. Three months after surgery, incidence and severity of neurocognitive dysfunction did not differ between control and RIPC. RIPC tended to decrease postoperative troponin T release at both 12 hours [0.60 (0.19-1.94 µg/L vs. 0.48 (0.07-1.84 µg/L] and 24 hours after surgery [0.36 (0.14-1.89 µg/L vs. 0.26 (0.07-0.90 µg/L]. CONCLUSIONS: We failed to demonstrate efficacy of a RIPC protocol with respect to incidence and severity of POCD and secondary outcome variables in patients undergoing a wide range of cardiac surgery. Therefore, definitive large-scale multicenter trials are needed. TRIAL REGISTRATION: ClinicalTrials.gov NCT00877305.

  2. Practicing evidence based medicine at the bedside: a randomized controlled pilot study in undergraduate medical students assessing the practicality of tablets, smartphones, and computers in clinical life.

    Science.gov (United States)

    Friederichs, Hendrik; Marschall, Bernhard; Weissenstein, Anne

    2014-12-05

    Practicing evidence-based medicine is an important aspect of providing good medical care. Accessing external information through literature searches on computer-based systems can effectively achieve integration in clinical care. We conducted a pilot study using smartphones, tablets, and stationary computers as search devices at the bedside. The objective was to determine possible differences between the various devices and assess students' internet use habits. In a randomized controlled pilot study, 120 students were divided in three groups. One control group solved clinical problems on a computer and two intervention groups used mobile devices at the bedside. In a questionnaire, students were asked to report their internet use habits as well as their satisfaction with their respective search tool using a 5-point Likert scale. Of 120 surveys, 94 (78.3%) complete data sets were analyzed. The mobility of the tablet (3.90) and the smartphone (4.39) was seen as a significant advantage over the computer (2.38, p computer (3.22) was rated superior to both tablet computers (2.13) and smartphones (1.68). No significant differences were detected between tablets and smartphones except satisfaction with screen size (tablet 4.10, smartphone 2.00, p computers. However, mobility is regarded as a substantial advantage, and therefore future applications might facilitate quick and simple searches at the bedside.

  3. Transcutaneous noninvasive vagus nerve stimulation (tVNS) in the treatment of schizophrenia: a bicentric randomized controlled pilot study.

    Science.gov (United States)

    Hasan, Alkomiet; Wolff-Menzler, Claus; Pfeiffer, Sebastian; Falkai, Peter; Weidinger, Elif; Jobst, Andrea; Hoell, Imke; Malchow, Berend; Yeganeh-Doost, Peyman; Strube, Wolfgang; Quast, Silke; Müller, Norbert; Wobrock, Thomas

    2015-10-01

    Despite many pharmacological and psychosocial treatment options, schizophrenia remains a debilitating disorder. Thus, new treatment strategies rooted in the pathophysiology of the disorder are needed. Recently, vagus nerve stimulation (VNS) has been proposed as a potential treatment option for various neuropsychiatric disorders including schizophrenia. The objective of this study was to investigate for the first time the feasibility, safety and efficacy of transcutaneous VNS in stable schizophrenia. A bicentric randomized, sham-controlled, double-blind trial was conducted from 2010 to 2012. Twenty schizophrenia patients were randomly assigned to one of two treatment groups. The first group (active tVNS) received daily active stimulation of the left auricle for 26 weeks. The second group (sham tVNS) received daily sham stimulation for 12 weeks followed by 14 weeks of active stimulation. Primary outcome was defined as change in the Positive and Negative Symptom Scale total score between baseline and week 12. Various other secondary measures were assessed to investigate safety and efficacy. The intervention was well tolerated with no relevant adverse effects. We could not observe a statistically significant difference in the improvement of schizophrenia psychopathology during the observation period. Neither psychopathological and neurocognitive measures nor safety measures showed significant differences between study groups. Application of tVNS was well tolerated, but did not improve schizophrenia symptoms in our 26-week trial. While unsatisfactory compliance questions the feasibility of patient-controlled neurostimulation in schizophrenia, the overall pattern of symptom change might warrant further investigations in this population.

  4. A Pilot Study Evaluating the Effectiveness of Platelet-Rich Plasma Therapy for Treating Degenerative Tendinopathies: A Randomized Control Trial with Synchronous Observational Cohort.

    Directory of Open Access Journals (Sweden)

    Marni Wesner

    Full Text Available This pilot study aimed to inform future research evaluating the effectiveness of Platelet Rich Plasma (PRP injection for tendinopathy.Randomized control trial (RCT and synchronous observational cohort studies. For the RCT, consecutive consenting patients treated at an academic sports medicine clinic were randomly assigned to either a PRP or placebo control group.The Glen Sather Sport Medicine Clinic, Edmonton, Canada.The RCT included 9 participants with rotator cuff tendinopathy. The cohort study included 178 participants with a variety of tendinopathies.Patients receiving PRP were injected with 4 ml of platelets into the supraspinatus and/or infraspinatus, while patients in the placebo group were injected with 4 ml of saline. All participants undertook a 3-month standardized, home-based, daily exercise program.Participants in the RCT were re-evaluated 3, and 6 months post-injection. Change scores before and after injection on pain, disability and MRI-documented pathology outcomes were compared. In the cohort study, pain and disability were measured at 1, 2 and 3 months post-injection.For the RCT, 7 participants received PRP and 2 received placebo injections. Patients receiving PRP reported clinically important improvements in pain (>1.5/10 on VAS, disability (>15 point DASH change, and tendon pathology while those receiving placebo injections did not. In the observational cohort, statistically and clinically significant improvements in pain and disability were observed.This pilot study provides information for planning future studies of PRP effectiveness. Preliminary results indicate intratendinous, ultrasound-guided PRP injection may lead to improvements in pain, function, and MRI-documented tendon pathology.Controlled-Trials.com ISRCTN68341698.

  5. Does wearing unstable shoes reduce low back pain and disability in nurses? A randomized controlled pilot study.

    Science.gov (United States)

    Vieira, Edgar R; Brunt, Denis

    2016-02-01

    To evaluate if wearing unstable shoes reduces low back pain and disability in nurses. A randomized controlled trial. Hospitals and homecare. A total of 20 matched female registered nurses with low back pain. The mean (standard deviation) age was 31 years (5) for the control and 34 years (6) for the intervention group; height was 161 cm (5) and 165 cm (7), respectively. The intervention group received unstable shoes at Week 2 to wear for at least 36 h/week for a month. The Oswestry Low Back Pain Disability Questionnaire and a visual analogue pain scale. The mean (standard deviation) pain level was 6 (1) at baseline vs. 6 (2) at Week 6 for the control group, and 5 (1) vs. 1 (1) for the intervention group. The mean (standard deviation) disability level was 31% (9) at baseline vs. 28% (7) at Week 6 for the control, and 27% (12) vs. 13% (5) for the intervention group. There were no significant changes over time on pain or disability levels for the control group. The intervention group reported lower levels of pain on Weeks 4 (mean difference ⩾-1.4, p ⩽ 0.009) and 6 (mean difference ⩾-3.1, p back pain and disability in nurses and might be helpful as part of the back pain rehabilitation process. © The Author(s) 2015.

  6. A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety

    DEFF Research Database (Denmark)

    Qintar, Mohammed; George, Jason J; Panko, Melanie

    2015-01-01

    consisted of two parts: part 1 (N = 690) was a prospective cross-sectional observational study of consecutive ICD patients. Patients completed the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder Scale (GAD-7), Florida Shock Anxiety Scale (FSAS), and Florida Patient Acceptance Survey (FPAS......PURPOSE: Stress and anxiety are potential consequences from arrhythmias and implantable cardioverter defibrillator (ICD) shocks that can contribute to substantial morbidity. We assessed anxiety associated with an ICD and whether cognitive behavioral therapy (CBT) reduces anxiety. METHODS: The study......) psychometric tests. Part 2 (N = 29) was a pilot randomized controlled trial of CBT (three sessions in 3 months) vs. usual care (UC) in patients with BAI ≥ 19 from part 1. RESULTS: The median BAI and GAD-7 scores were 5 and 2, respectively. By BAI scores, 64.5 % had minimal and 3.9 % had severe anxiety. By GAD...

  7. Beneficial effects of fenugreek glycoside supplementation in male subjects during resistance training:A randomized controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    Sachin Wankhede; Vishwaraman Mohan; Prasad Thakurdesai

    2016-01-01

    Purpose: To evaluate the efficacy and safety of the glycoside fraction of fenugreek (Trigonella foenum-graecum) seeds (Fenu-FG) on physiologi-cal parameters related to muscle anabolism, androgenic hormones, and body fat in healthy male subjects during an 8-week resistance training program using a prospective, randomized, double-blind, placebo controlled design. Methods: Sixty healthy male subjects were randomized to ingest capsules of Fenu-FG (1 capsule of 300 mg, twice per day) or the matching placebo at a 1:1 ratio. The subjects participated in a supervised 4-day per week resistance-training program for 8 weeks. The outcome measurements were recorded at recruitment (baseline) and at the end of the treatment (8 weeks). The efficacy outcome included serum testosterone (total and free) levels, muscle strength and repetitions to failure, metabolic markers for anabolic activity (serum creatinine and blood urea nitrogen), and % body fat. The standard safety measurements such as adverse events monitoring, vital signs, hematology, biochemistry, and urinalysis were performed. Results: Fenu-FG supplementation demonstrated significant anabolic and androgenic activity as compared with the placebo. Fenu-FG treated subjects showed significant improvements in body fat without a reduction in muscle strength or repetitions to failure. The Fenu-FG supplemen-tation was found to be safe and well-tolerated. Conclusion: Fenu-FG supplementation showed beneficial effects in male subjects during resistance training without any clinical side effects.

  8. Bilateral robotic priming before task-oriented approach in subacute stroke rehabilitation: a pilot randomized controlled trial.

    Science.gov (United States)

    Hsieh, Yu-Wei; Wu, Ching-Yi; Wang, Wei-En; Lin, Keh-Chung; Chang, Ku-Chou; Chen, Chih-Chi; Liu, Chien-Ting

    2017-02-01

    To investigate the treatment effects of bilateral robotic priming combined with the task-oriented approach on motor impairment, disability, daily function, and quality of life in patients with subacute stroke. A randomized controlled trial. Occupational therapy clinics in medical centers. Thirty-one subacute stroke patients were recruited. Participants were randomly assigned to receive bilateral priming combined with the task-oriented approach (i.e., primed group) or to the task-oriented approach alone (i.e., unprimed group) for 90 minutes/day, 5 days/week for 4 weeks. The primed group began with the bilateral priming technique by using a bimanual robot-aided device. Motor impairments were assessed by the Fugal-Meyer Assessment, grip strength, and the Box and Block Test. Disability and daily function were measured by the modified Rankin Scale, the Functional Independence Measure, and actigraphy. Quality of life was examined by the Stroke Impact Scale. The primed and unprimed groups improved significantly on most outcomes over time. The primed group demonstrated significantly better improvement on the Stroke Impact Scale strength subscale ( p = 0.012) and a trend for greater improvement on the modified Rankin Scale ( p = 0.065) than the unprimed group. Bilateral priming combined with the task-oriented approach elicited more improvements in self-reported strength and disability degrees than the task-oriented approach by itself. Further large-scale research with at least 31 participants in each intervention group is suggested to confirm the study findings.

  9. Effect of text messages to improve health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled pilot trial.

    Science.gov (United States)

    Sugita, Hideki; Shinohara, Ryoji; Yokomichi, Hiroshi; Suzuki, Kohta; Yamagata, Zentaro

    2017-08-01

    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 reminder messages that were sent to the control group. The primary outcome was the difference in the change rate of scores on the Morisky Eight-Item Medication Adherence Scale (MMAS-8). Forty-one participants were randomized into the intervention (n = 21) and control (n = 20) groups and completed the 6-month follow-up. Although almost participants read and understood the information provided in the messages, no significant difference was observed between groups for the primary outcome (p = 0.78). Our results suggested that medication adherence at 6 months after discharge in patients with type 2 diabetes did not significantly change by text messages, which aimed to improve their HL levels.

  10. Effectiveness of polaprezinc for low-dose aspirin-induced small-bowel mucosal injuries as evaluated by capsule endoscopy: a pilot randomized controlled study.

    Science.gov (United States)

    Watari, Ikue; Oka, Shiro; Tanaka, Shinji; Aoyama, Taiki; Imagawa, Hiroki; Shishido, Takayoshi; Yoshida, Shigeto; Chayama, Kazuaki

    2013-07-04

    Treatment of low-dose aspirin (LDA)-induced small-bowel injury has not been established. Polaprezinc, a chelate of zinc and L-carnosine, may be efficacious for such injury. We conducted a pilot randomized controlled study to investigate whether polaprezinc is effective against LDA-induced small-bowel injuries. Consecutive patients under long-term (>3 months) LDA treatment and who agreed to participate in our study underwent initial capsule endoscopy (CE). Patients with LDA-induced small-bowel injury apparent upon initial CE (n = 20) were randomized into a polaprezinc (150 mg/day for 4 weeks) group and a control (no polaprezinc treatment) group. All underwent follow-up CE after 4 weeks. Changes in the number and characteristics of small-bowel mucosal injuries were compared within and between the two groups. The median number of reddened lesions and erosions/ulcers upon follow-up CE in the polaprezinc group significantly decreased (P < 0.05). However, there was no significant difference in the median number of reddened lesions and erosions/ulcers upon follow-up CE in the control group. Co-administration of polaprezinc may be effective against small-bowel mucosal injury associated with long-term LDA therapy.

  11. Targeting Ruminative Thinking in Adolescents at Risk for Depressive Relapse: Rumination-Focused Cognitive Behavior Therapy in a Pilot Randomized Controlled Trial with Resting State fMRI.

    Science.gov (United States)

    Jacobs, Rachel H; Watkins, Edward R; Peters, Amy T; Feldhaus, Claudia G; Barba, Alyssa; Carbray, Julie; Langenecker, Scott A

    2016-01-01

    This pilot randomized control trial was designed to examine whether Rumination-Focused Cognitive Behavior Therapy (RFCBT) reduces rumination and residual depressive symptoms among adolescents with a history of Major Depressive Disorder (MDD) who are at risk for relapse. We also examined whether these changes in symptoms were associated with changes in functional connectivity of the posterior cingulate cortex (PCC), a key node in the default mode network (DMN). Thirty-three adolescents (ages 12-18) were randomized to eight weeks of RFCBT or an assessment only (AO) control. Twenty two adolescents successfully completed fMRI scans pre- and post-intervention. Adolescents were recruited from the clinic and community and met criteria for at least one previous episode of MDD and were currently in full or partial remission. An Independent Evaluator interviewed parent and child before and after the eight-week intervention. The left PCC (-5, -50, 36) seed was used to probe resting state functional connectivity of the DMN. Adolescents who received RFCBT demonstrated reduced rumination (F = -2.76, df = 112, p depression across eight weeks (F = -2.58, df = 113, p depression and rumination. These data suggest that rumination can be reduced over eight weeks and that this reduction is associated with parallel decreases in residual depressive symptoms and decreased functional connectivity of the left PCC with cognitive control nodes. These changes may enhance the ability of vulnerable youth to stay well during the transition to adulthood. ClinicalTrials.gov NCT01905267.

  12. Postoperative Neurocognitive Dysfunction in Patients Undergoing Cardiac Surgery after Remote Ischemic Preconditioning: A Double-Blind Randomized Controlled Pilot Study

    Science.gov (United States)

    Meybohm, Patrick; Renner, Jochen; Broch, Ole; Caliebe, Dorothee; Albrecht, Martin; Cremer, Jochen; Haake, Nils; Scholz, Jens; Zacharowski, Kai; Bein, Berthold

    2013-01-01

    Background Remote ischemic preconditioning (RIPC) has been shown to enhance the tolerance of remote organs to cope with a subsequent ischemic event. We hypothesized that RIPC reduces postoperative neurocognitive dysfunction (POCD) in patients undergoing complex cardiac surgery. Methods We conducted a prospective, randomized, double-blind, controlled trial including 180 adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. Patients were randomized either to RIPC or to control group. Primary endpoint was postoperative neurocognitive dysfunction 5–7 days after surgery assessed by a comprehensive test battery. Cognitive change was assumed if the preoperative to postoperative difference in 2 or more tasks assessing different cognitive domains exceeded more than one SD (1 SD criterion) or if the combined Z score was 1.96 or greater (Z score criterion). Results According to 1 SD criterion, 52% of control and 46% of RIPC patients had cognitive deterioration 5–7 days after surgery (p = 0.753). The summarized Z score showed a trend to more cognitive decline in the control group (2.16±5.30) compared to the RIPC group (1.14±4.02; p = 0.228). Three months after surgery, incidence and severity of neurocognitive dysfunction did not differ between control and RIPC. RIPC tended to decrease postoperative troponin T release at both 12 hours [0.60 (0.19–1.94) µg/L vs. 0.48 (0.07–1.84) µg/L] and 24 hours after surgery [0.36 (0.14–1.89) µg/L vs. 0.26 (0.07–0.90) µg/L]. Conclusions We failed to demonstrate efficacy of a RIPC protocol with respect to incidence and severity of POCD and secondary outcome variables in patients undergoing a wide range of cardiac surgery. Therefore, definitive large-scale multicenter trials are needed. Trial Registration ClinicalTrials.gov NCT00877305 PMID:23741380

  13. Acupuncture decreases competitive anxiety prior to a competition in young athletes: a randomized controlled trial pilot study.

    Science.gov (United States)

    Zarei, Sahar; Shayestehfar, Monir; Memari, Amir-Hossein; SeifBarghi, Tohid; Sobhani, Vahid

    2017-03-01

    Background Although a certain level of competitive anxiety may increase performance, many athletes with anxiety experience uncontrolled negative feelings and cognition that in turn can have overwhelming effects on their performance. Methods We aimed to assess the effect of acupuncture on competitive anxiety of the adolescent football players prior to the competition using psychological and physiological markers. A total of 30 athletes were randomly and equally allocated to either acupuncture or sham control group. Results The results of t-test on posttest scores showed that acupuncture had a significant effect on cognitive anxiety (p=0.001) and somatic anxiety (p0.05). Furthermore, the results showed that acupuncture significantly decreased the skin conductance in acupuncture group compared to sham group (p=0.006) (p<0.001). Conclusions In conclusion, the results suggested that acupuncture has the capacity to decrease cognitive and somatic anxiety prior to competition in adolescent athletes while this was accompanied by significant physiological changes.

  14. Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: pilot randomized controlled trial.

    Science.gov (United States)

    Twamley, Elizabeth W; Jak, Amy J; Delis, Dean C; Bondi, Mark W; Lohr, James B

    2014-01-01

    Traumatic brain injury (TBI) can result in cognitive impairments and persistent postconcussive symptoms that limit functional recovery, including return to work. We evaluated a 12 wk compensatory cognitive training intervention (Cognitive Symptom Management and Rehabilitation Therapy [CogSMART]) in the context of supported employment for Veterans with mild to moderate TBI. Participants were randomly assigned to receive 12 wk of supported employment plus CogSMART or enhanced supported employment that controlled for therapist attention (control). CogSMART sessions were delivered by the employment specialist and included psychoeducation regarding TBI; strategies to improve sleep, fatigue, headaches, and tension; and compensatory cognitive strategies in the domains of prospective memory, attention, learning and memory, and executive functioning. Compared with controls, those assigned to supported employment plus CogSMART demonstrated significant reductions in postconcussive symptoms (Cohen d = 0.97) and improvements in prospective memory functioning (Cohen d = 0.72). Effect sizes favoring CogSMART for posttraumatic stress disorder symptom severity, depressive symptom severity, and attainment of competitive work within 14 wk were in the small to medium range (Cohen d = 0.35-0.49). Those who received CogSMART rated the intervention highly. Results suggest that adding CogSMART to supported employment may improve postconcussive symptoms and prospective memory. These effects, as well as smaller effects on psychiatric symptoms and ability to return to work, warrant replication in a larger trial.

  15. Effect of honey on 50% complement hemolytic activity in infants with protein energy malnutrition: a randomized controlled pilot study.

    Science.gov (United States)

    Abdulrhman, Mamdouh Abdulmaksoud; Nassar, May Fouad; Mostafa, Hisham Waheed; El-Khayat, Zakaria Abdulhalim; Abu El Naga, Marwa Wageh

    2011-05-01

    Protein energy malnutrition (PEM) is associated with a significant impairment of cell-mediated immunity and complement system, which may be responsible for the high incidence of infections among these patients. This study was designed to examine the effect of honey, as a natural substance, on the 50% complement hemolytic activity (CH50) in patients with PEM. Thirty patients with PEM and 20 healthy infants serving as controls participated in this study. The patients were randomized to receive either honey (group 1) or placebo (group 2), in addition to conventional nutritional rehabilitation therapy. Measurements of weight, midarm circumference, skin fold thickness, serum albumin, and CH50 were done for all patients before and after 2 weeks of rehabilitation. Before nutritional rehabilitation, the CH50 was significantly lower in the PEM groups compared with the control. However, after rehabilitation, the CH50 increased significantly in both PEM groups, compared with the pre-interventional state and with the controls. Moreover, the rise of CH50 was significantly more in the honey group compared with the placebo. On the other hand, the improvement in the anthropometric measures and serum albumin did not differ significantly between the honey and placebo groups after rehabilitation. Thus honey supplementation in patients with PEM increased the level of CH50. Whether this would have an effect on the frequency and severity of infections in patients with PEM needs further studies.

  16. Text Message Feedback to Support Mindfulness Practice in People With Depressive Symptoms: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Kraft, Susanne; Wolf, Markus; Klein, Thomas; Becker, Thomas; Bauer, Stephanie; Puschner, Bernd

    2017-05-02

    full-size RCT. Such a larger study should also include a process evaluation to investigate moderators of the effect of mindfulness practice and text message feedback on clinical outcome. International Standard Randomized Controlled Trial Number (ISRCTN): 58808893; http://www.controlled-trials.com/ISRCTN58808893 (Archived by Webcite at http://www.webcitation.org/6pmrDRnGt).

  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. 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.

    2013-01-01

    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…

  20. 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…

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

    Science.gov (United States)

    Ginsburg, Golda S.; 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%…

  2. Effects of sulfur bath on hip osteoarthritis: a randomized, controlled, single-blind, follow-up trial: a pilot study

    Science.gov (United States)

    Kovács, Csaba; Bozsik, Ágnes; Pecze, Mariann; Borbély, Ildikó; Fogarasi, Andrea; Kovács, Lajos; Tefner, Ildikó Katalin; Bender, Tamás

    2016-11-01

    The effects of balneotherapy were evaluated in patients with osteoarthritis of the hip. This randomized, controlled, investigator-blinded study enrolled outpatients with hip osteoarthritis according to ACR criteria. In addition to home exercise therapy, one patient group received balneotherapy for 3 weeks on 15 occasions. The mineral water used in this study is one of the mineral waters with the highest sulfide ion content (13.2 mg/L) in Hungary. The control group received exercise therapy alone. The WOMAC Likert 3.1 index and the EQ-5D quality of life self-administered questionnaire were completed three times during the study: prior to first treatment, at the end of the 3-week treatment course, and 12 weeks later. The main endpoint was achievement of Minimal Clinically Important Improvement (MCII) at 12 weeks, defined as ≥7.9 points in a normalized WOMAC function score. The intention to treat analysis included 20 controls and 21 balneotherapy patients. At 12 weeks, 17 (81 %) balneotherapy group patients had Minimal Clinically Important Improvement and 6 (30 %) of controls ( p = 0.001). Comparing the results of the two groups at the end of treatment, there was a significant difference in the WOMAC stiffness score only, whereas after 12 weeks, the WOMAC pain, stiffness, function, and total scores also showed a significant difference in favor of the balneotherapy group. The difference between the two groups was significant after 12 weeks in point of EQVAS score, too. The results of our study suggest that the combination of balneotherapy and exercise therapy achieves more sustained improvement of joint function and decreases in pain than exercise therapy alone.

  3. Internet-based acceptance and commitment therapy for psychological distress experienced by people with hearing problems: a pilot randomized controlled trial.

    Science.gov (United States)

    Molander, Peter; Hesser, Hugo; Weineland, Sandra; Bergwall, Kajsa; Buck, Sonia; Jäder Malmlöf, Johan; Lantz, Henning; Lunner, Thomas; Andersson, Gerhard

    2017-09-12

    Psychological distress is common among people with hearing problems, but treatments that specifically target this aspect have been almost non-existent. In this pilot randomized controlled trial, an eight-week long Internet-based treatment, informed by Acceptance and Commitment Therapy, was administered to explore the feasibility and efficacy of such a treatment. Included participants were randomized to either treatment (n = 31) or wait-list control (n = 30) condition. All participants were measured prior to randomization and immediately after treatment ended using standardized self-report instruments measuring hearing-related emotional and social adjustment (Hearing Handicap Inventory for the Elderly - S, HHIE-S), quality of life (Quality of Life Inventory, QOLI), and symptoms of depression and anxiety (Patient health Questionnaire, PHQ-9 and Generalized Anxiety Disorder scale, GAD-7). Linear mixed effects regression analysis using the full intention-to-treat sample demonstrated that the treatment had superior outcomes on the main outcome measure as compared with the control group, Cohen's d = 0.93, 95% CI [0.24, 1.63]. The benefits of treatment over control were also evident in scores of depression, Cohen's d = 0.61, 95% CI [0.04, 1.19], and quality of life, Cohen's d = 0.88, 95% CI [0.14, 1.61]. The results provide preliminary support for Internet-delivered acceptance and commitment therapy as a potentially effective treatment of psychological symptoms associated with hearing problems.

  4. Effects of tai chi qigong on psychosocial well-being among hidden elderly, using elderly neighborhood volunteer approach: a pilot randomized controlled trial

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    Chan AW

    2017-01-01

    Full Text Available Aileen WK Chan, Doris SF Yu, KC Choi The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR Purpose: 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. Patients and methods: “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 workers. Primary outcomes were assessed by means of the Lubben social network and De Jong Gieveld loneliness scales, and by a revised social support questionnaire. Secondary outcomes were covered by a mental health inventory and the Rosenberg self-esteem scale, and quality of life by using the 12-Item Short Form Health Survey. Data was collected at baseline, and at three and six months thereafter. Results: The generalized estimating equations model revealed general improvement in outcomes among participants on the tai chi qigong program. In particular, participants reported a significantly greater improvement on the loneliness scale (B=-1.32, 95% confidence interval [CI] -2.54 to -0.11, P=0.033 and the satisfaction component of the social support questionnaire (B=3.43, 95% CI 0.10–6.76, P=0.044 than the control group. Conclusion: The pilot study confirmed that tai chi qigong with elderly neighborhood volunteers is a safe and feasible social intervention for hidden elderly. Its potential benefits in

  5. Effect of inspiratory muscle training on respiratory capacity and walking ability with subacute stroke patients: a randomized controlled pilot trial.

    Science.gov (United States)

    Jung, Kyeong-Man; Bang, Dae-Hyouk

    2017-02-01

    [Purpose] To investigate the effects of inspiratory muscle training on respiratory capacity and walking ability in subacute stroke patients. [Subjects and Methods] The subjects were randomly assigned to an experimental group (n=6) or a control group (n=6). Patients in the experimental group received inspiratory muscle training for 30 minutes (six sets of five-minutes) and traditional physical therapy once a day, five days a week, for four weeks. The control group received aerobic exercise for 30 minutes and traditional physical therapy for 30 minutes a day, five days a week, for four weeks. [Results] After the intervention, both groups showed significant improvements in the forced vital capacity, forced expiratory volume in one second, 10-meter walking test, and six-minute walking test over the baseline results. There were significant between-group differences for the forced vital capacity, forced expiratory volume in one second, and six-minute walking test. No statistically significant differences were observed for measures of saturation pulse oximetry oxygen and 10-meter walking test between the groups. [Conclusion] These findings gave some indications that inspiratory muscle training may benefit in patients with subacute stroke, and it is feasible to be included in rehabilitation program with this population.

  6. Using technology to promote postpartum weight loss in urban, low-income mothers: a pilot randomized controlled trial.

    Science.gov (United States)

    Herring, Sharon J; Cruice, Jane F; Bennett, Gary G; Davey, Adam; Foster, Gary D

    2014-01-01

    To examine the feasibility, acceptability, and initial efficacy of a technology-based weight loss intervention for urban, low-income mothers. Eighteen obese, ethnic minority, socioeconomically disadvantaged mothers in the first year after childbirth were randomly assigned to either: 1) technology-based intervention, which included empirically supported behavior-change strategies, daily skills, and self-monitoring text messages with personalized feedback, biweekly counseling calls from a health coach, and access to a Facebook support group, or 2) usual-care control. After 14 weeks of treatment, the technology-based intervention participants had significantly greater weight loss (-2.9 ± 3.6 kg) than usual care (0.5 ± 2.3 kg; adjusted mean difference: -3.2 kg, 95% confidence interval -6.2 to -0.1 kg, P = .04). One-third of intervention participants (3 of 9) and no control participants lost > 5% of their initial body weight at follow up. Results suggest the potential for using technology to deliver a postpartum weight loss intervention among low-income racial/ethnic minorities. Copyright © 2014 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  7. Mirror therapy enhances motor performance in the paretic upper limb after stroke: a pilot randomized controlled trial.

    Science.gov (United States)

    Samuelkamaleshkumar, Selvaraj; Reethajanetsureka, Stephen; Pauljebaraj, Paul; Benshamir, Bright; Padankatti, Sanjeev Manasseh; David, Judy Ann

    2014-11-01

    To investigate the effectiveness of mirror therapy (MT) combined with bilateral arm training and graded activities to improve motor performance in the paretic upper limb after stroke. Randomized, controlled, assessor-blinded study. Inpatient stroke rehabilitation center of a tertiary care teaching hospital. Patients with first-time ischemic or hemorrhagic stroke (N=20), confined to the territory of the middle cerebral artery, occurring rehabilitation program including conventional occupational therapy, physical therapy, and speech therapy for 5 d/wk, 6 h/d, over 3 weeks. The participants in the MT group received 1 hour of MT in addition to the conventional stroke rehabilitation. The Upper Extremity Fugl-Meyer Assessment for motor recovery, Brunnstrom stages of motor recovery for the arm and hand, Box and Block Test for gross manual hand dexterity, and modified Ashworth scale to assess the spasticity. After 3 weeks of MT, mean change scores were significantly greater in the MT group than in the control group for the Fugl-Meyer Assessment (P=.008), Brunnstrom stages of motor recovery for the arm (P=.003) and hand (P=.003), and the Box and Block Test (P=.022). No significant difference was found between the groups for modified Ashworth scale (P=.647). MT when combined with bilateral arm training and graded activities was effective in improving motor performance of the paretic upper limb after stroke compared with conventional therapy without MT. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  8. Meditation and Music Improve Memory and Cognitive Function in Adults with Subjective Cognitive Decline: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

    2017-01-01

    While effective therapies for preventing or slowing cognitive decline in at-risk populations remain elusive, evidence suggests mind-body interventions may hold promise. In this study, we assessed the effects of Kirtan Kriya meditation (KK) and music listening (ML) on cognitive outcomes in adults experiencing subjective cognitive decline (SCD), a strong predictor of Alzheimer's disease. Sixty participants with SCD were randomized to a KK or ML program and asked to practice 12 minutes/day for 3 months, then at their discretion for the ensuing 3 months. At baseline, 3 months, and 6 months we measured memory and cognitive functioning [Memory Functioning Questionnaire (MFQ), Trail-making Test (TMT-A/B), and Digit-Symbol Substitution Test (DSST)]. The 6-month study was completed by 53 participants (88%). Participants performed an average of 93% (91% KK, 94% ML) of sessions in the first 3 months, and 71% (68% KK, 74% ML) during the 3-month, practice-optional, follow-up period. Both groups showed marked and significant improvements at 3 months in memory and cognitive performance (MFQ, DSST, TMT-A/B; p's≤0.04). At 6 months, overall gains were maintained or improved (p's≤0.006), with effect sizes ranging from medium (DSST, ML group) to large (DSST, KK group; TMT-A/B, MFQ). Changes were unrelated to treatment expectancies and did not differ by age, gender, baseline cognition scores, or other factors. Findings of this preliminary randomized controlled trial suggest practice of meditation or ML can significantly enhance both subjective memory function and objective cognitive performance in adults with SCD, and may offer promise for improving outcomes in this population.

  9. Methylphenidate for treating tobacco dependence in non-attention deficit hyperactivity disorder smokers: A pilot randomized placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Croghan Ivana T

    2011-01-01

    Full Text Available Abstract Background Methylphenidate blocks the re-uptake of dopamine by binding to the dopamine transporter in the presynaptic cell membrane and increases extracellular dopamine levels. Similarities in neuropsychologic effects between nicotine and methylphenidate make it an intriguing potential therapeutic option. Previous research of methylphenidate in smokers has suggested a possible beneficial effect for the relief of nicotine withdrawal symptoms, but showed no efficacy in helping smokers with attention deficit hyperactivity disorder (ADHD to stop smoking. Methods To investigate potential efficacy for relieving nicotine withdrawal symptoms and promoting smoking abstinence, we conducted a randomized, double-blind, placebo-controlled, phase II study of once-a-day osmotic-release oral system methylphenidate (OROS-MPH, Concerta® at a target dose of 54-mg/day for 8 weeks compared with placebo in 80 adult cigarette smokers. Results Of the 80 randomized subjects and median smoking rate was 20 cigarettes per day. At the end of the medication phase, the biochemically confirmed 7-day point prevalence smoking abstinence was 10% (4/40 for the placebo group and 2.5% (1/40 for the OROS-MPH group. Nicotine withdrawal was not found to differ significantly between treatment groups during the first 14 days following the start of medication prior to the target quit date (p = 0.464 or during the first 14 days following the target quit date (p = 0.786. Conclusion We observed no evidence of efficacy of OROS-MPH to aid smokers to stop smoking. Although there are biologically plausible hypotheses that support the use of OROS-MPH for treating tobacco dependence, we found no evidence to support such hypotheses. In addition to no increase in smoking abstinence, we saw no effect of OROS-MPH for tobacco withdrawal symptom relief and no change in smoking rates was observed in the OROS-MPH group compared to the placebo group.

  10. Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial

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    Seungwon Shin

    2016-01-01

    Full Text Available This pilot multicentered, randomized, parallel, sham-controlled trial is intended to evaluate the effectiveness and safety of electroacupuncture therapy for poststroke patients with urinary incontinence. Forty stroke survivors aged >19 years will be recruited in 2 hospitals in the Republic of Korea. Patients who experienced stroke within 2 years and satisfy criteria of urinary frequencies ≥2 with either 3 to 4 points on the Patient Perception of Intensity of Urgency Scale or 13 points or more on the Korean version of the International Prostate Symptom Scale (K-IPSS will be identified, along with other eligibility criteria. Patients will be randomly allocated to either a treatment or control group to receive 10 sessions of electroacupuncture or sham therapies, respectively. Patients and outcome assessors will be blinded. The primary outcome is the change of Total Urgency and Frequency Score between the baseline and the trial endpoint. The K-IPSS, the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form, and the Lower Urinary Tract Symptoms Outcome Score will be evaluated for effectiveness assessment. Adverse events will be reported after every session. The Blinding Index will also be calculated. Data will be statistically analyzed with 0.05 significance levels by 2-sided testing.

  11. A randomized controlled dose-response pilot study of addition of hCG to recombinant FSH during controlled ovarian stimulation for in vitro fertilization.

    Science.gov (United States)

    Thuesen, L L; Loft, A; Egeberg, A N; Smitz, J; Petersen, J H; Andersen, A Nyboe

    2012-10-01

    Is it possible to define an optimal dose of hCG in combination with rFSH from the first day of stimulation in the GnRH agonist protocol applied to IVF? Supplementation with hCG from the first day of stimulation may increase the number of top-quality embryos per patient. Daily doses of hCG up to 150 IU are compatible with good live birth rates. A ceiling level of estradiol (E(2)) was reached with hCG doses above 100 IU/day. A positive dose-response was seen for pre-ovulatory progesterone, but concentrations remained below values for which an impairment of endometrial receptivity has been previously reported. We suggest a large clinical trial to be proceeded with a group given 100 IU hCG daily versus a control group. Prospective multicentre studies have indicated increased live birth rates and increased number of top-quality embryos when low doses of hCG were associated with FSH. We analysed the clinical, embryological and endocrine aspects of adding increasing doses of hCG to rFSH from the first day of stimulation for IVF. A prospective randomized, controlled, open-label dose-response pilot study was conducted between February 2009 and June 2010 at Copenhagen University Hospital, Rigshospitalet, Denmark. Adequate allocation concealment was assured from sequentially numbered, opaque, sealed envelopes prepared from a computer-generated list. Scoring of the embryos was done in an assessor-blinded way. Endocrinologically normal IVF patients aged 25-37 years, BMI 18-30 kg/m(2), regular cycles and FSH D100; n= 16) and Dose 150 (D150; n= 15). Two patients in D150 were withdrawn after randomization because of major (10- to 30-fold) hCG dosing errors, leaving 13 patients in this group. Thus, the results are based on the per protocol population. The mean numbers of top-quality embryos per patient were D0: 0.8 ± 1.2, D50: 0.5 ± 0.7, D100: 1.2 ± 1.7 and D150: 1.5 ± 1.7 (P= 0.04). All pregnancies were singleton gestations, and the live birth rates per started cycle were D0

  12. Effects of inspiratory muscle training on exercise capacity and spontaneous physical activity in elderly subjects: a randomized controlled pilot trial.

    Science.gov (United States)

    Aznar-Lain, S; Webster, A L; Cañete, S; San Juan, A F; López Mojares, L M; Pérez, M; Lucia, A; Chicharro, J L

    2007-12-01

    Inspiratory muscle training (IMT) has been shown to improve exercise capacity in diseased populations. We chose to examine the effects of eight weeks of IMT on exercise capacity and spontaneous physical activity in elderly individuals. Eighteen moderately active elderly subjects (68.1 +/- 6.8 years [mean +/- SD]; range 58 - 78 years) were randomly assigned to either an experimental group (n = 9) or a control group (n = 9) in a double-blind manner. All subjects underwent inspiratory muscle testing, treadmill exercise testing and a four-day measurement period of spontaneous physical activity (using accelerometry) both pre- and post-intervention. The experimental group underwent eight weeks of incremental IMT using a pressure threshold device, while the control group underwent sham training using identical devices. After IMT training, inspiratory muscle strength (mean + 21.5 cm H (2)O; 95 % CI: 9.3, 33.7; p = 0.002), V.O (2peak) (+ 2.8 ml x min (-1) x kg (-1); 95 % CI: 0.5, 5.2; p = 0.022), time to exhaustion during a fixed workload treadmill test (+ 7.1 min; 95 % CI: 1.8, 2.4; p = 0.013) and time engaged in moderate-to-vigorous physical activity (+ 59 min; 95 % CI: 15, 78; p = 0.008) improved. Except for a decline in moderate-to-vigorous physical activity, no significant changes were seen in the control group. Therefore, IMT may be a useful technique for positively influencing exercise capacity and physical activity in elderly individuals.

