WorldWideScience

Sample records for randomized pilot trial

  1. 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...... 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...... that the playful interaction with the modular interactive tiles has a significant effect even after a very short time of play. The average total training time to obtain the statistical significant effect amounted to just 2h45m....

  2. Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

    Science.gov (United States)

    Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

    2017-12-01

    Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

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

    NARCIS (Netherlands)

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

    2010-01-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Anup Katheria

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

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

    OpenAIRE

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

    2013-01-01

    Background Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. Objective To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues....

  7. Computer-Based Cognitive Training for Mild Cognitive Impairment: Results from a Pilot Randomized, Controlled Trial

    OpenAIRE

    Barnes, Deborah E.; Yaffe, Kristine; Belfor, Nataliya; Jagust, William J.; DeCarli, Charles; Reed, Bruce R.; Kramer, Joel H.

    2009-01-01

    We performed a pilot randomized, controlled trial of intensive, computer-based cognitive training in 47 subjects with mild cognitive impairment (MCI). The intervention group performed exercises specifically designed to improve auditory processing speed and accuracy for 100 minutes/day, 5 days/week for 6 weeks; the control group performed more passive computer activities (reading, listening, visuospatial game) for similar amounts of time. Subjects had a mean age of 74 years and 60% were men; 7...

  8. 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.

  9. Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

    Directory of Open Access Journals (Sweden)

    Tulledge-Scheitel Sidna M

    2009-12-01

    Full Text Available Abstract Background Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1 preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE for postmenopausal women at risk for osteoporotic fractures; and (2 assess the feasibility and validity (i.e., absence of contamination of patient-level randomization (vs. cluster randomization in pilot trials of decision aid efficacy. Methods/Design This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of STEOPOROSIS CHOICE on five outcomes: (a patient knowledge regarding osteoporosis risk factors and treatment; (b quality of the decision-making process for both the patient and clinician; (c patient and clinician acceptability and satisfaction with the decision aid; (d rate of bisphosphonate use and adherence, and (e trial processes (e.g., ability to recruit participants, collect patient outcomes. To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination. Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. Discussion This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform

  10. 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

  11. Restrictive versus liberal transfusion strategies for older mechanically ventilated critically ill patients: a randomized pilot trial.

    Science.gov (United States)

    Walsh, Timothy S; Boyd, Julia A; Watson, Douglas; Hope, David; Lewis, Steff; Krishan, Ashma; Forbes, John F; Ramsay, Pamela; Pearse, Rupert; Wallis, Charles; Cairns, Christopher; Cole, Stephen; Wyncoll, Duncan

    2013-10-01

    To compare hemoglobin concentration (Hb), RBC use, and patient outcomes when restrictive or liberal blood transfusion strategies are used to treat anemic (Hb≤90 g/L) critically ill patients of age≥55 years requiring≥4 days of mechanical ventilation in ICU. Parallel-group randomized multicenter pilot trial. Six ICUs in the United Kingdom participated between August 2009 and December 2010. One hundred patients (51 restrictive and 49 liberal groups). Patients were randomized to a restrictive (Hb trigger, 70 g/L; target, 71-90 g/L) or liberal (90 g/L; target, 91-110 g/L) transfusion strategy for 14 days or the remainder of ICU stay, whichever was longest. Baseline comorbidity rates and illness severity were high, notably for ischemic heart disease (32%). The Hb difference among groups was 13.8 g/L (95% CI, 11.5-16.0 g/L); pdisease, Acute Physiology and Chronic Health Evaluation II score, and total non-neurologic Sequential Organ Failure Assessment score at baseline (hazard ratio, 0.54 [95% CI, 0.28-1.03]; p=0.061). A large trial of transfusion strategies in older mechanically ventilated patients is feasible. This pilot trial found a nonsignificant trend toward lower mortality with restrictive transfusion practice.

  12. Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials.

    Science.gov (United States)

    Sood, Beena G; Keszler, Martin; Garg, Meena; Klein, Jonathan M; Ohls, Robin; Ambalavanan, Namasivayam; Cotten, C Michael; Malian, Monica; Sanchez, Pablo J; Lakshminrusimha, Satyan; Nelin, Leif D; Van Meurs, Krisa P; Bara, Rebecca; Saha, Shampa; Das, Abhik; Wallace, Dennis; Higgins, Rosemary D; Shankaran, Seetha

    2014-12-12

    Inhaled nitric oxide (INO), a selective pulmonary vasodilator, has revolutionized the treatment of neonatal hypoxemic respiratory failure (NHRF). However, there is lack of sustained improvement in 30 to 46% of infants. Aerosolized prostaglandins I2 (PGI2) and E1 (PGE1) have been reported to be effective selective pulmonary vasodilators. The objective of this study was to evaluate the feasibility of a randomized controlled trial (RCT) of inhaled PGE1 (IPGE1) in NHRF. Two pilot multicenter phase II RCTs are included in this report. In the first pilot, late preterm and term neonates with NHRF, who had an oxygenation index (OI) of ≥15 and <25 on two arterial blood gases and had not previously received INO, were randomly assigned to receive two doses of IPGE1 (300 and 150 ng/kg/min) or placebo. The primary outcome was the enrollment of 50 infants in six to nine months at 10 sites. The first pilot was halted after four months for failure to enroll a single infant. The most common cause for non-enrollment was prior initiation of INO. In a re-designed second pilot, co-administration of IPGE1 and INO was permitted. Infants with suboptimal response to INO received either aerosolized saline or IPGE1 at a low (150 ng/kg/min) or high dose (300 ng/kg/min) for a maximum duration of 72 hours. The primary outcome was the recruitment of an adequate number of patients (n = 50) in a nine-month-period, with fewer than 20% protocol violations. No infants were enrolled in the first pilot. Seven patients were enrolled in the second pilot; three in the control, two in the low-dose IPGE1, and two in the high-dose IPGE1 groups. The study was halted for recruitment futility after approximately six months as enrollment targets were not met. No serious adverse events, one minor protocol deviation and one pharmacy protocol violation were reported. These two pilot RCTs failed to recruit adequate eligible newborns with NHRF. Complex management RCTs of novel therapies for persistent pulmonary

  13. Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

    Science.gov (United States)

    Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

    2015-01-01

    Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and

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

    Science.gov (United States)

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

    2015-03-01

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

  15. 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

  16. Effects of manipulating eating frequency during a behavioral weight loss intervention: a pilot randomized controlled trial.

    Science.gov (United States)

    Bachman, Jessica L; Raynor, Hollie A

    2012-05-01

    Eating frequency has been inversely related to BMI but the impact of eating frequency on weight loss is unclear. This randomized controlled trial pilot study examined the effect of eating frequency on hunger, energy intake, and weight loss during a 6-month behavioral weight loss intervention. Participants (age: 51.0 ± 9.9 years, BMI: 35.5 ± 4.8 kg/m(2), 57.8% female, 94.1% white) were randomized to one of two eating frequency prescriptions: Three meal (n = 25): three eating bouts/day; or grazing (n = 26): eat at least 100 kcals every 2-3 h. Both groups attended 20 sessions and had identical dietary (1,200-1,500 kcals/day, frequency than three meal at 6 months (5.8 ± 1.1 eating bouts/day vs. 3.2 ± 0.6 eating bouts/day, P weight loss intervention.

  17. Running injuries in novice runners enrolled in different training interventions: a pilot randomized controlled trial.

    Science.gov (United States)

    Baltich, J; Emery, C A; Whittaker, J L; Nigg, B M

    2017-11-01

    The purpose of this trial was to evaluate injury risk in novice runners participating in different strength training interventions. This was a pilot randomized controlled trial. Novice runners (n = 129, 18-60 years old, running experience) were block randomized to one of three groups: a "resistance" strength training group, a "functional" strength training group, or a stretching "control" group. The primary outcome was running related injury. The number of participants with complaints and the injury rate (IR = no. injuries/1000 running hours) were quantified for each intervention group. For the first 8 weeks, participants were instructed to complete their training intervention three to five times a week. The remaining 4 months was a maintenance period. NCT01900262. A total of 52 of the 129 (40%) novice runners experienced at least one running related injury: 21 in the functional strength training program, 16 in the resistance strength training program and 15 in the control stretching program. Injury rates did not differ between study groups [IR = 32.9 (95% CI 20.8, 49.3) in the functional group, IR = 31.6 (95% CI 18.4, 50.5) in the resistance group, and IR = 26.7 (95% CI 15.2, 43.2)] in the control group. Although this was a pilot assessment, home-based strength training did not appear to alter injury rates compared to stretching. Future studies should consider methods to minimize participant drop out to allow for the assessment of injury risk. Injury risk in novice runners based on this pilot study will inform the development of future larger studies investigating the impact of injury prevention interventions. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Wean earlier and automatically with new technology (the WEAN study). A multicenter, pilot randomized controlled trial.

    Science.gov (United States)

    Burns, Karen E A; Meade, Maureen O; Lessard, Martin R; Hand, Lori; Zhou, Qi; Keenan, Sean P; Lellouche, Francois

    2013-06-01

    Automated weaning has not been compared with a paper-based weaning protocol in North America. We conducted a pilot randomized trial comparing automated weaning with protocolized weaning in critically ill adults to evaluate clinician compliance and acceptance of the weaning and sedation protocols, recruitment, and impact on outcomes. From August 2007 to October 2009, we enrolled critically ill adults requiring more than 24 hours of mechanical ventilation and at least partial reversal of the condition precipitating respiratory failure at nine Canadian intensive care units. We randomized patients who tolerated at least 30 minutes of pressure support and either failed or were not yet ready to undergo a spontaneous breathing trial to automated or protocolized weaning. Both groups used pressure support, included spontaneous breathing trials, used a common positive end-expiratory pressure-FI(O(2)) chart, sedation protocol, and criteria for extubation, reintubation, and noninvasive ventilation. We recruited 92 patients (49 automated, 43 protocolized) over 26 months. Adherence to assigned weaning protocols and extreme sedation scale scores fell within prespecified thresholds. Combined physician-respiratory therapist and nurse acceptance scores of the study weaning and sedation protocols, respectively, were not significantly different. Automated weaning patients had significantly shorter median times to first successful spontaneous breathing trial (1.0 vs. 4.0 d; P 4.0 d; P = 0.02), and successful extubation (4.0 vs. 5.0 d; P = 0.01), and underwent fewer tracheostomies and episodes of protracted ventilation. Compared with a standardized protocol, automated weaning was associated with promising outcomes that warrant further investigation. Minor protocol modifications may increase compliance, facilitate recruitment, and enhance feasibility. Clinical trial registered with www.controlled-trials.com (ISRCTN43760151).

  19. Randomized Pilot Trial of Two Modified Endotracheal Tubes To Prevent Ventilator-associated Pneumonia.

    Science.gov (United States)

    Deem, Steven; Yanez, David; Sissons-Ross, Laura; Broeckel, Jo Ann Elrod; Daniel, Stephen; Treggiari, Miriam

    2016-01-01

    Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns. We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial. This study was conducted with institutional review board approval under exception from informed consent. We randomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count >10(6) cfu per milliliter and the incidence of invasively diagnosed VAP. A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n = 77), and the remainder occurred out of hospital (n = 25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP

  20. 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.

  1. A pilot randomized trial teaching mindfulness-based stress reduction to traumatized youth in foster care.

    Science.gov (United States)

    Jee, Sandra H; Couderc, Jean-Philippe; Swanson, Dena; Gallegos, Autumn; Hilliard, Cammie; Blumkin, Aaron; Cunningham, Kendall; Heinert, Sara

    2015-08-01

    This article presents a pilot project implementing a mindfulness-based stress reduction program among traumatized youth in foster and kinship care over 10 weeks. Forty-two youth participated in this randomized controlled trial that used a mixed-methods (quantitative, qualitative, and physiologic) evaluation. Youth self-report measuring mental health problems, mindfulness, and stress were lower than anticipated, and the relatively short time-frame to teach these skills to traumatized youth may not have been sufficient to capture significant changes in stress as measured by electrocardiograms. Main themes from qualitative data included expressed competence in managing ongoing stress, enhanced self-awareness, and new strategies to manage stress. We share our experiences and recommendations for future research and practice, including focusing efforts on younger youth, and using community-based participatory research principles to promote engagement and co-learning. CLINICALTRIALS.GOV: Protocol Registration System ID NCT01708291. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. 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.

    2016-01-01

    This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem solving skills training (PSST) compared to treatment as usual (TAU) 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 10–17 years with chronic pain randomized to PSST (n = 31) or TAU (n = 30). Parents receiving PSST participated in 4–6 individual sessions of training in problem solving skills. Outcomes were assessed at pre-treatment, immediately post-treatment, and at 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 post-treatment 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 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youth 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. PMID:26845525

  3. Cognitive Analytic Therapy for Bipolar Disorder: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Evans, Mark; Kellett, Stephen; Heyland, Simon; Hall, Jo; Majid, Shazmin

    2017-01-01

    The evidence base for treatment of bipolar affective disorder (BD) demands the evaluation of new psychotherapies in order to broaden patient choice. This study reports on the feasibility, safety, helpfulness and effectiveness of cognitive analytic therapy (CAT). In a pilot randomized controlled trial, BD patients in remission were randomized to either receiving 24 sessions of CAT (n = 9) or treatment as usual (n = 9) and were assessed in terms of symptoms, functioning and service usage over time. In the CAT arm no adverse events occurred, 8/9 completed treatment, 5/8 attended all 24 sessions and 2/8 were categorized as recovered. The most common helpful event during CAT was recognition of patterns in mood variability, with helpfulness themes changing according to phase of therapy. No major differences were found when comparing the arms over time in terms of service usage or psychometric outcomes. The study suggests that conducting further research into the effectiveness of CAT in treating BD is warranted and guidance regarding future trials is provided. Copyright © 2016 John Wiley & Sons, Ltd. Treating BD with CAT appears feasible and safe. Retaining fidelity to the reformulation, recognition and revision structure of CAT appears useful. Participants stated that across the phases of CAT, focussing on patterns of mood variability was consistently helpful. Copyright © 2016 John Wiley & Sons, Ltd.

  4. 1% hydrocortisone ointment is an effective treatment of pruritus ani: a pilot randomized controlled crossover trial.