  13. Yoga for Risk Reduction of Metabolic Syndrome: Patient-Reported Outcomes from a Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Stephanie J. Sohl

    2016-01-01

    Full Text Available Lifestyle change is recommended as treatment for adults at risk for metabolic syndrome (MetS, although adoption of new behavioral patterns is limited. In addition, most existing lifestyle interventions do not address psychological stress or quality of life, both of which impact the burden of MetS. Yoga, a form of physical activity that incorporates psychological components (e.g., maintaining attention, relaxation, is a promising intervention for improving the burden of MetS. This randomized controlled trial assessed the feasibility and preliminary efficacy of a 12-week yoga program coupled with an evidence-based health education program (HED compared to HED alone. A secondary, exploratory aim examined perceived stress, quality of life, and related psychological outcomes (mindfulness, perceived health competence, and mood. Sixty-seven adults at risk for MetS enrolled (mean age [SD]: 58 [10] years; 50% male; 79% non-Hispanic White. Preliminary results revealed significantly larger improvements in two quality of life domains (role-physical and general health perceptions in the HED plus yoga group versus HED alone (ps<0.05. This is the first study that implemented lifestyle education along with yoga to evaluate the potential unique effects of yoga on participants at risk for MetS. A larger clinical trial is warranted to further investigate these promising patient-reported outcomes.

  14. A Pilot Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey, and Conventional Dressing in Healing Diabetic Foot Ulcer

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    Ka-Kit Tsang

    2017-01-01

    Full Text Available Nanocrystalline silver (nAg and Manuka honey (MH dressing have increasing popularity for treating diabetic foot ulcer (DFU. This study was an open-label randomized controlled trial with three parallel groups’ design in examining the preliminary effectiveness of nAg against MH and conventional dressing in healing DFU in terms of ulcer healing, ulcer infection, and inflammation. 31 participants (11 in the nAg group, 10 in the MH group, and 10 in the convention group diagnosed with type 2 diabetes were enrolled. Wound cleaning, debridement, and topical dressing application were performed according to the group allocation in each visit at weeks 1, 2, 3, 4, 6, 8, 10, and 12. The results found that the proportions of complete ulcer healing were 81.8%, 50%, and 40% in the nAg, MH, and conventional groups, respectively. The ulcer size reduction rate was potentially higher in the nAg group (97.45% than the MH group (86.21% and the conventional group (75.17%. In bacteriology, nAg showed a greater rate of microorganism reduction although it was not significant. To conclude, nAg alginate was potentially superior to MH and conventional dressing in healing diabetic foot ulcer in terms of ulcer size reduction rate.

  15. Impact of biofeedback on self-efficacy and stress reduction in obesity: a randomized controlled pilot study.

    Science.gov (United States)

    Teufel, Martin; Stephan, Kerstin; Kowalski, Axel; Käsberger, Saskia; Enck, Paul; Zipfel, Stephan; Giel, Katrin E

    2013-09-01

    Biofeedback application is an evidence-based technique to induce relaxation. A primary mechanism of action is the improvement of self-efficacy, which is needed to facilitate the translation of health behavioral intentions into action. Obesity is often associated with low self-efficacy and dysfunctional eating patterns, including comfort eating as an inexpedient relaxation technique. This is the first study investigating the effects of biofeedback on self-efficacy and relaxation in obesity. In the present experiment, 31 women, mean body mass index 35.5 kg/m², were randomized to a food-specific biofeedback paradigm, a non-specific relaxation biofeedback paradigm, or a waiting list control. Eight sessions of biofeedback of the electrodermal activity were performed while presenting either a challenging food stimulus or a non-specific landscape stimulus. Self-efficacy, stress, ability to relax, eating behavior, and electrodermal activity were assessed before, directly after, and 3 months after the intervention. The food-specific biofeedback predominantly showed effects on food-related self-efficacy and perceived stress. The non-specific relaxation biofeedback showed effects on the ability to relax. Self-reported improvements were confirmed by corresponding decrease in the electrodermal reaction to food stimuli. Biofeedback treatment is effective in improving self-efficacy in individuals with obesity and might therefore be a valuable additional intervention in obesity treatment.

  16. Effects of combined exercise on physical fitness and neurotransmitters in children with ADHD: a pilot randomized controlled study

    Science.gov (United States)

    Lee, Sun-Kyoung; Lee, Chung-Moo; Park, Jong-Hwan

    2015-01-01

    [Purpose] The purpose of the present study was to determine the effect of a jump rope and ball combined exercise program on the physical fitness the neurotransmitter (epinephrine, serotonin) levels of children with attention-deficit hyperactivity disorder. [Subjects and Methods] The subjects were 12 boys attending elementary school, whose grade levels ranged from 1–4. The block randomization method was used to distribute the participants between the combined exercise group (n = 6) and control group (n = 6). The program consisted of a 60-min exercise (10-min warm-up, 40-min main exercise, and 10-min cool down) performed three times a week, for a total of 12 weeks. [Results] The exercise group showed a significant improvement in cardiorespiratory endurance, muscle strength, muscle endurance and flexibility after 12 weeks. A significant increase in the epinephrine level was observed in the exercise group. [Conclusion] The 12-week combined exercise program in the current study (jump rope and ball exercises) had a positive effect on overall fitness level, and neurotransmission in children with attention-deficit hyperactivity disorder. PMID:26504324

  17. A Pilot Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey, and Conventional Dressing in Healing Diabetic Foot Ulcer

    Science.gov (United States)

    Kwong, Enid Wai-Yung; To, Tony Shing-Shun; Wong, Thomas Kwok-Shing

    2017-01-01

    Nanocrystalline silver (nAg) and Manuka honey (MH) dressing have increasing popularity for treating diabetic foot ulcer (DFU). This study was an open-label randomized controlled trial with three parallel groups' design in examining the preliminary effectiveness of nAg against MH and conventional dressing in healing DFU in terms of ulcer healing, ulcer infection, and inflammation. 31 participants (11 in the nAg group, 10 in the MH group, and 10 in the convention group) diagnosed with type 2 diabetes were enrolled. Wound cleaning, debridement, and topical dressing application were performed according to the group allocation in each visit at weeks 1, 2, 3, 4, 6, 8, 10, and 12. The results found that the proportions of complete ulcer healing were 81.8%, 50%, and 40% in the nAg, MH, and conventional groups, respectively. The ulcer size reduction rate was potentially higher in the nAg group (97.45%) than the MH group (86.21%) and the conventional group (75.17%). In bacteriology, nAg showed a greater rate of microorganism reduction although it was not significant. To conclude, nAg alginate was potentially superior to MH and conventional dressing in healing diabetic foot ulcer in terms of ulcer size reduction rate. PMID:28239398

  18. Practice-based randomized controlled-comparison clinical trial of chiropractic adjustments and brief massage treatment at sites of subluxation in subjects with essential hypertension: pilot study.

    Science.gov (United States)

    Plaugher, Gregory; Long, Cynthia R; Alcantara, Joel; Silveus, Alyssa D; Wood, Herbert; Lotun, Kapildeo; Menke, J Michael; Meeker, William C; Rowe, Stephen H

    2002-05-01

    To determine the feasibility of conducting a randomized clinical trial in the private practice setting examining short- and long-term effects of chiropractic adjustments for subjects with essential hypertension compared with a brief soft tissue massage, as well as a nontreatment control group. Randomized controlled-comparison trial with 3 parallel groups. Private practice outpatient chiropractic clinic. Twenty-three subjects, aged 24 to 50 years with systolic or diastolic essential hypertension. Two months of full-spine chiropractic care (ie, Gonstead) consisting primarily of specific-contact, short-lever-arm adjustments delivered at motion segments exhibiting signs of subluxation. The massage group had a brief effleurage procedure delivered at localized regions of the spine believed to be exhibiting signs of subluxation. The nontreatment control group rested alone for a period of approximately 5 minutes in an adjustment room. Cost per enrolled subject, as well as systolic and diastolic blood pressure (BP) measured with a random-0 sphygmomanometer and patient reported health status (SF-36). Pilot study outcome measures also included an assessment of cooperation of subjects to randomization procedures and drop-out rates, recruitment effectiveness, analysis of temporal stability of BPs at the beginning of care, and the effects of inclusion/exclusion criteria on the subject pool. Thirty subjects enrolled, yielding a cost of $161 per enrolled subject. One subject was later determined to be ineligible, and 6 others dropped out. In both the chiropractic and massage therapy groups, all subjects were classified as either overweight or obese; in the control group there were only 2 classified as such. SF-36 profiles for the groups were similar to that of a normal population. The mean change in diastolic BP was -4 (95% confidence interval [CI]: -8.6, 0.5) in the chiropractic care group, 0.5 (95% CI: -3.5, 4.5) in the brief massage treatment group, and -4.9 (95% CI: -9.7, -0

  19. Efficacy of moxibustion for pre- or stage I hypertension: study protocol for a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Shin Kyung-Min

    2012-10-01

    Full Text Available Abstract Background Hypertension is a risk factor for cardiovascular disease, and the prevalence of hypertension tends to increase with age. Current treatments for hypertension have adverse side effects and poor adherence. The purpose of this study is to evaluate the effects of moxibustion on blood pressure in individuals with pre- or stage I hypertension. Methods/design Forty-five subjects with pre- or stage I hypertension will be randomized into three groups: treatment group A (2 times/week, treatment group B (3 times/week, and the control group (non-treated group. The inclusion criteria will be as follows: (1 aged between 19 and 65 years; (2 prehypertension or stage I hypertension (JNC 7, Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; (3 the participants are volunteers and written consent obtained. The participants in the treatment group A will undergo indirect moxibustion 2 times per week for 4 weeks, and the participants in the treatment group B will undergo indirect moxibustion 3 times per week for 4 weeks. The participants in the control group (non-treated group will maintain their current lifestyle, including diet and exercise. The use of antihypertensive medication is not permitted. The primary endpoint will be a change in patient blood pressure. The secondary endpoints will be the body mass index, lipid profile, EuroQol and Heart Rate Variability. The data will be analyzed with the Student’s t-test and analysis of variance (ANOVA (p Discussion The results of this study will help to establish the optimal approach for the care of adults with pre- or stage I hypertension. Trial registration Clinical Research Information Service KCT0000469

  20. Dialysis-associated hypertension treated with Telmisartan--DiaTel: a pilot, placebo-controlled, cross-over, randomized trial.

    Directory of Open Access Journals (Sweden)

    Matthias Huber

    Full Text Available Treatment of hypertension in hemodialysis (HD patients is characterised by lack of evidence for both the blood pressure (BP target goal and the recommended drug class to use. Telmisartan, an Angiotensin receptor blocker (ARB that is metabolised in the liver and not excreted via HD extracorporeal circuit might be particularly suitable for HD patients. We designed and conducted a randomised, placebo-controlled, double-blind and cross-over trial for treatment of dialysis-associated hypertension with telmisartan 80 mg once daily or placebo on top of standard antihypertensive treatment excluding other Renin-Angiotensin-System (RAS blockers. In 29 patients after randomization we analysed BP after a treatment period of 8 weeks, while 13 started with telmisartan and 16 with placebo; after 8 weeks 11 continued with telmisartan and 12 with placebo after cross-over, respectively. Patients exhibited a significant reduction of systolic pre-HD BP from 141.9±21.8 before to 131.3±17.3 mmHg after the first treatment period with telmisartan or placebo. However, no average significant influence of telmisartan was observed compared to placebo. The latter may be due to a large inter-individual variability of BP responses reaching from a 40 mmHg decrease under placebo to 40 mmHg increase under telmisartan. Antihypertensive co-medication was changed for clinical reasons in 7 out of 21 patients with no significant difference between telmisartan and placebo groups. Our starting hypothesis, that telmisartan on top of standard therapy lowers systolic office BP in HD patients could not be confirmed. In conclusion, this small trial indicates that testing antihypertensive drug efficacy in HD patients is challenging due to complicated standardization of concomitant medication and other confounding factors, e.g. volume status, salt load and neurohormonal activation, that influence BP control in HD patients.Clinicaltrialsregister.eu 2005-005021-60.

  1. Effects of a tailored interactive multimedia computer program on determinants of colorectal cancer screening: a randomized controlled pilot study in physician offices.

    Science.gov (United States)

    Jerant, Anthony; Kravitz, Richard L; Rooney, Mairin; Amerson, Scott; Kreuter, Matthew; Franks, Peter

    2007-04-01

    Screening reduces colorectal cancer (CRC) mortality and is cost-effective, yet uptake is suboptimal. We developed and evaluated a personally tailored interactive multimedia computer program (IMCP) to encourage CRC screening. Randomized controlled pilot trial evaluating the effects of the personally tailored CRC screening IMCP as compared with a non-tailored IMCP ("electronic leaflet") control. The IMCP was tailored to patient preference, self-efficacy, barriers, and readiness and deployed in busy primary care offices before scheduled doctor visits. Main outcomes were: CRC screening knowledge, self-efficacy, benefits and barriers, and stage of readiness. We enrolled 54 subjects; software glitches occurred in 5, leaving 49 subjects for analysis. In adjusted analyses, compared with control, the experimental group had a significant increase in CRC screening self-efficacy (p=0.049), a significantly greater likelihood of moving to a more advanced stage of readiness for screening (p=0.034), a trend toward fewer perceived barriers to screening (p=0.149), and no difference in perceived benefits or knowledge of screening. Our personally tailored IMCP was significantly more effective than control in bolstering CRC screening readiness and self-efficacy. If further streamlined, personally tailored IMCPs might be usefully deployed in busy primary care offices to improve uptake of CRC screening.

  2. Wearable Sensor-Based Biofeedback Training for Balance and Gait in Parkinson Disease: A Pilot Randomized Controlled Trial.

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    Carpinella, Ilaria; Cattaneo, Davide; Bonora, Gianluca; Bowman, Thomas; Martina, Laura; Montesano, Angelo; Ferrarin, Maurizio

    2017-04-01

    To analyze the feasibility and efficacy of a novel system (Gamepad [GAMing Experience in PArkinson's Disease]) for biofeedback rehabilitation of balance and gait in Parkinson disease (PD). Randomized controlled trial. Clinical rehabilitation gym. Subjects with PD (N=42) were randomized into experimental and physiotherapy without biofeedback groups. Both groups underwent 20 sessions of training for balance and gait. The experimental group performed tailored functional tasks using Gamepad. The system, based on wearable inertial sensors, provided users with real-time visual and acoustic feedback about their movement during the exercises. The physiotherapy group underwent individually structured physiotherapy without feedback. Assessments were performed by a blinded examiner preintervention, postintervention, and at 1-month follow-up. Primary outcomes were the Berg Balance Scale (BBS) and 10-m walk test (10MWT). Secondary outcomes included instrumental stabilometric indexes and the Tele-healthcare Satisfaction Questionnaire. Gamepad was well accepted by participants. Statistically significant between-group differences in BBS scores suggested better balance performances of the experimental group compared with the physiotherapy without biofeedback group both posttraining (experimental group-physiotherapy without biofeedback group: mean, 2.3±3.4 points; P=.047) and at follow-up (experimental group-physiotherapy without biofeedback group: mean, 2.7±3.3 points; P=.018). Posttraining stabilometric indexes showed that mediolateral body sway during upright stance was significantly reduced in the experimental group compared with the physiotherapy without biofeedback group (experimental group-physiotherapy without biofeedback group: -1.6±1.5mm; P=.003). No significant between-group differences were found in the other outcomes. Gamepad-based training was feasible and superior to physiotherapy without feedback in improving BBS performance and retaining it for 1 month. After

  3. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial

    Science.gov (United States)

    2013-01-01

    Background Lateral epicondylitis is the most frequent cause of pain around the elbow joint. It causes pain in the region of the elbow joint and results in dysfunction of the elbow and deterioration of the quality of life. The purpose of this study is to compare the effects of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis. Methods/design Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. The inclusion criteria will be as follows: (1) age between 19 and 65 years with pain due to one-sided lateral epicondylitis that persisted for at least four weeks, (2) with tenderness on pressure limited to regions around the elbow joint, (3) complaining of pain during resistive extension of the middle finger or the wrist, (4) with average pain of NRS 4 or higher during the last one week at a screening visit and (5) voluntarily agree to this study and sign a written consent. Acupuncture treatment will be given 10 times in total for 4 weeks to all groups. Follow up observations will be conducted after the completion of the treatment, 8 weeks and 12 weeks after the random assignment. Ipsilateral acupuncture group and contralateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points. The sham acupuncture group will receive treatment on acupuncture points not related to the lateral epicondylitis using a non-invasive method. The needles will be maintained for 20 minutes. The primary outcome will be differences in the visual analogue scale (VAS) for elbow pain between the groups. The secondary outcome will be differences in patient-rated tennis elbow evaluation (PRTEE), pain-free/maximum grip strength (Dynamometer), pressure pain threshold, clinically relevant improvement, patient global assessment, and the EQ-5D. The data will be analyzed with the paired t

  4. A Web-Based Training Program Using Cognitive Behavioral Therapy to Alleviate Psychological Distress Among Employees: Randomized Controlled Pilot Trial

    Science.gov (United States)

    Tajima, Miyuki; Kimura, Risa; Sasaki, Norio; Somemura, Hironori; Ito, Yukio; Okanoya, June; Yamamoto, Megumi; Nakamura, Saki; Tanaka, Katsutoshi

    2014-01-01

    Background A number of psychoeducational programs based on cognitive behavioral therapy (CBT) to alleviate psychological distress have been developed for implementation in clinical settings. However, while these programs are considered critical components of stress management education in a workplace setting, they are required to be brief and simple to implement, which can hinder development. Objective The intent of the study was to examine the effects of a brief training program based on CBT in alleviating psychological distress among employees and facilitating self-evaluation of stress management skills, including improving the ability to recognize dysfunctional thinking patterns, transform dysfunctional thoughts to functional ones, cope with stress, and solve problems. Methods Of the 187 employees at an information technology company in Tokyo, Japan, 168 consented to participate in our non-blinded randomized controlled study. The training group received CBT group education by a qualified CBT expert and 1 month of follow-up Web-based CBT homework. The effects of this educational program on the psychological distress and stress management skills of employees were examined immediately after completion of training and then again after 6 months. Results Although the training group did exhibit lower mean scores on the Kessler-6 (K6) scale for psychological distress after 6 months, the difference from the control group was not significant. However, the ability of training group participants to recognize dysfunctional thinking was significantly improved both immediately after training completion and after 6 months. While the ability of participants to cope with stress was not significantly improved immediately after training, improvement was noted after 6 months in the training group. No notable improvements were observed in the ability of participants to transform thoughts from dysfunctional to functional or in problem-solving skills. A sub-analysis of participants who

  5. A randomized controlled pilot study of home-based step training in older people using videogame technology.

    Directory of Open Access Journals (Sweden)

    Daniel Schoene

    Full Text Available BACKGROUND: Stepping impairments are associated with physical and cognitive decline in older adults and increased fall risk. Exercise interventions can reduce fall risk, but adherence is often low. A new exergame involving step training may provide an enjoyable exercise alternative for preventing falls in older people. PURPOSE: To assess the feasibility and safety of unsupervised, home-based step pad training and determine the effectiveness of this intervention on stepping performance and associated fall risk in older people. DESIGN: Single-blinded two-arm randomized controlled trial comparing step pad training with control (no-intervention. SETTING/PARTICIPANTS: Thirty-seven older adults residing in independent-living units of a retirement village in Sydney, Australia. INTERVENTION: Intervention group (IG participants were provided with a computerized step pad system connected to their TVs and played a step game as often as they liked (with a recommended dose of 2-3 sessions per week for 15-20 minutes each for eight weeks. In addition, IG participants were asked to complete a choice stepping reaction time (CSRT task once each week. MAIN OUTCOME MEASURES: CSRT, the Physiological Profile Assessment (PPA, neuropsychological and functional mobility measures were assessed at baseline and eight week follow-up. RESULTS: Thirty-two participants completed the study (86.5%. IG participants played a median 2.75 sessions/week and no adverse events were reported. Compared to the control group, the IG significantly improved their CSRT (F31,1 = 18.203, p<.001, PPA composite scores (F31,1 = 12.706, p = 0.001, as well as the postural sway (F31,1 = 4.226, p = 0.049 and contrast sensitivity (F31,1 = 4.415, p = 0.044 PPA sub-component scores. In addition, the IG improved significantly in their dual-task ability as assessed by a timed up and go test/verbal fluency task (F31,1 = 4.226, p = 0.049. CONCLUSIONS: Step pad training can

  6. Topical treatment with fresh human milk versus emollient on atopic eczema spots in young children: a small, randomized, split body, controlled, blinded pilot study.

    Science.gov (United States)

    Berents, Teresa Løvold; Rønnevig, Jørgen; Søyland, Elisabeth; Gaustad, Peter; Nylander, Gro; Løland, Beate Fossum

    2015-05-04

    Public health nurses report on effects of fresh human milk as treatment for conjunctivitis, rhinitis and atopic eczema (AE), the latter being highly prevalent in early childhood. Emollients and topical corticosteroids are first line treatment of AE. As many caregivers have steroid phobia, alternative treatment options for mild AE are of interest. The aim of this small pilot study was to assess the potential effects and risks of applying fresh human milk locally on eczema spots in children with AE. This was a split body, controlled, randomized and physician blinded pilot study, of children with AE with two similar contralateral eczema spots having a mother breastfeeding the child or a sibling. Fresh expressed milk and emollient was applied on the intervention spot and emollient alone on the control area, three times a day for four weeks. The severity and area of the eczema spots was evaluated weekly, and samples from milk and the spots were analysed weekly with respect to bacterial colonisation. Of nine patients included, six completed the study. Mean age at inclusion was 18.5 months. The spots examined were localized on the arms, legs or cheeks. The spots were similar in severity, but differed in area. In one patient the eczema ceased after inclusion. In four patients both control and intervention areas increased during the intervention. The relative change in eczema area compared to baseline showed less increase in the intervention spots in two patients, whereas the opposite was observed in three. In four children Staphylococcus aureus was found in their eczema once or more. In three of the 28 human milk samples, Staphylococcus aureus, alfa haemolytic streptococci or coagulase negative staphylococci were detected. Staphylococcus aureus was found once both in human milk and in the eczema spots, no clinical signs of infection were however observed. No secondary infection due to milk application was detected. In this small pilot study, no effect was found on eczema

  7. The mechanical effect of kinesiology tape on rounded shoulder posture in seated male workers: a single-blinded randomized controlled pilot study.

    Science.gov (United States)

    Han, Jin-Tae; Lee, Jung-Hoon; Yoon, Chul-Han

    2015-02-01

    Single-blinded randomized controlled pilot study. To examine the changes in pectoralis minor length (PML), the supine measurement of rounded shoulder posture (RSP), and the total scapular distance (TSD) in seated male workers with RSP, after rounded-shoulder-taping (RST) using kinesiology tape with (experimental taping) and without stretch (placebo taping). RSP, a postural impairment, is a known cause of upper quarter pain. Fourteen men with RSP, who worked for at least 7 h/d in a seated position, were selected for RST, with the shoulders randomly assigned to two kinesiology taping methods: (1) with 35-40% stretch of its original length; and (2) without stretch. The PML, supine measurements of RSP, and TSD, before and after kinesiology taping, with and without stretch, were assessed. Kinesiology taping with stretch significantly increased the PML and significantly decreased the supine measurement of RSP and TSD; kinesiology taping without stretch did not increase the PML significantly and did not decrease the supine measurement of RSP and TSD. RST using kinesiology tape with stretch produces immediate mechanical correction of RSP in seated male workers.

  8. Pleiotropic benefit of monomeric and oligomeric flavanols on vascular health--a randomized controlled clinical pilot study.

    Directory of Open Access Journals (Sweden)

    Antje R Weseler

    Full Text Available BACKGROUND: Cardiovascular diseases are expanding to a major social-economic burden in the Western World and undermine man's deep desire for healthy ageing. Epidemiological studies suggest that flavanol-rich foods (e.g. grapes, wine, chocolate sustain cardiovascular health. For an evidenced-based application, however, sound clinical data on their efficacy are strongly demanded. METHODS: In a double-blind, randomized, placebo-controlled intervention study we supplemented 28 male smokers with 200 mg per day of monomeric and oligomeric flavanols (MOF from grape seeds. At baseline, after 4 and 8 weeks we measured macro- and microvascular function and a cluster of systemic biomarkers for major pathological processes occurring in the vasculature: disturbances in lipid metabolism and cellular redox balance, and activation of inflammatory cells and platelets. RESULTS: In the MOF group serum total cholesterol and LDL decreased significantly (P ≤ 0.05 by 5% (n = 11 and 7% (n = 9, respectively in volunteers with elevated baseline levels. Additionally, after 8 weeks the ratio of glutathione to glutathione disulphide in erythrocytes rose from baseline by 22% (n = 15, P<0.05 in MOF supplemented subjects. We also observed that MOF supplementation exerts anti-inflammatory effects in blood towards ex vivo added bacterial endotoxin and significantly reduces expression of inflammatory genes in leukocytes. Conversely, alterations in macro- and microvascular function, platelet aggregation, plasma levels of nitric oxide surrogates, endothelin-1, C-reactive protein, fibrinogen, prostaglandin F2alpha, plasma antioxidant capacity and gene expression levels of antioxidant defense enzymes did not reach statistical significance after 8 weeks MOF supplementation. However, integrating all measured effects into a global, so-called vascular health index revealed a significant improvement of overall vascular health by MOF compared to placebo (P ≤ 0.05. CONCLUSION: Our

  9. A randomized controlled pilot study of outcomes of strict allowance of fluid therapy in hyponatremic heart failure (SALT-HF).

    Science.gov (United States)

    Albert, Nancy M; Nutter, Benjamin; Forney, Jennifer; Slifcak, Ellen; Tang, W H Wilson

    2013-01-01

    Currently, fluid restriction recommendations in heart failure (HF) are based on expert opinion. After implementing a 1,000-mL/d fluid restriction for 60 days after discharge, outcomes were examined. In a randomized controlled design, hyponatremic patients (serum sodium ≤137 mg/dL) received usual care (UC; n = 26) or 1,000 mL/d fluid restriction (n = 20) at discharge. Quality of life (QoL), thirst, difficulty following fluid recommendations, adherence to fluid restriction, HF emergency care, HF rehospitalization, and all-cause death were examined. Mean age was 62.8 ± 12.8 years; 46% were white. There were no differences by group in baseline demographics, comorbidities, and QoL, except that more UC patients had New York Heart Association (NYHA) functional class III/IV status (P = .019). Median [interquartile range] QoL scores were better in the 1,000 mL/d group for symptom burden (83.3 [68.8-91.7] vs 50 [29.2-79.2]; P = .018), total symptoms (77.1 [58.1-91.7] vs 54.2 [30.2-73.9]; P = .022), overall QoL summary (72.6 [52.2-86.3] vs 51.0 [37.7-68.5]; P = .038), and clinical QoL summary (75.5 [57.8-92.9] vs 59.1 [35.7-77.3]; P = .039). There were no group differences in thirst, difficulty adhering to fluid recommendations, adherence to fluid restriction, or health care consumption. The 1,000 mL/d fluid restriction led to improved QoL at 60 days after discharge. Future research in a larger more heterogeneous sample is needed. Copyright © 2013 Elsevier Inc. All rights reserved.

  10. Tai chi qigong as a means to improve night-time sleep quality among older adults with cognitive impairment: a pilot randomized controlled trial.

    Science.gov (United States)

    Chan, Aileen Wk; Yu, Doris Sf; Choi, K C; Lee, Diana Tf; Sit, Janet Wh; Chan, Helen Yl

    2016-01-01

    Age-related cognitivee decline is a growing public health concern worldwide. More than a quarter of adults with cognitive impairment experience sleep disturbance. The objective of this pilot study was to evaluate the preliminary effects of tai chi qigong (TCQ) on improving the night-time sleep quality of older adults with cognitive impairment. Older adults with cognitive impairment who complain of sleep disturbance. A randomized controlled trial with two groups. Fifty-two subjects were recruited from two district elderly community centers and randomly assigned to either the TCQ group (n=27) or the control group (n=25). The intervention group received TCQ training consisting of two 60-minute sessions each week for 2 months. The control group was advised to maintain their usual activities. Sleep quality was measured by the Chinese Pittsburgh Sleep Quality Index. Quality of life was measured by Short-form 12, cognitive functions measured by mini-mental state examination, and subjective memory deficits measured by the memory inventory for Chinese. Data were collected at baseline, 2 months, and 6 months. Significant results were noted at 6 months in the Chinese Pittsburgh Sleep Quality Index global score (P=0.004), sleep duration (P=0.003), habitual sleep efficiency (P=0.002), and the Short-form 12 mental health component (P<0.001). The TCQ participants reported better sleep quality and a better (quality of life) mental health component than the control group. TCQ can be considered a useful nonpharmacological approach for improving sleep quality in older adults with cognitive impairment. CUHK_CCT00448 (https://www2.ccrb.cuhk.edu.hk/registry/public/287).

  11. Tai chi qigong as a means to improve night-time sleep quality among older adults with cognitive impairment: a pilot randomized controlled trial

    Science.gov (United States)

    Chan, Aileen WK; Yu, Doris SF; Choi, KC; Lee, Diana TF; Sit, Janet WH; Chan, Helen YL

    2016-01-01

    Purpose Age-related cognitivee decline is a growing public health concern worldwide. More than a quarter of adults with cognitive impairment experience sleep disturbance. The objective of this pilot study was to evaluate the preliminary effects of tai chi qigong (TCQ) on improving the night-time sleep quality of older adults with cognitive impairment. Participants Older adults with cognitive impairment who complain of sleep disturbance. Methods A randomized controlled trial with two groups. Fifty-two subjects were recruited from two district elderly community centers and randomly assigned to either the TCQ group (n=27) or the control group (n=25). The intervention group received TCQ training consisting of two 60-minute sessions each week for 2 months. The control group was advised to maintain their usual activities. Sleep quality was measured by the Chinese Pittsburgh Sleep Quality Index. Quality of life was measured by Short-form 12, cognitive functions measured by mini-mental state examination, and subjective memory deficits measured by the memory inventory for Chinese. Results Data were collected at baseline, 2 months, and 6 months. Significant results were noted at 6 months in the Chinese Pittsburgh Sleep Quality Index global score (P=0.004), sleep duration (P=0.003), habitual sleep efficiency (P=0.002), and the Short-form 12 mental health component (P<0.001). The TCQ participants reported better sleep quality and a better (quality of life) mental health component than the control group. Conclusion TCQ can be considered a useful nonpharmacological approach for improving sleep quality in older adults with cognitive impairment. Clinical trial registration CUHK_CCT00448 (https://www2.ccrb.cuhk.edu.hk/registry/public/287). PMID:27698557

  12. Feasibility of Pairing Behavioral Activation With Exercise for Women With Type 2 Diabetes and Depression: The Get It Study Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Schneider, Kristin L; Panza, Emily; Handschin, Barbara; Ma, Yunsheng; Busch, Andrew M; Waring, Molly E; Appelhans, Bradley M; Whited, Matthew C; Keeney, Jacey; Kern, Daniel; Blendea, Mihaela; Ockene, Ira; Pagoto, Sherry L

    2016-03-01

    Major depressive disorder is often comorbid with diabetes and associated with worse glycemic control. Exercise improves glycemic control and depression, and thus could be a parsimonious intervention for patients with comorbid diabetes and major depression. Because patients with diabetes and comorbid depression are often sedentary and lack motivation to exercise, we developed a group exercise intervention that integrates strategies from behavioral activation therapy for depression to increase motivation for and enjoyment of exercise. We conducted a 6-month pilot randomized controlled trial to test the feasibility of the behavioral activation exercise intervention (EX) for women with diabetes and depression. Of the 715 individuals who contacted us about the study, 29 participants were randomized to the EX condition or an enhanced usual care condition (EUC), which represents 4.1% of participants who initially contacted us. Inclusion criteria made recruitment challenging and limits the feasibility of recruiting women with diabetes and depression for a larger trial of the intervention. Retention was 96.5% and 86.2% at 3 and 6months. Participants reported high treatment acceptability; use of behavioral activation strategies and exercise class attendance was acceptable. No condition differences were observed for glycemic control, depressive symptoms, and physical activity, though depressive symptoms and self-reported physical activity improved over time. Compared to participants in the EUC condition, participants in the EX condition reported greater exercise enjoyment and no increase in avoidance behavior over time. Using behavioral activation strategies to increase exercise is feasible in a group exercise setting. However, whether these strategies can be delivered in a less intensive manner to a broader population of sedentary adults, for greater initiation and maintenance of physical activity, deserves further study.

  13. The effect of a cognitive-motor intervention on voluntary step execution under single and dual task conditions in older adults: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Pichierri G

    2012-07-01

    Full Text Available Giuseppe Pichierri,1 Amos Coppe,1 Silvio Lorenzetti,2 Kurt Murer,1 Eling D de Bruin11Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, Switzerland; 2Institute for Biomechanics, Department of Health Sciences and Technology, ETH Zurich, SwitzerlandBackground: This randomized controlled pilot study aimed to explore whether a cognitive-motor exercise program that combines traditional physical exercise with dance video gaming can improve the voluntary stepping responses of older adults under attention demanding dual task conditions.Methods: Elderly subjects received twice weekly cognitive-motor exercise that included progressive strength and balance training supplemented by dance video gaming for 12 weeks (intervention group. The control group received no specific intervention. Voluntary step execution under single and dual task conditions was recorded at baseline and post intervention (Week 12.Results: After intervention between-group comparison revealed significant differences for initiation time of forward steps under dual task conditions (U = 9, P = 0.034, r = 0.55 and backward steps under dual task conditions (U = 10, P = 0.045, r = 0.52 in favor of the intervention group, showing altered stepping levels in the intervention group compared to the control group.Conclusion: A cognitive-motor intervention based on strength and balance exercises with additional dance video gaming is able to improve voluntary step execution under both single and dual task conditions in older adults.Keywords: fall prevention, exercise, dance, video game

  14. Effectiveness of mirror therapy on lower extremity motor recovery, balance and mobility in patients with acute stroke: A randomized sham-controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Uthra Mohan

    2013-01-01

    Full Text Available Objective: To evaluate the effectiveness of mirror therapy on lower extremity motor recovery, balance and mobility in patients with acute stroke. Design: A randomized, sham-controlled, assessor blinded, pilot trial. Setting: Inpatient stroke rehabilitation unit. Subjects: First time onset of stroke with mean post-stroke duration of 6.41 days, able to respond to verbal instructions, and Brunnstrom recovery stage 2 and above were enrolled. Intervention: Mirror therapy group performed 30 minutes of functional synergy movements of non-paretic lower extremity, whereas control group underwent sham therapy with similar duration. In addition, both groups were administered with conventional stroke rehabilitation regime. Altogether 90 minutes therapy session per day, six days a week, for two weeks duration was administered to both groups. Outcome Measures: Lower extremity motor subscale of Fugl Meyer Assessment (FMA, Brunnel Balance Assessment (BBA and Functional Ambulation Categories (FAC. Results: Amongst the 22 patients included, equal number of patients participated in mirror group (N = 11 and control group (N = 11. Baseline variables were similar in both groups, except for Brunnstrom recovery stage. There was no statistical difference between groups, except for FAC. (FMA: P = 0.894; BBA: P = 0.358; FAC: P = 0.02. Significance was set at P < 0.05. Conclusion: Administration of mirror therapy early after stroke is not superior to conventional treatment in improving lower limb motor recovery and balance, except for improvement in mobility.

  15. Effectiveness of mirror therapy on lower extremity motor recovery, balance and mobility in patients with acute stroke: A randomized sham-controlled pilot trial.

    Science.gov (United States)

    Mohan, Uthra; Babu, S Karthik; Kumar, K Vijay; Suresh, B V; Misri, Z K; Chakrapani, M

    2013-10-01

    To evaluate the effectiveness of mirror therapy on lower extremity motor recovery, balance and mobility in patients with acute stroke. A randomized, sham-controlled, assessor blinded, pilot trial. Inpatient stroke rehabilitation unit. First time onset of stroke with mean post-stroke duration of 6.41 days, able to respond to verbal instructions, and Brunnstrom recovery stage 2 and above were enrolled. Mirror therapy group performed 30 minutes of functional synergy movements of non-paretic lower extremity, whereas control group underwent sham therapy with similar duration. In addition, both groups were administered with conventional stroke rehabilitation regime. Altogether 90 minutes therapy session per day, six days a week, for two weeks duration was administered to both groups. Lower extremity motor subscale of Fugl Meyer Assessment (FMA), Brunnel Balance Assessment (BBA) and Functional Ambulation Categories (FAC). Amongst the 22 patients included, equal number of patients participated in mirror group (N = 11) and control group (N = 11). Baseline variables were similar in both groups, except for Brunnstrom recovery stage. There was no statistical difference between groups, except for FAC. (FMA: P = 0.894; BBA: P = 0.358; FAC: P = 0.02). Significance was set at P mirror therapy early after stroke is not superior to conventional treatment in improving lower limb motor recovery and balance, except for improvement in mobility.