    Science.gov (United States)

    Al-Ghnaniem, R; Short, K; Pullen, A; Fuller, L C; Rennie, J A; Leather, A J M

    2007-12-01

    Pruritus ani (PA) is a common condition which is difficult to treat in the absence of obvious predisposing factors. There is paucity of evidence-based guidelines on the treatment of this condition. We examined whether 1% hydrocortisone ointment is an effective treatment for PA. A pilot randomized, double-blind, placebo-controlled, crossover trial was carried out. Eleven patients consented to take part in the trial and ten completed the study. After a 2-week run-in period, patients with primary PA were randomly allocated to receive 1% hydrocortisone ointment or placebo for 2 weeks followed by the opposite treatment for a further 2-week period. There was a washout period of 2 weeks between treatments. The primary outcome measure was reduction in itch using a visual analogue score (VAS). The secondary outcome measures were improvement in quality of life measured using a validated questionnaire (Dermatology Life Quality Index, DLQI) and improvement in clinical appearance of the perianal skin using the Eczema Area and Severity Index (EASI) score. Treatment with 1% hydrocortisone ointment resulted in a 68% reduction in VAS compared with placebo (P=0.019), a 75% reduction in DLQI score (P=0.067), and 81% reduction in EASI score (P=0.01). A short course of mild steroid ointment is an effective treatment for PA.

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

    Science.gov (United States)

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

    2018-01-01

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

  6. Illness Management & Recovery (IMR) in the Netherlands : A naturalistic pilot study to explore the feasibility of a randomized controlled trial

    NARCIS (Netherlands)

    Roosenschoon, B.J.; Van Weeghel, J.; Bogaards, M.; Deen, M.L.; Mulder, C.L.

    2016-01-01

    Background Illness Management & Recovery (IMR) is a curriculum-based program for people with severe and persistent mental illness. To date, four randomized controlled trials (RCTs) have been published on it. As these produced mixed results, we conducted a pilot study to test the feasibility of

  7. Illness Management & Recovery (IMR) in the Netherlands; a naturalistic pilot study to explore the feasibility of a randomized controlled trial

    NARCIS (Netherlands)

    B.J. Roosenschoon (Bert); J. van Weeghel (Jaap); Bogaards, M. (Moniek); M. Deen (Mathijs); C.L. Mulder (Niels)

    2016-01-01

    textabstractBackground: Illness Management & Recovery (IMR) is a curriculum-based program for people with severe and persistent mental illness. To date, four randomized controlled trials (RCTs) have been published on it. As these produced mixed results, we conducted a pilot study to test the

  8. Effect of Continuous Positive Airway Pressure on Stroke Rehabilitation: A Pilot Randomized Sham-Controlled Trial

    Science.gov (United States)

    Khot, Sandeep P.; Davis, Arielle P.; Crane, Deborah A.; Tanzi, Patricia M.; Li Lue, Denise; Claflin, Edward S.; Becker, Kyra J.; Longstreth, W.T.; Watson, Nathaniel F.; Billings, Martha E.

    2016-01-01

    Study Objectives: Obstructive sleep apnea (OSA) predicts poor functional outcome after stroke and increases the risk for recurrent stroke. Less is known about continuous positive airway pressure (CPAP) treatment on stroke recovery. Methods: In a pilot randomized, double-blind, sham-controlled trial, adult stroke rehabilitation patients were assigned to auto-titrating or sham CPAP without diagnostic testing for OSA. Change in Functional Independence Measure (FIM), a measure of disability, was assessed between rehabilitation admission and discharge. Results: Over 18 months, 40 patients were enrolled and 10 withdrew from the study: 7 from active and 3 from sham CPAP (p > 0.10). For the remaining 30 patients, median duration of CPAP use was 14 days. Average CPAP use was 3.7 h/night, with at least 4 h nightly use among 15 patients. Adherence was not influenced by treatment assignment or stroke severity. In intention-to-treat analyses (n = 40), the median change in FIM favored active CPAP over sham but did not reach statistical significance (34 versus 26, p = 0.25), except for the cognitive component (6 versus 2.5, p = 0.04). The on-treatment analyses (n = 30) yielded similar results (total FIM: 32 versus 26, p = 0.11; cognitive FIM: 6 versus 2, p = 0.06). Conclusions: A sham-controlled CPAP trial among stroke rehabilitation patients was feasible in terms of recruitment, treatment without diagnostic testing and adequate blinding—though was limited by study retention and CPAP adherence. Despite these limitations, a trend towards a benefit of CPAP on recovery was evident. Tolerance and adherence must be improved before the full benefits of CPAP on recovery can be assessed in larger trials. Citation: Khot SP, Davis AP, Crane DA, Tanzi PM, Li Lue D, Claflin ES, Becker KJ, Longstreth WT, Watson NF, Billings ME. Effect of continuous positive airway pressure on stroke rehabilitation: a pilot randomized sham-controlled trial. J Clin Sleep Med 2016;12(7):1019–1026. PMID

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

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    Mark W. Vander Weg

    2016-08-01

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

  10. Cognitive-behavioural suicide prevention for male prisoners: a pilot randomized controlled trial.

    Science.gov (United States)

    Pratt, D; Tarrier, N; Dunn, G; Awenat, Y; Shaw, J; Ulph, F; Gooding, P

    2015-12-01

    Prisoners have an exceptional risk of suicide. Cognitive-behavioural therapy for suicidal behaviour has been shown to offer considerable potential, but has yet to be formally evaluated within prisons. This study investigated the feasibility of delivering and evaluating a novel, manualized cognitive-behavioural suicide prevention (CBSP) therapy for suicidal male prisoners. A pilot randomized controlled trial of CBSP in addition to treatment as usual (CBSP; n = 31) compared with treatment as usual (TAU; n = 31) alone was conducted in a male prison in England. The primary outcome was self-injurious behaviour occurring within the past 6 months. Secondary outcomes were dimensions of suicidal ideation, psychiatric symptomatology, personality dysfunction and psychological determinants of suicide, including depression and hopelessness. The trial was prospectively registered (number ISRCTN59909209). Relative to TAU, participants receiving CBSP therapy achieved a significantly greater reduction in suicidal behaviours with a moderate treatment effect [Cohen's d = -0.72, 95% confidence interval -1.71 to 0.09; baseline mean TAU: 1.39 (S.D. = 3.28) v. CBSP: 1.06 (S.D. = 2.10), 6 months mean TAU: 1.48 (S.D. = 3.23) v. CBSP: 0.58 (S.D. = 1.52)]. Significant improvements were achieved on measures of psychiatric symptomatology and personality dysfunction. Improvements on psychological determinants of suicide were non-significant. More than half of the participants in the CBSP group achieved a clinically significant recovery by the end of therapy, compared with a quarter of the TAU group. The delivery and evaluation of CBSP therapy within a prison is feasible. CBSP therapy offers significant promise in the prevention of prison suicide and an adequately powered randomized controlled trial is warranted.

  11. Honest, Open, Proud for adolescents with mental illness: pilot randomized controlled trial.

    Science.gov (United States)

    Mulfinger, Nadine; Müller, Sabine; Böge, Isabel; Sakar, Vehbi; Corrigan, Patrick W; Evans-Lacko, Sara; Nehf, Luise; Djamali, Julia; Samarelli, Anna; Kempter, Michael; Ruckes, Christian; Libal, Gerhard; Oexle, Nathalie; Noterdaeme, Michele; Rüsch, Nicolas

    2018-06-01

    Due to public stigma or self-stigma and shame, many adolescents with mental illness (MI) struggle with the decision whether to disclose their MI to others. Both disclosure and nondisclosure are associated with risks and benefits. Honest, Open, Proud (HOP) is a peer-led group program that supports participants with disclosure decisions in order to reduce stigma's impact. Previously, HOP had only been evaluated among adults with MI. This two-arm pilot randomized controlled trial included 98 adolescents with MI. Participants were randomly assigned to HOP and treatment as usual (TAU) or to TAU alone. Outcomes were assessed pre (T0/baseline), post (T1/after the HOP program), and at 3-week follow-up (T2/6 weeks after T0). Primary endpoints were stigma stress at T1 and quality of life at T2. Secondary outcomes included self-stigma, disclosure-related distress, empowerment, help-seeking intentions, recovery, and depressive symptoms. The trial is registered on ClinicalTrials (NCT02751229; http://www.clinicaltrials.gov). Compared to TAU, adolescents in the HOP program showed significantly reduced stigma stress at T1 (d = .92, p self-stigma, disclosure-related distress, secrecy, help-seeking intentions, attitudes to disclosure, recovery, and depressive symptoms. Effects at T1 remained stable or improved further at follow-up. In a limited economic evaluation HOP was cost-efficient in relation to gains in quality of life. As HOP is a compact three-session program and showed positive effects on stigma and disclosure variables as well as on symptoms and quality of life, it could help to reduce stigma's negative impact among adolescents with MI. © 2017 Association for Child and Adolescent Mental Health.

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

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    Ineke Van Der Meulen

    2016-11-01

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

  13. 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.

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

    Directory of Open Access Journals (Sweden)

    Ceren Acarturk

    2015-05-01

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

  15. Dialectical behavior therapy for adolescents with bipolar disorder: results from a pilot randomized trial.

    Science.gov (United States)

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

    2015-03-01

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

  16. A Pilot Randomized Controlled Trial of Novel Dressing and Securement Techniques in 101 Pediatric Patients.

    Science.gov (United States)

    Kleidon, Tricia M; Ullman, Amanda J; Gibson, Victoria; Chaseling, Brett; Schoutrop, Jason; Mihala, Gabor; Rickard, Claire M

    2017-11-01

    To evaluate feasibility of an efficacy trial comparing peripherally inserted central catheter (PICC) dressing and securement techniques to prevent complications and failure. This pilot, 3-armed, randomized controlled trial was undertaken at Royal Children's Hospital and Lady Cilento Children's Hospital, Brisbane, Australia, between April 2014 and September 2015. Pediatric participants (N = 101; age range, 0-18 y) were assigned to standard care (bordered polyurethane [BPU] dressing, sutureless securement device), tissue adhesive (TA) (plus BPU dressing), or integrated securement dressings (ISDs). Average PICC dwell time was 8.1 days (range, 0.2-27.7 d). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were PICC complications, dressing performance, and parent and staff satisfaction. Protocol feasibility was established. PICC failure was 6% (2/32) with standard care, 6% (2/31) with ISD, and 3% (1/32) with TA. PICC complications were 16% across all groups. TA provided immediate postoperative hemostasis, prolonging the first dressing change until 5.5 days compared with 3.5 days and 2.5 days with standard care and ISD respectively. Bleeding was the most common reason for first dressing change: standard care (n = 18; 75%), ISD (n = 11; 69%), TA (n = 4; 27%). Parental satisfaction (median 9.7/10; P = .006) and staff feedback (9.2/10; P = .002) were most positive for ISD. This research suggests safety and acceptability of different securement dressings compared with standard care; securement dressings may also reduce dressing changes after insertion. Further research is required to confirm clinically cost-effective methods to prevent PICC failure. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

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

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    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

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

    Science.gov (United States)

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

    2015-11-01

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

  19. 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

  20. 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

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

    Science.gov (United States)

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

    2017-03-01

    To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. A pilot two-group randomized trial was conducted with parents/children (ages 3-8 years) receiving AME + P ( n  =  9) or attention control ( n  =  7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Despite child benefit, findings do not support parent delivery of AME + P. © The Author 2016. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  2. Efficacy of an educational manual for childbirth companions: pilot study of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Liana Mara Rocha Teles

    2018-05-01

    Full Text Available ABSTRACT Objective: to evaluate the effectiveness of an educational manual in the instrumentalization of companions to provide support to the parturients and check its influence on the satisfaction of companions and women during vaginal delivery. Method: pilot study of a randomized controlled clinical trial with 65 companions and puerperal women (intervention = 21 and control = 44. The previous knowledge of the companions was evaluated at baseline. The Evaluation Form for Companions in the Delivery Room was used to measure the actions provided and the satisfaction with the experience, and the Questionnaire for Evaluation of the Experience and Satisfaction of Puerperal Women with Labor and Delivery was used to evaluate the satisfaction of women with childbirth. The Student’s t-test or Wilcoxon, chi-square or Fisher’s exact test, risk ratios and 95% confidence intervals were used. Results: the companions in the intervention group performed a greater number of support actions (7.2 vs 4.6, p: 0.001 and had higher satisfaction scores (72.4 vs 64.2; p = 0.00. Puerperal women in the intervention group had higher satisfaction with childbirth (119.6 vs 107.9; p: 0.000. Conclusion: the manual was effective for the instrumentalization of companions, contributed to support actions to the parturients and had repercussions on the satisfaction of companions and women with the birthing process. RBR-776d9s

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

    Directory of Open Access Journals (Sweden)

    Pai Menaka

    2013-01-01

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

  4. A Pilot Randomized Trial of a Companion Robot for People With Dementia Living in the Community.

    Science.gov (United States)

    Liang, Amy; Piroth, Isabell; Robinson, Hayley; MacDonald, Bruce; Fisher, Mark; Nater, Urs M; Skoluda, Nadine; Broadbent, Elizabeth

    2017-10-01

    To investigate the affective, social, behavioral, and physiological effects of the companion robot Paro for people with dementia in both a day care center and a home setting. A pilot block randomized controlled trial over 12 weeks. Participants were randomized to the intervention (Paro) or control condition (standard care). Two dementia day care centers and participants' homes in Auckland, New Zealand. Thirty dyads (consisting of a care recipient with dementia and their caregiver) took part in this study. All care recipients attended dementia day care centers at Selwyn Foundation and had a formal diagnosis of dementia. Thirty-minute unstructured group sessions with Paro at the day care center were run 2 to 3 times a week for 6 weeks. Participants also had Paro at home for 6 weeks. At the day care centers, observations of the care recipients' behavior, affect, and social responses were recorded using a time sampling method. Observations of interactions with Paro for participants in the intervention were also recorded. Blood pressure and salivary cortisol were collected from care recipients before and after sessions at day care. In the home setting, level of cognition, depressive symptoms, neuropsychiatric symptoms, behavioral agitation, and blood pressure were measured at baseline, 6 weeks, and 12 weeks. Hair cortisol measures were collected at baseline and at 6 weeks. Observations showed that Paro significantly improved facial expressions (affect) and communication with staff (social interaction) at the day care centers. Subanalyses showed that care recipients with less cognitive impairment responded significantly better to Paro. There were no significant differences in care recipient dementia symptoms, nor physiological measures between the intervention and control group. Paro shows promise in enhancing affective and social outcomes for certain individuals with dementia in a community context. Larger randomized controlled trials in community settings, with

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

    Science.gov (United States)

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

    2012-01-01

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

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

    Science.gov (United States)

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

    2016-12-01

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

  7. Overcoming Barriers to Disseminating Exposure Therapies for Anxiety Disorders: A Pilot Randomized Controlled Trial of Training Methods

    OpenAIRE

    Harned, Melanie S.; Dimeff, Linda A.; Woodcock, Eric A.; Skutch, Julie M.