  16. The effects of long-term noninvasive ventilation in hypercapnic COPD patients: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    De Backer L

    2011-11-01

    Full Text Available L De Backer¹, W Vos², B Dieriks¹, D Daems¹, S Verhulst¹, S Vinchurkar², K Ides¹, J De Backer², P Germonpre¹, W De Backer¹1Antwerp University Hospital, Department of Respiratory Medicine, 2FluidDa, Antwerp, BelgiumIntroduction: Noninvasive ventilation (NIV is a well-established treatment for acute-on-chronic respiratory failure in hypercapnic COPD patients. Less is known about the effects of a long-term treatment with NIV in hypercapnic COPD patients and about the factors that may predict response in terms of improved oxygenation and lowered CO2 retention.Methods: In this study, we randomized 15 patients to a routine pharmacological treatment (n = 5, age 66 [standard deviation ± 6] years, FEV1 30.5 [±5.1] %pred, PaO2 65 [±6] mmHg, PaCO2 52.4 [±6.0] mmHg or to a routine treatment and NIV (using the Synchrony BiPAP device [Respironics, Inc, Murrsville, PA] (n = 10, age 65 [±7] years, FEV1 29.5 [±9.0] %pred, PaO2 59 [±13] mmHg, PaCO2 55.4 [±7.7] mmHg for 6 months. We looked at arterial blood gasses, lung function parameters and performed a low-dose computed tomography of the thorax, which was later used for segmentation (providing lobe and airway volumes, iVlobe and iVaw and post-processing with computer methods (providing airway resistance, iRaw giving overall a functional image of the separate airways and lobes.Results: In both groups there was a nonsignificant change in FEV1 (NIV group 29.5 [9.0] to 38.5 [14.6] %pred, control group 30.5 [5.1] to 36.8 [8.7] mmHg. PaCO2 dropped significantly only in the NIV group (NIV: 55.4 [7.7] → 44.5 [4.70], P = 0.0076; control: 52.4 [6.0] → 47.6 [8.2], NS. Patients actively treated with NIV developed a more inhomogeneous redistribution of mass flow than control patients. Subsequent analysis indicated that in NIV-treated patients that improve their blood gases, mass flow was also redistributed towards areas with higher vessel density and less emphysema, indicating that flow was

  17. A pilot randomized controlled trial comparing the efficacy of exercise, spinal manipulation, and neuro emotional technique for the treatment of pregnancy-related low back pain

    Directory of Open Access Journals (Sweden)

    Peterson Caroline D

    2012-06-01

    Full Text Available Abstract Background This pilot randomized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise, spinal manipulation, and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain, a common morbidity of pregnancy. Methods Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy. Once enrolled, they remained in the study until they had their babies. Women were randomly allocated into one of three treatment groups using opaque envelopes. The treatment schedule paralleled the prenatal care schedule and women received individualized intervention. Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain. Our primary outcome measure was the Roland Morris Disability Questionnaire and our secondary outcome measure was the Numeric Pain Rating Scale. Intention to treat analysis was conducted. For the primary analysis, regression was conducted to compare groups on the outcome measure scores. In a secondary responder analysis, difference in proportions of participants in attaining 30% and 50% improvement were calculated. Feasibility factors for conducting a future larger trial were also evaluated such as recruitment, compliance to study protocols, cost, and adverse events. Results Fifty-seven participants were randomized into the exercise (n = 22, spinal manipulation (n = 15, and Neuro Emotional Technique (n = 20 treatment arms. At least 50% of participants in each treatment group experienced clinically meaningful improvement in symptoms for the Roland Morris Disability Questionnaire. At least 50% of the exercise and spinal manipulation participants also experienced clinically meaningful improvement for the Numeric Pain Rating Scale. There were no clinically

  18. Treatment of patients with severe sepsis using Ulinastatin and Thymosin α1: a prospective, randomized, controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    CHEN Hao; HE Ming-yan; LI Yu-min

    2009-01-01

    Background Tradition treatment of sepsis and new therapies, including high dose corticosteroids and non-steroidal anti-inflammatory drugs, have proven unsuccessful in improving survival. This study aimed to evaluate the potential efficacy of immunomodulating therapy using Ulinastatin (UTI) plus Thymosin α1 (Tα1) for improving organ function and reducing mortality in patients with severe sepsis.Methods A prospective study was carried out with randomized and controlled clinical analysis of 114 patients conforming to the enrollment standard. All patients had severe sepsis and received standard supportive care and antimicrobial therapy. Fifty-nine patients were also administered UTI plus Tα1 (defined as Group A), 55 patients were given a placebo (defined as Group B). Clinical parameters were determined by evaluation with the Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ), multiple organ failure (MOF) and the Glasgow Coma Scores (GCS) on entry and after therapy on the 3rd, 8th, and 28th day. By flow cytometery and ELISA lymphocyte subsets and cytokines were analyzed. Survival analysis was determined by the Kaplan-Meier method at 28, 60, and 90 days. Results Based on comparison of the two groups, patients in Group A exhibited a better performance in organ failure scores which was noticeable soon after initiation of treatment. Patients in Group A also demonstrated a better resolution of pre-existing organ failures during the observation period. After initiation of treatment, significant improvements in the CD4+/CD8+ ratio, a quicker balance between proinflammatory mediators such as tumor necrosis factor a, interleukin 6 and anti-inflammatory cytokines including interleukin 4 and interleukin 10 were found. This was followed by cumulative survival increases of 17.3% at 28 days, 28.9% at 60 days, and 31.4% at 90 days in Group A. The reduction in mortality was accompanied by a considerably shorter stay in the ICU and a shorter length of supportive

  19. Intraperitoneal Vancomycin Plus Either Oral Moxifloxacin or Intraperitoneal Ceftazidime for the Treatment of Peritoneal Dialysis-Related Peritonitis: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Xu, Rong; Yang, Zhikai; Qu, Zhen; Wang, Huan; Tian, Xue; Johnson, David W; Dong, Jie

    2017-07-01

    Intraperitoneal administration of antibiotics is recommended as a first treatment for managing peritoneal dialysis (PD)-related peritonitis. However, the efficacy of oral administration of quinolones has not been well studied. Randomized controlled pilot study. 80 eligible patients with PD-related peritonitis from Peking University First Hospital (40 in each arm). Intraperitoneal vancomycin, 1g, every 5 days plus oral moxifloxacin, 400mg, every day (treatment group) versus intraperitoneal vancomycin, 1g, every 5 days plus intraperitoneal ceftazidime, 1g, every day (control group). The primary end point was complete resolution of peritonitis, and secondary end points were primary or secondary treatment failure. PD effluent white blood cell count. Baseline demographic and clinical characteristics of the 2 groups were comparable. There were 24 and 22 Gram-positive organisms, 6 and 7 Gram-negative organisms, 9 and 10 culture-negative samples, and 1 and 1 fungal sample in the treatment and control groups, respectively. Complete resolution of peritonitis was achieved in 78% and 80% of cases in the treatment and control groups, respectively (OR, 0.86; 95% CI, 0.30-2.52; P=0.8). There were 3 and 1 cases of relapse in the treatment and control groups, respectively. Primary and secondary treatment failure rates were not significantly different (33% vs 20% and 10% vs 13%, respectively). In each group, there was 1 peritonitis-related death and 6 transfers to hemodialysis therapy. During the 3-month follow-up period, 7 and 3 successive episodes of peritonitis occurred in the treatment and control groups, respectively. Only 2 adverse drug reactions (mild nausea and mild rash, respectively) were observed in the 2 groups. Sample size was relatively small and the eligibility ratio was low. Also, the number of peritonitis episodes was low, limiting the power to detect a difference between groups. This pilot study suggests that intraperitoneal vancomycin with oral moxifloxacin is a

  20. Back to the future – feasibility of recruitment and retention to patient education and telephone follow-up after hip fracture: a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Langford DP

    2015-09-01

    Full Text Available Dolores P Langford,1,2 Lena Fleig,3–5 Kristin C Brown,3,4 Nancy J Cho,1,2 Maeve Frost,1 Monique Ledoyen,1 Jayne Lehn,1 Kostas Panagiotopoulos,1,6 Nina Sharpe,1 Maureen C Ashe3,4 1Vancouver Coastal Health, 2Department of Physical Therapy, The University of British Columbia (UBC, 3Department of Family Practice, The University of British Columbia (UBC, 4Centre for Hip Health and Mobility, Vancouver, BC, Canada; 5Freie Universität Berlin, Health Psychology, Berlin, Germany; 6Department of Orthopaedics, The University of British Columbia (UBC, Vancouver, BC, Canada Objectives: Our primary aim of this pilot study was to test feasibility of the planned design, the interventions (education plus telephone coaching, and the outcome measures, and to facilitate a power calculation for a future randomized controlled trial to improve adherence to recovery goals following hip fracture.Design: This is a parallel 1:1 randomized controlled feasibility study.Setting: The study was conducted in a teaching hospital in Vancouver, BC, Canada.Participants: Participants were community-dwelling adults over 60 years of age with a recent hip fracture. They were recruited and assessed in hospital, and then randomized after hospital discharge to the intervention or control group by a web-based randomization service. Treatment allocation was concealed to the investigators, measurement team, and data entry assistants and analysts. Participants and the research physiotherapist were aware of treatment allocation.Intervention: Intervention included usual care for hip fracture plus a 1-hour in-hospital educational session using a patient-centered educational manual and four videos, and up to five postdischarge telephone calls from a physiotherapist to provide recovery coaching. The control group received usual care plus a 1-hour in-hospital educational session using the educational manual and videos.Measurement: Our primary outcome was feasibility, specifically recruitment

  1. The Kidney and Periodontal Disease (KAPD) study: A pilot randomized controlled trial testing the effect of non-surgical periodontal therapy on chronic kidney disease.

    Science.gov (United States)

    Grubbs, Vanessa; Garcia, Faviola; Jue, Bonnie L; Vittinghoff, Eric; Ryder, Mark; Lovett, David; Carrillo, Jacqueline; Offenbacher, Steven; Ganz, Peter; Bibbins-Domingo, Kirsten; Powe, Neil R

    2017-02-01

    Chronic kidney disease (CKD) remains a prevalent public health problem that disproportionately affects minorities and the poor, despite intense efforts targeting traditional risk factors. Periodontal diseases are common bacterial plaque-induced inflammatory conditions that can respond to treatment and have been implicated as a CKD risk factor. However there is limited evidence that treatment of periodontal disease slows the progression of CKD. We describe the protocol of the Kidney and Periodontal Disease (KAPD) study, a 12-month un-blinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1. immediate intensive non-surgical periodontal treatment or 2. rescue treatment with delayed intensive treatment. The goals of this pilot study are to test the feasibility of conducting a larger trial in an ethnically and racially diverse, underserved population (mostly poor and/or low literacy) with both CKD and significant periodontal disease to determine the effect of intensive periodontal treatment on renal and inflammatory biomarkers over a 12-month period. To date, KAPD has identified 634 potentially eligible patients who were invited to in-person screening. Of the 83 (13.1%) of potentially eligible patients who attended in-person screening, 51 (61.4%) were eligible for participation and 46 enrolled in the study. The mean age of participants is 59.2years (range 34 to 73). Twenty of the participants (43.5%) are Black and 22 (47.8%) are Hispanic. Results from the KAPD study will provide needed preliminary evidence of the effectiveness of non-surgical periodontal treatment to slow CKD progression and inform the design future clinical research trials. Copyright © 2016. Published by Elsevier Inc.

  2. A randomized controlled pilot trial of a Web-based resource to improve cancer knowledge in adolescent and young adult survivors of childhood cancer.

    Science.gov (United States)

    Kunin-Batson, Alicia; Steele, Jeanne; Mertens, Ann; Neglia, Joseph P

    2016-11-01

    This study examined cancer knowledge in adolescent and young adult (AYA) survivors and pilot tested a Web-based resource to provide individually tailored information regarding cancer treatment history, late effects risk, and resources. Fifty-two survivors (15-28 years old) who completed cancer treatment were recruited from the University of Minnesota oncology clinics. Participants were randomly assigned to receive access to personalized health history, late effects information, and resources via a password-protected Web portal or to standard of care (physician counseling) only. Participants completed surveys measuring cancer knowledge, health locus of control, and psychosocial well-being prior to randomization and approximately 1 year later. Overall, few participants accurately reported their chemotherapy history with detail (19% at baseline and 33% at follow-up), and many did not recognize that previous cancer treatments could impact future health (60% at baseline and 54% at follow-up). Among those randomized to the receive access to the website, utilization was very low, making it difficult to draw conclusions about efficacy. Nonetheless, these data suggest that offering tailored information through the Web was not more effective than standard of care at improving cancer knowledge. Anxiety and health beliefs were associated with cancer knowledge, including knowledge of steps survivors could take to mitigate late effects risks (p < 01). Knowledge gaps exist among AYA survivors regarding important aspects of their treatment histories and ongoing health risks. Offering purely educational information (either in person by providers or via the Web) does not appear to be enough to close this gap. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  3. Effects of Mobile Augmented Reality Learning Compared to Textbook Learning on Medical Students: Randomized Controlled Pilot Study

    Science.gov (United States)

    2013-01-01

    Background By adding new levels of experience, mobile Augmented Reality (mAR) can significantly increase the attractiveness of mobile learning applications in medical education. Objective To compare the impact of the heightened realism of a self-developed mAR blended learning environment (mARble) on learners to textbook material, especially for ethically sensitive subjects such as forensic medicine, while taking into account basic psychological aspects (usability and higher level of emotional involvement) as well as learning outcomes (increased learning efficiency). Methods A prestudy was conducted based on a convenience sample of 10 third-year medical students. The initial emotional status was captured using the “Profile of Mood States” questionnaire (POMS, German variation); previous knowledge about forensic medicine was determined using a 10-item single-choice (SC) test. During the 30-minute learning period, the students were randomized into two groups: the first group consisted of pairs of students, each equipped with one iPhone with a preinstalled copy of mARble, while the second group was provided with textbook material. Subsequently, both groups were asked to once again complete the POMS questionnaire and SC test to measure changes in emotional state and knowledge gain. Usability as well as pragmatic and hedonic qualities of the learning material was captured using AttrakDiff2 questionnaires. Data evaluation was conducted anonymously. Descriptive statistics for the score in total and the subgroups were calculated before and after the intervention. The scores of both groups were tested against each other using paired and unpaired signed-rank tests. An item analysis was performed for the SC test to objectify difficulty and selectivity. Results Statistically significant, the mARble group (6/10) showed greater knowledge gain than the control group (4/10) (Wilcoxon z=2.232, P=.03). The item analysis of the SC test showed a difficulty of P=0.768 (s=0.09) and a

  4. Effects of mobile augmented reality learning compared to textbook learning on medical students: randomized controlled pilot study.

    Science.gov (United States)

    Albrecht, Urs-Vito; Folta-Schoofs, Kristian; Behrends, Marianne; von Jan, Ute

    2013-08-20

    By adding new levels of experience, mobile Augmented Reality (mAR) can significantly increase the attractiveness of mobile learning applications in medical education. To compare the impact of the heightened realism of a self-developed mAR blended learning environment (mARble) on learners to textbook material, especially for ethically sensitive subjects such as forensic medicine, while taking into account basic psychological aspects (usability and higher level of emotional involvement) as well as learning outcomes (increased learning efficiency). A prestudy was conducted based on a convenience sample of 10 third-year medical students. The initial emotional status was captured using the "Profile of Mood States" questionnaire (POMS, German variation); previous knowledge about forensic medicine was determined using a 10-item single-choice (SC) test. During the 30-minute learning period, the students were randomized into two groups: the first group consisted of pairs of students, each equipped with one iPhone with a preinstalled copy of mARble, while the second group was provided with textbook material. Subsequently, both groups were asked to once again complete the POMS questionnaire and SC test to measure changes in emotional state and knowledge gain. Usability as well as pragmatic and hedonic qualities of the learning material was captured using AttrakDiff2 questionnaires. Data evaluation was conducted anonymously. Descriptive statistics for the score in total and the subgroups were calculated before and after the intervention. The scores of both groups were tested against each other using paired and unpaired signed-rank tests. An item analysis was performed for the SC test to objectify difficulty and selectivity. Statistically significant, the mARble group (6/10) showed greater knowledge gain than the control group (4/10) (Wilcoxon z=2.232, P=.03). The item analysis of the SC test showed a difficulty of P=0.768 (s=0.09) and a selectivity of RPB=0.2. For m

  5. BounceBack™ capsules for reduction of DOMS after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study

    Directory of Open Access Journals (Sweden)

    Singh Betsy B

    2009-06-01

    Full Text Available Abstract Background Delayed onset muscle soreness (DOMS is muscle pain and discomfort experienced approximately one to three days after exercise. DOMS is thought to be a result of microscopic muscle fiber tears that occur more commonly after eccentric exercise rather than concentric exercise. This study sought to test the efficacy of a proprietary dietary supplement, BounceBack™, to alleviate the severity of DOMS after standardized eccentric exercise. Methods The study was a randomized, double-blind, placebo-controlled, crossover study. Ten healthy community-dwelling untrained subjects, ranging in age from 18–45 years, were enrolled. Mean differences within and between groups were assessed inferentially at each data collection time-point using t-tests for all outcome measures. Results In this controlled pilot study, intake of BounceBack™ capsules for 30 days resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise compared to the placebo group. There were trends towards reductions in plasma indicators of inflammation (high sensitivity C-reactive protein and muscle damage (creatine phosphokinase and myoglobin. Conclusion BounceBack™ capsules were able to significantly reduce standardized measures of pain and tenderness at several post-eccentric exercise time points in comparison to placebo. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings. The product appears to have a good safety profile and further study with a larger sample size is warranted based on the current results.

  6. Effects of treadmill training on cognitive and motor features of patients with mild to moderate Parkinson’s disease: a pilot, single-blind, randomized controlled trial

    Science.gov (United States)

    Picelli, Alessandro; Varalta, Valentina; Melotti, Camilla; Zatezalo, Vanja; Fonte, Cristina; Amato, Stefania; Saltuari, Leopold; Santamato, Andrea; Fiore, Pietro; Smania, Nicola

    2016-01-01

    Summary The aim of this pilot randomized controlled trial was to evaluate the effects of treadmill training on cognitive and motor performance in patients with Parkinson’s disease (PD). Seventeen persons with mild to moderate PD were enrolled. Nine patients were allocated to the Intervention group and received twelve 45-minute sessions of treadmill training: one session a day, three days a week, for four consecutive weeks. Eight patients were allocated to the Control group; these patients did not undergo physical training but were required to have regular social interactions, following a specific lifestyle program. All the patients were evaluated at baseline and one month later. The primary outcome measures were the Frontal Assessment Battery-Italian version (FAB-it) and the 6-minute walking test (6MWT). At the one-month evaluation significant differences were found between the groups in their performance on the FAB-it (p=0.005) and the 6MWT (p=0.018). Our findings support the hypothesis that treadmill training might effectively improve cognitive and motor features in patients with PD. PMID:27027891

  7. Effect of HSV-2 Suppressive Therapy on Genital Tract HIV-1 RNA Shedding among Women on HAART: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    A. E. Nijhawan

    2012-01-01

    Full Text Available Background. The role of suppressive HSV therapy in women coinfected with HSV-2 and HIV-1 taking highly active antiretroviral therapy (HAART is unclear. Methods. 60 women with HIV-1/HSV-2 coinfection on HAART with plasma HIV-1 viral load (PVL ≤75 copies/mL were randomized to receive acyclovir (N=30 or no acyclovir (N=30. PVL, genital tract (GT HIV-1, and GT HSV were measured every 4 weeks for one year. Results. Detection of GT HIV-1 was not significantly different in the two arms (OR 1.23, P=0.67, although this pilot study was underpowered to detect this difference. When PVL was undetectable, the odds of detecting GT HIV were 0.4 times smaller in the acyclovir arm than in the control arm, though this was not statistically significant (P=0.07. The odds of detecting GT HSV DNA in women receiving acyclovir were significantly lower than in women in the control group, OR 0.38, P<0.05. Conclusions. Chronic suppressive therapy with acyclovir in HIV-1/HSV-2-positive women on HAART significantly reduces asymptomatic GT HSV shedding, though not GT HIV shedding or PVL. PVL was strongly associated with GT HIV shedding, reinforcing the importance of HAART in decreasing HIV sexual transmission.

  8. Proprietary arabinogalactan extract increases antibody response to the pneumonia vaccine: a randomized, double-blind, placebo-controlled, pilot study in healthy volunteers

    Directory of Open Access Journals (Sweden)

    Udani Jay K

    2010-08-01

    Full Text Available Abstract Background Arabinogalactan from Larch tree (Larix spp. bark has previously demonstrated immunostimulatory activity. The purpose of this study was to test the hypothesis that ingestion of a proprietary arabinogalactan extract, ResistAid™, would selectively enhance the antibody response to the pneumococcal (pneumonia vaccine in healthy adults. Methods This randomized, double-blind, placebo-controlled, parallel group pilot study included 45 healthy adults who had not previously been vaccinated against Streptococcus pneumoniae. The volunteers began taking the study product or placebo (daily dosage 4.5 g at the screening visit (V1-Day 0 and continued over the entire 72 day study period. After 30 days the subjects received the 23-valent pneumococcal vaccine (V2. They were monitored the following day (V3-Day 31, as well as 21 days (V4-Day 51 and 42 days (V5-Day 72 after vaccination. Responses by the adaptive immune system (antigen specific were measured via pneumococcal IgG antibodies (subtypes 4, 6B, 9V, 14, 18C, 19F, and 23F and salivary IgA levels. Responses by the innate immune system (non-specific were measured via white blood cell counts, inflammatory cytokines and the complement system. Results Vaccination significantly increased pneumococcal IgG levels as expected. The arabinogalactan group demonstrated a statistically significant greater IgG antibody response than the placebo group in two antibodies subtypes (18C and 23F at both Day 51 (p = 0.006 and p = 0.002 and at Day 72 (p = 0.008 and p = 0.041. These same subtypes (18C and 23F also demonstrated change scores from baseline which were significant, in favor of the arabinogalactan group, at Day 51 (p = 0.033 and 0.001 and at Day 72 (p = 0.012 and p = 0.003. Change scores from baseline and mean values were greater in the arabinogalactan group than placebo for most time points in antibody subtypes 4, 6B, 9V, and 19F, but these differences did not reach statistical significance. There

  9. Cardiorespiratory fitness moderates the effect of an affect-guided physical activity prescription: A pilot randomized controlled trial

    NARCIS (Netherlands)

    Baldwin, A.S.; Kangas, J.L.; Denman, D.C.; Smits, J.A.J.; Yamada, T.; Otto, M.W.

    2016-01-01

    Physical activity (PA) interventions have a clear role in promoting mental health. Current PA guidelines directed toward specific PA intensities may have negative effects on affective response to exercise, and affective response is an important determinant of PA adherence. In this randomized trial

  10. Garlic as an inhibitor of Pseudomonas aeruginosa quorum sensing in cystic fibrosis--a pilot randomized controlled trial

    DEFF Research Database (Denmark)

    Smyth, Alan R; Cifelli, Paramita M; Ortori, Catharine A

    2010-01-01

    of a QS inhibitor.We randomized 34 patients to garlic or olive oil capsules (both 656 mg daily). Clinical outcomes and safety bloods were measured at baseline and after 8 weeks treatment. In this exploratory study, analysis was per protocol.Eight patients withdrew, leaving 26 for analysis (13 garlic...

  11. The Feasibility and Effects of Acupuncture on Quality of Life Scores During Chemotherapy in Ovarian Cancer: Results from a Pilot, Randomized Sham-Controlled Trial

    Science.gov (United States)

    Matulonis, Ursula A.; Dunn, Julie E.; Lee, Hang; Doherty-Gilman, Anne; Dean-Clower, Elizabeth; Goodman, Annekathryn; Davis, Roger B.; Buring, Julie; Wayne, Peter; Rosenthal, David S.; Penson, Richard T.

    2012-01-01

    Abstract Background Within a pilot trial regarding chemotherapy-induced neutropenia, the secondary aim of the main study was explored. This involved measuring the effects—as shown on two key measurement scales reflecting quality of life (QoL)—of verum versus sham acupuncture on patients with ovarian cancer during chemotherapy. Objective The aim of this substudy was to determine the feasibility of determining the effects of verum acupuncture versus sham acupuncture on QoL in patients with ovarian cancer during chemotherapy. Design This was a randomized, sham-controlled trial. Setting The trial was conducted at two cancer centers. Patients Patients with ovarian cancer (N=21) who were receiving chemotherapy—primarily intravenous carboplatin and paclitaxel—participated in this substudy. Intervention The participants were given either active or sham acupuncture 1 week prior to cycle 2 of chemotherapy. There were ten sessions of acupuncture, with manual and electro-stimulation over a 4-week period. Main Outcome Measures The European Organization for Research and Treatment of Cancer-Quality-of-Life Questionnaire-Core 30 Item (EORTC-QLQ-C30) and the Quality of Life Questionnaire–Ovarian Cancer Module-28 Item (QLQ-OV28) were administered to the patients at baseline and at the end of their acupuncture sessions. Results Of the original 21, 15 patients (71%) completed the study, and 93% of them completed the questionnaires. The EORTC-QLQ-C30 subscores were improved in the acupuncture arm, including the mean scores of social function (SF), pain, and insomnia (p=0.05). However, after adjusting for baseline differences, only the SF score was significantly higher in the active acupuncture arm, compared with the sham acupuncture arm (p=0.03). Conclusions It appears feasible to conduct a randomized sham-controlled acupuncture trial measuring QoL for patients with ovarian cancer who are undergoing chemotherapy. Acupuncture may have a role in improving QoL during

  12. Effect of whole-body vibration exercise on mobility, balance ability and general health status in frail elderly patients: a pilot randomized controlled trial.

    Science.gov (United States)

    Zhang, Li; Weng, Changshui; Liu, Miao; Wang, Qiuhua; Liu, Liming; He, Yao

    2014-01-01

    To study the effects of whole-body vibration exercises on the mobility function, balance and general health status, and its feasibility as an intervention in frail elderly patients. Pilot randomized controlled trial. Forty-four frail older persons (85.27 ± 3.63 years) meeting the Fried Frailty Criteria. All eligible subjects were randomly assigned to the experimental group, who received a whole-body vibration exercise alone (vibration amplitude: 1-3 mm; frequency: 6-26 Hz; 4-5 bouts × 60 seconds; 3-5 times weekly), or a control group, who received usual care and exercises for eight weeks. The Timed Up and Go Test, 30-second chair stand test, lower extremities muscle strength, balance function, balance confidence and General Health Status were assessed at the beginning of the study, after four weeks and eight weeks of the intervention. Whole-body vibration exercise reduced the time of the Timed Up and Go Test (40.47 ± 15.94 s to 21.34 ± 4.42 s), improved the bilateral knees extensor strength (6.96 ± 1.70 kg to 11.26 ± 2.08 kg), the posture stability (surface area ellipse: 404.58 ± 177.05 to 255.95 ± 107.28) and General Health Status (Short-form Health Survey score: 24.51 ± 10.69 and 49.63 ± 9.85 to 45.03 ± 11.15 and 65.23 ± 9.39, respectively). The repeated-measures ANOVA showed that there were significant differences in the Timed Up and Go Test, 30-second chair stand test, bilateral knees extensor strength, activities-specific balance confidence score and general health status between the two groups (P balance and the general health status in the frail elderly.

  13. An Exploratory Analysis of the Smoking and Physical Activity Outcomes From a Pilot Randomized Controlled Trial of an Exercise Assisted Reduction to Stop Smoking Intervention in Disadvantaged Groups.

    Science.gov (United States)

    Thompson, Tom Paul; Greaves, Colin J; Ayres, Richard; Aveyard, Paul; Warren, Fiona C; Byng, Richard; Taylor, Rod S; Campbell, John L; Ussher, Michael; Green, Colin; Michie, Susan; West, Robert; Taylor, Adrian

    2016-03-01

    Economically disadvantaged smokers not intending to stop may benefit from interventions aimed at reducing their smoking. This study assessed the effects of a behavioral intervention promoting an increase in physical activity versus usual care in a pilot randomized controlled trial. Disadvantaged smokers who wanted to reduce but not quit were randomized to either a counseling intervention of up to 12 weeks to support smoking reduction and increased physical activity (n = 49) or usual care (n = 50). Data at 16 weeks were collected for various smoking and physical activity outcomes. Primary analyses consisted of an intention to treat analysis based on complete case data. Secondary analyses explored the impact of handling missing data. Compared with controls, intervention smokers were more likely to initiate a quit attempt (36 vs. 10%; odds ratio 5.05, [95% CI: 1.10; 23.15]), and a greater proportion achieved at least 50% reduction in cigarettes smoked (63 vs. 32%; 4.21 [1.32; 13.39]). Postquit abstinence measured by exhaled carbon monoxide at 4-week follow-up showed promising differences between groups (23% vs. 6%; 4.91 [0.80; 30.24]). No benefit of intervention on physical activity was found. Secondary analyses suggested that the standard missing data assumption of "missing" being equivalent to "smoking" may be conservative resulting in a reduced intervention effect. A smoking reduction intervention for economically disadvantaged smokers which involved personal support to increase physical activity appears to be more effective than usual care in achieving reduction and may promote cessation. The effect does not appear to be influenced by an increase in physical activity. © The Author 2015. 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. Comparison of intensive insulin therapy versus conventional glucose control in traumatic brain injury patients on parenteral nutrition: A pilot randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Seyedeh Neda Mousavi

    2014-01-01

    Full Text Available Background: Parenteral nutrition (PN is a valuable life saving intervention, which can improve the nutritional status of hospitalized malnourished patients. PN is associated with complications including hyperglycemia. This study was conducted to compare two methods of blood glucose control in traumatic brain injury patients on PN. Materials and Methods: A randomized, open-label, controlled trial with blinded end point assessment was designed. Traumatic brain injury patients (GCS = 4-9 on PN, without diabetes, pancreatitis, liver disease, kidney complication, were participated. Patients were randomly assigned to receive continuous insulin infusion to maintain glucose levels between 4.4 mmol/l (80 mg/dl and 6.6 mmol/l (120 mg/dl (n = 13 or conventional treatment (n = 13. Patients in the conventional group were not received insulin unless glucose levels were greater than 10 mmol/l (>180 mg/dl. These methods were done to maintain normoglycemia in ICU. The primary outcome was hypo/hyperglycemic episodes. Other factors such as C-reactive protein, blood electrolytes, liver function tests, lipid profile and mid-arm circumference were compared. Results: Mean glucose concentration were significantly lower in IIT group (118 ± 28 mg/dl vs conventional group (210 ± 31 mg/dl (P < 0.01. No hypoglycemic episode occurred in two groups. Triglyceride (P = 0.02 and C-reactive protein (P = 0.001 was decreased in the IIT group, significantly. There were also significant differences in the electrolytes, with magnesium and phosphorus being lower in the IIT group (P = 0.05. Conclusion: In this pilot study, blood glucose level, CRP and TG were lower in IIT group. Further data collection is warranted to reach definitive conclusions.

  15. Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study

    Directory of Open Access Journals (Sweden)

    Irish AK

    2017-01-01

    Full Text Available Amanda K Irish,1 Constance M Erickson,1 Terry L Wahls,2,3 Linda G Snetselaar,4 Warren G Darling1 1Motor Control Laboratories, Department of Health and Human Physiology, College of Liberal Arts and Sciences, The University of Iowa, 2Veterans Affairs Medical Center, 3Department of Internal Medicine, Carver College of Medicine, 4Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City, IA, USA Background/objective: A Paleolithic diet may improve fatigue and quality of life in progressive multiple sclerosis (MS patients, but past research has evaluated the effects of this dietary intervention in combination with other treatments such as exercise. Thus, the purpose of this pilot study was to evaluate a modified Paleolithic dietary intervention (MPDI in the treatment of fatigue and other symptoms in relapsing-remitting MS (RRMS.Methods: We measured the effects of a MPDI in 17 individuals with RRMS. Of 34 subjects randomly assigned to control (maintain usual diet and intervention (MPDI groups, nine subjects (one man completed the control group and eight subjects (one man completed the MPDI.Results: Significant improvements were seen in Fatigue Severity Scale score and also in Multiple Sclerosis Quality of Life-54 and time to complete (dominant hand 9-Hole Peg Test from baseline in MPDI subjects compared to controls. Increased vitamin K serum levels were also observed in MPDI subjects postprotocol compared to controls.Conclusion: A Paleolithic diet may be useful in the treatment and management of MS, by reducing perceived fatigue, increasing mental and physical quality of life, increasing exercise capacity, and improving hand and leg function. By increasing vitamin K serum levels, the MPDI may also reduce inflammation. Keywords: diet therapy, nutrition therapy, gluten-free, quality of life, fatigue, complementary medicine, alternative medicine

  16. Effectiveness of an innovative hip energy storage walking orthosis for improving paraplegic walking: A pilot randomized controlled study.

    Science.gov (United States)

    Yang, Mingliang; Li, Jianjun; Guan, Xinyu; Gao, Lianjun; Gao, Feng; Du, Liangjie; Zhao, Hongmei; Yang, Degang; Yu, Yan; Wang, Qimin; Wang, Rencheng; Ji, Linhong

    2017-09-01

    The high energy cost of paraplegic walking using a reciprocating gait orthosis (RGO) is attributed to limited hip motion and excessive upper limb loading for support. To address the limitation, we designed the hip energy storage walking orthosis (HESWO) which uses a spring assembly on the pelvic shell to store energy from the movements of the healthy upper limbs and flexion-extension of the lumbar spine and hip and returns this energy to lift the pelvis and lower limb to assist with the swing and stance components of a stride. Our aim was to evaluate gait and energy cost indices for the HESWO compared to the RGO in patients with paraplegia. The cross-over design was used in the pilot study. Twelve patients with a complete T4-L5 chronic spinal cord injury underwent gait training using the HESWO and RGO. Gait performance (continuous walking distance, as well as the maximum and comfortable walking speeds) and energy expenditure (at a walking speed of 3.3m/min on a treadmill) were measured at the end of the 4-week training session. Compared to the RGO, the HESWO increased continuous walking distance by 24.7% (Penergy expenditure by 13.9% (P<0.05). Our preliminary results provide support for the use of the HESWO as an alternative support for paraplegic walking. Copyright © 2017. Published by Elsevier B.V.

  17. Physiotherapy and a Homeopathic Complex for Chronic Low Back Pain Due to Osteoarthritis: A Randomized, Controlled Pilot Study

    OpenAIRE

    Pellow, Janice

    2016-01-01

    Abstract:Context: Osteoarthritis (OA) is a common cause of chronic low back pain (CLBP) and can be managed with the use of drug therapy and physiotherapy. Homeopathic remedies may assist in the management of OA; however, research that supports their effectiveness is limited. Objectives: The study aimed to investigate the efficacy of a homeopathic complex in combination with physiotherapy in the treatment of CLBP due to OA. Design: The study was a six-week, randomized, double-blind, placebo-co...

  18. Interleukin-1 Blockade in Acute Decompensated Heart Failure: A Randomized, Double-Blinded, Placebo-Controlled Pilot Study.

    Science.gov (United States)

    Van Tassell, Benjamin W; Abouzaki, Nayef A; Oddi Erdle, Claudia; Carbone, Salvatore; Trankle, Cory R; Melchior, Ryan D; Turlington, Jeremy S; Thurber, Clinton J; Christopher, Sanah; Dixon, Dave L; Fronk, Daniel T; Thomas, Christopher S; Rose, Scott W; Buckley, Leo F; Dinarello, Charles A; Biondi-Zoccai, Giuseppe; Abbate, Antonio

    2016-06-01

    Heart failure is an inflammatory disease. Patients with acute decompensated heart failure (ADHF) exhibit significant inflammatory activity on admission. We hypothesized that Interleukin-1 blockade, with anakinra (Kineret, Swedish Orphan Biovitrum), would quench the acute inflammatory response in patients with ADHF. We randomized 30 patients with ADHF, reduced left ventricular ejection fraction (Interleukin-1 blockade with anakinra reduces the systemic inflammatory response in patients with ADHF. Further studies are warranted to determine whether this anti-inflammatory effect translates into improved clinical outcomes.

  19. A pilot randomized controlled trial of the feasibility of a self-directed coping skills intervention for couples facing prostate cancer: Rationale and design

    Directory of Open Access Journals (Sweden)

    Lambert Sylvie D

    2012-09-01

    Full Text Available Abstract Background Although it is known both patients’ and partners’ reactions to a prostate cancer diagnosis include fear, uncertainty, anxiety and depression with patients’ partners’ reactions mutually determining how they cope with and adjust to the illness, few psychosocial interventions target couples. Those that are available tend to be led by highly trained professionals, limiting their accessibility and long-term sustainability. In addition, it is recognised that patients who might benefit from conventional face-to-face psychosocial interventions do not access these, either by preference or because of geographical or mobility barriers. Self-directed interventions can overcome some of these limitations and have been shown to contribute to patient well-being. This study will examine the feasibility of a self-directed, coping skills intervention for couples affected by cancer, called Coping-Together, and begin to explore its potential impact on couples’ illness adjustment. The pilot version of Coping-Together includes a series of four booklets, a DVD, and a relaxation audio CD. Methods/design In this double-blind, two-group, parallel, randomized controlled trial, 70 couples will be recruited within 4 months of a prostate cancer diagnosis through urology private practices and randomized to: 1 Coping-Together or 2 a minimal ethical care condition. Minimal ethical care condition couples will be mailed information booklets available at the Cancer Council New South Wales and a brochure for the Cancer Council Helpline. The primary outcome (anxiety and additional secondary outcomes (distress, depression, dyadic adjustment, quality of life, illness or caregiving appraisal, self-efficacy, and dyadic and individual coping will be assessed at baseline (before receiving study material and 2 months post-baseline. Intention-to-treat and per protocol analysis will be conducted. Discussion As partners’ distress rates exceed not only population

  20. A pilot randomized controlled trial of cognitive behavioral therapy for perinatal depression adapted for women with low incomes.

    Science.gov (United States)

    O'Mahen, Heather; Himle, Joseph A; Fedock, Gina; Henshaw, Erin; Flynn, Heather

    2013-07-01

    Perinatal women with identified depression in prenatal care settings have low rates of engagement and adherence with depression-specific psychotherapy. We report the feasibility and symptom outcomes of Cognitive Behavioral Therapy (CBT) modified (mCBT) to address the needs of perinatal, low-income women with Major Depressive Disorder (MDD). Pregnant women (n = 1421) were screened for depressive symptoms in obstetrics clinics in conjunction with prenatal care visits. A total of 59 women met diagnostic criteria for MDD; 55 women were randomly assigned to mCBT or Treatment as Usual (TAU). The mCBT intervention included an initial engagement session, outreach, specific perinatal content and interpersonal components. Measures were gathered at pre-treatment, 16 week post-randomization, and 3-month follow-up. Most participants attended at least one CBT session and met study criteria for treatment adherence. Active research staff outreach promoted engagement and retention in the trial. Treatment satisfaction was rated as very good. In both observed and multiple imputation results, women who received mCBT demonstrated greater improvement in depressed mood than those in TAU at 16-week post-randomization and 3-month follow-up, Cohen's d = -0.71 (95% CI -4.93, -5.70). Modified CBT offers promise as a feasible and acceptable treatment for perinatal women with low-incomes in prenatal care settings. Targeted delivery and content modifications are needed to engage populations tailored to setting and psychosocial challenges specific to the perinatal period. © 2013 Wiley Periodicals, Inc.

  1. A pilot six-week randomized controlled trial of oxytocin on social cognition and social skills in schizophrenia.

    Science.gov (United States)

    Gibson, Clare M; Penn, David L; Smedley, Kelly L; Leserman, Jane; Elliott, Tonya; Pedersen, Cort A

    2014-07-01

    The current study explored whether oxytocin can improve social cognition and social skills in individuals with schizophrenia using a six-week, double-blind design. Fourteen participants with schizophrenia were randomized to receive either intranasal oxytocin or a placebo solution and completed a battery of social cognitive, social skills and clinical psychiatric symptom measures. Results showed within group improvements in fear recognition, perspective taking, and a reduction in negative symptoms in the oxytocin group. These preliminary findings indicate oxytocin treatment may help improve certain components of functioning in schizophrenia. Implications for the treatment of social functioning in schizophrenia are discussed. Published by Elsevier B.V.

  2. A Pilot Randomized Controlled Clinical Trial to Assess Tolerance and Efficacy of Navy Bean and Rice Bran Supplementation for Lowering Cholesterol in Children

    Directory of Open Access Journals (Sweden)

    Erica C. Borresen MPH

    2017-02-01

    Full Text Available Background: Navy beans and rice bran demonstrate efficacy to regulate serum cholesterol in hypercholesterolemic adults; however, the cardiovascular disease (CVD protective properties of these foods in children are unknown and merit investigation. Objective: The objectives were to determine whether cooked navy bean powder (NBP and/or heat-stabilized rice bran (RB supplementation is tolerable, improves dietary fiber intake in children, and modulates lipid profiles. Methods: Children aged 8 to 13 years at risk for CVD due to abnormal lipids were recruited. Elevated cholesterol levels were defined as total cholesterol ≥180 mg/dL and high-density lipoprotein (HDL 100 mg/dL and HDL <60 mg/dL. Participants completed a pilot 4-week, randomized controlled, 4-arm dietary intervention. They consumed study-provided muffins or a smoothie daily that included 0 g NBP or RB (control, 17.5 g NBP, 15 g RB, or a combination 9 g NBP + 8 g RB. Fasting blood was collected at baseline and week 4. Participants also completed 3-day food logs and gastrointestinal health questionnaires. Results: Thirty-eight children completed the trial (n = 9 control, n = 10 NBP, n = 9 RB, and n = 10 NBP + RB groups. Only 3 participants withdrew due to noncompliance of required food consumption. Participants in the intervention groups significantly increased intake of NBP and RB at week 4 (p≤.01. The NBP and NBP + RB groups increased total fiber intake from baseline to week 4 (p=.02 and p=<.01, respectively. HDL-cholesterol was higher in NBP-group participants compared to control at week 4 (P = .02. Conclusion: Increasing NBP and/or RB intake is tolerable for children, and our findings suggest higher daily intakes are needed for a longer duration to induce favorable changes across multiple serum lipid parameters.

  3. The effectiveness of sit-stand workstations for changing office workers' sitting time: results from the Stand@Work randomized controlled trial pilot.

    Science.gov (United States)

    Chau, Josephine Y; Daley, Michelle; Dunn, Scott; Srinivasan, Anu; Do, Anna; Bauman, Adrian E; van der Ploeg, Hidde P

    2014-10-08

    Prolonged sitting time is detrimental for health. Individuals with desk-based occupations tend to sit a great deal and sit-stand workstations have been identified as a potential strategy to reduce sitting time. Hence, the objective of the current study was to examine the effects of using sit-stand workstations on office workers' sitting time at work and over the whole day. We conducted a randomized controlled trial pilot with crossover design and waiting list control in Sydney, Australia from September 2011 to July 2012 (n = 42; 86% female; mean age 38 ± 11 years). Participants used a sit-stand workstation for four weeks in the intervention condition. In the time-matched control condition, participants received nothing and crossed over to the intervention condition after four weeks. The primary outcomes, sitting, standing and walking time at work, were assessed before and after using the workstations with ActivPALs and self-report questionnaires. Secondary outcomes, domain-specific sitting over the whole day, were assessed by self-report. Linear mixed models estimated changes in outcomes adjusting for measurement time, study grouping and covariates. Intervention participants significantly reduced objectively assessed time spent sitting at work by 73 min/workday (95% CI: -106,-39) and increased standing time at work by 65 min/workday (95% CI: 47, 83); these changes were significant relative to controls (p = 0.004 and p sitting time significantly declined in intervention participants (-80 min/workday; 95% CI: -155, -4). This study shows that introducing sit-stand workstations in the office can reduce desk-based workers' sitting time at work in the short term. Larger scale studies on more representative samples are needed to determine the public health impact of sit-stand workstations. ACTRN12612000072819.

  4. Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET Pilot Study.

    Directory of Open Access Journals (Sweden)

    Peter T Choi

    Full Text Available Early randomized controlled trials have suggested that neuraxial blockade may reduce cardiorespiratory complications after non-cardiothoracic surgery, but recent larger trials have been inconclusive. We conducted a pilot study to assess the feasibility of conducting a large multicentre randomized controlled trial in Canada.After Research Ethics Board approvals from the participating institutions, subjects were recruited if they were > or = 45 years old, had an expected hospital stay > or = 48 hours, were undergoing a noncardiothoracic procedure amenable to epidural analgesia, met one of six risk criteria, and did not have contraindications to neuraxial blockade. After informed consent, subjects were randomly allocated to combined epidural analgesia (epidural group and neuraxial anesthesia, with or without general anesthesia, or intravenous opioid analgesia (IV group and general anesthesia. The primary outcomes were the rate of recruitment and the percents of eligible patients recruited, crossed over, and followed completely. Feasibility targets were defined a priori. A blinded, independent committee adjudicated the secondary clinical outcomes. Subjects were followed daily while in hospital and then at 30 days after surgery. Analysis was intention-to-treat. Over a 15-month period, the recruitment rate was 0.5+/-0.3 (mean+/-SEM subjects per week per centre; 112/494 (22.7% eligible subjects were recruited at four tertiary-care teaching hospitals in Canada. Thirteen (26.5% of 49 subjects in the epidural group crossed over to the IV group; seven (14.3% were due to failed or inadequate analgesia or complications from epidural analgesia. Five (9.8% of 51 subjects in the IV group crossed over to the epidural group but none were due to inadequate analgesia or complications. Ninety-eight (97.0% of 101 subjects were successfully followed up until 30 days after their surgery.Of the criteria we defined for the feasibility of a full-scale trial, only the

  5. Pilot cluster randomized controlled trials to evaluate adoption of water, sanitation, and hygiene interventions and their combination in rural western Kenya.

    Science.gov (United States)

    Christensen, Garret; Dentz, Holly N; Pickering, Amy J; Bourdier, Tomoé; Arnold, Benjamin F; Colford, John M; Null, Clair

    2015-02-01

    In preparation for a larger trial, the Water, Sanitation, and Hygiene (WASH) Benefits pilot study enrolled 72 villages and 499 subjects in two closely related randomized trials of WASH interventions in rural western Kenya. Intervention households received hardware and promotion for one of the following: water treatment, sanitation and latrine improvements, handwashing with soap, or the combination of all three. Interventions were clustered by village. A follow-up survey was conducted 4 months after intervention delivery to assess uptake. Intervention households were significantly more likely than controls to have chlorinated stored water (36-60 percentage point increases), covers over latrine drop holes (55-75 percentage point increases), less stool visible on latrine floors (16-47 percentage point reductions), and a place for handwashing (71-85 percentage point increases) with soap available (49-66 percentage point increases). The high uptake in all arms shows that combined interventions can achieve high short-term adoption rates if well-designed. © The American Society of Tropical Medicine and Hygiene.

  6. Is there a need for cervical collar usage post anterior cervical decompression and fusion using interbody cages? A randomized controlled pilot trial.

    Science.gov (United States)

    Abbott, Allan; Halvorsen, Marie; Dedering, Asa

    2013-05-01

    Anterior cervical discectomy and fusion (ACDF) is a common surgical intervention for radiculopathy resulting from degenerative cervical spine conditions. Post-surgical cervical collar use is believed to reduce post-operative pain, provide the patient with a sense of security during activities of daily living and even reduce rates of non-fusion. This prospective randomized controlled pilot trial investigates trial design feasibility in relation to prospective physical, functional, and quality of life-related outcomes of patients undergoing ACDF with interbody cage, with (n = 17) and without (n = 16) post-operative cervical collar usage. Results show that the sample provides sufficient statistical power to show that the use of a rigid cervical collar during 6 post-operative weeks is associated with significantly lower levels of neck disability index after 6 weeks and significantly lower levels of prospective neck pain. To investigate causal quality of life or fusion rate outcomes, sample size needs to be increased at least fourfold and optimally sixfold when accounting for data loss in prospective follow-up. The study suggests that post-surgical cervical collar usage may help certain patients cope with initial post-operative pain and disability.

  7. The Bipolar Depression Electrical Treatment Trial (BETTER: Design, Rationale, and Objectives of a Randomized, Sham-Controlled Trial and Data from the Pilot Study Phase

    Directory of Open Access Journals (Sweden)

    Bernardo de Sampaio Pereira Junior

    2015-01-01

    Full Text Available Background. Bipolar depression (BD is a prevalent condition, with poor therapeutic options and a high degree of refractoriness. This justifies the development of novel treatment strategies, such as transcranial direct current stimulation (tDCS that showed promising results in unipolar depression. Methods. We describe a randomized, sham-controlled, double-blinded trial using tDCS for refractory, acutely symptomatic BD (the bipolar depression electrical treatment trial, BETTER. Sixty patients will be enrolled and assessed with clinical and neuropsychological tests. The primary outcome is change (over time and across groups in the scores of the Hamilton Depression Rating Scale (17 items. Biological markers such as blood neurotrophins and interleukins, genetic polymorphisms, heart rate variability, and motor cortical excitability will be assessed. Twelve anodal-left/cathodal-right 2 mA tDCS sessions over the dorsolateral prefrontal cortex will be performed in 6 weeks. Results. In the pilot phase, five patients received active tDCS and were double-blindly assessed, two presenting clinical response. TDCS was well-tolerated, with no changes in cognitive scores. Conclusion. This upcoming clinical trial will address the efficacy of tDCS for BD on different degrees of refractoriness. The evaluation of biological markers will also help in understanding the pathophysiology of BD and the mechanisms of action of tDCS.

  8. Core stability exercise is as effective as task-oriented motor training in improving motor proficiency in children with developmental coordination disorder: a randomized controlled pilot study.

    Science.gov (United States)

    Au, Mei K; Chan, Wai M; Lee, Lin; Chen, Tracy Mk; Chau, Rosanna Mw; Pang, Marco Yc

    2014-10-01

    To compare the effectiveness of a core stability program with a task-oriented motor training program in improving motor proficiency in children with developmental coordination disorder (DCD). Randomized controlled pilot trial. Outpatient unit in a hospital. Twenty-two children diagnosed with DCD aged 6-9 years were randomly allocated to the core stability program or the task-oriented motor program. Both groups underwent their respective face-to-face training session once per week for eight consecutive weeks. They were also instructed to carry out home exercises on a daily basis during the intervention period. Short Form of the Bruininks-Oseretsky Test of Motor Proficiency (Second Edition) and Sensory Organization Test at pre- and post-intervention. Intention-to-treat analysis revealed no significant between-group difference in the change of motor proficiency standard score (P=0.717), and composite equilibrium score derived from the Sensory Organization Test (P=0.100). Further analysis showed significant improvement in motor proficiency in both the core stability (mean change (SD)=6.3(5.4); p=0.008) and task-oriented training groups (mean change(SD)=5.1(4.0); P=0.007). The composite equilibrium score was significantly increased in the task-oriented training group (mean change (SD)=6.0(5.5); P=0.009), but not in the core stability group (mean change(SD) =0.0(9.6); P=0.812). In the task-oriented training group, compliance with the home program was positively correlated with change in motor proficiency (ρ=0.680, P=0.030) and composite equilibrium score (ρ=0.638, P=0.047). The core stability exercise program is as effective as task-oriented training in improving motor proficiency among children with DCD. © The Author(s) 2014.

  9. Pilot randomized controlled trial of a mindfulness-based group intervention in adolescent girls at risk for type 2 diabetes with depressive symptoms.

    Science.gov (United States)

    Shomaker, Lauren B; Bruggink, Stephanie; Pivarunas, Bernadette; Skoranski, Amanda; Foss, Jillian; Chaffin, Ella; Dalager, Stephanie; Annameier, Shelly; Quaglia, Jordan; Brown, Kirk Warren; Broderick, Patricia; Bell, Christopher

    2017-06-01

    (1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance. Parallel-group, randomized controlled pilot trial conducted at a university. Thirty-three girls 12-17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n=17) or cognitive-behavioral program (n=16). Both interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation. Adolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition. Most adolescents attended ≥80% sessions (mindfulness: 92% versus cognitive-behavioral: 87%, p=1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (psmindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (psmindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive symptoms and better insulin resistance. ClinicalTrials.gov identifier: NCT02218138

  10. Fatty acids and sleep in UK children: subjective and pilot objective sleep results from the DOLAB study--a randomized controlled trial.

    Science.gov (United States)

    Montgomery, Paul; Burton, Jennifer R; Sewell, Richard P; Spreckelsen, Thees F; Richardson, Alexandra J

    2014-08-01

    Sleep problems in children are associated with poor health, behavioural and cognitive problems, as are deficiencies of long-chain omega-3 fatty acids such as docosahexaenoic acid. Theory and some evidence support a role for these fatty acids in sleep regulation, but this issue has received little formal investigation. We examined associations between blood fatty acid concentrations (from fingerstick blood samples) and subjective sleep (using an age-standardized parent questionnaire) in a large epidemiological sample of healthy children aged 7-9 years (n = 395) from mainstream UK schools. In a randomized controlled trial, we then explored whether 16-week supplementation (600 mg day(-1) ) with algal docosahexaenoic acid versus placebo might improve sleep in a subset of those children (n = 362) who were underperforming in reading. In a randomly selected subsample (n = 43), sleep was also assessed objectively via actigraphy. In 40% of the epidemiological sample, Child Sleep Habits Questionnaire scores indicated clinical-level sleep problems. Furthermore, poorer total sleep disturbance scores were associated weakly but significantly with lower blood docosahexaenoic acid (std coeff. -0.105*) and a lower docosahexaenoic acid : arachidonic acid ratio (std coeff. -0.119**). The treatment trial showed no significant effects on subjective sleep measures. However, in the small actigraphy subsample, docosahexaenoic acid supplementation led on average to seven fewer wake episodes and 58 min more sleep per night. Cautiously, we conclude that higher blood levels of docosahexaenoic acid may relate to better child sleep, as rated by parents. Exploratory pilot objective evidence from actigraphy suggests that docosahexaenoic acid supplementation may improve children's sleep, but further investigations are needed.

  11. Prehabilitation with Whey Protein Supplementation on Perioperative Functional Exercise Capacity in Patients Undergoing Colorectal Resection for Cancer: A Pilot Double-Blinded Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Gillis, Chelsia; Loiselle, Sarah-Eve; Fiore, Julio F; Awasthi, Rashami; Wykes, Linda; Liberman, A Sender; Stein, Barry; Charlebois, Patrick; Carli, Francesco

    2016-05-01

    A previous comprehensive prehabilitation program, providing nutrition counseling with whey protein supplementation, exercise, and psychological care, initiated 4 weeks before colorectal surgery for cancer, improved functional capacity before surgery and accelerated functional recovery. Those receiving standard of care deteriorated. The specific role of nutritional prehabilitation alone on functional recovery is unknown. This study was undertaken to estimate the impact of nutrition counseling with whey protein on preoperative functional walking capacity and recovery in patients undergoing colorectal resection for cancer. We conducted a double-blinded randomized controlled trial at a single university-affiliated tertiary center located in Montreal, Quebec, Canada. Colon cancer patients (n=48) awaiting elective surgery for nonmetastatic disease were randomized to receive either individualized nutrition counseling with whey protein supplementation to meet protein needs or individualized nutrition counseling with a nonnutritive placebo. Counseling and supplementation began 4 weeks before surgery and continued for 4 weeks after surgery. The primary outcome was change in functional walking capacity as measured with the 6-minute walk test. The distance was recorded at baseline, the day of surgery, and 4 weeks after surgery. A change of 20 m was considered clinically meaningful. The whey group experienced a mean improvement in functional walking capacity before surgery of +20.8 m, with a standard deviation of 42.6 m, and the placebo group improved by +1.2 (65.5) m (P=0.27). Four weeks after surgery, recovery rates were similar between groups (P=0.81). Clinically meaningful improvements in functional walking capacity were achieved before surgery with whey protein supplementation. These pilot results are encouraging and justify larger-scale trials to define the specific role of nutrition prehabilitation on functional recovery after surgery. Copyright © 2016 Academy of

  12. Training symmetry of weight distribution after stroke: a randomized controlled pilot study comparing task-related reach, Bobath and feedback training approaches.

    Science.gov (United States)

    Mudie, M H; Winzeler-Mercay, U; Radwan, S; Lee, L

    2002-09-01

    To determine (1) the most effective of three treatment approaches to retrain seated weight distribution long-term after stroke and (2) whether improvements could be generalized to weight distribution in standing. Inpatient rehabilitation unit. Forty asymmetrical acute stroke subjects were randomly allocated to one of four groups in this pilot study. Changes in weight distribution were compared between the 10 subjects of each of three treatment groups (task-specific reach, Bobath, or Balance Performance Monitor [BPM] feedback training) and a no specific treatment control group. One week of measurement only was followed by two weeks of daily training sessions with the treatment to which the subject was randomly allocated. Measurements were performed using the BPM daily before treatment sessions, two weeks after cessation of treatment and 12 weeks post study. Weight distribution was calculated in terms of mean balance (percentage of total body weight) or the mean of 300 balance points over a 30-s data run. In the short term, the Bobath approach was the most effective treatment for retraining sitting symmetry after stroke (p = 0.004). Training with the BPM and no training were also significant (p = 0.038 and p = 0.035 respectively) and task-specific reach training failed to reach significance (p = 0.26). At 12 weeks post study 83% of the BPM training group, 38% of the task-specific reach group, 29% of the Bobath group and 0% of the untrained group were found to be distributing their weight to both sides. Some generalization of symmetry training in sitting to standing was noted in the BPM training group which appeared to persist long term. Results should be treated with caution due to the small group sizes. However, these preliminary findings suggest that it might be possible to restore postural symmetry in sitting in the early stages of rehabilitation with therapy that focuses on creating an awareness of body position.

  13. Aerobic or Resistance Training and Pulse Wave Velocity in Kidney Transplant Recipients: A 12-Week Pilot Randomized Controlled Trial (the Exercise in Renal Transplant [ExeRT] Trial).

    Science.gov (United States)

    Greenwood, Sharlene A; Koufaki, Pelagia; Mercer, Thomas H; Rush, Robert; O'Connor, Ellen; Tuffnell, Rachel; Lindup, Herolin; Haggis, Lynda; Dew, Tracy; Abdulnassir, Lyndsey; Nugent, Eilish; Goldsmith, David; Macdougall, Iain C

    2015-10-01

    Cardiovascular disease remains the leading cause of death in kidney transplant recipients. This pilot study examined the potential effect of aerobic training or resistance training on vascular health and indexes of cardiovascular risk in kidney transplant recipients. Single-blind, randomized, controlled, parallel trial. 60 participants (mean age, 54 years; 34 men) were randomly assigned to aerobic training (n=20), resistance training (n=20), or usual care (n=20). Participants were included if they had a kidney transplant within 12 months prior to baseline assessment. Patients were excluded if they had unstable medical conditions or had recently started regular exercise. Aerobic training and resistance training were delivered 3 days per week for a 12-week period. The usual-care group received standard care. Pulse wave velocity, peak oxygen uptake (Vo2peak), sit-to-stand 60, isometric quadriceps force, and inflammatory biomarkers were assessed at 0 and 12 weeks. The anticipated 60 participants were recruited within 12 months. 46 participants completed the study (aerobic training, n=13; resistance training, n=13; and usual care, n=20), resulting in a 23% attrition rate. Analyses of covariance, adjusted for baseline values, age, and dialysis vintage pretransplantation, revealed significant mean differences between aerobic training and usual care in pulse wave velocity of -2.2±0.4 (95% CI, -3.1 to -1.3) m/s (PPilot study, small sample size, no measure of endothelial function. Both aerobic training and resistance training interventions appear to be feasible and clinically beneficial in this patient population. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  14. Tailored education for older patients to facilitate engagement in falls prevention strategies after hospital discharge--a pilot randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Anne-Marie Hill

    Full Text Available BACKGROUND: The aims of the study were to evaluate the effect of providing tailored falls prevention education in hospital on: i engagement in targeted falls prevention behaviors in the month after discharge: ii patients' self-perceived risk and knowledge about falls and falls prevention strategies after receiving the education. METHODS: A pilot randomized controlled trial (n = 50: baseline and outcome assessments conducted by blinded researchers. PARTICIPANTS: hospital inpatients 60 years or older, discharged to the community. Participants were randomized into two groups. The intervention was a tailored education package consisting of multimedia falls prevention information with trained health professional follow-up, delivered in addition to usual care. Outcome measures were engagement in falls prevention behaviors in the month after discharge measured at one month after discharge with a structured survey, and participants' knowledge, confidence and motivation levels before and after receiving the education. The feasibility of providing the intervention was examined and falls outcomes (falls, fall-related injuries were also collected. RESULTS: Forty-eight patients (98% provided follow-up data. The complete package was provided to 21 (84% intervention group participants. Participants in the intervention group were significantly more likely to plan how to safely restart functional activities [Adjusted odds ratio 3.80, 95% CI (1.07, 13.52, p = 0.04] and more likely to complete other targeted behaviors such as completing their own home exercise program [Adjusted odds ratio 2.76, 95% CI (0.72, 10.50, p = 0.14] than the control group. The intervention group was significantly more knowledgeable, confident and motivated to engage in falls prevention strategies after receiving the education than the control group. There were 23 falls (n = 5 intervention; n = 18 control and falls rates were 5.4/1000 patient days (intervention; 18.7/1000 patient days

  15. Feasibility of the “Bring Your Own Device” Model in Clinical Research: Results from a Randomized Controlled Pilot Study of a Mobile Patient Engagement Tool

    Science.gov (United States)

    Pugliese, Laura; Woodriff, Molly; Crowley, Olga; Sohn, Jeremy; Bradley, Scott

    2016-01-01

    Background Rising rates of smartphone ownership highlight opportunities for improved mobile application usage in clinical trials. While current methods call for device provisioning, the "bring your own device” (BYOD) model permits participants to use personal phones allowing for improved patient engagement and lowered operational costs. However, more evidence is needed to demonstrate the BYOD model’s feasibility in research settings. Objective To assess if CentrosHealth, a mobile application designed to support trial compliance, produces different outcomes in medication adherence and application engagement when distributed through study-provisioned devices compared to the BYOD model. Methods 87 participants were randomly selected to use the mobile application or no intervention for a 28-day pilot study at a 2:1 randomization ratio (2 intervention: 1 control) and asked to consume a twice-daily probiotic supplement. The application users were further randomized into two groups: receiving the application on a personal "BYOD” or study-provided smartphone. In-depth interviews were performed in a randomly-selected subset of the intervention group (five BYOD and five study-provided smartphone users). Results The BYOD subgroup showed significantly greater engagement than study-provided phone users, as shown by higher application use frequency and duration over the study period. The BYOD subgroup also demonstrated a significant effect of engagement on medication adherence for number of application sessions (unstandardized regression coefficient beta=0.0006, p=0.02) and time spent therein (beta=0.00001, p=0.03). Study-provided phone users showed higher initial adherence rates, but greater decline (5.7%) than BYOD users (0.9%) over the study period. In-depth interviews revealed that participants preferred the BYOD model over using study-provided devices.  Conclusions Results indicate that the BYOD model is feasible in health research settings and improves participant

  16. Dialysis-associated hypertension treated with Telmisartan--DiaTel: a pilot, placebo-controlled, cross-over, randomized trial

    National Research Council Canada - National Science Library

    Huber, Matthias; Treutler, Till; Martus, Peter; Kurzidim, Antje; Kreutz, Reinhold; Beige, Joachim

    2013-01-01

    .... We designed and conducted a randomised, placebo-controlled, double-blind and cross-over trial for treatment of dialysis-associated hypertension with telmisartan 80 mg once daily or placebo on top...

  17. Feasibility, acceptability, and adherence of two educational programs for care staff concerning nursing home patients' fecal incontinence: a pilot study preceding a cluster-randomized controlled trial.

    Science.gov (United States)

    Blekken, Lene Elisabeth; Nakrem, Sigrid; Gjeilo, Kari Hanne; Norton, Christine; Mørkved, Siv; Vinsnes, Anne Guttormsen

    2015-05-23

    Fecal incontinence has a high prevalence in the nursing home population which cannot be explained by co-morbidity or anatomic and physiological changes of aging alone. Our hypothesis is that fecal incontinence can be prevented, cured, or ameliorated by offering care staff knowledge of best practice. However, it is not clear which educational model is most effective. To assess the effect of two educational programs for care staff, we planned a three armed cluster-randomized controlled trial. There is a lack of research reporting effects of interventions targeting improved continence care processes in older patients. Thus, to improve the quality of the planned trial, we decided to carry out a pilot study to investigate the feasibility of the planned design, the interventions (educational programs) and the outcome measures, and to enable a power calculation. This paper reports the results from the pilot study. Three nursing homes, representing each arm of the planned trial, were recruited. Criteria for assessing success of feasibility were pre-specified. Methods, outcome measures, acceptability, and adherence of the components of the intervention were evaluated by descriptive statistical analyses and qualitative content analysis of one focus group interview (n = 7) and four individual interviews. The main study is feasible with one major and some minor modifications. Due to challenges with recruitment and indications supporting the assumption that a single intervention with one workshop is not sufficient as an implementation strategy, the main study will be reduced to two arms: a multifaceted education intervention and control. The components of the multifaceted intervention seemed to work well together and need only minor modification. Important barriers to consider were sub-optimal use of skill-mix, problems of communicating important assessments and care plans, and isolated nurses with an indistinct nurse identity. Overall, the main study is feasible. The

  18. Comparison of survival time and comfort between 2 clear overlay retainers with different thicknesses: A pilot randomized controlled trial.

    Science.gov (United States)

    Zhu, Yafen; Lin, Jianchang; Long, Hu; Ye, Niansong; Huang, Renhuan; Yang, Xin; Jian, Fan; Lai, Wenli

    2017-03-01

    The objective of this 2-arm parallel trial was to compare the survival times, failure rates, and comfort of 2 clear overlay retainers with different thicknesses (0.75 and 1.00 mm). Eighty eligible participants who had undergone orthodontic treatment at West China Stomatology Hospital of Sichuan University were recruited and randomly assigned to either the 0.75-mm group or the 1.00-mm group. Eligibility criteria included patients with central incisors, canines, and first molars and no systemic or oral disease. The main outcomes were survival time and total failure rate; the secondary outcomes were rates of different types of failure (fracture, loss, nonfitting, and abrasion); tertiary outcomes included patients' comfort levels assessed with a visual analog scale and a health survey. Randomization was accomplished by tossing a coin, with the allocations concealed in sequentially numbered, opaque, sealed envelopes, and blinding implemented among practitioners, patients, and analysts. Patients were evaluated at 1, 3, 6, and 12 months of follow-up. A total of 80 patients were initially recruited and randomized (42 in the 0.75-mm group, 38 in the 1.00-mm group); 72 patients completed the study and were analyzed (37 in the 0.75-mm group, 35 in the 1.00-mm group); there were 8 dropouts. Baseline characteristics were similar between the groups. At the end of the 1-year follow-up, survival time did not differ significantly between the groups (46.5 days; 95% confidence interval [CI], -10.3 -103.2; P = 0.111). The hazard ratio was 0.77 (95% CI, 0.48-1.24; P = 0.281). With regard to total failure rate, no statistical difference (P = 0.118) existed between the 0.75-mm group (43.2%) and the 1.00-mm group (25.7%) (risk difference, 17.5%; 95% CI, -4.0%-39.1%). Among the different failure types, we found that fracture rates were significantly higher in the 0.75-mm group than in the 1.00-mm group (P = 0.028), whereas other failure types were similar between the groups

  19. Eye Movement Desensitization and Reprocessing (EMDR Versus Treatment as Usual for Non-Specific Chronic Back Pain Patients with Psychological Trauma: A Randomized Controlled Pilot Study

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    Andreas Gerhardt

    2016-12-01

    Full Text Available Objective: Eye-Movement-Desensitization and Reprocessing (EMDR – an evidence-based approach to eliminate emotional distress from traumatic experiences – was recently suggested for the treatment of chronic pain. Aim of this study was to estimate preliminary efficacy of a pain-focused EMDR intervention for the treatment of non-specific chronic back pain.Design: Randomized controlled pilot study.Methods: Forty non-specific chronic back pain patients reporting previous experiences of psychological trauma were consecutively recruited from outpatient tertiary-care pain centers. After baseline assessment, patients were randomized to intervention or control group (1:1. The intervention group received ten sessions standardized pain-focused EMDR in addition to treatment-as-usual. The control group received treatment-as-usual alone.The primary outcome was preliminary efficacy, measured by pain intensity, disability, and treatment satisfaction from the patients' perspective. Clinical relevance of changes was determined according to established recommendations. Assessments were conducted at the baseline, post-treatment, and at a 6-month follow-up. Intention-to-treat-analysis with last-observation-carried-forward method was used. Registered with ClinicalTrials.gov (NCT01850875.Results: Estimated effect sizes (between-group, pooled standard deviation for pain intensity and disability were d=0.79 (CI95%: 0.13, 1.42 and d=0.39 (CI95%: -0.24, 1.01 post-treatment, and d=0.50 (CI95%: 0.14, 1.12 and d=0.14 (CI95%: -0.48, 0.76 at 6-month follow-up. Evaluation on individual patient basis showed that about 50% of the patients in the intervention group improved clinically relevant and also rated their situation as clinically satisfactory improved, compared to zero patients in the control group.Conclusions: There is preliminary evidence that pain-focused EMDR might be useful for non-specific chronic back pain patients with previous experiences of psychological trauma

  20. Tai chi qigong as a means to improve night-time sleep quality among older adults with cognitive impairment: a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chan AWK

    2016-09-01

    Full Text Available Aileen WK Chan, Doris SF Yu, KC Choi, Diana TF Lee, Janet WH Sit, Helen YL Chan The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, People’s Republic of China Purpose: Age-related cognitive decline is a growing public health concern worldwide. More than a quarter of adults with cognitive impairment experience sleep disturbance. The objective of this pilot study was to evaluate the preliminary effects of tai chi qigong (TCQ on improving the night-time sleep quality of older adults with cognitive impairment. Participants: Older adults with cognitive impairment who complain of sleep disturbance. Methods: A randomized controlled trial with two groups. Fifty-two subjects were recruited from two district elderly community centers and randomly assigned to either the TCQ group (n=27 or the control group (n=25. The intervention group received TCQ training consisting of two 60-minute sessions each week for 2 months. The control group was advised to maintain their usual activities. Sleep quality was measured by the Chinese Pittsburgh Sleep Quality Index. Quality of life was measured by Short-form 12, cognitive functions measured by mini-mental state examination, and subjective memory deficits measured by the memory inventory for Chinese. Results: Data were collected at baseline, 2 months, and 6 months. Significant results were noted at 6 months in the Chinese Pittsburgh Sleep Quality Index global score (P=0.004, sleep duration (P=0.003, habitual sleep efficiency (P=0.002, and the Short-form 12 mental health component (P<0.001. The TCQ participants reported better sleep quality and a better (quality of life mental health component than the control group. Conclusion: TCQ can be considered a useful nonpharmacological approach for improving sleep quality in older adults with cognitive impairment.Clinical trial registration: CUHK_CCT00448 (https://www2.ccrb.cuhk.edu.hk/registry/public/287. Keywords: cognitive decline, mind

  1. Listening to music during cystoscopy decreases anxiety, pain, and dissatisfaction in patients: a pilot randomized controlled trial.

    Science.gov (United States)

    Yeo, Jeong Kyun; Cho, Dae Yeon; Oh, Mi Mi; Park, Seok San; Park, Min Gu

    2013-04-01

    To determine whether listening to music during cystoscopy decreases anxiety, pain, and dissatisfaction among patients and results in a more comfortable and better-tolerated procedure. Seventy male patients who underwent rigid cystoscopy between May 2011 and December 2011 were randomized into the following: no music (Group I, n=35) or classical music during procedure (Group II, n=35). Before cystoscopy, lidocaine gel was instilled in the urethra, and both groups viewed their procedures on a video monitor. Anxiety levels were quantified according to the State-Trait Anxiety Inventory. A visual analog scale (0-10) was used for a self-assessment of satisfaction, discomfort, and willingness among patients to repeat the cystoscopy. Demographic characteristics, mean age, procedure duration, and procedure indications were statistically similar between the two groups. The mean anxiety level and mean pain score of Group II were significantly lower than those of Group I (pmusic during rigid cystoscopy significantly reduces feelings of pain, discomfort, and dissatisfaction. Music can serve as a simple, inexpensive, and effective adjunct to sedation during cystoscopy. We recommend the application of music during rigid cystoscopy for clinical use.

  2. SM-03A RANDOMIZED, PLACEBO-CONTROLLED PILOT TRIAL OF ARMODAFINIL FOR FATIGUE IN PATIENTS WITH GLIOMAS UNDERGOING RADIOTHERAPY

    Science.gov (United States)

    Lee, Eudocia; Muzikansky, Alona; Kesari, Santosh; Wong, Eric; Fadul, Camilo; Reardon, David; Norden, Andrew; Nayak, Lakshmi; Rinne, Mikael; Alexander, Brian; Arvold, Nils; Doherty, Lisa; LaFrankie, Debra; Pulverenti, Julee; Smith, Katrina; Gaffey, Sarah; Kenney, Alexandra; Hammond, Samantha; Drappatz, Jan; Wen, Patrick

    2014-01-01

    BACKGROUND: Fatigue is a common symptom among glioma patients and affects quality of life. Armodafinil, a wakefulness-promoting medication, benefits patients with fatigue of various causes. This study evaluates the effects of armodafinil on fatigue in glioma patients undergoing radiation therapy (RT). METHODS: Eligibility criteria included age ≥ 18; KPS ≥ 60; grade 2-4 glioma undergoing RT to a total dose of 50-60 Gy with or without chemotherapy. Patients were randomized 1:1 to armodafinil or placebo. Fatigue assessments were made at baseline, Day 22, Day 43, and Day 56 with the FACIT-F Fatigue Scale, FACT-G, Brief Fatigue Inventory (BFI), and Cancer Fatigue Scale (CFS). The primary aim was to detect a difference in the 42-day change in FACIT-F fatigue subscale scores between the two groups using a 2-sample Wilcoxon statistic. Secondary outcomes include a 42-day change in FACT-G, CFS, and BFI. RESULTS: In the armodafinil arm, median age was 56 (25-79), median KPS was 90 (70-100), 58.5% with grade 4 glioma, 34.2% with grade 3 glioma, 2.4% with grade 2 glioma. In the placebo arm, median age was 54 (19-78), median KPS was 90 (70-100), 47.8% with grade 4 glioma, 30.8% with grade 3 glioma, 10.3% with grade 2 glioma. The median 42-day change in the FACIT-F fatigue subscale scores in the armodafinil arm was 1 (range -40 to 26) and in the placebo arm was -5.50 (range -65 to 28) with Wilcoxon p-value of 0.14. Toxicity was rare and similar between arms. CONCLUSIONS: Treatment with armodafinil is well tolerated in glioma patients undergoing RT. Preliminary results do not demonstrate statistically significant reduction in fatigue between groups. Updated results will be presented.

  3. Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Michelle L Dossett

    Full Text Available It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1 either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2 either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41, however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01. Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this

  4. Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

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    Chaitanya Pradeep Joshi

    2016-01-01

    Full Text Available Background: A randomized, prospective clinical, radiographical, and histological study was conducted to evaluate healing after alveolar ridge preservation technique using two different graft materials, namely, a novel autogenous graft material i. e., autogenous tooth graft (ATG and beta-tricalcium phosphate (β-TCP alloplast. Materials and Methods: Fifteen patients undergoing extraction of at least three teeth were selected. Atraumatic extractions were performed. Of the three extraction sockets, one was grafted with ATG, other with β-TCP, and the third was left ungrafted. Cone-beam computed tomography scans were taken immediately after grafting and 4 months postoperatively to check the changes in alveolar crest height and width at all the sites. Three patients in whom implant placement was done after complete healing; bone samples were harvested using a 3 mm diameter trephine during osteotomy preparation from both the ridge preserved sites and studied histologically. Results: There was a statistically significant difference when the changes in width and height of alveolar crest were compared within all the three groups (P < 0.05. Among three sites, ATG-grafted sites showed the most superior results with a minimal reduction in alveolar crest height and width. Histological analysis also showed the same trend with more new bone formation at ATG-grafted sites as compared to β-TCP-grafted sites. Conclusion: Postextraction, ridge preservation leads to more predictable maintenance of alveolar ridge height and width. ATG as compared to β-TCP provided superior results. Based on this, we conclude that ATG material can serve as a better alternative to conventional bone graft materials.

  5. Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults: A randomized controlled pilot trial.

    Science.gov (United States)

    Deer, Rachel R; Dickinson, Jared M; Fisher, Steve R; Ju, Hyunsu; Volpi, Elena

    2016-07-01

    Hospitalization induces functional decline in older adults. Many geriatric patients fail to fully recover physical function after hospitalization, which increases the risk of frailty, disability, dependence, re-hospitalization, and mortality. There is a lack of evidence-based therapies that can be implemented following hospitalization to accelerate functional improvements. The aims of this Phase I clinical trial are to determine 1) the effect size and variability of targeted interventions in accelerating functional recovery from hospitalization and 2) the feasibility of implementing such interventions in community-dwelling older adults. Older patients (≥65years, n=100) will be recruited from a single site during hospitalization for an acute medical condition. Subjects will be randomized to one of five interventions initiated immediately upon discharge: 1. protein supplementation, 2. in-home rehabilitation plus placebo supplementation, 3. in-home rehabilitation plus protein supplementation, 4. single testosterone injection, or 5. isocaloric placebo supplementation. Testing will occur during hospitalization (baseline) and at 1 and 4weeks post-discharge. Each testing session will include measures of muscle strength, physical function/performance, body composition, and psychological function. Physical activity levels will be continuously monitored throughout study participation. Feasibility will be determined through collection of the number of eligible, contacted, and enrolled patients; intervention adherence and compliance; and reasons for declining enrollment and study withdrawal. This research will determine the feasibility of post-hospitalization strategies to improve physical function in older adults. These results will also provide a foundation for performing larger, multi-site clinical trials to improve physical function and reduce readmissions in geriatric patents.

  6. A Randomized Controlled Pilot Trial Investigating the Impact of a Workplace Resilience Program During a Time of Significant Organizational Change.

    Science.gov (United States)

    Rogerson, Shane; Meir, Rudi; Crowley-McHattan, Zac; McEwen, Kathryn; Pastoors, Rachel

    2016-04-01

    The aim of this study was to investigate the effectiveness of a short-term resilience intervention as measured by the Resilience at Work (RAW) scale. A 5-week resilience program was implemented with 28 volunteers and assessed by the 20-item RAW scale. The scale was administered electronically and participants were match paired into either a treatment or control group. Statistical analysis was conducted using a 2 × 2 group (Treatment, control) × time (pre, post) analysis of variance with repeated measures. Postintervention time point RAW total score was significantly greater in the treatment group (P < 0.01) and statistical significance was also achieved for four of the seven subscales. Employee resilience can be improved via specific educational and skills training requiring a total time commitment of just 5 hours, making this intervention feasible for most working environments.

  7. N-acetyl-L-cysteine combined with mesalamine in the treatment of ulcerative colitis: Randomized, placebo-controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    Luis G Guijarro; David Prieto-Merino; Venancio Gonzalez Lara; Amado Salvador Pe(n)a; Jose Mate; Javier P Gisbert; Jose Luis Perez-Calle; Ignacio Marín-Jimenez; Encarna Arriaza; Tomás Olleros; Maria Delgado; Maria S Castillejo

    2008-01-01

    AIM: To evaluate the effectiveness and safety of oral N-acetyI-L-cysteine (NAC) co-administration with mesalamine in ulcerative colitis (UC) patients.METHODS: Thirty seven patients with mild to moderate UC were randomized to receive a fourowk course of oral mesalamine (2.4 g/d) plus N-acetyI-L-cysteine (0.8 g/d)(group A) or mesalamine plus placebo (group B).Patients were monitored using the Modified TrueloveWitts Severity Index (MIWSI). The primary endpoint was clinical remission (MIWSI ≤ 2) at 4 wk. Secondary endpoints were clinical response (defined as a reduction from baseline in the MIWSI of≥ 2 points) and drug safety. The serum TNF-α, interleukin-6, interleukin-8 and MCP-1 were evaluated at baseline and at 4 wk of treatment.RESULTS: Analysis per-protocol criteria showed clinical remission rates of 63% and 50% after 4 wk treatment with mesalamine plus N-acetyI-L-cysteine (group A) and mesalamine plus placebo (group 13) respectively (OR = 1.71;95% CI: 0.46 to 6.36; P = 0.19; NNT = 7.7). Analysis of variance (ANOVA) of data indicated a significant reduction of MIWSI in group A (P = 0.046) with respect to basal condition without significant changes in the group B (P = 0.735) during treatment. Clinical responses were 66% (group A) vs 44% (group B) alter 4 wk of treatment (OR = 2.5; 95% CI: 0.64 to 9.65; P = 0.11; NNT = 4.5).Clinical improvement in group A correlated with a decrease of IL-8 and MCP-1. Rates of adverse events did not differ significantly between both groups.CONCLUSION: In group A (oral NAC combined with mesalamine) contrarily to group B (mesalamine alone),the clinical improvement correlates with a decrease of chemokines such as MCP-1 and IL-8. NAC addition not produced any side effects.

  8. Erythropoietin prevention trial of coronary restenosis and cardiac remodeling after ST-elevated acute myocardial infarction (EPOC-AMI): a pilot, randomized, placebo-controlled study.