    2011-01-01

    The present study evaluated methods for training mental health providers (N=46) in exposure therapies (ETs) for anxiety disorders. A pilot randomized controlled trial compared: 1) an interactive, multimedia online training (ET OLT), 2) the ET OLT plus a brief Motivational Interviewing-based intervention (ET OLT + MI), and 3) a placebo control OLT. Assessments were completed at baseline, post-training, and one week following training. Both ET OLT and ET OLT + MI received high satisfaction rati...

  8. Melodic intonation therapy in chronic aphasia: Evidence from a pilot randomized controlled trial

    NARCIS (Netherlands)

    I. van der Meulen (Ineke); W.M.E. van de Sandt-Koenderman (Mieke); Heijenbrok, M.H. (Majanka H.); E.G. Visch-Brink (Evy); Ribber, G.M. (Gerard M.)

    2016-01-01

    textabstractMelodic Intonation Therapy (MIT) is a language production therapy for severely nonfluent 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

  9. SMS text message reminders to improve infant vaccination coverage in Guatemala: A pilot randomized controlled trial.

    Science.gov (United States)

    Domek, Gretchen J; Contreras-Roldan, Ingrid L; O'Leary, Sean T; Bull, Sheana; Furniss, Anna; Kempe, Allison; Asturias, Edwin J

    2016-05-05

    Patient reminder systems are an evidence-based way to improve childhood vaccination rates but are difficult to implement in low- and middle-income countries (LMICs). Short Message Service (SMS) texts may offer a potential low-cost solution, especially in LMICs where mobile phones are becoming more ubiquitous. To determine if an SMS-based vaccination reminder system aimed at improving completion of the infant primary immunization series is feasible and acceptable in Guatemala. A pilot randomized controlled trial was conducted at two public health clinics in Guatemala City. Infants aged 8-14 weeks presenting for the first dose of the primary immunization series were enrolled in March-April 2013. Participants randomized into the intervention received three SMS reminders one week before the second and third dose. A follow-up acceptability survey was administered to both groups. The participation rate was 86.8% (321/370); 8 did not own a cell phone and 12 could not use SMS. 96.9% of intervention parents were sent at least one SMS reminder prior to visit 2 and 96.3% prior to visit 3. Both intervention and usual care participants had high rates of vaccine and visit completion, with a non-statistically significant higher percentage of children in the intervention completing both visit 2 (95.0% vs. 90.1%, p=.12) and visit 3 (84.4% vs. 80.7%, p=.69). More intervention vs. usual care parents agreed that SMS reminders would be helpful for remembering appointments (p<.0001), agreed to being interested in receiving future SMS reminders (p<.0001), and said that they would be willing to pay for future SMS reminders (p=.01). This proof of concept evaluation showed that a new application of SMS technology is feasible to implement in a LMIC with high user satisfaction. Larger studies with modifications in the SMS system are needed to determine effectiveness (Clinical Trial Registry NCT01663636). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  10. Recruitment for 'A pilot study of randomized controlled trial to evaluate the efficacy of lung cancer screening by thoracic CT'

    International Nuclear Information System (INIS)

    Sagawa, Motoyasu; Tanaka, Makoto; Mizukami, Satoru

    2011-01-01

    The objective of this study was to evaluate the efficacy of lung cancer screening by thoracic computed tomography (CT), a randomized controlled trial was planned in Japan. The randomized trial was designed as follows: participants were randomly assigned into 2 groups, CT group and XP group; XP group would receive 10 times of lung cancer screening by chest x-ray annually for 10 years; smokers in CT group would receive 10 times of lung cancer screening by thoracic CT annually for 10 years; non-smokers in CT group would receive 3 times of lung cancer screening by thoracic CT and 7 times of chest x-ray during 10 years. A pilot study was performed to evaluate the feasibility of the trial. A letter for recruitment to participate in the above trial was mailed to the citizens in Hakui City, who were 50-64 years old and underwent regular lung cancer screening using chest x-ray this year. In the letter we explained that the efficacy of lung cancer screening by thoracic CT had not been proved yet; only half of the participants could undergo thoracic CT screening; thoracic CT screening might cause unfavorable consequences like radiation exposure, false positives or overdiagnosis. Of 329 persons who received the letter of recruitment, 117 replied. After meeting with us for detailed explanation, 111 persons participated in the above randomized trial. The compliance of recruitment is high (approximately one third) and the above trial may be feasible. (author)

  11. 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

  12. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    John F. Emerson

    2015-12-01

    Full Text Available Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32% by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention

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

    Science.gov (United States)

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

    2018-02-13

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

  14. Warm ambient temperature decreases food intake in a simulated office setting: A pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Molly eBernhard

    2015-08-01

    Full Text Available Background: We hypothesized that exposure to temperatures above the thermoneutral zone would decrease food intake in young adults in a sedentary office environment over a 2-hour period. Methods: Participants wearing standardized clothing were randomized to perform routine office work in either within the thermoneutral zone, considered control (19-20°C, or above the thermoneutral zone considered warmer (26-27°C treatment in parallel-group design (n=11 and 9, respectively. Thermal images of the inner canthus of their eye and middle finger nail bed, representing proxies of core and peripheral temperatures, respectively, were taken at baseline, 1st, and 2nd hour during this lunchtime study. Relative heat dissipation was estimated as peripheral temperature. General linear models were conducted to examine the effects of thermal treatment the calories intake and potential mediation. Researchers conducted the trial registered as NCT02386891 at Clinicaltrials.gov during April- May 2014. Results: During the 2 hours stay in different ambient temperatures, the participants in the control conditions ate 99.5 kcal more than those in the warmer conditions; however, the difference was not statistically significant. Female participants ate about 350 kcal less than the male participants (P=0.024 in both groups and there was no significant association between calories intake and participant’s BMI. After controlling for thermal treatment, gender and BMI, the participant’s peripheral temperature was significantly associated with calories intake (p=0.002, suggesting a mediating effect. Specifically, for every 1°C increase in peripheral temperature indicating reduced heat dissipation, participants ate 85.9 kcal less food. Conclusions: This pilot study provided preliminary evidence of effects of thermal environment on food intake and the decreased food intake in the experimental (warmer environment is potentially mediated through thermoregulatory mechanisms.