    Science.gov (United States)

    Taniguchi, Norimasa; Nakamura, Takeshi; Sawada, Takahisa; Matsubara, Kinya; Furukawa, Keizo; Hadase, Mitsuyoshi; Nakahara, Yoshifumi; Nakamura, Takashi; Matsubara, Hiroaki

    2010-11-01

    Erythropoietin (EPO) enhances re-endothelialization and anti-apoptotic action. Larger clinical studies to examine the effects of high-dose EPO are in progress in patients with acute myocardial infarction (AMI). The aim of this multi-center pilot study was to investigate the effect of `low-dose EPO' (6,000 IU during percutaneous coronary intervention (PCI), 24 h and 48 h) in 35 patients with a first ST-elevated AMI undergoing PCI who was randomly assigned to EPO or placebo (saline) treatment. Neointimal volume, cardiac function and infarct size were examined in the acute phase and 6 months later (ClinicalTrials.gov identifier: NCT00423020). No significant regression in in-stent neointimal volume was observed, whereas left ventricular (LV) ejection fraction was significantly improved (49.2% to 55.7%, P=0.003) and LV end-systolic volume was decreased in the EPO group (47.7 ml to 39.0 ml, P=0.036). LV end-diastolic volume tended to be reduced from 90.2% to 84.5% (P=0.159), whereas in the control group it was inversely increased (91.7% to 93.7%, P=0.385). Infarction sizes were significantly reduced by 38.5% (P=0.003) but not in the control group (23.7%, P=0.051). Hemoglobin, peak creatine kinase values, and CD34(+)/CD133(+)/CD45(dim) endothelial progenitors showed no significant changes. No adverse events were observed during study periods. This is a first study demonstrating that short-term `low-dose' EPO to PCI-treated AMI patients did not prevent neointimal hyperplasia but rather improved cardiac function and infarct size without any clinical adverse effects.

  9. Do Mothers Benefit from a Child-Focused Cognitive Behavioral Treatment (CBT for Childhood Functional Abdominal Pain? A Randomized Controlled Pilot Trial

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    Claudia Calvano

    2017-02-01

    Full Text Available While the efficacy of cognitive-behavioral treatment (CBT approaches for childhood functional abdominal pain (FAP is well-established for child outcomes, only a few studies have reported on parent-specific outcomes. This randomized controlled pilot trial analyzed effects of a group CBT on maternal variables (i.e., pain-related behavior, worries and self-efficacy, as well as general psychosocial strain. Methods: The sample constituted of 15 mothers in the intervention group (IG and 14 mothers in the waitlist control group (WLC. Outcome measures were assessed pre-treatment, post-treatment and at three months follow-up. Results: Analyses revealed significant, large changes in maladaptive maternal reactions related to the child’s abdominal pain in the IG compared to the WLC—i.e., reduced attention (d = 0.95, medical help-seeking (d = 0.92, worries (d = 1.03, as well as a significant increase in behaviors that encourage the child’s self-management (d = 1.03. In addition, maternal self-efficacy in dealing with a child’s pain significantly increased in the IG as well (d = 0.92. Treatment effects emerged post-treatment and could be maintained until three months follow-up. There were no effects on general self-efficacy and maternal quality of life. Conclusion: While these results are promising, and underline the efficacy of the CBT approach for both the child and mothers, further studies, including long-term follow-ups, are warranted.

  10. Do Mothers Benefit from a Child-Focused Cognitive Behavioral Treatment (CBT) for Childhood Functional Abdominal Pain? A Randomized Controlled Pilot Trial

    Science.gov (United States)

    Calvano, Claudia; Groß, Martina; Warschburger, Petra

    2017-01-01

    While the efficacy of cognitive-behavioral treatment (CBT) approaches for childhood functional abdominal pain (FAP) is well-established for child outcomes, only a few studies have reported on parent-specific outcomes. This randomized controlled pilot trial analyzed effects of a group CBT on maternal variables (i.e., pain-related behavior, worries and self-efficacy, as well as general psychosocial strain). Methods: The sample constituted of 15 mothers in the intervention group (IG) and 14 mothers in the waitlist control group (WLC). Outcome measures were assessed pre-treatment, post-treatment and at three months follow-up. Results: Analyses revealed significant, large changes in maladaptive maternal reactions related to the child’s abdominal pain in the IG compared to the WLC—i.e., reduced attention (d = 0.95), medical help-seeking (d = 0.92), worries (d = 1.03), as well as a significant increase in behaviors that encourage the child’s self-management (d = 1.03). In addition, maternal self-efficacy in dealing with a child’s pain significantly increased in the IG as well (d = 0.92). Treatment effects emerged post-treatment and could be maintained until three months follow-up. There were no effects on general self-efficacy and maternal quality of life. Conclusion: While these results are promising, and underline the efficacy of the CBT approach for both the child and mothers, further studies, including long-term follow-ups, are warranted. PMID:28212279

  11. Feasibility of a Personal Health Technology-Based Psychological Intervention for Men with Stress and Mood Problems: Randomized Controlled Pilot Trial

    Science.gov (United States)

    Kaipainen, Kirsikka; Lappalainen, Raimo; Hoffrén, Henna; Myllymäki, Tero; Kinnunen, Marja-Liisa; Mattila, Elina; Happonen, Antti P; Rusko, Heikki; Korhonen, Ilkka

    2013-01-01

    Background Work-related stress is a significant problem for both people and organizations. It may lead to mental illnesses such as anxiety and depression, resulting in increased work absences and disabilities. Scalable interventions to prevent and manage harmful stress can be delivered with the help of technology tools to support self-observations and skills training. Objective The aim of this study was to assess the feasibility of the P4Well intervention in treatment of stress-related psychological problems. P4Well is a novel intervention which combines modern psychotherapy (the cognitive behavioral therapy and the acceptance and commitment therapy) with personal health technologies to deliver the intervention via multiple channels, includinggroup meetings, Internet/Web portal, mobile phone applications, and personal monitoring devices. Methods This pilot study design was a small-scale randomized controlled trial that compared the P4Well intervention with a waiting list control group. In addition to personal health technologies for self-assessment, the intervention consisted of 3 psychologist-assisted group meetings. Self-assessed psychological measures through questionnaires were collected offline pre- and post-intervention, and 6 months after the intervention for the intervention group. Acceptance and usage of technology tools were measured with user experience questionnaires and usage logs. Results A total of 24 subjects were randomized: 11 participants were followed up in the intervention group (1 was lost to follow-up) and 12 participants did not receive any intervention (control group). Depressive and psychological symptoms decreased and self-rated health and working ability increased. All participants reported they had benefited from the intervention. All technology tools had active users and 10/11 participants used at least 1 tool actively. Physiological measurements with personal feedback were considered the most useful intervention component. Conclusions

  12. Effect of Hominis placenta Pharmacopuncture on the Dysmenorrhea (A Pilot study, Single blind, Randomized, Controlled Clinical Trial

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    Su-Min Kim

    2008-09-01

    Full Text Available Objective : This study was designed to evaluate the effect of Hominis placenta Pharmacopuncture treatment on Dysmenorrhea of Women. Methods : 49 subjects who were suffering from dysmenorrhea volunteered to answer the MMP(Measure of Menstrual Pain and MSSL(Menstrual Symptom Severity List questionnaire. They were divided into two groups, a Hominis placenta Pharmacopuncture treatment group(Experiment al group, n=25 and a Normal Saline(N/S treatment group(Control group, n=24. The two groups were injected on the CV4, S36, Sp9 and Sp6 acupuncture point. They were treated totally five times depending on the individual menstruation cycles. The scores of MMP and MSSL were measured overall three times before and after the menstruation cycle. The collected data were analyzed as paired t-test, independent t-test using SPSS 12.0 WIN Program. Results : As a result of the evaluation by MMP and MSSL, a significant improvement on dysmenorrhea was made in the two groups(p<0.05, and both scores of Experiment group were decreased more than Control group. But there was no significant difference between the two groups. Conclusions : The Hominis placenta Pharmacopuncture treatment and the Normal Saline treatment were effective in decreasing the symptom of Dysmenorrhea.

  13. The effects of Bobath-based trunk exercises on trunk control, functional capacity, balance, and gait: a pilot randomized controlled trial.

    Science.gov (United States)

    Kılınç, Muhammed; Avcu, Fatma; Onursal, Ozge; Ayvat, Ender; Savcun Demirci, Cevher; Aksu Yildirim, Sibel

    2016-02-01

    The aim of this study was to investigate the effects of Bobath-based individually designed trunk exercises on trunk control, upper and lower extremity function, and walking and balance in stroke patients. The main aim of treatment was to eliminate individual trunk impairments during various patient functions. The study was planned as an assessor-blinded, randomized controlled trial. A total of 22 patients volunteered to participate in the study. Trunk function, functional capacity, and gait were assessed with the Trunk Impairment Scale (TIS), stroke rehabilitation assessment of movement (STREAM), and a 10-m walking test, respectively. The Berg Balance Test (BBT), functional reach (FR), and timed up-and-go (TUG) tests were used to evaluate balance. After the initial assessment, the patients were divided randomly into two groups, the study group (12 patients) and the control group (10 patients). The mean age of the patients in the study group was 55.91 years (duration of stroke 58.66 months) and that of the control group was 54.00 years (duration of stroke 67.20 months). Individual training programs were determined for the patients in the study group, taking into consideration their evaluation results; and strengthening, stretching, range of motion, and mat exercises were determined for the control group according to their functional level. The participants in both groups were taken into the physiotherapy program for 12 weeks, 3 days a week for 1 hour a day. In group analyses, both groups showed improvement in STREAM, TIS, and TUG tests. Only the study group produced significant gains in the BBT, FR, and 10 m walking tests (P 0.05). Individually developed exercise programs in the Bobath concept improve trunk performance, balance, and walking ability in stroke patients more than do conventional exercises.

  14. Efficacy of Deep Dry Needling on Latent Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain: A Randomized, Controlled Clinical Trial Pilot Study

    Science.gov (United States)

    Pacheco-da-Costa, Soraya; Hita-Herranz, Edgar

    2017-01-01

    Background: Nonspecific shoulder pain has a high prevalence in older adults and causes functional alterations. Furthermore, there are difficulties in establishing a clinical diagnosis, effective treatments are lacking, and little evidence has been found regarding the use of invasive physical therapy techniques in this age group. Purpose: To determine the efficacy of a single physical therapy intervention with deep dry needling (DDN) on latent and active myofascial trigger points (MTrPs) in older adults with nonspecific shoulder pain. Methods: This pilot study is a single-blind, randomized, controlled clinical trial that included 20 participants, aged 65 years and older, who were diagnosed with nonspecific shoulder pain. The study was approved by the Clinical Research Ethics Committee of the area. Participants were recruited at their homes or at a care center and were randomly assigned into either an experimental group (n = 10), which received a session of DDN on 1 active and 1 latent MTrP of the infraspinatus muscle, or a control group (n = 10), which received a session of DDN on only 1 active MTrP. A blind examiner assessed the pain intensity, pain pressure threshold on the anterior deltoid, and extensor carpi radialis brevis muscles and grip strength before, immediately after, and 1 week after the intervention. Results: Statistically significant differences (P < .05) in the pressure pain thresholds (PPTs) of the extensor carpi radialis brevis were found in the experimental group in both posttreatment assessments. Moreover, the effect size values (d Cohen) varied from small for grip strength (0.017-0.36) to moderate for the pain intensity (0.46-0.78) and PPT in the anterior deltoid (0.49-0.66) and to large for the PPT in the extensor carpi radialis brevis (1.06-1.58). Conclusions: A single physical therapy intervention with DDN on 1 latent MTrP, in conjunction with 1 active MTrP, in the infraspinatus muscle may increase the PPT of the extensor carpi radialis

  15. Preventative tele-health supported services for early stage chronic obstructive pulmonary disease: a protocol for a pragmatic randomized controlled trial pilot

    Directory of Open Access Journals (Sweden)

    Mountain Gail A

    2011-01-01

    Full Text Available Abstract Background Chronic Obstructive Pulmonary Disease (COPD is a prevalent debilitating long term condition. It is the second most common cause of emergency admission to hospital in the UK and remains one of the most costly conditions to treat through acute care. Tele-health monitoring offers potential to reduce the rates of re-hospitalisation and emergency department visits and improve quality of life for people with COPD. However, the current evidence base to support technology adoption and implementation is limited and the resource implications for implementing tele-health in practice can be very high. This trial will employ tele-health monitoring in a preventative capacity for patients diagnosed with early stage COPD following discharge from hospital to determine whether it reduces their need for additional health service support or hospital admission and improves their quality of life. Methods/Design We describe a pilot study for a two arm, one site randomized controlled trial (RCT to determine the effect of tele-health monitoring on self-management, quality of life and patient satisfaction. Sixty patients who have been discharged from one acute trust with a primary diagnosis of COPD and who have agreed to receive community clinical support following discharge from acute care will be randomly assigned to one of two groups: (a Tele-health supported Community COPD Service; or (b Usual Care. The tele-health supported service involves the patient receiving two home visits with a specialist COPD clinician (nurse or physiotherapist then participating in daily tele-monitoring over an eight week period. Usual care consists of six home visits to the patient by specialist COPD clinicians again over eight successive weeks. Health status and quality of life data for all participants will be measured at baseline, on discharge from the service and at six months post discharge from the service. Discussion The tele-health service under study is a

  16. Efficacy of Deep Dry Needling on Latent Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain: A Randomized, Controlled Clinical Trial Pilot Study.

    Science.gov (United States)

    Calvo-Lobo, César; Pacheco-da-Costa, Soraya; Hita-Herranz, Edgar

    Nonspecific shoulder pain has a high prevalence in older adults and causes functional alterations. Furthermore, there are difficulties in establishing a clinical diagnosis, effective treatments are lacking, and little evidence has been found regarding the use of invasive physical therapy techniques in this age group. To determine the efficacy of a single physical therapy intervention with deep dry needling (DDN) on latent and active myofascial trigger points (MTrPs) in older adults with nonspecific shoulder pain. This pilot study is a single-blind, randomized, controlled clinical trial that included 20 participants, aged 65 years and older, who were diagnosed with nonspecific shoulder pain. The study was approved by the Clinical Research Ethics Committee of the area. Participants were recruited at their homes or at a care center and were randomly assigned into either an experimental group (n = 10), which received a session of DDN on 1 active and 1 latent MTrP of the infraspinatus muscle, or a control group (n = 10), which received a session of DDN on only 1 active MTrP. A blind examiner assessed the pain intensity, pain pressure threshold on the anterior deltoid, and extensor carpi radialis brevis muscles and grip strength before, immediately after, and 1 week after the intervention. Statistically significant differences (P < .05) in the pressure pain thresholds (PPTs) of the extensor carpi radialis brevis were found in the experimental group in both posttreatment assessments. Moreover, the effect size values (d Cohen) varied from small for grip strength (0.017-0.36) to moderate for the pain intensity (0.46-0.78) and PPT in the anterior deltoid (0.49-0.66) and to large for the PPT in the extensor carpi radialis brevis (1.06-1.58). A single physical therapy intervention with DDN on 1 latent MTrP, in conjunction with 1 active MTrP, in the infraspinatus muscle may increase the PPT of the extensor carpi radialis brevis muscle area immediately following and 1 week after

  17. A pilot randomized controlled trial of the effects of cognitive-behavioral therapy for insomnia on sleep and daytime functioning in college students.

    Science.gov (United States)

    Taylor, Daniel J; Zimmerman, Marian R; Gardner, Christie E; Williams, Jacob M; Grieser, Emily A; Tatum, Jolyn I; Bramoweth, Adam D; Francetich, Jade M; Ruggero, Camilo

    2014-05-01

    The purpose of this study was to pilot test if cognitive behavioral therapy for insomnia (CBT-I) is an effective intervention for insomnia and daytime functioning in college students. College students' developmental stage and lifestyle are significantly different than the general adult population, yet there have been no studies of CBT-I in this age group. Thirty-four college students (ages 18-27; M=19.71, SD=2.10) were randomly assigned to and completed either six sessions of CBT-I or a 6-week wait list control (WLC). All participants completed 1-week sleep diaries and actigraphy, as well as sleep and daytime functioning questionnaires at baseline and posttreatment. The treatment group repeated all measures at 3-month follow-up. Students who received CBT-I showed greater baseline to posttreatment improvements in sleep efficiency, sleep onset latency, number of awakenings, time awake after sleep onset, sleep quality, insomnia severity, dysfunctional beliefs about sleep, general fatigue, and global sleep quality than the WLC group. These improvements were durable at 3-month follow-up. Ninety-four percent of participants in the CBT-I condition completed at least 4 sessions of treatment. Significantly more participants in the CBT-I group than the WLC group responded (68.8% vs 7.7%, respectively) and remitted (68.8% vs 15.4%, respectively). CBT-I is an effective treatment for insomnia in college students. This study found that treatment responses were similar to results from studies in the general population. The treatment appeared to be well tolerated based on very low attrition rates.

  18. A telehealth program for self-management of COPD exacerbations and promotion of an active lifestyle: a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tabak M

    2014-09-01

    Full Text Available Monique Tabak,1,2 Marjolein Brusse-Keizer,3 Paul van der Valk,3,4 Hermie Hermens,1,2 Miriam Vollenbroek-Hutten1,2 1Telemedicine Group, Roessingh Research and Development, 2Telemedicine Group, University of Twente, 3Department of Pulmonary Medicine, Medisch Spectrum Twente, 4Medical School Twente, Medisch Spectrum Twente, Enschede, the Netherlands Abstract: The objective of this pilot study was to investigate the use of and satisfaction with a chronic obstructive pulmonary disease (COPD telehealth program applied in both primary and secondary care. The program consisted of four modules: 1 activity coach for ambulant activity monitoring and real-time coaching of daily activity behavior, 2 web-based exercise program for home exercising, 3 self-management of COPD exacerbations via a triage diary on the web portal, including self-treatment of exacerbations, and 4 teleconsultation. Twenty-nine COPD patients were randomly assigned to either the intervention group (telehealth program for 9 months or the control group (usual care. Page hits on the web portal showed the use of the program, and the Client Satisfaction Questionnaire showed satisfaction with received care. The telehealth program with decision support showed good satisfaction (mean 26.4, maximum score 32. The program was accessed on 86% of the treatment days, especially the diary. Patient adherence with the exercise scheme was low (21%. Health care providers seem to play an important role in patients' adherence to telehealth in usual care. Future research should focus on full-scale implementation in daily care and investigating technological advances, like gaming, to increase adherence. Keywords: COPD, physical activity, exacerbations, telehealth, self-management

  19. A randomized, controlled pilot study of MDMA (± 3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD).

    Science.gov (United States)

    Oehen, Peter; Traber, Rafael; Widmer, Verena; Schnyder, Ulrich

    2013-01-01

    Psychiatrists and psychotherapists in the US (1970s to 1985) and Switzerland (1988-1993) used MDMA legally as a prescription drug, to enhance the effectiveness of psychotherapy. Early reports suggest that it is useful in treating trauma-related disorders. Recently, the first completed pilot study of MDMA-assisted psychotherapy for PTSD yielded encouraging results. Designed to test the safety and efficacy of MDMA-assisted psychotherapy in patients with treatment-resistant PTSD; our randomized, double-blind, active-placebo controlled trial enrolled 12 patients for treatment with either low-dose (25 mg, plus 12.5 mg supplemental dose) or full-dose MDMA (125 mg, plus 62.5 mg supplemental dose). MDMA was administered during three experimental sessions, interspersed with weekly non-drug-based psychotherapy sessions. Outcome measures used were the Clinician-Administered PTSD Scale (CAPS) and the Posttraumatic Diagnostic Scale (PDS). Patients were assessed at baseline, three weeks after the second and third MDMA session (end of treatment), and at the 2-month and 1-year follow-ups. We found that MDMA-assisted psychotherapy can be safely administered in a clinical setting. No drug-related serious adverse events occurred. We did not see statistically significant reductions in CAPS scores (p = 0.066), although there was clinically and statistically significant self-reported (PDS) improvement (p = 0.014). CAPS scores improved further at the 1-year follow-up. In addition, three MDMA sessions were more effective than two (p = 0.016).

  20. Effects of sardine-enriched diet on metabolic control, inflammation and gut microbiota in drug-naïve patients with type 2 diabetes: a pilot randomized trial.

    Science.gov (United States)

    Balfegó, Mariona; Canivell, Silvia; Hanzu, Felicia A; Sala-Vila, Aleix; Martínez-Medina, Margarita; Murillo, Serafín; Mur, Teresa; Ruano, Elena G; Linares, Francisca; Porras, Nuria; Valladares, Silvia; Fontalba, Maria; Roura, Elena; Novials, Anna; Hernández, Cristina; Aranda, Gloria; Sisó-Almirall, Antoni; Rojo-Martínez, Gemma; Simó, Rafael; Gomis, Ramon

    2016-04-18

    Nutrition therapy is the cornerstone of treating diabetes mellitus. The inclusion of fish (particularly oily fish) at least two times per week is recommended by current international dietary guidelines for type 2 diabetes. In contrast to a large number of human studies examining the effects of oily fish on different cardiovascular risk factors, little research on this topic is available in patients with type 2 diabetes. The aims of this pilot study were to investigate the effects of a sardine-enriched diet on metabolic control, adiponectin, inflammatory markers, erythrocyte membrane fatty acid (EMFA) composition, and gut microbiota in drug-naïve patients with type 2 diabetes. 35 drug-naïve patients with type 2 diabetes were randomized to follow either a type 2 diabetes standard diet (control group: CG), or a standard diet enriched with 100 g of sardines 5 days a week (sardine group: SG) for 6 months. Anthropometric, dietary information, fasting glycated hemoglobin, glucose, insulin, adiponectin, inflammatory markers, EMFA and specific bacterial strains were determined before and after intervention. There were no significant differences in glycemic control between groups at the end of the study. Both groups decreased plasma insulin (SG: -35.3%, P = 0.01, CG: -22.6%, P = 0.02) and homeostasis model of assessment--insulin resistance (HOMA-IR) (SG: -39.2%, P = 0.007, CG: -21.8%, P = 0.04) at 6-months from baseline. However only SG increased adiponectin in plasma compared to baseline level (+40.7%, P = 0.04). The omega-3 index increased 2.6% in the SG compared to 0.6% in the CG (P = 0.001). Both dietary interventions decreased phylum Firmicutes (SG and CG: P = 0.04) and increased E. coli concentrations (SG: P = 0.01, CG: P = 0.03) at the end of the study from baseline, whereas SG decreased Firmicutes/Bacteroidetes ratio (P = 0.04) and increased Bacteroides-Prevotella (P = 0.004) compared to baseline. Although enriching diet with 100 g of sardines 5 days a week during

  1. Efficacy of brief motivational interviewing to improve adherence to inhaled corticosteroids among adult asthmatics: results from a randomized controlled pilot feasibility trial

    Directory of Open Access Journals (Sweden)

    Lavoie KL

    2014-11-01

    Full Text Available Kim L Lavoie,1–3 Gregory Moullec,1,2,4 Catherine Lemiere,2 Lucie Blais,2 Manon Labrecque,2 Marie-France Beauchesne,2 Veronique Pepin,2,4 André Cartier,2 Simon L Bacon1,2,41Montreal Behavioural Medicine Centre, 2Research Centre, Hôpital du Sacré-Cœur de Montréal – A University of Montreal Affiliated Hospital, Montréal, 3Department of Psychology, University of Quebec at Montreal (UQAM, Succursale Center-Ville, Montreal, 4Department of Exercise Science, Concordia University, Montreal, Quebec, CanadaPurpose: Daily adherence to inhaled corticosteroid (ICS regimens is one of the most important factors linked to achieving optimal asthma control. Motivational interviewing (MI is a client-centered communication style that focuses on enhancing intrinsic motivation to engage in appropriate self-management behaviors. MI has been shown to improve a variety of health behaviors including medication adherence in other disorders, but its efficacy for the improvement of ICS adherence in asthmatics has yet to be examined. This pilot “proof of concept” trial assessed the feasibility of MI to improve daily ICS adherence and asthma control levels in adult asthmatics.Methods: Fifty-four poorly controlled (Asthma Control Questionnaire [ACQ] score ≥1.5, highly nonadherent (filled <50% of ICS medication in the last year adult asthmatics were recruited from the outpatient asthma clinic of a university-affiliated hospital. Participants underwent baseline assessments and were randomly assigned to MI (3×30 minutes sessions within a 6-week period, n=26 or a usual care (UC control group (n=28. ICS adherence (% pharmacy refills and asthma control (ACQ, Asthma Control Test [ACT] were measured at 6 and 12 months postintervention. Mixed model repeated measure analyses for both intent-to-treat and per-protocol were used. Results were adjusted for a priori-defined covariates including baseline adherence. Patients in the MI group also reported their impressions of

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

    Science.gov (United States)

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

    2014-10-11

    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 research program on the basis of a Palaeolithic-type diet was obtained. Thirty-four subjects, with at least two characteristics of the metabolic syndrome, were randomized to a two weeks Palaeolithic-type diet (n = 18) or an isoenergetic healthy reference diet, based on the guidelines of the Dutch Health Council (n = 14). Thirty-two subjects completed the study. Measures were taken to keep bodyweight stable. As primary outcomes oral glucose tolerance and characteristics of the metabolic syndrome (abdominal circumference, blood pressure, glucose, lipids) were measured. Secondary outcomes were intestinal permeability, inflammation and salivary cortisol. Data were collected at baseline and after the intervention. Subjects were 53.5 (SD9.7) year old men (n = 9) and women (n = 25) with mean BMI of 31.8 (SD5.7) kg/m2. The Palaeolithic-type diet resulted in lower systolic blood pressure (-9.1 mmHg; P = 0.015), diastolic blood pressure (-5.2 mmHg; P = 0.038), total cholesterol (-0.52 mmol/l; P = 0.037), triglycerides (-0.89 mmol/l; P = 0.001) and higher HDL-cholesterol (+0.15 mmol/l; P = 0.013), compared to reference. The number of characteristics of the metabolic syndrome decreased with 1.07 (P = 0.010) upon the Palaeolithic-type diet, compared to reference. Despite efforts to keep bodyweight stable, it decreased in the Palaeolithic group compared to reference (-1.32 kg; P = 0.012). However, favourable effects remained after post-hoc adjustments for this

  3. A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy.

    Directory of Open Access Journals (Sweden)

    Tih-Shih Lee

    Full Text Available Cognitive decline in aging is a pressing issue associated with significant healthcare costs and deterioration in quality of life. Previously, we reported the successful use of a novel brain-computer interface (BCI training system in improving symptoms of attention deficit hyperactivity disorder. Here, we examine the feasibility of the BCI system with a new game that incorporates memory training in improving memory and attention in a pilot sample of healthy elderly. This study investigates the safety, usability and acceptability of our BCI system to elderly, and obtains an efficacy estimate to warrant a phase III trial. Thirty-one healthy elderly were randomized into intervention (n = 15 and waitlist control arms (n = 16. Intervention consisted of an 8-week training comprising 24 half-hour sessions. A usability and acceptability questionnaire was administered at the end of training. Safety was investigated by querying users about adverse events after every session. Efficacy of the system was measured by the change of total score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS before and after training. Feedback on the usability and acceptability questionnaire was positive. No adverse events were reported for all participants across all sessions. Though the median difference in the RBANS change scores between arms was not statistically significant, an effect size of 0.6SD was obtained, which reflects potential clinical utility according to Simon's randomized phase II trial design. Pooled data from both arms also showed that the median change in total scores pre and post-training was statistically significant (Mdn = 4.0; p<0.001. Specifically, there were significant improvements in immediate memory (p = 0.038, visuospatial/constructional (p = 0.014, attention (p = 0.039, and delayed memory (p<0.001 scores. Our BCI-based system shows promise in improving memory and attention in healthy

  4. High versus moderate energy use of bipolar fractional radiofrequency in the treatment of acne scars: a split-face double-blinded randomized control trial pilot study.

    Science.gov (United States)

    Phothong, Weeranut; Wanitphakdeedecha, Rungsima; Sathaworawong, Angkana; Manuskiatti, Woraphong

    2016-02-01

    Bipolar fractional radiofrequency (FRF) device was firstly FDA-approved for treating atrophic acne scar in 2008 through the process of dermal coagulation and minimal epidermal ablation. The average energy at 60 mJ/pin was widely used to treat atrophic acne scars. However, the higher energy was delivered, the deeper ablation and coagulation were found. At present, the new generation of a device with bipolar FRF technology with electrode-pin tip was developed to maximize ability to deliver energy up to 100 mJ/pin. The objective of the study was to explore and compare the efficacy of utilizing high energy (100 mJ/pin) and moderate energy (60 mJ/pin) of bipolar fractional radiofrequency in treatment of atrophic acne scar in Asians. This is a split-face, double-blinded, randomized control trial, pilot study by using parallel group design technique. Thirty healthy subjects with Fitzpatrick skin phototype III-IV diagnosed as atrophic acne scares were enrolled. All subjects received four monthly sessions of bipolar FRF treatment. Left and right facial sides of individual patients were randomly assigned for different energy (high energy at 100 mJ/pin versus moderate energy at 60 mJ/pin). Acne scars improvement was blinded graded by dermatologist using global acne scarring score (GASS) which was subjectively evaluated at baseline, 1-, 3-, and 6-month follow-up. Objective scar analysis was also done using UVA-light video camera to measure scar volume, skin smoothness, and wrinkle at baseline, 3-, and 6-month follow-up after the last treatment. Side effects including pain, erythema, swelling, and crusting were also recorded. Thirty subjects completed the study with full 4-treatment course. The mean GASS of high energy side and moderate energy side was significantly reduced at 1-, 3-, and 6-month follow-up visits. At 1 month follow-visit, high energy side demonstrated significant improvement compared with moderate energy side (p = 0.03). Postinflammatory hyperpigmentation

  5. Is prophylactic somatostatin effective to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis or hyperamylasemia? A randomized, placebo-controlled pilot trial

    Institute of Scientific and Technical Information of China (English)

    WANG Zi-kai; YANG Yun-sheng; CAI Feng-chun; WANG Yong-hua; SHI Xiao-lin; DING Chen; LI Wen

    2013-01-01

    Background Effects of prophylactic somatostatin on post-endoscopic retrograde cholangiopancreatography (ERCP)pancreatitis (PEP) and hyperamylasemia remain inconclusive.This study aimed to examine whether high-dose,long-term continuous infusion of somatostatin can reduce the incidence of PEP and post-ERCP hyperamylasemia.Methods This was a randomized,placebo-controlled pilot trial.One hundred and twenty-four patients scheduled for ERCP from December 2008 to May 2010 randomly received one of the following three interventions:pre-ERCP somatostatin (0.5 mg/h for 24 hours,starting 1 hour prior to ERCP; n=36),post-ERCP somatostatin (0.5 mg/h for 24 hours,starting 1 hour after ERCP; n=47),or placebo (saline for 24 hours,starting 1 hour prior to ERCP; n=41).Serum amylase and lipase concentrations were measured 1 to 3 hours prior to ERCP and 6,24,and 48 hours after ERCP.Results The three groups did not differ in age,gender,medical history,or ERCP procedure (catheterization using contrast or guidewire,pancreatic duct visualization,procedure time,or procedure type).The rate of PEP was 13.7% (17/124)in the overall study sample and 16.7% (6/36),10.6% (5/47),and 14.6% (6/41) in the pre-ERCP somatostatin,postERCP somatostatin,and placebo groups,respectively (P=0.715).The rate of post-ERCP hyperamylasemia was 19.4% (7/36),21.3% (10/47),and 46.3% (19/41) in the pre-ERCP somatostatin,post-ERCP somatostatin,and placebo groups,respectively (P=0.011).Conclusions High-dose,long-term continuous infusion (0.5 mg/h for 24 hours) of somatostatin,performed as either a pre-or post-ERCP,can reduce the incidence of hyperamylasemia,but not PEP.

  6. The effectiveness of the Incredible Years Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken W.

    2015-01-01

    -arm, parallel, pilot, randomized controlled trial (RCT) where 128 families with newborn infants up to four-months-old are recruited in two municipalities in Denmark. Families are randomized to the Incredible Years Parents and Babies Program or usual care with a 2:1 allocation ratio. The primary outcome...... is parenting confidence measured after 20 weeks by the Karitane Parenting Confidence Scale and Parental Stress Scale. Secondary outcomes include measures of parent health, reflective functioning, relationship with the infant, and infant development. Interviewers and data analysts are blind to allocation status...

  7. Clinical usefulness of brain-computer interface-controlled functional electrical stimulation for improving brain activity in children with spastic cerebral palsy: a pilot randomized controlled trial

    Science.gov (United States)

    Kim, Tae-Woo; Lee, Byoung-Hee

    2016-01-01

    [Purpose] Evaluating the effect of brain-computer interface (BCI)-based functional electrical stimulation (FES) training on brain activity in children with spastic cerebral palsy (CP) was the aim of this study. [Subjects and Methods] Subjects were randomized into a BCI-FES group (n=9) and a functional electrical stimulation (FES) control group (n=9). Subjects in the BCI-FES group received wrist and hand extension training with FES for 30 minutes per day, 5 times per week for 6 weeks under the BCI-based program. The FES group received wrist and hand extension training with FES for the same amount of time. Sensorimotor rhythms (SMR) and middle beta waves (M-beta) were measured in frontopolar regions 1 and 2 (Fp1, Fp2) to determine the effects of BCI-FES training. [Results] Significant improvements in the SMR and M-beta of Fp1 and Fp2 were seen in the BCI-FES group. In contrast, significant improvement was only seen in the SMR and M-beta of Fp2 in the control group. [Conclusion] The results of the present study suggest that BCI-controlled FES training may be helpful in improving brain activity in patients with cerebral palsy and may be applied as effectively as traditional FES training. PMID:27799677

  8. 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.)

  9. A mixed methods pilot study with a cluster randomized control trial to evaluate the impact of a leadership intervention on guideline implementation in home care nursing

    Directory of Open Access Journals (Sweden)

    Tourangeau Ann

    2008-12-01

    Full Text Available Abstract Background Foot ulcers are a significant problem for people with diabetes. Comprehensive assessments of risk factors associated with diabetic foot ulcer are recommended in clinical guidelines to decrease complications such as prolonged healing, gangrene and amputations, and to promote effective management. However, the translation of clinical guidelines into nursing practice remains fragmented and inconsistent, and a recent homecare chart audit showed less than half the recommended risk factors for diabetic foot ulcers were assessed, and peripheral neuropathy (the most significant predictor of complications was not assessed at all. Strong leadership is consistently described as significant to successfully transfer guidelines into practice. Limited research exists however regarding which leadership behaviours facilitate and support implementation in nursing. The purpose of this pilot study is to evaluate the impact of a leadership intervention in community nursing on implementing recommendations from a clinical guideline on the nursing assessment and management of diabetic foot ulcers. Methods Two phase mixed methods design is proposed (ISRCTN 12345678. Phase I: Descriptive qualitative to understand barriers to implementing the guideline recommendations, and to inform the intervention. Phase II: Matched pair cluster randomized controlled trial (n = 4 centers will evaluate differences in outcomes between two implementation strategies. Primary outcome: Nursing assessments of client risk factors, a composite score of 8 items based on Diabetes/Foot Ulcer guideline recommendations. Intervention: In addition to the organization's 'usual' implementation strategy, a 12 week leadership strategy will be offered to managerial and clinical leaders consisting of: a printed materials, b one day interactive workshop to develop a leadership action plan tailored to barriers to support implementation; c three post-workshop teleconferences. Discussion This

  10. A Web-Based Psychoeducational Program for Informal Caregivers of Patients With Alzheimer’s Disease: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Wrobel, Jérémy; Cantegreil-Kallen, Inge; Dub, Timothée; Rouquette, Alexandra; Rigaud, Anne-Sophie

    2015-01-01

    Background 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. Objective 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. Methods 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. Results 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

  11. A Randomized Controlled Pilot Trial of Classroom-Based Mindfulness Meditation Compared to an Active Control Condition in 6th Grade Children

    OpenAIRE

    Britton, Willoughby B.; Lepp, Nathaniel E.; Niles, Halsey F.; Rocha, Tomas; Fisher, Nathan; Gold, Jonathan

    2014-01-01

    Children in the United States are at risk for numerous psychological problems, such as anxiety, attention problems, and mood disorders, and are underserved by current mental health provisions. The current study is a pilot trial to examine the effects of a nonelective, classroom-based, teacher-implemented, mindfulness meditation intervention on standard clinical measures of mental health and affect in middle school children. A total of 101 healthy sixth-grade students (55 boys and 46 girls) we...

  12. A randomized controlled pilot study of VO2 max testing: a potential model for measuring relative in vivo efficacy of different red blood cell products.

    Science.gov (United States)

    Bennett-Guerrero, Elliott; Lockhart, Evelyn L; Bandarenko, Nicholas; Campbell, Mary L; Natoli, Michael J; Jamnik, Veronika K; Carter, Timothy R; Moon, Richard E

    2017-03-01

    Randomized trials, for example, RECESS, comparing "young" (median, 7-day) versus "middle-aged" (median, 28-day) red blood cells (RBCs), showed no difference in outcome. These data are important; however, they do not inform us about the safety and effectiveness of the oldest RBCs, which some patients receive. It may not be feasible to conduct a clinical trial randomizing patients to receive the oldest blood. Therefore, we propose strenuous exercise (VO2 max testing) as a model to study the relative efficacy to increase oxygen delivery to tissue of different RBC products, for example, extremes of storage duration. In this pilot study, eight healthy subjects had 2 units of leukoreduced RBCs collected by apheresis in AS-3 using standard methods. Subjects were randomized to receive both (2) units of their autologous RBCs at either 7 or 42 days after blood collection. VO2 max testing on a cycle ergometer was performed 2 days before (Monday) and 2 days after (Friday) the transfusion visit (Wednesday). This design avoids confounding effects on intravascular volume from the 2-unit blood transfusion. The primary outcome was the difference in VO2 max between Friday and Monday (delta VO2 max). VO2 max increased more in the 7-day RBC arm (8.7 ± 6.9% vs. 1.9 ± 6.5%, p = 0.202 for comparison between arms). Exercise duration (seconds) increased in the 7-day RBC arm (8.4 ± 1.7%) but actually decreased in the 42-day arm (-2.6 ± 3.6%, p = 0.002). This pilot study suggests that VO2 max testing has potential as a rigorous and quantitative in vivo functional assay of RBC function. Our preliminary results suggest that 42-day RBCs are inferior to 7-day RBCs at delivering oxygen to tissues. © 2016 AABB.

  13. Fecal Microbiota Transplant for Relapsing Clostridium difficile Infection Using a Frozen Inoculum From Unrelated Donors: A Randomized, Open-Label, Controlled Pilot Study

    OpenAIRE

    Youngster, Ilan; Sauk, Jenny; Pindar, Christina; Wilson, Robin G; Kaplan, Jess L.; Smith, Mark B.; Alm, Eric J; Gevers, Dirk; Russell, George H.; Hohmann, Elizabeth L.

    2014-01-01

    Fecal microbiota transplant is increasingly used to treat recurrent or relapsing Clostridium difficile infection. In this randomized controlled study, using a frozen inoculum from unrelated donors was safe and effective, whether administered by nasogastric tube or by colonoscopy.

  14. A randomized, double blind, placebo and active comparator controlled pilot study of UP446, a novel dual pathway inhibitor anti-inflammatory agent of botanical origin

    Directory of Open Access Journals (Sweden)

    Sampalis John S

    2012-04-01

    Full Text Available Abstract Background Current use of prescribed or over the counter non-steroidal anti-inflammatory drugs (NSAIDs for pain and osteoarthritis (OA have untoward gastrointestinal and cardiovascular related side effects, as a result the need for a safe and effective alternative has become unequivocally crucial. Method A randomized, double blind, placebo and active controlled pilot study of a novel dual pathway, COX1/2 and LOX, inhibitor anti-inflammatory agent of botanical origin, UP446 was conducted. Sixty subjects (age 40-75 with symptomatic OA of the hip or knee were assigned to 4 treatment groups (n = 15; Group A0 (Placebo, CMC capsule, Group A1 (UP446 250 mg/day, Group A2 (UP446 500 mg/day and Group A3 (Celecoxib, 200 mg/day. MOS-SF-36 and Western Ontario and McMaster University Osteoarthritis Index (WOMAC data were collected at baseline and after 30, 60 and 90 days of treatment as a measure of efficacy. Erythrocyte sedimentation rate, C-reactive protein, plasma thrombin time (PTT, fructosamine, Hematology, clinical chemistry and fecal occult blood were monitored for safety. Results Statistically significant decrease in WOMAC pain score were observed for Group A1 at day 90, Group A2 at 30 and 90 days and Group A3 at 60 and 90 days. Statistically significant decrease in WOMAC stiffness score were observed for Group A1 and Group A2 at 30, 60 and 90 days; but not for Group A0 and Group A3. The mean change in WOMAC functional impairment scores were statistically significant for Group A1 and Group A2 respectively at 30 days (p = 0.006 and p = 0.006, at 60 days (p = 0.016 and p = 0.002 and at 90 days (p = 0.018 and p = 0.002, these changes were not significant for Group A0 and Group A3. Based on MOS -SF-36 questionnaires, statistically significant improvements in physical function, endurance and mental health scores were observed for all active treatment groups compared to placebo. No significant changes suggestive of toxicity in routine hematologies

  15. Early individualised manipulative rehabilitation following lumbar open laser microdiscectomy improves early post-operative functional disability: A randomized, controlled pilot study.

    Science.gov (United States)

    Kim, Byungho J; Ahn, Junghoon; Cho, Heecheol; Kim, Dongyun; Kim, Taeyeong; Yoon, Bumchul

    2016-01-01

    Lumbar open laser microdiscectomy has been shown to be an effective intervention and safe approach for lumbar disc prolapse. However early post-operative physical disability affecting daily activities have been sporadically reported. To evaluate the feasibility of using early individualised manipulative rehabilitation to improve early post-operative functional disability following lumbar discectomy. Randomised controlled pilot trial. Setting at a major metropolitan spine surgery hospital. Twenty-one patients aged 25-69 years who underwent lumbar microdiscectomy were randomised to either the manipulative rehabilitation treatment group or the active control group. Rehabilitation was initiated 2-3 weeks after surgery, twice a week for 4 weeks. Each session was for 30 minutes. Primary outcomes were the Roland-Morris disability questionnaire and the visual analogue pain scale. Outcome measures were assessed at baseline and post-intervention. Early post-operative physical disability was improved with a 55% reduction by early individualised manipulative rehabilitation, compared to that of control care with a 5% increase. Early post-operative residual leg pain decreased with rehabilitation (55%) and control care (9%). This pilot study supports the feasibility of a future definitive randomised control trial and indicates this type of rehabilitation may be an important option for post-operative management after spinal surgery.

  16. A randomized controlled pilot study of CBT-I Coach: Feasibility, acceptability, and potential impact of a mobile phone application for patients in cognitive behavioral therapy for insomnia.

    Science.gov (United States)

    Koffel, Erin; Kuhn, Eric; Petsoulis, Napoleon; Erbes, Christopher R; Anders, Samantha; Hoffman, Julia E; Ruzek, Josef I; Polusny, Melissa A

    2016-06-27

    There has been growing interest in utilizing mobile phone applications (apps) to enhance traditional psychotherapy. Previous research has suggested that apps may facilitate patients' completion of cognitive behavioral therapy for insomnia (CBT-I) tasks and potentially increase adherence. This randomized clinical trial pilot study (n = 18) sought to examine the feasibility, acceptability, and potential impact on adherence and sleep outcomes related to CBT-I Coach use. All participants were engaged in CBT-I, with one group receiving the app as a supplement and one non-app group. We found that patients consistently used the app as intended, particularly the sleep diary and reminder functions. They reported that it was highly acceptable to use. Importantly, the app did not compromise or undermine benefits of cognitive behavioral therapy for insomnia and patients in both groups had significantly improved sleep outcomes following treatment. © The Author(s) 2016.

  17. A yeast fermentate improves gastrointestinal discomfort and constipation by modulation of the gut microbiome: results from a randomized double-blind placebo-controlled pilot trial.

    Science.gov (United States)

    Pinheiro, Iris; Robinson, Larry; Verhelst, An; Marzorati, Massimo; Winkens, Björn; den Abbeele, Pieter Van; Possemiers, Sam

    2017-09-04

    Constipation and symptoms of gastrointestinal discomfort such as bloating are common among otherwise healthy individuals, but with significant impact on quality of life. Despite the recognized contribution of the gut microbiome to this pathology, little is known about which group(s) of microorganism(s) are playing a role. A previous study performed in vitro suggests that EpiCor® fermentate has prebiotic-like properties, being able to favorably modulate the composition of the gut microbiome. Therefore, the aim of this study was to investigate the effects of EpiCor fermentate in a population with symptoms of gastrointestinal discomfort and reduced bowel movements and to evaluate its effect at the level of the gut microbiome. This pilot study was performed according to a randomized, double-blind, placebo-controlled parallel design. Eighty subjects with symptoms of gastrointestinal discomfort and constipation were allocated to one of two trial arms (placebo or EpiCor fermentate). Randomization was done in a stratified manner according to symptom severity, resulting in two subgroups of patients: severe and moderate. Daily records of gastrointestinal symptoms were assessed on a 5-point scale, and also stool frequency and consistency were documented during a 2-week run-in and a 6-week intervention phases. Averages over two-week intervals were calculated. Constipation-associated quality of life and general perceived stress were assessed at baseline and after 3 and 6 weeks of intervention. Fecal samples were also collected at these same time points. EpiCor fermentate led to a significant improvement of symptoms such as bloating/distension (p = 0.033 and p = 0.024 after 2 and 4 weeks of intervention, respectively), feeling of fullness (p = 0.004 and p = 0.023 after 2 and 4 weeks of intervention, respectively) and general daily scores (p = 0.046 after 2 weeks of intervention) in the moderate subgroup. A significant improvement in stool consistency was observed

  18. A pilot randomized controlled trial using EEG-based brain–computer interface training for a Chinese-speaking group of healthy elderly

    Directory of Open Access Journals (Sweden)

    Lee TS

    2015-01-01

    Full Text Available Tih-Shih Lee,1 Shin Yi Quek,1 Siau Juinn Alexa Goh,1 Rachel Phillips,2 Cuntai Guan,3 Yin Bun Cheung,4 Lei Feng,5 Chuan Chu Wang,3 Zheng Yang Chin,3 Haihong Zhang,3 Jimmy Lee,6 Tze Pin Ng,5 K Ranga Rama Krishnan1 1Department of Neuroscience and Behavioral Disorders, Duke-NUS Graduate Medical School, Singapore; 2Singapore Clinical Research Institute, Singapore; 3Institute for Infocomm Research, Agency for Science, Technology and Research, Singapore; 4Centre for Quantitative Medicine, Duke-NUS Graduate Medical School, Singapore; 5Department of Psychological Medicine, National University of Singapore, Singapore; 6Department of General Psychiatry/Department of Research, Institute of Mental Health, Singapore Background: There is growing evidence that cognitive training (CT can improve the cognitive functioning of the elderly. CT may be influenced by cultural and linguistic factors, but research examining CT programs has mostly been conducted on Western populations. We have developed an innovative electroencephalography (EEG-based brain–computer interface (BCI CT program that has shown preliminary efficacy in improving cognition in 32 healthy English-speaking elderly adults in Singapore. In this second pilot trial, we examine the acceptability, safety, and preliminary efficacy of our BCI CT program in healthy Chinese-speaking Singaporean elderly.Methods: Thirty-nine elderly participants were randomized into intervention (n=21 and waitlist control (n=18 arms. Intervention consisted of 24 half-hour sessions with our BCI-based CT training system to be completed in 8 weeks; the control arm received the same intervention after an initial 8-week waiting period. At the end of the training, a usability and acceptability questionnaire was administered. Efficacy was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS, which was translated and culturally adapted for the Chinese-speaking local population. Users were asked

  19. Lee Silverman voice treatment versus standard NHS speech and language therapy versus control in Parkinson’s disease (PD COMM pilot): study protocol for a randomized controlled trial

    OpenAIRE

    Sackley, Catherine M.; Smith, Christina H; Rick, Caroline; Brady, Marian C; Ives, Natalie; Patel, Ramilla; Roberts, Helen; Dowling, Francis; Jowett, Sue; Wheatley, Keith; Patel, Smitaa; Kelly, Debbie; Sands, Gina; Clarke, Carl

    2014-01-01

    Background Parkinson’s disease is a common movement disorder affecting approximately 127,000 people in the UK, with an estimated two thirds having speech-related problems. Currently there is no preferred approach to speech and language therapy within the NHS and there is little evidence for the effectiveness of standard NHS therapy or Lee Silverman voice treatment. This trial aims to investigate the feasibility and acceptability of randomizing people with Parkinson’s disease-related speech or...

  20. Pilot feasibility and safety study examining the effect of medium chain triglyceride supplementation in subjects with mild cognitive impairment: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Candida J. Rebello

    2015-06-01

    Conclusions: Consumption of 56 g/day of MCTs for 24 weeks increases serum ketone concentrations and appears to be a candidate for larger randomized control trials in the future that quantify the modulation of cognitive function through supplementation with ketone precursors, in patients with MCI.

  1. Insulin-like growth factor I (IGF-I) replacement therapy increases albumin concentration in liver cirrhosis : Results of a pilot randomized controlled clinical trial

    NARCIS (Netherlands)

    Conchillo, M; de Knegt, RJ; Payeras, M; Quiroga, J; Sangro, B; Herrero, JI; Castilla-Cortazar, [No Value; Frystyk, J; Flyvbjerg, A; Yoshizawa, C; Jansen, PLM; Scharschmidt, B; Prieto, J

    2005-01-01

    Background/Aims: Insulin-like growth factor I (IGF-I) is an anabolic hormone synthesized in the liver whose levels decrease sharply in liver cirrhosis. Methods: We conducted a randomized double-blind placebo-controlled clinical trial to evaluate the effect of subcutaneous administration of IGF-I (20

  2. Insulin-like growth factor I (IGF-I) replacement therapy increases albumin concentration in liver cirrhosis : Results of a pilot randomized controlled clinical trial

    NARCIS (Netherlands)

    Conchillo, M; de Knegt, RJ; Payeras, M; Quiroga, J; Sangro, B; Herrero, JI; Castilla-Cortazar, [No Value; Frystyk, J; Flyvbjerg, A; Yoshizawa, C; Jansen, PLM; Scharschmidt, B; Prieto, J

    2005-01-01

    Background/Aims: Insulin-like growth factor I (IGF-I) is an anabolic hormone synthesized in the liver whose levels decrease sharply in liver cirrhosis. Methods: We conducted a randomized double-blind placebo-controlled clinical trial to evaluate the effect of subcutaneous administration of IGF-I (20

  3. Supplementation with Eicosapentaenoic Omega-3 Fatty Acid Does Not Influence Serum Brain-Derived Neurotrophic Factor in Diabetes Mellitus Patients with Major Depression : A Randomized Controlled Pilot Study

    NARCIS (Netherlands)

    Bot, Mariska; Pouwer, Francois; Assies, Johanna; Jansen, Eugene H. J. M.; Beekman, Aartjan T. F.; de Jonge, Peter

    2011-01-01

    Background: Low brain-derived neurotrophic factor (BDNF) levels are observed in both depressed and diabetes patients. Animal research has shown that omega-3 polyunsaturated fatty acids increase BDNF levels. In this exploratory randomized double-blind placebo-controlled study in diabetes patients wit

  4. "Effectiveness of continuous vertebral resonant oscillation using the POLD method in the treatment of lumbar disc hernia". A randomized controlled pilot study.

    Science.gov (United States)

    López-Díaz, Juan Vicente; Arias-Buría, José Luis; Lopez-Gordo, Estrella; Lopez Gordo, Sandra; Oyarzún, Alejandra P Aros

    2015-06-01

    This study analyses the efficacy of manual oscillatory therapy, following the POLD technique, for acute Lumbar Disc Hernia (LDH) and compares it to usual treatment. A randomised, controlled, triple-blind pilot clinical trial. The sample of 30 patients was divided into two homogeneous groups to receive usual treatment (A) or treatment with the POLD technique (B). We analysed range of motion and subjective variables such as the severity (visual analogue pain scale (VAS)) and extension of the pain. With the application of POLD therapy, patients presented significant changes on range of motion (forward flexion with p POLD Method was shown to be an effective manual therapy approach for reducing the severity and irradiation of the pain in LDH patients with sciatica, and more efficient than usual treatment. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. Can a six-week exercise intervention improve gross motor function for non-ambulant children with cerebral palsy? A pilot randomized controlled trial.

    Science.gov (United States)

    Bryant, Elizabeth; Pountney, Terry; Williams, Heather; Edelman, Natalie

    2013-02-01

    To determine the effect of a six-week exercise intervention on gross motor function for non-ambulant children with cerebral palsy. A parallel arm randomized controlled trial. Four special schools. Thirty-five children aged 8-17 with bilateral cerebral palsy; Gross Motor Function Classification System levels IV-V. Participants were randomly allocated to a static bike group, a treadmill group or control group. Participants in the bike and treadmill groups received exercise training sessions, three times weekly for six weeks. The control group received their usual care. Blinded assessments were performed at baseline and six weeks and followed up at 12 and 18 weeks. Gross Motor Function Measures GMFM-66, GMFM-88D and GMFM-88E. At six weeks significant differences were found in GMFM-88D scores between the bike group and the control group, and the treadmill group and the control group (P exercise groups. The improvements observed declined during the follow-up period. This study provides preliminary evidence that exercising on a bike or treadmill may provide short-term improvements in gross motor function for non-ambulant children with cerebral palsy. This needs to be tested in a large-scale randomized trial.

  6. The Effects of Ramelteon on Glucose Metabolism and Sleep Quality in Type 2 Diabetic Patients With Insomnia: A Pilot Prospective Randomized Controlled Trial

    Science.gov (United States)

    Tsunoda, Tetsuji; Yamada, Masayo; Akiyama, Tomoaki; Minami, Taichi; Yoshii, Taishi; Kondo, Yoshinobu; Satoh, Shinobu; Terauchi, Yasuo

    2016-01-01

    Background Insomnia is associated with the onset and development of diabetes. Melatonin affects sleep quality and glucose metabolism in diabetic patients with insomnia. We administered ramelteon, an agonist of melatonin, to type 2 diabetic patients and investigated its effects on glucose metabolism and insomnia. Methods This multicenter, prospective, randomized, and observational pilot study was performed between April 2014 and April 2015 at three institutes in Japan. Patients were prescribed ramelteon 8 mg/day for 3 months (first period). And patients were divided at random into the continuation group that continued taking ramelteon and the discontinuation group that discontinued taking ramelteon for 3 additional months (second period). The primary endpoint was change in glycated hemoglobin (HbA1c) level. Secondary endpoints were changes in global Pittsburgh sleep questionnaire index (PSQI) score and other glucose metabolism makers. Results We enrolled 42 patients, and 32 patients completed the first period. Their mean HbA1c was 6.7%, and global PSQI score was 8.1 on average. HbA1c level did not change but global PSQI score improved from 8.1 to 7.2 by ramelteon (P = 0.030). Thirty-one patients completed the second period. HbA1c level did not change in the continuation group, but it increased from 6.7% to 6.9% (P = 0.003) in the discontinuation group. Global PSQI score did not change in each group. There was no rebound insomnia. Conclusion Treatment with ramelteon did not change the HbA1c level but improved sleep quality in type 2 diabetic patients with insomnia. Discontinuation of ramelteon slightly increased the HbA1c level and did not worsen sleep quality. PMID:27829954

  7. The effectiveness of the Incredible Years Parents and Babies Program as a universal prevention intervention for parents of infants in Denmark: study protocol for a pilot randomized controlled trial

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken W.

    2015-01-01

    support parents in providing sensitive and responsive care, and reinforce healthy development for their infants. This study aims to evaluate the impact of the Incredible Years™ Parents and Babies Program in a universal setting for parents with infants. Methods/Design: This is a pragmatic, two......-arm, parallel, pilot, randomized controlled trial (RCT) where 128 families with newborn infants up to four-months-old are recruited in two municipalities in Denmark. Families are randomized to the Incredible Years Parents and Babies Program or usual care with a 2:1 allocation ratio. The primary outcome....... Discussion: This is the first RCT of the Incredible Years Parents and Babies Program, and one of the first rigorous evaluations of a universally offered preventive intervention for parents with infants. The trial will provide important information on the effectiveness of a relatively brief, universally...

  8. Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Ritvo, Paul; Obadia, Maya; Santa Mina, Daniel; Alibhai, Shabbir; Sabiston, Catherine; Oh, Paul; Campbell, Kristin; McCready, David; Auger, Leslie; Jones, Jennifer Michelle

    2017-08-24

    Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary clinical outcome will be directly

  9. A double-blind, randomized, placebo-controlled pilot trial to determine the efficacy and safety of ibudilast, a potential glial attenuator, in chronic migraine

    Science.gov (United States)

    Kwok, Yuen H; Swift, James E; Gazerani, Parisa; Rolan, Paul

    2016-01-01

    Background Chronic migraine (CM) is problematic, and there are few effective treatments. Recently, it has been hypothesized that glial activation may be a contributor to migraine; therefore, this study investigated whether the potential glial inhibitor, ibudilast, could attenuate CM. Methods The study was of double-blind, randomized, placebo-controlled, two-period crossover design. Participants were randomized to receive either ibudilast (40 mg twice daily) or placebo treatment for 8 weeks. Subsequently, the participants underwent a 4-week washout period followed by a second 8-week treatment block with the alternative treatment. CM participants completed a headache diary 4 weeks before randomization throughout both treatment periods and 4 weeks after treatment. Questionnaires assessing quality of life and cutaneous allodynia were collected on eight occasions throughout the study. Results A total of 33 participants were randomized, and 14 participants completed the study. Ibudilast was generally well tolerated with mild, transient adverse events, principally nausea. Eight weeks of ibudilast treatment did not reduce the frequency of moderate to severe headache or of secondary outcome measures such as headache index, intake of symptomatic medications, quality of life or change in cutaneous allodynia. Conclusion Using the current regimen, ibudilast does not improve migraine with CM participants. PMID:27826212

  10. A double-blind, randomized, placebo-controlled pilot trial to determine the efficacy and safety of ibudilast, a potential glial attenuator, in chronic migraine

    Directory of Open Access Journals (Sweden)

    Kwok YH

    2016-10-01

    Full Text Available Yuen H Kwok,1 James E Swift,1 Parisa Gazerani,2 Paul Rolan1 1Discipline of Pharmacology, University of Adelaide, Level 5 Medical School North, South Australia, Australia; 2Department of Health Science & Technology, Aalborg University, Aalborg, Denmark Background: Chronic migraine (CM is problematic, and there are few effective treatments. Recently, it has been hypothesized that glial activation may be a contributor to migraine; therefore, this study investigated whether the potential glial inhibitor, ibudilast, could attenuate CM. Methods: The study was of double-blind, randomized, placebo-controlled, two-period crossover design. Participants were randomized to receive either ibudilast (40 mg twice daily or placebo treatment for 8 weeks. Subsequently, the participants underwent a 4-week washout period followed by a second 8-week treatment block with the alternative treatment. CM participants completed a headache diary 4 weeks before randomization throughout both treatment periods and 4 weeks after treatment. Questionnaires assessing quality of life and cutaneous allodynia were collected on eight occasions throughout the study. Results: A total of 33 participants were randomized, and 14 participants completed the study. Ibudilast was generally well tolerated with mild, transient adverse events, principally nausea. Eight weeks of ibudilast treatment did not reduce the frequency of moderate to severe headache or of secondary outcome measures such as headache index, intake of symptomatic medications, quality of life or change in cutaneous allodynia. Conclusion: Using the current regimen, ibudilast does not improve migraine with CM participants. Keywords: chronic migraine, glia, ibudilast, headache, immune system

  11. Efficacy of synbiotics to reduce acute radiation proctitis symptoms and improve quality of life: a randomized, double-blind, placebo-controlled pilot trial.

    Science.gov (United States)

    Nascimento, Mariana; Aguilar-Nascimento, José Eduardo; Caporossi, Cervantes; Castro-Barcellos, Heloisa Michelon; Motta, Rodrigo Teixeira

    2014-10-01

    To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer. Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10(8) colony-forming units and 4.3 g of soluble fiber (Nestlé) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis-23 items) questionnaire were the main endpoints. This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance). Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. Efficacy of Synbiotics to Reduce Acute Radiation Proctitis Symptoms and Improve Quality of Life: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

    Energy Technology Data Exchange (ETDEWEB)

    Nascimento, Mariana, E-mail: mari1980hemato@yahoo.com.br [Department of Medicine, University Center of Varzea Grande (UNIVAG), Varzea Grande, Mato Grosso (Brazil); Aguilar-Nascimento, José Eduardo [Department of Medicine, University Center of Varzea Grande (UNIVAG), Varzea Grande, Mato Grosso (Brazil); Caporossi, Cervantes; Castro-Barcellos, Heloisa Michelon; Motta, Rodrigo Teixeira [Department of Medicine, Federal University of Mato Grosso (UFMT), Cuiabá, Mato Grosso (Brazil)

    2014-10-01

    Purpose: To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer. Methods and Materials: Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10{sup 8} colony-forming units and 4.3 g of soluble fiber (Nestlé) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis–23 items) questionnaire were the main endpoints. Results: This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance). Conclusions: Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer.

  13. A randomized controlled dose-response pilot study of addition of hCG to recombinant FSH during controlled ovarian stimulation for in vitro fertilization

    DEFF Research Database (Denmark)

    Loft, A; Egeberg, Anne Noes; Smitz, J;

    2012-01-01

    Is it possible to define an optimal dose of hCG in combination with rFSH from the first day of stimulation in the GnRH agonist protocol applied to IVF? SUMMARY ANSWER: Supplementation with hCG from the first day of stimulation may increase the number of top-quality embryos per patient. Daily doses...... of hCG up to 150 IU are compatible with good live birth rates. A ceiling level of estradiol (E(2)) was reached with hCG doses above 100 IU/day. A positive dose-response was seen for pre-ovulatory progesterone, but concentrations remained below values for which an impairment of endometrial receptivity...... has been previously reported. We suggest a large clinical trial to be proceeded with a group given 100 IU hCG daily versus a control group. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: Prospective multicentre studies have indicated increased live birth rates and increased number of top-quality embryos when...

  14. Combining rTMS and Task-Oriented Training in the Rehabilitation of the Arm after Stroke: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Xie, Haiqun

    2013-01-01

    Introduction. Repetitive transcranial magnetic stimulation (rTMS) is a promising technique for promoting rehabilitation of arm function after stroke. The feasibility and impact of rTMS as an adjunct to traditional task-oriented training to improve arm function have not yet been demonstrated. Objective. Evaluate the feasibility of a randomized controlled trial aimed at determining the efficacy of rTMS as an adjunct to task-oriented therapy in facilitating restoration of arm function after stroke. Methods. Stratified block-randomized controlled trial set in the general community. Eleven stroke persons with mild to severe arm deficits were recruited and randomized to receive 8 sessions of real-rTMS or sham-rTMS followed by ninety minutes of arm tasks designed to improve function. Results. Medium to large, statistically significant effect sizes (0.49 to 1.63) were observed in both groups on several measures of arm function at the postintervention evaluation. Three out of four subjects in the real-TMS condition showed increased levels of corticomotor excitability after the first stimulation session. Conclusions. Preliminary evidence suggests that an rTMS protocol potent enough to induce transient increases in cortical excitability of the lesioned hemisphere is feasible but did not show promising results as an adjunct to task-specific training. This trial is registration with Clinical Trials.gov NCT00850408. PMID:24363954

  15. 'Help for Hay Fever', a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial.

    Science.gov (United States)

    Porteous, Terry; Wyke, Sally; Smith, Sarah; Bond, Christine; Francis, Jill; Lee, Amanda J; Lowrie, Richard; Scotland, Graham; Sheikh, Aziz; Thomas, Mike; Smith, Lorraine

    2013-07-15

    Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based 'goal-focused' intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT). A pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome

  16. 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.

    Science.gov (United States)

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

    2014-07-30

    Despite the use of evidence-based preventive measures, delirium affects about 40% of patients following cardiac surgery with the potential for serious clinical complications and anxiety for caregivers. There is some evidence that family involvement as a core component of delirium management may be beneficial since familiarity helps patients stay in contact with reality, however, this merits further investigation. There is also currently a gap in the scientific literature regarding objective indicators that could enhance early detection and monitoring of delirium. 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 delirium in their relatives. It also explores the validity of a new and innovative measure that has potential as an indicator for delirium. In this two-group randomized pilot study (n = 30), the control group will receive usual care and the intervention group will receive the experimental intervention aimed at reducing delirium severity. The intervention nurse's objective will be to foster the family caregiver's self-efficacy in behaving in a supportive manner during delirium episodes. Data will be collected from standard delirium assessment scales and a novel measure of delirium, i.e., cerebral oximetry obtained using near infrared spectroscopy, as well as medical records and participants' responses to questionnaires. New strategies for early detection, monitoring, and management of delirium are needed in order to improve outcomes for both patients and families. The present article exposes feasibility issues based on the first few months of the empirical phase of the study that may be useful to the scientific community interested in improving the care of patients with delirium. Another potentially important contribution is in the exploration of cerebral oximetry, a promising measure as an objective

  17. Honey and a mixture of honey, beeswax, and olive oil-propolis extract in treatment of chemotherapy-induced oral mucositis: a randomized controlled pilot study.

    Science.gov (United States)

    Abdulrhman, Mamdouh; Elbarbary, Nancy Samir; Ahmed Amin, Dina; Saeid Ebrahim, Rania

    2012-04-01

    In spite of being one of the most investigated subjects among supportive care in cancer, no therapy has been found effective in treatment of chemotherapy-induced oral mucositis. Based on the observations that honey bees products have anti-inflammatory and wound healing effects, the present study tried to evaluate the effect of topical application of honey and a mixture of honey, olive oil-propolis extract, and beeswax (HOPE) in treatment of oral mucositis. This was a randomized controlled clinical trial conducted on 90 patients with acute lymphoblastic leukemia and oral mucositis grades 2 and 3. The mean age of enrolled patients was 6.9 years. The patients were assigned into 3 equal treatment groups: Honey, HOPE, and control groups. Topical treatment for each patient consists of honey, HOPE, and benzocaine gel for honey, HOPE, and control groups, respectively. Recovery time in grade 2 mucositis was significantly reduced in the honey group as compared with either HOPE or controls (P < .05). In grade 3 mucositis, recovery time did not differ significantly between honey and HOPE (P = 0.61) but compared with controls, healing was faster with either honey or HOPE (P < .01). Generally, in both grades of mucositis, honey produced faster healing than either HOPE or controls (P < .05). Based on our results that showed that honey produced faster healing in patients with grade 2/3 chemotherapy-induced mucositis, we recommend using honey and possibly other bee products and olive oil in future therapeutic trials targeting chemotherapy-induced mucositis.

  18. The Effect of Sweet Bee Venom Pharmacopuncture(SBVP on Cancer-Related Pain : A Randomized Controlled Trial and Double Blinded - Pilot study

    Directory of Open Access Journals (Sweden)

    Hwa-Seung Yoo

    2008-03-01

    Full Text Available Objectives : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale(NRS(0, no pain at all, 10, worst pain imaginable were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B(SBVP and control group, respectively using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP(1ml/day for group A and Normal Saline Placebo(1ml/day for group B was injected into the abdomen acupoint, Zhong Wan(CV 12. The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale(NRS before and after each treatment for “Pain right now” and “Average pain in last 24 hours”. Statistical Analysis : regarding variations in NRS was carried out by applying t-tests(independent sample t-test and paired sample ttest nd Wilcoxon signed rank test with level of significance at 5%. Results : fferences in NRS of “Pain right now” for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group(2.48°±1.52 vs 0.97°±1.88, p<0.05. Differences in average pain score before and after treatment in SBVP group were also significant(5.13°±1.77 vs 2.65°±0.67, p<0.05 compared with control group. The two groups showed no significant differences for long term effects in “Average pain in last 24 hours.” Conclusion : Although further study will be needed on

  19. Brief Client-Centered Motivational and Behavioral Intervention to Promote HPV Vaccination in a Hard-to-Reach Population: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Joseph, Natalie Pierre; Bernstein, Judith; Pelton, Steve; Belizaire, Myrdell; Goff, Ginette; Horanieh, Nour; Freund, Karen M

    2016-08-01

    Objective To evaluate the impact of a client-centered behavioral intervention (Brief Negotiated Interviewing) on mothers' human papillomavirus (HPV) vaccine knowledge and vaccination initiation for their adolescent daughters. Methods We randomized mothers to intervention (n = 100) and control (n = 100) groups, and followed them over 12 months. Electronic medical records were reviewed to determine vaccination status. The primary outcome was receipt of the first vaccine. The secondary outcome was HPV vaccine knowledge among mothers. Results Brief Negotiated Interviewing intervention mothers demonstrated increased knowledge about HPV (pre/post mean score of 5 to 10 out of a possible 11; P < .001) and significantly higher mean knowledge scores (10 vs 6, P < .001) than control mothers. However, initiation and completion rates of the vaccine were not significantly different between groups. Conclusions Increasing HPV vaccine knowledge did not translate into increased vaccine uptake or completion of vaccination series. Future intervention must explore vaccine reminders to increase HPV vaccination rates.

  20. An adapted mindfulness-based stress reduction program for elders in a continuing care retirement community: quantitative and qualitative results from a pilot randomized controlled trial.

    Science.gov (United States)

    Moss, Aleezé S; Reibel, Diane K; Greeson, Jeffrey M; Thapar, Anjali; Bubb, Rebecca; Salmon, Jacqueline; Newberg, Andrew B

    2015-06-01

    The purpose of this study was to test the feasibility and effectiveness of an adapted 8-week Mindfulness-Based Stress Reduction (MBSR) program for elders in a continuing care community. This mixed-methods study used both quantitative and qualitative measures. A randomized waitlist control design was used for the quantitative aspect of the study. Thirty-nine elderly were randomized to MBSR (n = 20) or a waitlist control group (n = 19), mean age was 82 years. Both groups completed pre-post measures of health-related quality of life, acceptance and psychological flexibility, facets of mindfulness, self-compassion, and psychological distress. A subset of MBSR participants completed qualitative interviews. MBSR participants showed significantly greater improvement in acceptance and psychological flexibility and in role limitations due to physical health. In the qualitative interviews, MBSR participants reported increased awareness, less judgment, and greater self-compassion. Study results demonstrate the feasibility and potential effectiveness of an adapted MBSR program in promoting mind-body health for elders.

  1. The safety and feasibility of an intervention to improve balance dysfunction in ambulant adults with cerebral palsy: a pilot randomized controlled trial.

    Science.gov (United States)

    Morgan, Prue; Murphy, Anna; Opheim, Arve; Pogrebnoy, Dina; Kravtsov, Stella; McGinley, Jennifer

    2015-09-01

    To investigate the safety, feasibility and potential efficacy of balance training in adults with cerebral palsy. Phase 2, assessor-blinded randomized controlled trial. Outpatient rehabilitation facility. A total of 17 ambulatory adults with cerebral palsy. Participants were randomly allocated to an eight-week, once-weekly, small group programme of balance training, or seated attention control activity. Balance training was individually tailored using the Balance Evaluation Systems test. Primary focus was feasibility, addressed by recruitment, retention, adherence, and safety. Efficacy was primarily evaluated with the Ambulatory Self-Confidence Questionnaire and the Balance Evaluation Systems test, at intervention conclusion and Week 24. Secondary outcomes included gait speed, walking distance, falls efficacy, fatigue, quality of life, and global impression of change. Interventions were safe and feasible with no major adverse events. Adherence was high. At eight and 24 weeks, there were negligible between-group differences in Balance Evaluation systems test total. At 24 weeks, there was a small, non-significant between-group difference in favour of the balance group with effect sizes of 0.14 for ambulatory self-confidence, 0.10 for falls efficacy, and 0.12 for fatigue. There were significant between-group differences for self-reported walking confidence and balance change, in favour of the balance group at Weeks 8 and 24 (p cerebral palsy. Small effects from balance training in selected outcomes occurred. Study replication with at least 38 participants per group to confirm efficacy is warranted. © The Author(s) 2014.

  2. The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders: a pilot randomized placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Lingler Jacqui

    2009-03-01

    Full Text Available Abstract Background The objective of this study was to examine whether fluoxetine was superior to placebo in the acute amelioration of depressive symptomatology in adolescents with depressive illness and a comorbid substance use disorder. Methods Eligible subjects ages 12–17 years with either a current major depressive disorder (MDD or a depressive disorder that were also suffering from a comorbid substance-related disorder were randomized to receive either fluoxetine or placebo in this single site, 8-week double-blind, placebo-controlled study. The primary outcome analysis was a random effects mixed model for repeated measurements of Children's Depression Rating Scale-Revised (CDRS-R scores compared between treatment groups across time. Results An interim analysis was performed after 34 patients were randomized. Based on the results of a futility analysis, study enrollment was halted. Twenty-nine males and 5 females were randomized to receive fluoxetine (n = 18 or placebo (n = 16. Their mean age was 16.5 (1.1 years. Overall, patients who received fluoxetine and placebo had a reduction in CDRS-R scores. However, there was no significant difference in mean change in CDRS-R total score in those subjects treated with fluoxetine and those who received placebo (treatment difference = 0.19, S.E. = 0.58, F = 0.14, p = .74. Furthermore, there was not a significant difference in rates of positive urine drug toxicology results between treatment groups at any post-randomization visit (F = 0.22, df = 1, p = 0.65. The main limitation of this study is its modest sample size and resulting low statistical power. Other significant limitations to this study include, but are not limited to, the brevity of the trial, high placebo response rate, limited dose range of fluoxetine, and the inclusion of youth who met criteria for depressive disorders other than MDD. Conclusion Fluoxetine was not superior to placebo in alleviating depressive symptoms or in decreasing

  3. Ayurvedic versus conventional dietary and lifestyle counseling for mothers with burnout-syndrome: A randomized controlled pilot study including a qualitative evaluation.

    Science.gov (United States)

    Kessler, Christian S; Eisenmann, Clemens; Oberzaucher, Frank; Forster, Martin; Steckhan, Nico; Meier, Larissa; Stapelfeldt, Elmar; Michalsen, Andreas; Jeitler, Michael

    2017-10-01

    Ayurveda claims to be effective in the treatment of psychosomatic disorders by means of lifestyle and nutritional counseling. In a randomized controlled study mothers with burnout were randomized into two groups: Ayurvedic nutritional counseling (according to tradition), and conventional nutritional counseling (following the recommendations of a family doctor). Patients received five counseling sessions over twelve weeks. Outcomes included levels of burnout, quality of life, sleep, stress, depression/anxiety, and spirituality at three and six months. It also included a qualitative evaluation of the communication processes. We randomized thirty four patients; twenty three participants were included in the per protocol analysis. No significant differences were observed between the groups. However, significant and clinically relevant intra-group mean changes for the primary outcome burnout, and secondary outcomes sleep, stress, depression and mental health were only found in the Ayurveda group. The qualitative part of the study identified different conversational styles and counseling techniques between the two study groups. In conventional consultations questions tended to be category bound, while counseling-advice was predominantly admonitory. The Ayurvedic practitioner used open-ended interrogative forms, devices for displaying understanding, and positive re-evaluation more frequently, leading to an overall less asymmetrical interaction. We found positive effects for both groups, which however were more pronounced in the Ayurvedic group. The conversational and counseling techniques in the Ayurvedic group offered more opportunities for problem description by patients as well as patient-centered practice and resource-oriented recommendations by the physician. NCT01797887. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. A randomized placebo-controlled double-blind pilot study of methotrexate in the treatment of H1 antihistamine-resistant chronic spontaneous urticaria

    Directory of Open Access Journals (Sweden)

    Vinod K Sharma

    2014-01-01

    Full Text Available Background: Chronic urticaria not responsive to antihistamines is a difficult disease to manage. Methotrexate has been used in difficult chronic urticarias with some benefit. Objective: To evaluate the efficacy of methotrexate in the treatment of chronic spontaneous urticaria poorly responsive to H1 antihistaminics. Methods: In a randomized double-blind trial at the Department of Dermatology and Venereology of a tertiary care centre, 29 patients with chronic spontaneous urticaria not responding well to H1 antihistaminics were recruited. Patients were randomly allocated to receive either a weekly dose of oral methotrexate 15 mg or placebo (calcium carbonate for a total duration of 12 weeks, after which treatment was stopped and patients were followed up for relapse of urticaria. Each group also received levocetrizine 5 mg once daily for symptom control. Primary outcome measured was a reduction by >2/3 rd of baseline urticaria scores after 12 week therapy. Secondary outcome was a reduction in antihistamine requirement after stopping therapy. Results: Fourteen patients were randomized to the methotrexate group and fifteen patients to the placebo group. Out of 17 patients who completed therapy, the primary outcome was achieved by 3.5 ± 1.9 (out of 10 patients in the methotrexate group and by 3.67 ± 1.03 (out of 7 patients in the placebo group (P > 0.05. Ten patients followed up, after stopping therapy, for a mean period of 3.5 ± 2.4 months; 3 remained in remission and 7 had relapsed. One patient had uncontrollable nausea and vomiting after taking methotrexate and was withdrawn from the study. The placebo group did not experience any side effects. Conclusions: Methotrexate 15 mg weekly for 3 months did not provide any additional benefit over H1 antihistamines in this study but an adequately powered study with longer follow up is required to assess its utility.

  5. The effect of an eyes-closed dance-specific training program on dynamic balance in elite pre-professional ballet dancers: a randomized controlled pilot study.

    Science.gov (United States)

    Hutt, Kimberley; Redding, Emma

    2014-03-01

    Visual conditions for a dancer vary greatly between theatrical performance environments and dance studios, and this variability may be detrimental to their dynamic balance performance, particularly under stage lighting. In order to maintain balance control, dancers reportedly rely heavily on visual input, yet those who rely more on proprioceptive strategies for balancing have been found to be more stable. The purpose of this study was to assess the capability of an eyes-closed, dance-specific training program to nurture in dancers proprioceptive mechanisms that may facilitate their dynamic balance control. Eighteen elite pre-professional ballet dancers were randomly assigned to either a control (eyes open) or experimental (eyes closed) group for the intervention. The balance abilities of all subjects were tested using five dance-specific variations of the Star Excursion Balance Test before and after a 4 week balance intervention. Reach distance and time to complete the tests were recorded separately as indirect measurements of dynamic balance. The intervention consisted of dance-specific, eyes-closed exercises integrated into the dancers' daily ballet class and designed progressively to challenge the dancers' balance. During the intervention period, the control group undertook the same exercise program with their eyes open. Results revealed significant improvements in time to complete the three "timed" balance tests, and distances reached significantly improved in one of the two "reach" balance tests. No significant improvements were observed in the control group for any variation of the tests. These results indicate that dancers can be trained to adopt proprioceptive strategies to maintain dynamic balance, which consequently improves their balance performance. Such findings could encourage use of eyes-closed training in daily dance classes due to its potential to improve dancers' balance control.

  6. Alginate dressing and polyurethane film versus paraffin gauze in the treatment of split-thickness skin graft donor sites: a randomized controlled pilot study.