  15. Warm Ambient Temperature Decreases Food Intake in a Simulated Office Setting: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Bernhard, Molly C; Li, Peng; Allison, David B; Gohlke, Julia M

    2015-01-01

    We hypothesized that exposure to temperatures above the thermoneutral zone (TNZ) would decrease food intake in young adults in a sedentary office environment over a 2-h period. Participants wearing standardized clothing were randomized to perform routine office work in the TNZ, considered control (19-20°C), or above the TNZ considered warmer (26-27°C) using a parallel-group design (n = 11 and 9, respectively). Thermal images of the inner canthus of their eye and middle finger nail bed, representing proxies of core and peripheral temperatures, respectively, were taken at baseline, first, and second hour during this lunchtime study. Heat dissipation was estimated using peripheral temperature. General linear models were built to examine the effects of thermal treatment on caloric intake and potential mediation by heat dissipation. Researchers conducted the trial registered as NCT02386891 at Clinicaltrials.gov during April to May 2014. During the 2-h stay in different ambient temperatures, the participants in the control conditions ate 99.5 kcal more than those in the warmer conditions; however, the difference was not statistically significant. Female participants ate about 350 kcal less than the male participants (p = 0.024) in both groups and there was no significant association between caloric intake and participant's body mass index (BMI). After controlling for thermal treatment, gender and BMI, the participant's peripheral temperature was significantly associated with caloric intake (p = 0.002), suggesting a mediating effect. Specifically, for every 1°C increase in peripheral temperature suggesting increased heat dissipation, participants ate 85.9 kcal less food. This pilot study provided preliminary evidence of effects of thermal environment on food intake. It suggests that decreased food intake in the experimental (warmer) environment is potentially mediated through thermoregulatory mechanisms.

  16. 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.

  17. 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.

  18. Healthy lifestyle promotion in primary schools through the board game Kaledo: a pilot cluster randomized trial.

    Science.gov (United States)

    Viggiano, Emanuela; Viggiano, Alessandro; Di Costanzo, Anna; Viggiano, Adela; Viggiano, Andrea; Andreozzi, Eleonora; Romano, Vincenzo; Vicidomini, Claudia; Di Tuoro, Daniela; Gargano, Giuliana; Incarnato, Lucia; Fevola, Celeste; Volta, Pietro; Tolomeo, Caterina; Scianni, Giuseppina; Santangelo, Caterina; Apicella, Maria; Battista, Roberta; Raia, Maddalena; Valentino, Ilaria; Palumbo, Marianna; Messina, Giovanni; Messina, Antonietta; Monda, Marcellino; De Luca, Bruno; Amaro, Salvatore

    2018-01-20

    The board game Kaledo was proven to be effective in improving nutrition knowledge and in modifying dietary behavior in students attending middle and high school. The present pilot study aims to reproduce these results in younger students (7-11 years old) attending primary school. A total of 1313 children from ten schools were recruited to participate in the present study. Participants were randomized into two groups: (1) the treatment group which consisted of playing Kaledo over 20 sessions and (2) the no intervention group. Anthropometric measures were carried out for both groups at baseline (prior to any treatment) and at two follow-up post-assessments (8 and 18 months). All the participants completed a questionnaire concerning physical activity and a 1-week food diary at each assessment. The primary outcomes were (i) BMI z-score, (ii) scores on physical activity, and (iii) scores on a dietary questionnaire. BMI z-score was significantly lower in the treated group compared to the control group at 8 months. Frequency and duration of self-reported physical activity were also significantly augmented in the treated group compared to the control group at both post-assessments. Moreover, a significant increase in the consumption of healthy food and a significant decrease in junk food intake were observed in the treated group. The present results confirm the efficacy of Kaledo in younger students in primary schools, and it can be used as a useful nutritional tool for obesity prevention programs in children. What is Known: • Kaledo is a new educational board game to improve nutrition knowledge and to promote a healthy lifestyle. • In two cluster randomized trials conducted in Campania region (Italy), we showed that Kaledo could improve nutrition knowledge and dietary behavior and have a positive effect on the BMI z-score in children with age ranging from 9 to 14 years old attending school. • Kaledo may be used as an effective tool for obesity prevention

  19. The Physiotherapy for Femoroacetabular Impingement Rehabilitation STudy (physioFIRST): A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Kemp, Joanne L; Coburn, Sally L; Jones, Denise M; Crossley, Kay M

    2018-04-01

    Study Design A pilot double-blind randomized controlled trial (RCT). Background The effectiveness of physical therapy for femoroacetabular impingement syndrome (FAIS) is unknown. Objectives To determine the feasibility of an RCT investigating the effectiveness of a physical therapy intervention for FAIS. Methods Participants were 17 women and 7 men (mean ± SD age, 37 ± 8 years; body mass index, 25.4 ± 3.4 kg/m 2 ) with FAIS who received physical therapy interventions provided over 12 weeks. The FAIS-specific physical therapy group received personalized progressive strengthening and functional retraining. The control group received standardized stretching exercises. In addition, both groups received manual therapy, progressive physical activity, and education. The primary outcome was feasibility, including integrity of the protocol, recruitment and retention, outcome measures, randomization procedure, and sample-size estimate. Secondary outcomes included hip pain and function (international Hip Outcome Tool-33 [iHOT-33]) and hip muscle strength. Poststudy interviews were conducted to determine potential improvements for future studies. Results Twenty-four (100%) patients with known eligibility agreed to participate. Four patients (17%) were lost to follow-up. All participants and the tester remained blinded, and the control intervention was acceptable to participants. The between-group mean differences in change scores were 16 (95% confidence interval [CI]: -9, 38) for the iHOT-33 and 0.24 (95% CI: 0.02, 0.47) Nm/kg for hip adduction strength, favoring the FAIS-specific physical therapy group. Using an effect size of 0.61, between-group improvements for the iHOT-33 suggest that 144 participants are required for a full-scale RCT. Conclusion A full-scale RCT of physical therapy for FAIS is feasible. A FAIS-specific physical therapy program has the potential for a moderate to large positive effect on hip pain, function, and hip adductor strength. Level of Evidence

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

    Science.gov (United States)

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

    2013-03-05

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

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

    Science.gov (United States)

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

    2018-01-01

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

  2. The ExStroke Pilot Trial: rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke

    DEFF Research Database (Denmark)

    Krarup, L.H.; Gluud, C.; Truelsen, T.

    2008-01-01

    of increasing stroke patients' level of physical activity and secondarily to associate the level of physical activity to the risk of recurrent stroke, myocardial infarction, and all-cause mortality in the two groups. We describe the rationale, design, and baseline data of the ExStroke Pilot Trial. METHODS......INTRODUCTION: A high level of physical activity is associated with a decreased risk of first stroke and physical activity modifies recognized stroke risk factors and is recommended for stroke survivors. Available research shows that stroke patients can increase their level of physical performance...... over a short period. When the intervention period is over, physical performance often declines towards baseline level. Currently, there is no evidence on the association between physical activity and the risk of recurrent stroke. The ExStroke Pilot Trial is a randomized clinical trial with the aim...