    Science.gov (United States)

    Kaiser, Dominik; Hafner, Jürg; Mayer, Dieter; French, Lars E; Läuchli, Severin

    2013-02-01

    To compare postoperative healing of split-thickness skin graft (STSG) donor sites using traditional dressings (paraffin gauze) or modern wound dressings (alginate dressing and polyurethane film) in a randomized controlled trial. Thirty patients were randomly assigned to treatment of an STSG donor site with an alginate dressing and a polyurethane film or nonadherent paraffin gauze. Outcome variables were pain (measured with a visual analog scale), amount of dressing changes, healing time, cosmetic outcome, treatment costs, and overall satisfaction with the procedure. There was no significant difference in pain (postoperative day 1: 2.1 vs 1.2, P = .26; postoperative days 5-7: 1.0 vs 0.9, P = .47; final removal: 1.9 vs 1.0, P = .19) and time to healing (18.1 vs 15.4 days, P = .29) between alginate/polyurethane film dressing and nonadherent paraffin gauze. The semiocclusive dressings with polyurethane film required multiple dressing changes, whereas the nonadherent paraffin gauze could be left in place until complete epithelialization. Treatment costs were substantially lower for paraffin gauze. Semiocclusive dressings with alginate dressings and polyurethane film showed no advantages over treatment with paraffin gauze. With lower costs and better patient acceptance, paraffin gauze dressings were the preferred treatment for STSG donor sites.

  7. The effects of nocturnal hemodialysis compared to conventional hemodialysis on change in left ventricular mass: Rationale and study design of a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Klarenbach Scott

    2006-02-01

    Full Text Available Abstract Background Nocturnal hemodialysis (NHD is an alternative to conventional three times per week hemodialysis (CvHD and has been reported to improve several health outcomes. To date, no randomized controlled trial (RCT has compared NHD and CvHD. We have undertaken a multi-center RCT in hemodialysis patients comparing the effect of NHD to CvHD on left ventricular (LV mass, as measured by cardiac magnetic resonance imaging (cMR. Methodology/design All patients in Alberta, Canada, expressing an interest in performing NHD are eligible for the study. Patients enrolled in the study will be randomized to either NHD or CvHD for a six month period. All patients will have a full clinical assessment, including collection of biochemical and cMR data at baseline and at 6 months. Both groups of patients will be monitored biweekly to optimize blood pressure (BP to a goal of Discussion To our knowledge, this study will be the first RCT evaluating health outcomes in NHD. The impact of NHD on LV mass represents a clinically important outcome which will further elucidate the potential benefits of NHD and guide future clinical endpoint studies.

  8. Emotional Freedom Techniques in the Treatment of Unhealthy Eating Behaviors and Related Psychological Constructs in Adolescents: A Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Stapleton, Peta; Chatwin, Hannah; William, Mary; Hutton, Amanda; Pain, Amanda; Porter, Brett; Sheldon, Terri

    2016-01-01

    In Australia and throughout much of the world, rates of obesity continue to climb as do the prevalence of eating disorders, particularly in adolescents. Psychological consequences of childhood obesity include low self-esteem, depression, body dissatisfaction, and social maladjustment (Young-Hyman et al., 2012). This feasibility study sought to examine the impact of a six-week Emotional Freedom Techniques (EFT) group treatment program upon eating behaviours, self-esteem, compassion, and psychological symptoms. Forty-four students were randomly allocated to either the EFT group or the waitlist control group. Results revealed a delayed effect for both groups at post-intervention, with improved eating habits, self-esteem, and compassion at follow-up. Findings provide preliminary support for EFT as an effective treatment strategy for increasing healthy eating behaviours and improving associated weight-related psychopathology. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. The effect of an expressive writing intervention (EWI) on stress in infertile couples undergoing assisted reproductive technlogy (ART) treatment: A randomized controlled pilot study

    DEFF Research Database (Denmark)

    Matthiesen, Signe Maria Schneevoigt; Klonoff-Cohen, Hillary; Zachariae, Robert

    2012-01-01

    Objectives. Infertile couples undergoing fertility treatments may experience stress and could benefit from psychological intervention. Expressive Writing Intervention (EWI) has shown promising results on various psychological outcomes, yet only one study has applied the method to infertility......-related stress. Our aim was to assess feasibility and effectiveness of EWI for patients in treatment with Assisted Reproductive Technology (ART). Design and participants. Patients enrolling in their first ART treatment at the fertility clinic, Aarhus University Hospital, Denmark were offered to participate....... A total of 82 participants (45 women, 37 men), mean age: 33.17, were randomized to home-based EWI or neutral writing control group and completed an infertility-related stress questionnaire at treatment enrollment, 3 weeks later (at the time of down regulation), and 6 weeks after the intervention...

  10. Insulin detemir in a twice daily insulin regimen versus a three times daily insulin regimen in the treatment of type 1 diabetes in children: A pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ho Josephine

    2011-11-01

    Full Text Available Abstract Background Children with type 1 diabetes (DM1 often use three daily (TID injections with intermediate acting insulin at breakfast and bedtime, and rapid acting insulin at breakfast and dinner. Substituting the evening intermediate acting insulin with a long acting insulin analogue (LAIA at dinner in a twice daily (BID injection regimen may be as effective as a TID regimen. The objective of this pilot study was to compare HbA1c in children with DM1 using a BID regimen with a LAIA at dinner (intervention to those using a standard TID regimen (control over 6 months. Methods Randomized controlled trial with main outcome measure being HbA1c at 0, 3 and 6 months. Secondary outcomes were frequency of adverse events (hypoglycemia, diabetic ketoacidosis, weight gain and scores on the Diabetes Quality of Life Measure for Youth (DQOLY. Results 18 subjects (10 control, 8 intervention. Mean years (standard deviations for control and intervention respectively were: age at diagnosis of DM1 6.31 (2.91 vs 7.76 (3.22, duration of DM1 5.96 (4.95 vs 3.76 (3.37. No significant differences were seen in the mean HbA1c between control and intervention at 0 months [8.48(0.86 vs 8.57(1.13], 3 months [8.47(0.50 vs 7.99(0.61], or 6 months [8.42(0.63 vs 8.30(0.76]. No significant differences were found between groups for frequency of adverse events or DQOLY. Conclusions In this pilot study, incorporating LAIA in a BID regimen did not cause deterioration in HbA1c or increases in adverse events; suggesting that this may be a viable option for families where a more simplified insulin regimen would be beneficial and compliance may be improved. Trial registration ClinicalTrials.gov: NCT00522210

  11. Chinese Herbal Medicine (Zi Shen Qing for Mild-to-Moderate Systematic Lupus Erythematosus: A Pilot Prospective, Single-Blinded, Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Linda L. D. Zhong

    2013-01-01

    Full Text Available Objective. The aim of this study is to investigate the effectiveness and safety of a Chinese herbal formula Zi Shen Qing (ZSQ in the treatment of systematic lupus erythematosus (SLE in Chinese patients. Methods. A randomized controlled trial was conducted over 12 weeks in 84 Chinese patients who reported total scores of SLE Disease Activity Index-2000 (SLEDAI-2000 was from 5 to 14. The primary outcome was the changes of the SLEDAI-2000. The secondary outcomes included score changes of Chinese Medicine Syndromes (CMS, the changes of steroid dosage, the incidence of disease flare-up and biologic markers. Results. ZSQ significantly reduced SLEDAI-2000, the total scores of CMS in the treatment group compared with the controlled group (P<0.05. Superiority of ZSQ over controlled group was also observed with greater improvement in the withdrawal dosage of corticosteroids and the incidence of disease flare-up (P<0.05. There were no serious adverse events, and safety indices of whole blood counts, renal and liver functions were normal, both before and after the treatment. Conclusion. ZSQ is safe and effective for decreasing SLE disease activity and withdrawal dosage of corticosteroids in the mild to moderate SLE patients with “Deficiency of Qi and Yin” Pattern.

  12. Glycemic control after hospital discharge in insulin-treated type 2 diabetes: a randomized pilot study of daily remote glucose monitoring.

    Science.gov (United States)

    Wei, Nancy J; Nathan, David M; Wexler, Deborah J

    2015-02-01

    Little is known about glycemic control in type 2 diabetes patients treated with insulin in the high-risk period between hospital discharge and follow-up. We sought to assess the impact of remote glucose monitoring on postdischarge glycemic control and insulin titration. We randomly assigned 28 hospitalized type 2 diabetes patients who were discharged home on insulin therapy to routine specialty care (RSC) or RSC with daily remote glucose monitoring (RGM). We compared the primary outcome of mean blood glucose and exploratory outcomes of hypoglycemia/hyperglycemia rates, change in hemoglobin A1c and glycated albumin, and insulin titration frequency between groups. Mean blood glucose was not significantly different between the treatment arms (144 ± 34 mg/dL in the RSC group and 172 ± 41 mg/dL in the RGM group; not significant), nor were there significant differences in any of the other measures of glycemia during the month after discharge. Hypoglycemia (glucometer reading control after hospital discharge; however, the high rate of hypoglycemia in the postdischarge transition period and the higher frequency of insulin titration in patients who used RGM suggest a safety role for such monitoring in the transition from hospital to home.

  13. Comparative alveolar ridge preservation using allogenous tooth graft versus free-dried bone allograft: A randomized, controlled, prospective, clinical pilot study

    Directory of Open Access Journals (Sweden)

    Chaitanya Pradeep Joshi

    2017-01-01

    Full Text Available Background: For the first time in India, allografts from human extracted teeth were prepared. A randomized, prospective, clinicoradiographical, histological study was conducted to evaluate their efficacy in comparison with freeze-dried bone allograft (FDBA in alveolar ridge preservation. Materials and Methods: Graft preparation: with written consent, teeth were collected from three donors (full mouth extraction cases. Once donors' serums were tested negative for HIV, HBV, HCV, and Venereal disease research laboratory (VDRL, mineralized whole tooth allograft (WTA and dentin allograft (DA were prepared using the standard protocol of Tissue Bank at Tata Memorial Hospital, Mumbai, India. Study Design: In this randomized controlled trial, 15 patients undergoing extraction of at least four teeth were selected. In each patient after atraumatic extractions, one socket was grafted with WTA, second with DA, third with FDBA, and fourth was left ungrafted (control site. All the sites were covered with chorion membrane. To estimate three-dimensional alveolar crest changes, cone beam computed tomography scans were taken immediately after grafting and 4 months postoperatively. Bone biopsies using 3 mm trephine bur were obtained from four patients at the time of implant placement and evaluated histologically. Results: Clinically uneventful healing was observed at all sites. Compared to other sites, WTA and DA consistently showed superior results demonstrating least reduction in alveolar crest height and width which was statistically significant (P < 0.05. Between WTA and DA sites, there was no statistically significant difference. Histological analysis also confirmed more new bone formation at WTA and DA sites. Conclusions: Rather than disposing extracted human teeth as a biomedical waste (common practice, they can be collected from suitable systemically healthy donors. With the help of tissue bank, they can be processed into an allograft, serving as an

  14. Comparative Alveolar Ridge Preservation Using Allogenous Tooth Graft versus Free-dried Bone Allograft: A Randomized, Controlled, Prospective, Clinical Pilot Study.

    Science.gov (United States)

    Joshi, Chaitanya Pradeep; D'Lima, Cynthia Bernardo; Samat, Urmila Chandrashekhar; Karde, Prerna Ashok; Patil, Agraja Ganpat; Dani, Nitin Hemchandra

    2017-01-01

    For the first time in India, allografts from human extracted teeth were prepared. A randomized, prospective, clinicoradiographical, histological study was conducted to evaluate their efficacy in comparison with freeze-dried bone allograft (FDBA) in alveolar ridge preservation. Graft preparation: with written consent, teeth were collected from three donors (full mouth extraction cases). Once donors' serums were tested negative for HIV, HBV, HCV, and Venereal disease research laboratory (VDRL), mineralized whole tooth allograft (WTA) and dentin allograft (DA) were prepared using the standard protocol of Tissue Bank at Tata Memorial Hospital, Mumbai, India. In this randomized controlled trial, 15 patients undergoing extraction of at least four teeth were selected. In each patient after atraumatic extractions, one socket was grafted with WTA, second with DA, third with FDBA, and fourth was left ungrafted (control site). All the sites were covered with chorion membrane. To estimate three-dimensional alveolar crest changes, cone beam computed tomography scans were taken immediately after grafting and 4 months postoperatively. Bone biopsies using 3 mm trephine bur were obtained from four patients at the time of implant placement and evaluated histologically. Clinically uneventful healing was observed at all sites. Compared to other sites, WTA and DA consistently showed superior results demonstrating least reduction in alveolar crest height and width which was statistically significant (P < 0.05). Between WTA and DA sites, there was no statistically significant difference. Histological analysis also confirmed more new bone formation at WTA and DA sites. Rather than disposing extracted human teeth as a biomedical waste (common practice), they can be collected from suitable systemically healthy donors. With the help of tissue bank, they can be processed into an allograft, serving as an excellent alternative to conventional allografts.

  15. A pilot study on the impact of a low fructose diet and allopurinol on clinic blood pressure among overweight and prehypertensive subjects: a randomized placebo controlled trial.

    Science.gov (United States)

    Madero, Magdalena; Rodríguez Castellanos, Francisco E; Jalal, Diana; Villalobos-Martín, Maria; Salazar, Jonathan; Vazquez-Rangel, Armando; Johnson, Richard J; Sanchez-Lozada, L Gabriela

    2015-11-01

    Fructose and sodium intake have been associated with hypertension and metabolic syndrome. Although various mechanisms are involved, fructose causes hypertension partly through rising intracellular and serum uric acid. To date, there are no studies in adults that have evaluated the impact of low fructose diets and allopurinol on prehypertensive and overweight subjects. The objective of this study was to compare the effect of low fructose diet and allopurinol or placebo on blood pressure (BP) and metabolic syndrome components The study was a controlled clinical trial and consisted of two phases; in the first phase of intervention (4 weeks), patients were randomized to either low fructose diet (34 patients) or control diet (38 patients). In the second phase of intervention (weeks 4-8), the same groups continued with the same diet prescriptions but were further randomized to receive placebo or allopurinol (300 mg/d). Clinic and 24-hour ambulatory BP, anthropometric measures, and laboratory data were determined at baseline, weeks 4 and 8. Seventy-two patients were included in the trial. At the end of the dietary phase, both diet groups significantly reduced their BP, but there were no between-group differences. Compared to placebo, at the end of follow-up, subjects in the allopurinol group had a lower clinic systolic blood pressure and this was significant within- and between-group comparisons. The percentage of dippers was higher in the allopurinol group, and weight was reduced significantly despite the absence of caloric restriction Allopurinol was associated with a significant reduction in clinic BP, an increase in the percentage of dippers, and significant weight loss. Larger studies with longer follow-up are needed to confirm our findings. Copyright © 2015 American Society of Hypertension. All rights reserved.

  16. A pilot double-blind, randomized, placebo-controlled trial of the efficacy of trace elements in the treatment of endometriosis-related pain: study design and methodology

    Directory of Open Access Journals (Sweden)

    Oberweis D

    2016-02-01

    Full Text Available Didier Oberweis,1 Patrick Madelenat,2 Michelle Nisolle,3 Etienne Demanet4 1Department of Gynecology and Obstetrics, CHU de Charleroi, Hôpital André Vésale, Montigny-le-Tilleul, Belgium; 2Private Consultation, Paris, France; 3Department of Gynecology and Obstetrics, CHR Citadelle, Liège, 4Clinical Research Unit, Charleroi, Belgium Abstract: Endometriosis is one of the most common benign gynecological disorders, affecting almost 10%–15% of all women of reproductive age and >30% of infertile women. The pathology is associated with various distressing symptoms, particularly pelvic pain, which adversely affect patients' quality of life. It is an estrogen-dependent disease. There is evidence both in animals and in humans that metal ions can activate the estrogen receptors. They are defined as a variety of xenoestrogens, called metalloestrogens, which could act as endocrine disruptors. Therefore, it could be considered to act on this gynecological disorder using food supplements containing trace elements (ie, nutripuncture. The assumption is that they could modulate estrogen receptors and thus influence the tropism and the survival of cells involved in endometriosis. By a modulation of the antioxidant system, they might also interact with various parameters influencing tissue biochemistry. The objective of this article is to describe and discuss the design and methodology of an ongoing double-blind, randomized, placebo-controlled study aiming to evaluate the efficacy of metal trace elements on the reduction of pain and improvement of quality of life, in patients with a revised American Fertility Society Score Stages II–IV endometriosis, combined or not with adenomyosis, during a treatment period of 4 months. Trace elements or placebo is proposed in the absence of any other treatment or as an add-on to current therapies, such as sexual hormones, nonsteroidal anti-inflammatory drugs, and surgery. A placebo run-in period of one menstrual cycle or

  17. An interdisciplinary knowledge translation intervention in long-term care: Study protocol for the vitamin D and osteoporosis study (ViDOS pilot cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kennedy Courtney C

    2012-05-01

    Full Text Available Abstract Background Knowledge translation (KT research in long-term care (LTC is still in its early stages. This protocol describes the evaluation of a multifaceted, interdisciplinary KT intervention aimed at integrating evidence-based osteoporosis and fracture prevention strategies into LTC care processes. Methods and design The Vitamin D and Osteoporosis Study (ViDOS is underway in 40 LTC homes (n = 19 intervention, n = 21 control across Ontario, Canada. The primary objectives of this study are to assess the feasibility of delivering the KT intervention, and clinically, to increase the percent of LTC residents prescribed ≥800 IU of vitamin D daily. Eligibility criteria are LTC homes that are serviced by our partner pharmacy provider and have more than one prescribing physician. The target audience within each LTC home is the Professional Advisory Committee (PAC, an interdisciplinary team who meets quarterly. The key elements of the intervention are three interactive educational sessions led by an expert opinion leader, action planning using a quality improvement cycle, audit and feedback reports, nominated internal champions, and reminders/point-of-care tools. Control homes do not receive any intervention, however both intervention and control homes received educational materials as part of the Ontario Osteoporosis Strategy. Primary outcomes are feasibility measures (recruitment, retention, attendance at educational sessions, action plan items identified and initiated, internal champions identified, performance reports provided and reviewed, and vitamin D (≥800 IU/daily prescribing at 6 and 12 months. Secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications, and falls and fractures. Qualitative methods will examine the experience of the LTC team with the KT intervention. Homes are centrally randomized to intervention and control groups in blocks of variable size using

  18. Goal-directed fluid management based on stroke volume variation and stroke volume optimization during high-risk surgery : a pilot multicentre randomized controlled trial

    NARCIS (Netherlands)

    Scheeren, Thomas; Wiesenack, Christoph; Gerlach, H.; Marx, G.

    2011-01-01

    Introduction: Perioperative hemodynamic optimization has been shown to be useful to improve the postoperative outcome of patients undergoing major surgery. We designed a pilot study in patients undergoing major abdominal, urologic or vascular surgery to investigate the effects of a goal-directed (GD

  19. Design and pilot results of a single blind randomized controlled trial of systematic demand-led home visits by nurses to frail elderly persons in primary care [ISRCTN05358495

    Directory of Open Access Journals (Sweden)

    Tybout Willemijn

    2005-09-01

    Full Text Available Abstract Background The objective of this article is to describe the design of an evaluation of the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients. Pilot objectives were: 1. To determine the feasibility of postal multidimensional frailty screening instruments; 2. to identify the need for home visits to elderly. Methods Main study: The main study concerns a randomized controlled in primary care practices (PCP with 18 months follow-up and blinded PCPs. Frail persons aged 75 years or older and living at home but neither terminally ill nor demented from 33 PCPs were eligible. Trained community nurses (1 visit patients at home and assess the care needs with the Resident Assessment Instrument-Home Care, a multidimensional computerized geriatric assessment instrument, enabling direct identification of problem areas; (2 determine the care priorities together with the patient; (3 design and execute interventions according to protocols; (4 and visit patients at least five times during a year in order to execute and monitor the care-plan. Controls receive usual care. Outcome measures are Quality of life, and Quality Adjusted Life Years; time to nursing home admission; mortality; hospital admissions; health care utilization. Pilot 1: Three brief postal multidimensional screening measures to identify frail health among elderly persons were tested on percentage complete item response (selected after a literature search: 1 Vulnerable Elders Screen, 2 Strawbridge's frailty screen, and 3 COOP-WONCA charts. Pilot 2: Three nurses visited elderly frail patients as identified by PCPs in a health center of 5400 patients and used an assessment protocol to identify psychosocial and medical problems. The needs and experiences of all participants were gathered by semi-structured interviews. Discussion The design holds several unique elements such as early identification of frail persons combined with case-management by

  20. Mirror therapy combined with biofeedback functional electrical stimulation for motor recovery of upper extremities after stroke: a pilot randomized controlled trial.

    Science.gov (United States)

    Kim, Jung Hee; Lee, Byoung-Hee

    2015-06-01

    The objective of this study was to evaluate the effects of mirror therapy in combination with biofeedback functional electrical stimulation (BF-FES) on motor recovery of the upper extremities after stroke. Twenty-nine patients who suffered a stroke > 6 months prior participated in this study and were randomly allocated to three groups. The BF-FES + mirror therapy and FES + mirror therapy groups practiced training for 5 × 30 min sessions over a 4-week period. The control group received a conventional physical therapy program. The following clinical tools were used to assess motor recovery of the upper extremities: electrical muscle tester, electrogoniometer, dual-inclinometer, electrodynamometer, the Box and Block Test (BBT) and Jabsen Taylor Hand Function Test (JHFT), the Functional Independence Measure, the Modified Ashworth Scale, and the Stroke Specific Quality of Life (SSQOL) assessment. The BF-FES + mirror therapy group showed significant improvement in wrist extension as revealed by the Manual Muscle Test and Range of Motion (p mirror therapy group showed significant improvement in the BBT, JTHT, and SSQOL compared with the FES + mirror therapy group and control group (p mirror therapy induced motor recovery and improved quality of life. These results suggest that mirror therapy, in combination with BF-FES, is feasible and effective for motor recovery of the upper extremities after stroke. Copyright © 2014 John Wiley & Sons, Ltd.

  1. Effectiveness of the Gaze Direction Recognition Task for Chronic Neck Pain and Cervical Range of Motion: A Randomized Controlled Pilot Study

    Directory of Open Access Journals (Sweden)

    Satoshi Nobusako

    2012-01-01

    Full Text Available We developed a mental task with gaze direction recognition (GDR by which subjects observed neck rotation of another individual from behind and attempted to recognize the direction of gaze. A randomized controlled trial was performed in test (=9 and control (=8 groups of subjects with chronic neck pain undergoing physical therapy either with or without the GDR task carried out over 12 sessions during a three-week period. Primary outcome measures were defined as the active range of motion and pain on rotation of the neck. Secondary outcome measures were reaction time (RT and response accuracy in the GDR task group. ANOVA indicated a main effect for task session and group, and interaction of session. Post hoc testing showed that the GDR task group exhibited a significant simple main effect upon session, and significant sequential improvement of neck motion and relief of neck pain. Rapid effectiveness was significant in both groups. The GDR task group had a significant session-to-session reduction of RTs in correct responses. In conclusion, the GDR task we developed provides a promising rehabilitation measure for chronic neck pain.

  2. The Benefit of a Mechanical Needle Stimulation Pad in Patients with Chronic Neck and Lower Back Pain: Two Randomized Controlled Pilot Studies

    Directory of Open Access Journals (Sweden)

    Claudia Hohmann

    2012-01-01

    Full Text Available Objectives. The objective was to investigate whether a treatment with a needle stimulation pad (NSP changes perceived pain and/or sensory thresholds in patients with chronic neck (NP and lower back pain (BP. Methods. 40 patients with chronic NP and 42 patients with chronic BP were equally randomized to either treatment or waiting list control group. The treatment group self-administered a NSP over a period of 14 days. Pain ratings were recorded on numerical rating scales (NRSs. Mechanical detection thresholds (MDTs and pressure pain thresholds (PPTs were determined at the site of maximal pain and in the adjacent region, vibration detection thresholds (VDT were measured at close spinal processes. The Northwick Park Neck Pain Questionnaire (NPQ and the Oswestry Disability Index (ODI were utilized for the NP and BP study, respectively. Results. NRS ratings were significantly reduced for the treatment groups compared to the control groups (NP: P=.021 and BP: P<.001, accompanied by a significant increase of PPT at pain maximum (NP: P=.032 and BP: P=.013. There was no effect on VDT and MDT. The NPQ showed also a significant improvement, but not the ODI. Conclusions. The mechanical NSP seems to be an effective treatment method for chronic NP and BP.

  3. Effects of Meditation versus Music Listening on Perceived Stress, Mood, Sleep, and Quality of Life in Adults with Early Memory Loss: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

    2016-04-08

    Older adults with subjective cognitive decline (SCD) are at increased risk not only for Alzheimer's disease, but for poor mental health, impaired sleep, and diminished quality of life (QOL), which in turn, contribute to further cognitive decline, highlighting the need for early intervention. In this randomized controlled trial, we assessed the effects of two 12-week relaxation programs, Kirtan Kriya Meditation (KK) and music listening (ML), on perceived stress, sleep, mood, and health-related QOL in older adults with SCD. Sixty community-dwelling older adults with SCD were randomized to a KK or ML program and asked to practice 12 minutes daily for 12 weeks, then at their discretion for the following 3 months. At baseline, 12 weeks, and 26 weeks, perceived stress, mood, psychological well-being, sleep quality, and health-related QOL were measured using well-validated instruments. Fifty-three participants (88%) completed the 6-month study. Participants in both groups showed significant improvement at 12 weeks in psychological well-being and in multiple domains of mood and sleep quality (p's≤0.05). Relative to ML, those assigned to KK showed greater gains in perceived stress, mood, psychological well-being, and QOL-Mental Health (p's≤0.09). Observed gains were sustained or improved at 6 months, with both groups showing marked and significant improvement in all outcomes. Changes were unrelated to treatment expectancies. Findings suggest that practice of a simple meditation or ML program may improve stress, mood, well-being, sleep, and QOL in adults with SCD, with benefits sustained at 6 months and gains that were particularly pronounced in the KK group.

  4. Effectiveness of a tailored neck training program on neck strength, movement, and fatigue in under-19 male rugby players: a randomized controlled pilot study.

    Science.gov (United States)

    Barrett, Matthew D; McLoughlin, Terence F; Gallagher, Kieran R; Gatherer, Don; Parratt, Michael Tr; Perera, Jonathan R; Briggs, Tim Wr

    2015-01-01

    To investigate the effect of a tailored neck muscle conditioning program on neck muscle strength, neck muscle fatigue, and range of neck movement in 16-18-year-old male rugby players. Thirty-four male rugby players were divided into forward and back playing positions and randomized within these groups. Seventeen players were randomly assigned to each group. The test group was given a tailored 6-week exercise regime based on their baseline measurements to be performed three times a week in addition to their normal training and playing. The control group trained and played as normal. The outcome measures used were cervical spine range of movement, neck strength, and neck muscle fatigability. There were no clinically relevant statistically significant differences between the two groups. Trends identified between the two groups suggest that a tailored neck exercise program increases neck strength, particularly neck extension, and increases resistance to fatigue, as well as influencing right- and left-sided neck muscle balance. A reduction in range of movement was also demonstrated in the test group. There was a great deal of variability in range of movement and strength within this age group. No previously undiagnosed neck conditions were detected, and there were no adverse events reported. This study has shown that neck strength, range of movement, and susceptibility of the neck muscles to fatigue can be influenced using a focused neck training regime. It forms an important basis for a larger, multicenter study to ensure the neck is given due attention in rugby training and receives the same focus of conditioning as other parts of the body.

  5. Randomized controlled pilot study: pain intensity and pressure pain thresholds in patients with neck and low back pain before and after traditional East Asian "gua sha" therapy.

    Science.gov (United States)

    Lauche, Romy; Wübbeling, Klaus; Lüdtke, Rainer; Cramer, Holger; Choi, Kyung-Eun; Rampp, Thomas; Michalsen, Andreas; Langhorst, Jost; Dobos, Gustav J

    2012-01-01

    Gua Sha is a traditional East Asian healing technique where the body surface is "press-stroked" with a smooth-edged instrument to raise therapeutic petechiae that last 2-5 days. The technique is traditionally used in the treatment of both acute and chronic neck and back pain. This study aimed to measure the effects of Gua Sha therapy on the pain ratings and pressure pain thresholds of patients with chronic neck pain (CNP) and chronic low back pain (CLBP). A total of 40 patients with either CNP or CLBP (mean age 49.23 ± 10.96 years) were randomized to either a treatment group (TG) or a waiting list control group (WLC). At baseline assessment (T1), all patients rated their pain on a 10 cm visual analog scale (VAS). Patients' pressure pain thresholds (PPT) at a site of maximal pain (pain-maximum) and an adjacent (pain-adjacent) site were also established. The treatment group then received a single Gua Sha treatment. Post-intervention measurements were taken for both groups at T2, seven days after baseline assessment (T1), using the same VAS and PPT measurements in precisely the same locations as at T1. Final analysis were conducted with 21 patients with CNP and 18 patients with CLBP. The study groups were equally distributed with regard to randomization. Patients in both the CNP and the CLBP treatment groups reported pain reduction (p treatment, as compared to the waiting list group. Pain sensitivity improved in the TG in CNP, but not in CLBP patients, possibly due to higher pressure sensitivity in the neck area. No adverse events were reported. These results suggest that Gua Sha may be an effective treatment for patients with chronic neck and low back pain. Further study of Gua Sha is warranted.

  6. Effect of Helicobacter pylori eradication on insulin resistance among prediabetic patients: A pilot study and single-blind randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Ali Kachuei

    2016-01-01

    Full Text Available Background: Type II diabetes mellitus (T2DM is the prevalent type of diabetes in the world. Prediabetic patients are the most probable group to get diabetes. Several studies have mentioned the role of inflammation in the incidence of diabetes. The origin of inflammation can be infection such as Helicobacter pylori (HP infection. This study was designed to explore the effect of HP eradication on insulin resistance. Materials and Methods: This single-blind randomized controlled clinical trial was conducted in 2014-2015. The sample size consisted of 49 individuals who were in prediabetes stage with HP infection. Patients with positive stool antigen were allocated randomly into two groups. The treatment group took medication to eradicate HP infection by the routine method of four-drug eradication. However, placebo capsules and tablets were given to the patients in the placebo group. Then fasting plasma glucose (FPG, fasting plasma insulin (FPI, and quantitative C-reactive protein (CRP levels were measured and homeostatic model assessment of insulin resistance (HOMA-IR, homeostatic model assessment of beta-cell function (HOMA-B, Matsuda index, insulinogenic index, and disposition index were calculated. Results: Results of this study showed that FPI and HOMA-IR increased significantly (P value of FPI = 0.023 and P value of HOMA-IR = 0.019 after HP eradication in the treatment group. On the other hand, comparison of differences at the baseline and after 6 weeks in FPG (P value = 0.045, FPI (P value = 0.013, and HOMA-B (P value = 0.038 revealed significant differences between the placebo group and treatment group. Conclusion: Results showed that HP eradication by a 2-week antibiotic medication did not decrease insulin resistance and even increased FPI and insulin resistance indices. So HP eradication among prediabetic patients is not recommended for the decrease of insulin resistance and postponement of the development of diabetes mellitus.

  7. Effect of Helicobacter pylori eradication on insulin resistance among prediabetic patients: A pilot study and single-blind randomized controlled clinical trial

    Science.gov (United States)

    Kachuei, Ali; Amini, Masoud; Sebghatollahi, Vahid; Feizi, Awat; Hamedani, Pooria; Iraj, Bijan

    2016-01-01

    Background: Type II diabetes mellitus (T2DM) is the prevalent type of diabetes in the world. Prediabetic patients are the most probable group to get diabetes. Several studies have mentioned the role of inflammation in the incidence of diabetes. The origin of inflammation can be infection such as Helicobacter pylori (HP) infection. This study was designed to explore the effect of HP eradication on insulin resistance. Materials and Methods: This single-blind randomized controlled clinical trial was conducted in 2014-2015. The sample size consisted of 49 individuals who were in prediabetes stage with HP infection. Patients with positive stool antigen were allocated randomly into two groups. The treatment group took medication to eradicate HP infection by the routine method of four-drug eradication. However, placebo capsules and tablets were given to the patients in the placebo group. Then fasting plasma glucose (FPG), fasting plasma insulin (FPI), and quantitative C-reactive protein (CRP) levels were measured and homeostatic model assessment of insulin resistance (HOMA-IR), homeostatic model assessment of beta-cell function (HOMA-B), Matsuda index, insulinogenic index, and disposition index were calculated. Results: Results of this study showed that FPI and HOMA-IR increased significantly (P value of FPI = 0.023 and P value of HOMA-IR = 0.019) after HP eradication in the treatment group. On the other hand, comparison of differences at the baseline and after 6 weeks in FPG (P value = 0.045), FPI (P value = 0.013), and HOMA-B (P value = 0.038) revealed significant differences between the placebo group and treatment group. Conclusion: Results showed that HP eradication by a 2-week antibiotic medication did not decrease insulin resistance and even increased FPI and insulin resistance indices. So HP eradication among prediabetic patients is not recommended for the decrease of insulin resistance and postponement of the development of diabetes mellitus. PMID:27904554

  8. Effects of mobile phone-based app learning compared to computer-based web learning on nursing students: pilot randomized controlled trial.

    Science.gov (United States)

    Lee, Myung Kyung

    2015-04-01

    This study aimed to determine the effect of mobile-based discussion versus computer-based discussion on self-directed learning readiness, academic motivation, learner-interface interaction, and flow state. This randomized controlled trial was conducted at one university. Eighty-six nursing students who were able to use a computer, had home Internet access, and used a mobile phone were recruited. Participants were randomly assigned to either the mobile phone app-based discussion group (n = 45) or a computer web-based discussion group (n = 41). The effect was measured at before and after an online discussion via self-reported surveys that addressed academic motivation, self-directed learning readiness, time distortion, learner-learner interaction, learner-interface interaction, and flow state. The change in extrinsic motivation on identified regulation in the academic motivation (p = 0.011) as well as independence and ability to use basic study (p = 0.047) and positive orientation to the future in self-directed learning readiness (p = 0.021) from pre-intervention to post-intervention was significantly more positive in the mobile phone app-based group compared to the computer web-based discussion group. Interaction between learner and interface (p = 0.002), having clear goals (p = 0.012), and giving and receiving unambiguous feedback (p = 0.049) in flow state was significantly higher in the mobile phone app-based discussion group than it was in the computer web-based discussion group at post-test. The mobile phone might offer more valuable learning opportunities for discussion teaching and learning methods in terms of self-directed learning readiness, academic motivation, learner-interface interaction, and the flow state of the learning process compared to the computer.

  9. A Pilot Randomized Controlled Trial of the Effects of Chair Yoga on Pain and Physical Function Among Community-Dwelling Older Adults With Lower Extremity Osteoarthritis.

    Science.gov (United States)

    Park, Juyoung; McCaffrey, Ruth; Newman, David; Liehr, Patricia; Ouslander, Joseph G

    2017-03-01

    To determine effects of Sit 'N' Fit Chair Yoga, compared to a Health Education program (HEP), on pain and physical function in older adults with lower extremity osteoarthritis (OA) who could not participate in standing exercise. Two-arm randomized controlled trial. One HUD senior housing facility and one day senior center in south Florida. Community-dwelling older adults (N = 131) were randomly assigned to chair yoga (n = 66) or HEP (n = 65). Thirteen dropped after assignment but prior to the intervention; six dropped during the intervention; 106 of 112 completed at least 12 of 16 sessions (95% retention rate). Participants attended either chair yoga or HEP. Both interventions consisted of twice-weekly 45-minute sessions for 8 weeks. Primary: pain, pain interference; secondary: balance, gait speed, fatigue, functional ability measured at baseline, after 4 weeks of intervention, at the end of the 8-week intervention, and post-intervention (1 and 3 months). The chair yoga group showed greater reduction in pain interference during the intervention (P = .01), sustained through 3 months (P = .022). WOMAC pain (P = .048), gait speed (P = .024), and fatigue (P = .037) were improved in the yoga group during the intervention (P = .048) but improvements were not sustained post intervention. Chair yoga had no effect on balance. An 8-week chair yoga program was associated with reduction in pain, pain interference, and fatigue, and improvement in gait speed, but only the effects on pain interference were sustained 3 months post intervention. Chair yoga should be further explored as a nonpharmacologic intervention for older people with OA in the lower extremities. ClinicalTrials.gov: NCT02113410. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  10. Reparative therapy for acute ischemic stroke with allogeneic mesenchymal stem cells from adipose tissue: a safety assessment: a phase II randomized, double-blind, placebo-controlled, single-center, pilot clinical trial.

    Science.gov (United States)

    Díez-Tejedor, Exuperio; Gutiérrez-Fernández, María; Martínez-Sánchez, Patricia; Rodríguez-Frutos, Berta; Ruiz-Ares, Gerardo; Lara, Manuel Lara; Gimeno, Blanca Fuentes

    2014-01-01

    Few studies have evaluated the possible beneficial effect of the administration of stem cells in the early stages of stroke. Intravenous administration of allogeneic mesenchymal stem cells (MSCs) from adipose tissue in patients with acute stroke could be a safe therapy for promoting neurovascular unit repair, consequently supporting better functional recovery. We aim to assess the safety and efficacy of MSC administration and evaluate its potential as a treatment for cerebral protection and repair. A Phase IIa, prospective, randomized, double-blind, placebo-controlled, single-center, pilot clinical trial. Twenty patients presenting acute ischemic stroke will be randomized in a 1:1 proportion to treatment with allogeneic MSCs from adipose tissue or to placebo (or vehicle) administered as a single intravenous dose within the first 2 weeks after the onset of stroke symptoms. The patients will be followed up for 2 years. Primary outcomes for safety analysis: adverse events (AEs) and serious AEs; neurologic and systemic complications, and tumor development. Secondary outcomes for efficacy analysis: modified Rankin Scale; NIHSS; infarct size; and biochemical markers of brain repair (vascular endothelial growth factor, brain-derived neurotrophic factor, and matrix metalloproteinases 9). To our knowledge, this is the first, phase II, pilot clinical trial to investigate the safety and efficacy of intravenous administration of allogeneic MSCs from adipose tissue within the first 2 weeks of stroke. In addition, its results will help us define the best criteria for a future phase III study. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  11. Does myofascial and trigger point treatment reduce pain and analgesic intake in patients undergoing OnabotulinumtoxinA injection due to chronic intractable migraine? A pilot, single-blind randomized controlled trial.