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

    Science.gov (United States)

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

    2008-01-01

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

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

    NARCIS (Netherlands)

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

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

  5. 'Huang Qi Elixir' for proteinuria in patients with diabetic nephropathy: a study protocol for a randomized controlled pilot trial.

    Science.gov (United States)

    Tu, Xiang; Liu, Fang; Jordan, James B; Ye, Xue Feng; Fu, Ping; Wang, Fei; Zhong, Sen

    2013-07-18

    Diabetic nephropathy (DN) is the major complication of diabetes; proteinuria is the hall mark of DN. Currently, the treatment for proteinuria is mainly limited to angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). According to Traditional Chinese Medicine (TCM) theory, Chinese medicinals 'securing essence and tonifying the kidney' may be appropriate for proteinuria. The most promising Chinese medicinals and formulae are introduced in the present study to form a potent formula for DN proteinuria. To make oral administration convenient, the formula will be processed in the form of granules. A randomized, multi-center pilot trial will be conducted. Forty eight participants with DN will be randomly assigned to one of four treatment groups: 1. A granule group, at 10 grams, three times daily (G10 group, n = 12); 2. A granule group, at 20 grams, three times daily (G20 group, n = 12); 3. A decoction group (D group, n = 12); and 4. An irbesartan group (Aprovel group, n = 12).The following outcome measures will be used: the percentage change of the albumin-to-creatinine ratio; and the changes in serum creatinine, glomerular filtration rate, fasting plasma glucose and hemoglobulin from baseline to the end of the trial. It is notable that most published clinical trials which assessed the efficacy of TCM on DN were of poor methodology and, therefore, their results have been invalidated. It is necessary to carry out well-designed clinical trials to provide sound evidence. The present trial is a study with potentially great value, for it will provide the parameters for future randomized, placebo-controlled, clinical trials with large sample sizes. The trial is registered on the Chinese Clinical Trial Registry: ChiCTR-TRC-12002718 (http://www.chictr.org/cn/proj/show.aspx?proj=3820).

  6. Constraint-Induced Aphasia Therapy for Treatment of Chronic Post-Stroke Aphasia: A Randomized, Blinded, Controlled Pilot Trial.

    Science.gov (United States)

    Szaflarski, Jerzy P; Ball, Angel L; Vannest, Jennifer; Dietz, Aimee R; Allendorfer, Jane B; Martin, Amber N; Hart, Kimberly; Lindsell, Christopher J

    2015-09-24

    To provide a preliminary estimate of efficacy of constraint-induced aphasia therapy (CIAT) when compared to no-intervention in patients with chronic (>1 year) post-stroke aphasia in order to plan an appropriately powered randomized controlled trial (RCT). We conducted a pilot single-blinded RCT. 24 patients were randomized: 14 to CIAT and 10 to no-intervention. CIAT groups received up to 4 hours/day of intervention for 10 consecutive business days (40 hours or therapy). Outcomes were assessed within 1 week of intervention and at 1 and 12 weeks after intervention and included several linguistic measures and a measure of overall subjective communication abilities (mini-Communicative Abilities Log (mini-CAL)). Clinicians treating patients (CIAT group) did not communicate with other team members to maintain blinding and the testing team members were blinded to treatment group assignment. Overall, the results of this pilot RCT support the results of previous observational studies that CIAT may lead to improvements in linguistic abilities. At 12 weeks, the treatment group reported better subjective communication abilities (mini-CAL) than the no-intervention group (p=0.019). Other measures trended towards better performance in the CIAT group. In this pilot RCT intensive language therapy led to an improvement in subjective language abilities. The effects demonstrated allow the design of a definitive trial of CIAT in patients with a variety of post-stroke aphasia types. In addition, our experiences have identified important considerations for designing subsequent trial(s) of CIAT or other interventions for post-stroke aphasia.

  7. Using pilot data to size a two-arm randomized trial to find a nearly optimal personalized treatment strategy.

    Science.gov (United States)

    Laber, Eric B; Zhao, Ying-Qi; Regh, Todd; Davidian, Marie; Tsiatis, Anastasios; Stanford, Joseph B; Zeng, Donglin; Song, Rui; Kosorok, Michael R

    2016-04-15

    A personalized treatment strategy formalizes evidence-based treatment selection by mapping patient information to a recommended treatment. Personalized treatment strategies can produce better patient outcomes while reducing cost and treatment burden. Thus, among clinical and intervention scientists, there is a growing interest in conducting randomized clinical trials when one of the primary aims is estimation of a personalized treatment strategy. However, at present, there are no appropriate sample size formulae to assist in the design of such a trial. Furthermore, because the sampling distribution of the estimated outcome under an estimated optimal treatment strategy can be highly sensitive to small perturbations in the underlying generative model, sample size calculations based on standard (uncorrected) asymptotic approximations or computer simulations may not be reliable. We offer a simple and robust method for powering a single stage, two-armed randomized clinical trial when the primary aim is estimating the optimal single stage personalized treatment strategy. The proposed method is based on inverting a plugin projection confidence interval and is thereby regular and robust to small perturbations of the underlying generative model. The proposed method requires elicitation of two clinically meaningful parameters from clinical scientists and uses data from a small pilot study to estimate nuisance parameters, which are not easily elicited. The method performs well in simulated experiments and is illustrated using data from a pilot study of time to conception and fertility awareness. Copyright © 2015 John Wiley & Sons, Ltd.

  8. A Pilot Randomized Trial of Text-Messaging for Symptom Awareness and Diabetes Knowledge in Adolescents With Type 1 Diabetes

    Science.gov (United States)

    Han, Yi; Faulkner, Melissa Spezia; Fritz, Heather; Fadoju, Doris; Muir, Andrew; Abowd, Gregory D.; Head, Lauren; Arriaga, Rosa I.

    2015-01-01

    Adolescents with type 1 diabetes typically receive clinical care every 3 months. Between visits, diabetes-related issues may not be frequently reflected, learned, and documented by the patients, limiting their self-awareness and knowledge about their condition. We designed a text-messaging system to help resolve this problem. In a pilot, randomized controlled trial with 30 adolescents, we examined the effect of text messages about symptom awareness and diabetes knowledge on glucose control and quality of life. The intervention group that received more text messages between visits had significant improvements in quality of life. PMID:25720675

  9. 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

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

    Science.gov (United States)

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

    2016-04-27

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

  11. Varenicline for opioid withdrawal in patients with chronic pain: a randomized, single-blinded, placebo controlled pilot trial.

    Science.gov (United States)

    Hooten, W Michael; Warner, David O

    2015-03-01

    The objectives of this randomized, single-blinded, placebo-controlled pilot trial were to investigate the effects of varenicline on opioid withdrawal among chronic pain patients undergoing opioid detoxification in an interdisciplinary pain program and the feasibility of varenicline use in this population. Twenty-one patients were recruited (varenicline=10, placebo=11), and 7 patients in the varenicline and 11 in the placebo group completed the study. Opioid withdrawal was quantified using the Clinical Opiate Withdrawal Scale, and varenicline-related adverse effects were assessed. Opioid withdrawal scores tended to decrease over the course of opioid tapering in those receiving varenicline and increase in those receiving placebo. Varenicline was well-tolerated in this population, with no adverse drug effects (including nausea) observed and no effect on improvements in pain severity and depression. This randomized pilot study provides preliminary data for future trials of varenicline in opioid-dependent adults with chronic pain undergoing medically directed opioid detoxification. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2018-05-01

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

  13. Provider Training to Screen and Initiate Evidence-Based Pediatric Obesity Treatment in Routine Practice Settings: A Randomized Pilot Trial.