    Science.gov (United States)

    Gandolfi, Marialuisa; Geroin, Christian; Valè, Nicola; Marchioretto, Fabio; Turrina, Andrea; Dimitrova, Eleonora; Tamburin, Stefano; Serina, Anna; Castellazzi, Paola; Meschieri, Andrea; Ricard, François; Saltuari, Leopold; Picelli, Alessandro; Smania, Nicola

    2017-07-27

    Chronic migraine is a disabling disorder associated with myofascial and trigger point disorders in the neck. Pharmacological management is the first line of treatment; however, rehabilitation procedures aimed at lessening symptoms of myofascial and trigger point disorders may add value in the management of headache symptoms. To evaluate the feasibility of myofascial and trigger point treatment in chronic migraine patients receiving prophylactic treatment with onabotulinumtoxinA. To evaluate the treatment effects on headache frequency and intensity, analgesic consumption, cervical range of motion, trigger point pressure pain threshold, quality of life, and disability. Pilot, single-blind randomized controlled trial with two parallel groups. Neurorehabilitation unit. 22 outpatients with chronic migraine. Patients were randomly assigned to receive either cervicothoracic manipulative treatment (n=12) or transcutaneous electrical nerve stimulation (TENS) in the upper trapezius (n=10). Treatment consisted of 4 sessions (30 min/session, 1 session/week for 4 weeks). A rater blinded to treatment allocation evaluated outcomes before treatment, during treatment, and 1 month after the end of treatment. Consistent with the pilot nature of the study, feasibility was considered the primary outcome and efficacy the secondary outcome. All patients completed the study. No adverse events were reported. No significant between-group differences in pain intensity were observed during the study period. At post-treatment evaluation, the total consumption of analgesics (p=.02) and non-steroidal anti-inflammatory (p=.02) drugs was significantly lower in the manipulative treatment group than in the TENS group. These effects paralleled significant improvements in trigger point sensitivity and cervical active range of motion. Manipulative techniques aimed at reducing peripheral nociceptive triggers might add value in the management of chronic migraine symptoms and lower acute medication use

  12. Improved sleep quality in older adults with insomnia reduces biomarkers of disease risk: pilot results from a randomized controlled comparative efficacy trial.

    Science.gov (United States)

    Carroll, Judith E; Seeman, Teresa E; Olmstead, Richard; Melendez, Gerson; Sadakane, Ryan; Bootzin, Richard; Nicassio, Perry; Irwin, Michael R

    2015-05-01

    Sleep disturbances have been linked to increased morbidity and mortality, yet it is unknown whether improving sleep quality in older adult patients with insomnia alters biomarkers of diabetes and cardiovascular disease risk. Determine the comparative efficacy of cognitive behavioral therapy (CBT), tai chi chih (TCC), and a sleep seminar control (SS) to reduce multisystem biomarkers of disease risk in older adults with insomnia. Randomized controlled comparative efficacy trial. Los Angeles community. A population-based sample of 109 older adults with chronic and primary insomnia. Random assignment to CBT, TCC, or SS for 2-h group sessions weekly over 4 months with a 16-month evaluation (1 year after follow-up). Multisystem biological risk comprised of 8 biomarkers: high-density lipoprotein, low-density lipoprotein, triglycerides, hemoglobinA1c, glucose, insulin, C-reactive protein, and fibrinogen. Using clinical laboratory cutoffs defined as abnormal, a multisystem risk score was computed representing a sum of the deviation around the cutoffs across the 8 biomarkers. In addition, high risk grouping was classified if subjects exhibited 4 or more biomarkers in the abnormal laboratory range. An interaction of time-by-treatment-by-high risk group was found (F(4, 197.2)=3.14, p=.02) in which both TCC (p=.04) and CBT (p=.001) showed significantly lower risk scores as compared to SS at 16-months. CBT reduced risk of being in the high risk group at 4-months (odds ratio [OR]=.21 [95% CI, .03-1.47], psleep quality, as defined by a clinical severity threshold, reduced the likelihood of being in the high risk group at 16-months, OR=.08 (95% CI, .008-.78); p=.01. Participants classified as having high multisystem biological risk at entry and assigned to CBT or TCC show improvements in risk scores after one year follow-up. Given that these clinical biomarkers are associated with cardiovascular, metabolic, and inflammatory disease risk, improving sleep quality has the potential to

  13. The Effect of Bee Venom Acupuncture(BVA on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study

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    Song, Ho-Seub

    2005-06-01

    Full Text Available Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC participated in the study, who were divided into two groups (A and B randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41 of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo or BVA was done and then acupuncture at 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41, 足三里(ST36, 陽陵泉(G34 of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS and Visual Analogue Scale(VAS were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective

  14. Effect of a single dose of lidocaine and ketamine on intraoperative opioids requirements in patients undergoing elective gynecological laparotomies under general anesthesia. A randomized, placebo controlled pilot study

    Directory of Open Access Journals (Sweden)

    Jusset Teresa García-Navia

    2016-01-01

    Full Text Available Background and goal of study: there is evidence that perioperative intravenous ketamine and lidocaine reduce postoperative pain, postoperative opioids consumption, shortens hospital stay and accelerates intestinal function recovery. However, it has not been studied the beneficial effects in the intraoperative period. The aim of this study was to evaluate the effect of a single dose of lidocaine and ketamine on intraoperative opioids requirements in patients undergoing elective gynecological laparotomies under general anesthesia. Materials and methods: we performed a single-centre, prospective, randomized, double-blinded, placebo-controlled study. We included 33 patients (11 in the ketamine group, 11 in the lidocaine group and 11 in the placebo group. Postoperative analgesia was accomplished by patient-controlled morphine. Patients were randomly assigned to receive either a 1.5 mg/kg of 2% lidocaine, 0.5 mg/kg of 5% ketamine or 0.9% saline bolus. The primary outcome was the opioids consumption during surgery. The secondary outcomes included: emergence time, pain scores, opioids consumption within 24 h after surgery and side effects. Results: decreased intraoperative opioids requirements were noted in the experimental groups (ketamine: 402.3 } 106.3 and lidocaine: 397.7 } 107.5, compared with saline: 561.4 } 97.1; p = 0.001. We found a positive correlation between intraoperative opioids consumption and emergence time (r = 0.864, p < 0.001. There was no significant difference between the groups in VAS pain scores at rest within the first 24 postoperative hours. Total morphine consumption within 24 h after surgery did not differ significantly among the groups (placebo: 27.54 } 11.75; ketamine: 30.95 } 7.88; lidocaine 34.77 } 10.25; p = 0.26. Postoperative nausea and vomiting were more common in placebo group (it was observed in 3 subjects in ketamine group, in 5 subjects in lidocaine group and in 9 subjects in placebo group; p = 0

  15. Testing the feasibility of a knowledge translation intervention designed to improve chiropractic care for adults with neck pain disorders: study protocol for a pilot cluster-randomized controlled trial.

    Science.gov (United States)

    Dhopte, Prakash; Ahmed, Sara; Mayo, Nancy; French, Simon; Quon, Jeffrey A; Bussières, André

    2016-01-01

    Neck pain in adults is common and a leading cause of physical disability. Recently, a guideline was developed for the management of non-specific neck pain (NSNP) with an aim to improve the quality of the delivery of chiropractic care. One key guideline recommendation is to undertake multimodal care for patients with NSNP. The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP. The design is a cluster-randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be approached to participate in the study. Thirty consenting chiropractors will be randomized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group. Each chiropractor will recruit five neck pain patients (a total of 150 patients) into the study. Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning, and a printed copy of the practice guideline. Primary feasibility outcomes for both chiropractors and patients include rates of (1) recruitment, (2) retention, and (3) adherence to the intervention. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations (e.g. exercise and self-care prescriptions) at study onset and at 3 months. Secondary outcomes include scores of behavioural constructs (level of knowledge and self-efficacy) for recommended multimodal care. Clinical outcomes include pain intensity and neck pain-specific disability. Analyses from this study will focus on generating point estimates and corresponding 95

  16. A double blind placebo controlled randomized trial of the effect of acute uric acid changes on inflammatory markers in humans: A pilot study.

    Science.gov (United States)

    Tanaka, Toshiko; Milaneschi, Yuri; Zhang, Yongqing; Becker, Kevin G; Zukley, Linda; Ferrucci, Luigi

    2017-01-01

    Uric acid has been linked with increased risk of chronic disease such as cardiovascular disease and this association has been attributed to a pro-inflammatory effect. Indeed, observational studies have shown that high uric acid is associated with high level of pro-inflammatory cytokines in the blood. However, whether high uric acid directly affects inflammation or rather represents a parallel defensive antioxidant mechanism in response to pathology that causes inflammation is unknown. To determine whether acute increase or decrease uric acid levels affects inflammation in healthy individuals, a randomized, placebo-controlled, double blind clinical study of uric acid or rasburicase with 20 healthy volunteers in each treatment-placebo group was conducted at the National Institute on Aging (NIA) Clinical Research Unit (CRU) at Harbor Hospital in Baltimore, MD. Change in inflammatory response was assessed by administering an oral lipid tolerance before and after the treatment of uric acid, rasburicase and placebo. Following uric acid administration, there was an accentuated increase in IL-6 during the oral lipid tolerance test (Puric acid with rasburicase. No side effects were reported throughout the trial. In health individuals, acute increase in uric acid results in an increased IL-6 response when challenged with lipid load. Such effect of amplification of inflammatory response may explain the higher risk of chronic diseases observed in subclinical hyperuricemia in observational studies. ClinicalTrials.gov NCT01323335.

  17. Canoe game-based virtual reality training to improve trunk postural stability, balance, and upper limb motor function in subacute stroke patients: a randomized controlled pilot study.

    Science.gov (United States)

    Lee, Myung-Mo; Shin, Doo-Chul; Song, Chang-Ho

    2016-07-01

    [Purpose] This study was aimed at investigating the preliminary therapeutic efficacy and usefulness of canoe game-based virtual reality training for stroke patients. [Subjects and Methods] Ten stroke patients were randomly assigned to an experimental group (EG; n=5) or a control group (CG; n=5). Patients in both groups participated in a conventional rehabilitation program, but those in the EG additionally participated in a 30-min canoe game-based virtual reality training program 3 days a week for 4 weeks. Therapeutic efficacy was assessed based on trunk postural stability, balance, and upper limb motor function. In addition, the usefulness of canoe game-based virtual reality training was assessed in the EG and therapist group (TG; n=20), which consisted of physical and occupational therapists, by using the System Usability Scale (SUS). [Results] Improvements in trunk postural stability, balance, and upper limb motor function were observed in the EG and CG, but were greater in the EG. The mean SUS scores in the EG and TG were 71 ± 5.2 and 74.2 ± 4.8, respectively. [Conclusion] Canoe game-based virtual reality training is an acceptable and effective intervention for improving trunk postural stability, balance, and upper limb motor function in stroke patients.

  18. A randomized controlled pilot study comparing aqueous cream with a beeswax and herbal oil cream in the provision of relief from postburn pruritus.

    Science.gov (United States)

    Lewis, Peter A; Wright, Kay; Webster, Anne; Steer, Matthew; Rudd, Michael; Doubrovsky, Anna; Gardner, Glenn

    2012-01-01

    Postburn itch is reported to affect up to 87% of the burn population. Although treatments for postburn itch are multimodal, they remain consistently ineffective. However, recent anecdotal evidence from several outpatients at a tertiary referral hospital suggests that a cream combining beeswax and several herbal oils may be effective in the minimization of postburn itch. The aim of this study was to test the efficacy of beeswax and herbal oil cream against the standard treatment of aqueous cream in the provision of relief from the symptoms of postburn itch. A randomized controlled trial compared two groups using a visual analog scale, frequency of cream application, itch recurrence after cream application, use of antipruritic medications, and sleep disturbance to determine the effect of itch severity and duration. Fifty-two participants were enrolled in the study (84% male) with a mean age of 35 years (SD = 16) and mean burn TBSA of 7.2% (SD = 7.7). Study results found that the beeswax and herbal oil cream reduce itch after application more frequently than aqueous cream (P = .001). In addition, when managed with beeswax and herbal oil cream, participants found that their itch recurred later (P ≤ .001) and their use of antipruritic medications was lower (P = .023). Findings of this study suggest beeswax and herbal oil cream to be more effective in the minimization of postburn itch than aqueous cream. Given this, a larger study examining the efficacy of beeswax and herbal oil cream appears warranted.

  19. Effects of mirror therapy integrated with task-oriented exercise on the balance function of patients with poststroke hemiparesis: a randomized-controlled pilot trial.

    Science.gov (United States)

    Cha, Hyun-Gyu; Oh, Duck-Won

    2016-03-01

    This study aimed to explore the effects of mirror therapy integrated with task-oriented exercise on balance function in poststroke hemiparesis. Twenty patients with poststroke hemiparesis were assigned randomly to an experimental group (EG) and a control group (CG), with 10 individuals each. Participants of the EG and CG received a task-oriented exercise program with a focus on the strengthening of the lower limb and the practice of balance-related functional tasks. An additional option for the EG was front and side wall mirrors to provide visual feedback for their own movements while performing the exercise. The program was performed for 30 min, twice a day, five times per week for 4 weeks. Outcome measures included the Berg balance scale, the timed up-and-go test, and quantitative data (balance index and dynamic limits of stability). In the EG and CG, all variables showed significant differences between pretest and post-test (Pmirror therapy may be used as a beneficial therapeutic option to facilitate the effects of a task-oriented exercise on balance function of patients with poststroke hemiparesis.

  20. Feasibility and effectiveness of adding object-related bilateral symmetrical training to mirror therapy in chronic stroke: A randomized controlled pilot study.

    Science.gov (United States)

    Rodrigues, Letícia Cardoso; Farias, Nayara Correa; Gomes, Raquel Pinheiro; Michaelsen, Stella Maris

    2016-01-01

    To evaluate the feasibility and effectiveness of adding object-related bilateral symmetrical training to mirror therapy (MT) to improve upper limb (UL) activity in chronic stroke patients. Sixteen patients with moderate UL impairment were randomly allocated to either the experimental (EG) or control (CG) group. Both groups performed 1 hour sessions, 3 days/week for 4 weeks, involving object-related bilateral symmetrical training. EG performed the tasks observing their nonparetic UL reflected in the mirror, while CG observed the paretic UL directly. The primary outcome measure was unilateral and bilateral UL activity according to the Test d'Évaluation des Membres Supérieurs de Personnes Âgées (TEMPA). All measurements were taken at baseline, post-training, and follow-up (2 weeks). TEMPA total score showed the main effect of time. Significant improvement was found for bilateral but not unilateral tasks. Both groups showed gains after training, with no differences between them. This study showed the feasibility of adding object-related bilateral training to MT. Both types of training improved UL bilateral activity; however, a larger sample is required for a definitive study. Other studies need to be carried out to evaluate the effectiveness of combining more distal-oriented movements and object-related unilateral training to improve these effects in chronic stroke patients.

  1. Pilot study of aprepitant for prevention of post-ERCP pancreatitis in high risk patients: a phase II randomized, double-blind placebo controlled trial

    Science.gov (United States)

    Shah, Tilak; Liddle, Rodger A.; Branch, M. Stanley; Jowell, Paul; Obando, Jorge; Poleski, Martin H.

    2013-01-01

    Objectives Animal studies have demonstrated a role for substance P binding to neurokinin-1 receptor in the pathogenesis of acute pancreatitis. Our aim was to assess the efficacy of a neurokinin-1 receptor antagonist (aprepitant) at preventing post-ERCP pancreatitis in high risk patients. Methods Randomized, double-blind, placebo controlled trial at a single academic medical center. Patients at high risk for post-ERCP pancreatitis received either placebo or oral aprepitant administered 4 hours prior to ERCP, 80 mg 24 hours after the first dose, and then 80 mg 24 hours after the second dose. Fisher's exact test was used to compare incidence of post-ERCP pancreatitis in the two groups. Results 34 patients received aprepitant and 39 patients received placebo. Baseline characteristics were similar between the two groups. Incidence of acute pancreatitis was 7 in the aprepitant group and 7 in the placebo group. Hospitalization within 7 days post-procedure for abdominal pain that did not meet criteria for acute pancreatitis occurred in 6 and 9 patients in the aprepitant and placebo groups respectively (p=0.77). Conclusions Aprepitant did not lower incidence of post-ERCP pancreatitis in this preliminary human study. Larger studies potentially using the recently available intravenous formulation are necessary to conclusively clarify the efficacy of aprepitant in this setting. PMID:22964958

  2. A 3-Month Randomized Controlled Pilot Trial of a Patient-Centered, Computer-Based Self-Monitoring System for the Care of Type 2 Diabetes Mellitus and Hypertension.

    Science.gov (United States)

    Or, Calvin; Tao, Da

    2016-04-01

    This study was performed to evaluate the effects of a patient-centered, tablet computer-based self-monitoring system for chronic disease care. A 3-month randomized controlled pilot trial was conducted to compare the use of a computer-based self-monitoring system in disease self-care (intervention group; n = 33) with a conventional self-monitoring method (control group; n = 30) in patients with type 2 diabetes mellitus and/or hypertension. The system was equipped with a 2-in-1 blood glucose and blood pressure monitor, a reminder feature, and video-based educational materials for the care of the two chronic diseases. The control patients were given only the 2-in-1 monitor for self-monitoring. The outcomes reported here included the glycated hemoglobin (HbA1c) level, fasting blood glucose level, systolic blood pressure, diastolic blood pressure, chronic disease knowledge, and frequency of self-monitoring. The data were collected at baseline and at 1-, 2-, and 3-month follow-up visits. The patients in the intervention group had a significant decrease in mean systolic blood pressure from baseline to 1 month (p diabetes control. The beneficial effects of the use of electronic self-care resources and support provided via mobile technologies require further confirmation in longer-term, larger trials.

  3. Effectiveness of a tailored neck training program on neck strength, movement, and fatigue in under-19 male rugby players: a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Barrett MD

    2015-05-01

    Full Text Available Matthew D Barrett,1 Terence F McLoughlin,2 Kieran R Gallagher,1 Don Gatherer,3 Michael TR Parratt,1 Jonathan R Perera,1 Tim WR Briggs1 1Royal National Orthopaedic Hospital, Stanmore, Middlesex, United Kingdom; 2Royal Liverpool University Hospital, Liverpool, Mersey Deanery, United Kingdom; 3The Gatherer Partnership, Aylesbury, United Kingdom Purpose: To investigate the effect of a tailored neck muscle conditioning program on neck muscle strength, neck muscle fatigue, and range of neck movement in 16–18-year-old male rugby players. Materials and methods: Thirty-four male rugby players were divided into forward and back playing positions and randomized within these groups. Seventeen players were randomly assigned to each group. The test group was given a tailored 6-week exercise regime based on their baseline measurements to be performed three times a week in addition to their normal training and playing. The control group trained and played as normal. The outcome measures used were cervical spine range of movement, neck strength, and neck muscle fatigability. Results: There were no clinically relevant statistically significant differences between the two groups. Trends identified between the two groups suggest that a tailored neck exercise program increases neck strength, particularly neck extension, and increases resistance to fatigue, as well as influencing right- and left-sided neck muscle balance. A reduction in range of movement was also demonstrated in the test group. There was a great deal of variability in range of movement and strength within this age group. No previously undiagnosed neck conditions were detected, and there were no adverse events reported. Conclusion: This study has shown that neck strength, range of movement, and susceptibility of the neck muscles to fatigue can be influenced using a focused neck training regime. It forms an important basis for a larger, multicenter study to ensure the neck is given due attention in

  4. Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study

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    Hossein Pakdaman

    2017-05-01

    Full Text Available Background and Aim: Mild cognitive impairment (MCI is characterized by declined cognitive function greater than that expected for a person’s age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients. Methods: Seventy-two patients with a diagnosis of MCI were recruited. The included participants were randomly assigned to groups to receive either MLC601 or placebo. An evaluation of global cognitive function was performed at baseline as well as at 3-month and 6-month follow-up visits. Global cognitive function was assessed by Mini-Mental State Examination (MMSE and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog scores. Efficacy was evaluated by comparing global function scores between the 2 groups during the study period. Safety assessment included adverse events (AEs and abnormal laboratory results. Results: Seventy patients completed the study, 34 in the MLC601 group and 36 in the placebo group. The mean changes (±SD in cognition scores over 6 months in the MLC601 group were –2.26 (±3.42 for the MMSE and 3.82 (±6.16 for the ADAS-cog; in the placebo group, they were –2.66 (±3.43 for the MMSE and 4.41 (±6.66 for the ADAS-cog. The cognition changes based on both MMSE and ADAS-cog scores were statistically significant between the placebo and the MLC601 group (p < 0.001. Only 5 patients (14.7% reported minor AEs in the MLC601 group, the most commonly reported of which were gastrointestinal, none of them leading to patient withdrawal. Conclusion: MLC601 has shown promising efficacy and acceptable AEs in MCI patients.

  5. Pilot Preferences on Displayed Aircraft Control Variables

    Science.gov (United States)

    Trujillo, Anna C.; Gregory, Irene M.

    2013-01-01

    The experiments described here explored how pilots want available maneuver authority information transmitted and how this information affects pilots before and after an aircraft failure. The aircraft dynamic variables relative to flight performance were narrowed to energy management variables. A survey was conducted to determine what these variables should be. Survey results indicated that bank angle, vertical velocity, and airspeed were the preferred variables. Based on this, two displays were designed to inform the pilot of available maneuver envelope expressed as bank angle, vertical velocity, and airspeed. These displays were used in an experiment involving control surface failures. Results indicate the displayed limitations in bank angle, vertical velocity, and airspeed were helpful to the pilots during aircraft surface failures. However, the additional information did lead to a slight increase in workload, a small decrease in perceived aircraft flying qualities, and no effect on aircraft situation awareness.

  6. Olive Oil, Sunflower Oil or no Oil for Baby Dry Skin or Massage: A Pilot, Assessor-blinded, Randomized Controlled Trial (the Oil in Baby SkincaRE [OBSeRvE] Study).

    Science.gov (United States)

    Cooke, Alison; Cork, Michael J; Victor, Suresh; Campbell, Malcolm; Danby, Simon; Chittock, John; Lavender, Tina

    2016-03-01

    Topical oils on baby skin may contribute to development of childhood atopic eczema. A pilot, assessor-blinded, randomized controlled trial assessed feasibility of a definitive trial investigating their impact in neonates. One-hundred and fifteen healthy, full-term neonates were randomly assigned to olive oil, sunflower oil or no oil, twice daily for 4 weeks, stratified by family history of atopic eczema. We measured spectral profile of lipid lamellae, trans-epidermal water loss (TEWL), stratum corneum hydration and pH and recorded clinical observations, at baseline, and 4 weeks post-birth. Recruitment was challenging (recruitment 11.1%; retention 80%), protocol adherence reasonable (79-100%). Both oil groups had significantly improved hydration but significantly less improvement in lipid lamellae structure compared to the no oil group. There were no significant differences in TEWL, pH or erythema/skin scores. The study was not powered for clinical significance, but until further research is conducted, caution should be exercised when recommending oils for neonatal skin.

  7. Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study.

    Science.gov (United States)

    Wright, Alexis A; Donaldson, Megan; Wassinger, Craig A; Emerson-Kavchak, Alicia J

    2017-09-01

    To determine the subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder non-thrust plus exercise in patients with subacromial pathology. This was a randomized, single blinded controlled trial pilot study. This trial was registered at ClinicalTrials.gov (NCT01753271) and reported according to Consolidated Standards of Reporting Trials requirements. Patients were randomly assigned to either shoulder treatment plus cervicothoracic spinal thrust/non-thrust or shoulder treatment-only group. Primary outcomes were average pain intensity (Numeric Pain Rating Scale) and physical function (Shoulder Pain and Disability Index) at 2 weeks, 4 weeks, and patient discharge. 18 patients, mean age 43.1(15.8) years satisfied the eligibility criteria and were analyzed for follow-up data. Both groups showed statistically significant improvements in both pain and function at 2 weeks, 4 weeks, and discharge. The between-group differences for changes in pain or physical function were not significant at any time point. The addition of cervicothoracic spinal thrust/non-thrust to the shoulder treatment-only group did not significantly alter improvement in pain or function in patients with subacromial pathology. Both approaches appeared to provide an equally notable benefit. Both groups improved on all outcomes and met the criteria for clinical relevance for both pain and function. 2b.

  8. Pilot control through the TAFCOS automatic flight control system

    Science.gov (United States)

    Wehrend, W. R., Jr.

    1979-01-01

    The set of flight control logic used in a recently completed flight test program to evaluate the total automatic flight control system (TAFCOS) with the controller operating in a fully automatic mode, was used to perform an unmanned simulation on an IBM 360 computer in which the TAFCOS concept was extended to provide a multilevel pilot interface. A pilot TAFCOS interface for direct pilot control by use of a velocity-control-wheel-steering mode was defined as well as a means for calling up conventional autopilot modes. It is concluded that the TAFCOS structure is easily adaptable to the addition of a pilot control through a stick-wheel-throttle control similar to conventional airplane controls. Conventional autopilot modes, such as airspeed-hold, altitude-hold, heading-hold, and flight path angle-hold, can also be included.

  9. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial

    Science.gov (United States)

    Henderson, John C.; Neradilek, Moni B.; Moyer, Nicolas A.; Ashcraft, Kristine C.; Thirumaran, Ranjit K.

    2017-01-01

    Background In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST) on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED) visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients. Methods and findings This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110) were randomized to pharmacogenetic profiling (n = 57). The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53) received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR), 0.65; 95% confidence interval (CI), 0.32–1.28; P = 0.21) and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27–0.82; P = 0.007). The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31–1.21; P = 0.16) and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34–0.99; P = 0.045). Differences in composite outcomes at

  10. A pilot randomized controlled trial of a post-discharge program to support emerging adults with type 1 diabetes mellitus transition from pediatric to adult care.

    Science.gov (United States)

    Steinbeck, Katharine S; Shrewsbury, Vanessa A; Harvey, Vanessa; Mikler, Kara; Donaghue, Kim C; Craig, Maria E; Woodhead, Helen J

    2015-12-01

    There is a paucity of randomized controlled trials (RCT) examining transition from pediatric to adult care in type 1 diabetes mellitus (T1DM). This study aimed to determine if transition in T1DM is more effective with a comprehensive transition program (CTP) compared with standard clinical practice (SCP). This RCT recruited as young people left pediatric diabetes services. The trial co-ordinator provided CTP participants with standardized telephone communication support at week 1, and 3, 6, and 12 months post-discharge from pediatric care. SCP participants were briefly contacted at 6 and 12 months post-discharge to confirm transfer status; they received no other post-discharge contact as per usual practice. At 12 months, the primary outcomes were engagement and retention in the adult service and secondary outcomes included hemoglobin A1c (HbA1c), diabetes-related hospitalizations, microvascular complication appearance, and global self-worth. Most CTP participants (11/14) and all SCP (12/12) participants (P = 0.2) transferred to an adult diabetes service; the median time to transfer was 14-15 wk. Overall, participants' frequency of adult diabetes service visits was sub-optimal but their retention in adult care was high. The only group difference was a higher HbA1c at baseline and follow-up in the CTP group. However, a general linear model found that follow-up HbA1c increased by 1.2% for each percentage increase in baseline HbA1c [95% confidence interval (0.4, 1.9; P = 0.01)], independent of treatment group. Despite the challenges in recruiting adequate numbers, these findings provide valuable insights for future T1DM transition RCTs that are needed to build a more solid evidence-base in this field. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  11. Comparison of the Effect of Lateral and Backward Walking Training on Walking Function in Patients with Poststroke Hemiplegia: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Kim, Chang-Yong; Lee, Jung-Sun; Kim, Hyeong-Dong

    2017-02-01

    The purposes of the present study were to compare the effects of backward and lateral walking training and to identify whether additional backward or lateral walking training would be more effective in increasing the walking function of poststroke patients. Fifty-one subjects with hemiplegic stroke were randomly allocated to 3 groups, each containing 17 subjects: the control group, the backward walking training group, and the lateral walking training group. The walking abilities of each group were assessed using a 10-m walk test and the GAITRite system for spatiotemporal gait. The results show that there were significantly greater posttest increases in gait velocity (F = -12.09, P = 0.02) and stride length (F = -11.50, P = 0.02), decreases in the values of the 10-m walk test (F = -7.10, P = 0.03) (P training group compared with those in the other 2 groups. These findings demonstrate that asymmetric gait patterns in poststroke patients could be improved by receiving additional lateral walking training therapy rather than backward walking training. Complete the self-assessment activity and evaluation online at http://www.physiatry.org/JournalCME CME OBJECTIVES: Upon completion of this article, the reader should be able to: (1) understand the potential benefits of backward walking (BW) and lateral walking (LW) training on improving muscle strength and gait; (2) appreciate the potential value of backward and lateral walking gait training in the treatment of hemiplegic stroke patients; and (3) appropriately incorporate backward and lateral walking gait training into the treatment plan of hemiplegic stroke patients. Advanced ACCREDITATION: The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.The Association of Academic Physiatrists designates this activity for a maximum of 1.5 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit

  12. Can temporal repetitive transcranial magnetic stimulation be enhanced by targeting affective components of tinnitus with frontal rTMS? a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Peter Michael Kreuzer

    2011-11-01

    Full Text Available Objectives: Low-frequency repetitive transcranial magnetic stimulation (rTMS of the temporal cortex has been investigated as a new treatment tool for chronic tinnitus during the last years and has shown moderate efficacy. However, there is growing evidence that tinnitus is not a pathology of a specific brain region, but rather the result of network dysfunction involving both auditory and non-auditory brain regions. In functional imaging studies the right dorsolateral prefrontal cortex has been identified as an important hub in tinnitus related networks and has been shown to particularly reflect the affective components of tinnitus. Based on these findings we aimed to investigate whether the effects of left low frequency rTMS can be enhanced by antecedent right prefrontal low-frequency rTMS. Study Design: Fifty-six patients were randomized to receive either low-frequency left temporal rTMS or a combination of low-frequency right prefrontal followed by low-frequency left temporal rTMS. The change of the tinnitus questionnaire (TQ score was the primary outcome, secondary outcome parameters included the Tinnitus Handicap Inventory, numeric rating scales and the Beck Depression Inventory. The study is registered in clinicaltrials.gov (NCT01261949.Results: Directly after therapy there was a significant improvement of the TQ-score in both groups. Comparison of both groups revealed a trend towards more pronounced effects for the combined group (effect size: Cohen’s d=0.176, but this effect did not reach significance. A persistent trend towards better efficacy was also observed in all other outcome criteria. Conclusion: Additional stimulation of the right prefrontal cortex seems to be a promising strategy for enhancing TMS effects over the temporal cortex. These results further support the involvement of the right DLPFC in the pathophysiology of tinnitus. The small effect size might be due to the study design comparing the protocol to an active control

  13. Novel TRPM8 agonist cooling compound against chronic itch: results from a randomized, double-blind, controlled, pilot study in dry skin.

    Science.gov (United States)

    Ständer, S; Augustin, M; Roggenkamp, D; Blome, C; Heitkemper, T; Worthmann, A C; Neufang, G

    2017-06-01

    Patients suffering from chronic pruritus (CP) due to dry skin with are often applying emollients containing menthol. However, topical menthol may be irritating and of weak potency in severe pruritus. Two TRPM8 agonists, (1R,2S,5R)-N-(2-(2-pyridinyl)ethyl)-2-ispropyl-5-methylcyclohexancarboxamide and menthoxypropanediol, combined as cooling compound (CC) have shown stronger activation of TRPM8 than menthol. Objective of this study was to evaluate the efficacy and safety of CC in alleviating pruritus in patients with dry itchy skin. In this vehicle-controlled, double-blind, randomized (1 : 1) study, 70 dry skin patients with pruritus intensity measured by Numerical Rating Scale (NRS) ≥3, were treated twice daily over 4 weeks, either with a lotion containing CC or with its vehicle. At treatment end, pruritus, assessed by a global score, improved significantly more in the CC than in the vehicle group (79.2% vs. 47.1%; P cooling effect. The health-related quality of life improved significantly more in the CC group (P = 0.023). Skin roughness, dryness and hydration improved significantly in both groups without significant differences in-between them. There were no severe adverse events reported. Treatment of dry and pruritic skin with a lotion containing the TRPM8 agonist combination ameliorates severe pruritus and represents a possible novel treatment for the burdensome symptom. The most suitable treatment concentration needs still to be identified. ClinicalTrials.gov: NCT00669708. © 2016 European Academy of Dermatology and Venereology.

  14. Synbiotic therapy decreases microbial translocation and inflammation and improves immunological status in HIV-infected patients: a double-blind randomized controlled pilot trial

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    González-Hernández Luz A

    2012-10-01

    Full Text Available Abstract Background HIV-infection results in damage and dysfunction of the gastrointestinal system. HIV enteropathy includes pronounced CD4+ T-cell loss, increased intestinal permeability, and microbial translocation that promotes systemic immune activation, which is implicated in disease progression. A synbiotic is the combination of probiotics and prebiotics that could improve gut barrier function. Our study goal was to determine whether the use of a synbiotic, probiotics or a prebiotic can recover immunological parameters in HIV-infected subjects through of a reduction of microbial translocation and pro-inflammatory cytokine production. Methods A randomized, double-blind controlled study was performed; twenty Antiretroviral treatment-naïve HIV-infected subjects were subgrouped and assigned to receive a synbiotic, probiotics, a prebiotic, or a placebo throughout 16 weeks. Results We had no reports of serious adverse-events. From baseline to week 16, the synbiotic group showed a reduction in bacterial DNA concentrations in plasma (p = 0.048. Moreover, the probiotic and synbiotic groups demonstrated a decrease in total bacterial load in feces (p = 0.05. The probiotic group exhibited a significant increment of beneficial bacteria load (such as Bifidobacterium; p = 0.05 and a decrease in harmful bacteria load (such as Clostridium; p = 0.063. In the synbiotic group, the CD4+ T-cells count increased (median: +102 cells/μL; p = 0.05 and the level of Interleukin 6 cytokine decreased significantly (p = 0.016. Conclusions Our study showed a significant increase in CD4+ T lymphocyte levels in the synbiotic group, which could delay the initiation of antiretroviral therapy and decrease costs in countries with limited resources.

  15. Clinical evaluation of XaraColl®, a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies

    Directory of Open Access Journals (Sweden)

    Cusack SL

    2012-06-01

    Full Text Available Susan L Cusack,1 Mark Jaros,2 Michael Kuss,3 Harold S Minkowitz,4 Peter Winkle,5 Lisa Hemsen61Cusack Pharmaceutical Consulting, Burlington, NJ, 2Summit Analytical, Denver, CO, USA; 3Premier Research Group, Austin, TX, USA; 4Memorial Hermann Memorial City Medical Center, Houston, TX, USA; 5Advanced Clinical Research Institute, Anaheim, CA, USA; 6Innocoll Technologies, Athlone, IrelandBackground: XaraColl®, a collagen-based implant that delivers bupivacaine to the site of surgical trauma, is under development for postoperative analgesia. Because of differing patient attitudes to postoperative pain control and the inability to assess baseline pain, standard clinical methods for evaluating analgesic efficacy are compromised and justify application of novel integrated approaches.Methods: We conducted two independent, multicenter, double-blind, placebo-controlled studies in men undergoing unilateral inguinal hernioplasty by open laparotomy to evaluate the safety and efficacy of XaraColl at different doses (100 mg and 200 mg of bupivacaine hydrochloride; study 1 and 2, respectively. Enrolled patients (50 in study 1 and 53 in study 2 were randomized to receive active or placebo implants in a 1:1 ratio. Postoperative pain intensity and use of supplementary opioid medication were recorded through 72 hours. Safety was assessed through 30 days. The principal efficacy variables were the summed pain intensity (SPI, total use of opioid analgesia (TOpA, and an integrated endpoint (I-SPI-TOpA. Each variable was analyzed at 24, 48, and 72 hours after implantation. A pooled analysis of both studies was also performed retrospectively.Results: Through 24 and 48 hours, XaraColl-treated patients experienced significantly less pain in study 1 (P < 0.001 and P = 0.012, respectively whereas they took significantly less opioid analgesia in study 2 (P = 0.004 and P = 0.042, respectively. Over the same time intervals in the pooled analysis, treated patients experienced

  16. Postural control and shoulder steadiness in F-16 pilots

    DEFF Research Database (Denmark)

    Lange, Britt; Murray, Mike; Chreiteh, Shadi S

    2014-01-01

    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. RESULTS: 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. DISCUSSION: 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...

  17. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study

    Directory of Open Access Journals (Sweden)

    Mainz JG

    2014-02-01

    Full Text Available Jochen G Mainz,1 Katja Schädlich,1 Claudia Schien,1 Ruth Michl,1 Petra Schelhorn-Neise,2 Assen Koitschev,3 Christiane Koitschev,4 Peter M Keller,5 Joachim Riethmüller,6 Baerbel Wiedemann,7 James F Beck1 1Cystic Fibrosis Centre, Department of Pediatrics, Jena University Hospital, Jena, Germany; 2Otorhinolaryngology Department, Jena University Hospital, Jena, Germany; 3Otorhinolaryngology Department, Klinikum Stuttgart, Germany; 4Otorhinolaryngology Department, University Hospital, Tübingen, Germany; 5Microbiology, Jena University Hospital, Jena, Germany; 6University Hospital, Pediatric CF-Centre, Tübingen, Germany; 7Technical University, Biometrics, Dresden, Germany Rationale: In cystic fibrosis (CF, the paranasal sinuses are sites of first and persistent colonization by pathogens such as Pseudomonas aeruginosa. Pathogens subsequently descend to the lower airways, with P. aeruginosa remaining the primary cause of premature death in patients with the inherited disease. Unlike conventional aerosols, vibrating aerosols applied with the PARI Sinus™ nebulizer deposit drugs into the paranasal sinuses. This trial assessed the effects of vibrating sinonasal inhalation of the antibiotic tobramycin in CF patients positive for P. aeruginosa in nasal lavage. Objectives: To evaluate the effects of sinonasal inhalation of tobramycin on P. aeruginosa quantification in nasal lavage; and on patient quality of life, measured with the Sino-Nasal Outcome Test (SNOT-20, and otologic and renal safety and tolerability. Methods: Patients were randomized to inhalation of tobramycin (80 mg/2 mL or placebo (2 mL isotonic saline once daily (4 minutes/nostril with the PARI Sinus™ nebulizer over 28 days, with all patients eligible for a subsequent course of open-label inhalation of tobramycin for 28 days. Nasal lavage was obtained before starting and 2 days after the end of each treatment period by rinsing each nostril with 10 mL of isotonic saline. Results: Nine

  18. Evaluation of Cyclosporine A with β-TCP in the Treatment of Human Infra bony Defects – A Randomized Controlled Pilot Study

    Science.gov (United States)

    Reddy, Krishnajaneya; Avula, Haritha; Mishra, Ashank; Kalakonda, Butchibabu; Pandey, Ruchi

    2017-01-01

    Abstract Introduction Cyclosporine A (CsA), an immunosuppressant, is considered a life saver drug in organ transplant cases. It has also been tested in animal and human studies for periodontal applications as it selectively inhibits T lymphocyte proliferation, Interleukin-2 (IL-2) and other cytokine production, without any effect on T suppressor cells, thereby suppressing the cell mediated immunity and suppressing the inflammation. Inflammatory and immunological responses have been found to be decreased and bone formation is found to be increased in immunosuppressed animals. CsA is also supposed to potentiate osseous regeneration due to increase in the bone alkaline phosphatase levels and a direct activating effect on osteoblasts. Aim The present study was aimed at evaluating locally administered low dose of CsA which is potent immunosuppressant along with β-Tricalcium phosphate (β-TCP) in comparison with β TCP alone, in the treatment of human infrabony defects, over a period of six months. Materials and Methods Thirty two systemically healthy chronic periodontitis patients with infrabony defects were included in the randomized, controlled, parallel arm study and were allocated into either Group A (n =16), patients treated with β-TCP + CsA (2 mg) or Group B (n =16), patients treated with β-TCP. Clinical parameters [Relative Attachment Level (RAL), Probing Depth (PD), Gingival Recession (GR)] and radiographic parameters were measured at baseline and six months postoperatively. Statistical analysis was done using SPSS version 16 software. Student’s paired and independent t-test were used for intra and inter-group analysis. Results Both Group A and Group B showed statistically significant improvements in clinical and radiographic parameters from base line to six months post-operatively. The Clinical Attachment Level (CAL) gain, Linear Bone Growth (LBG) and Percentage Bone Fill (% BF) were 2.38±1.12 mm, 1.90±1.48 mm and 4