    Science.gov (United States)

    Kolko, Rachel P; Kass, Andrea E; Hayes, Jacqueline F; Levine, Michele D; Garbutt, Jane M; Proctor, Enola K; Wilfley, Denise E

    This randomized pilot trial evaluated two training modalities for first-line, evidence-based pediatric obesity services (screening and goal setting) among nursing students. Participants (N = 63) were randomized to live interactive training or Web-facilitated self-study training. Pretraining, post-training, and 1-month follow-up assessments evaluated training feasibility, acceptability, and impact (knowledge and skill via simulation). Moderator (previous experience) and predictor (content engagement) analyses were conducted. Nearly all participants (98%) completed assessments. Both types of training were acceptable, with higher ratings for live training and participants with previous experience (ps pediatric obesity services. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

  14. Meal-Replacements followed by Topiramate for the Treatment of Adolescent Severe Obesity: A Pilot Randomized Controlled Trial

    Science.gov (United States)

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

    2016-01-01

    Objective The objective of this pilot study was to assess the safety and efficacy of short-term meal replacement therapy followed by topiramate for body mass index (BMI) reduction in adolescents with severe obesity. Methods Adolescents (ages 12-18 years) with severe obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m2) were recruited for this double-blind, randomized, placebo-controlled trial. Participants completed 4 weeks of meal replacement therapy followed by randomization (1:1) to either 24 weeks of topiramate 75 mg/day or placebo. Mean changes were compared between groups. Results Thirty adolescents (mean age 15.2 ± 1.7 years, mean BMI 40.3 ± 4.6 kg/m2) completed the meal replacement phase and were randomized; 21 completed the study. The difference in mean percent change in BMI between the topiramate and placebo groups was not significant (−1.9% [95% CI (−5.2%, +1.5%); P=0.291]). Significant improvements in visceral fat and VLDL-c were observed in the topiramate compared to the placebo group. There were no concerning changes in neurocognitive function or bone health. Conclusion In this pilot study, 4 weeks of meal replacement therapy followed by 24 weeks of low-dose topiramate compared to meal replacement therapy alone did not result in significant BMI reduction for adolescents with severe obesity. PMID:27807925

  15. Muscle energy technique compared to eccentric loading exercise in the management of achilles tendinitis: A pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hariharasudhan Ravichandran

    2017-01-01

    Full Text Available Background: Achilles tendinitis is a common overuse injury among both elite and recreational athletes involved in activities such as repetitive jumping and running. Aim: The aim of this single-blinded randomized study was to compare the efficacy of muscle energy technique (MET and eccentric loading exercise (ELE interventions on improving functional ability and pain reduction among athletes with Achilles tendinitis. Methods: A single-blinded, pilot, randomized study was conducted in the Department of Physical Therapy, Global Hospitals and Health City, India, with 6-week follow-up. A total of 30 patients with Achilles tendinitis were randomly allocated to receive either MET (n = 15 or ELE (n = 15 treatment. Treatment effects were evaluated by pre- and post-treatment assessment of visual analog scale (VAS and Victorian Institute of Sports Assessment-Achilles (VISA-A questionnaire. Measures were performed by single-blinded evaluators at baseline and at 2, 4, and after 6 weeks of treatment. Results: Both groups showed a significant difference in VAS after 6 weeks' ELE group showed a significant improvement during treatment at 2 and 4 weeks in comparison with MET group. The VISA-A scale score significantly improved in both groups. Yet, comparison of VISA scores between groups showed marginally significant difference (P = 0.012. Conclusion: This pilot randomized controlled trial (RCT showed the efficacy of ELE in reducing pain and improving functional ability among patients with Achilles tendinitis. The findings of this study provide the rationale for undertaking a large-scale RCT. A large sized trial is needed to establish evidence for clinical practice of ELE in Achilles tendinitis cases.

  16. Symptomatic treatment (ibuprofen or antibiotics (ciprofloxacin for uncomplicated urinary tract infection? - Results of a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Wegscheider Karl

    2010-05-01

    Full Text Available Abstract Background Uncomplicated lower urinary tract infections (UTI are usually treated with antibiotics. However, there is little evidence for alternative therapeutic options. This pilot study was set out 1 to make a rough estimate of the equivalence of ibuprofen and ciprofloxacin for uncomplicated urinary tract infection with regard to symptom resolution, and 2 to demonstrate the feasibility of a double-blind, randomized controlled drug trial in German general practices. Methods We performed a double-blind, randomized controlled pilot trial in 29 German general practices. Eighty otherwise healthy women aged 18 to 85 years, presenting with at least one of the main UTI symptoms dysuria and frequency and without any complicating factors, were randomly assigned to receive either ibuprofen 3 × 400 mg oral or ciprofloxacin 2 × 250 mg (+1 placebo oral, both for three days. Intensity of main symptoms - dysuria, frequency, low abdominal pain - was recorded at inclusion and after 4, 7 and 28 days, scoring each symptom from 0 (none to 4 (very strong. The primary endpoint was symptom resolution on Day 4. Secondary outcomes were the burden of symptoms on Days 4 and 7 (based on the sum score of all symptoms, symptom resolution on Day 7 and frequency of relapses. Equivalence margins for symptom burden on Day 4 were pre-specified as +/- 0.5 sum score points. Data analysis was done by intention to treat and per protocol. Randomization was carried out on patient level by computer programme in blocks of six. Results Seventy-nine patients were analyzed (ibuprofen n = 40, ciprofloxacin n = 39. On Day 4, 21/36 (58.3% of patients in the ibuprofen-group were symptom-free versus 17/33 (51.5% in the ciprofloxacin-group. On Day 4, ibuprofen patients reported fewer symptoms in terms of total sum score (1; SD 1,42 than ciprofloxacin patients (1,3; SD 1,9, difference -0,33 (95% CI (-1,13 to +0,47, PP (per protocol analysis. During Days 0 and 9, 12/36 (33% of patients

  17. Early vibration assisted physiotherapy in toddlers with cerebral palsy ? a randomized controlled pilot trial

    OpenAIRE

    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). Intervention: 14 weeks sWBV with ten 9-minute sessions weekly (non-individualized). Group A started with sWBV, followed by 14 weeks without; in group B this order was reversed. Feasibility (?70% adherence) a...

  18. A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects.

    Science.gov (United States)

    Carpenter, Matthew J; Heckman, Bryan W; Wahlquist, Amy E; Wagener, Theodore L; Goniewicz, Maciej L; Gray, Kevin M; Froeliger, Brett; Cummings, K Michael

    2017-12-01

    Background: Most studies of electronic nicotine delivery systems (ENDS) compare self-selected users versus nonusers. The few randomized studies to date generally support a positive impact on reducing smoking behavior, but these studies are focused on guided ENDS use. This study presents a randomized, naturalistic trial of ENDS with prospective outcomes of uptake and behavioral changes in smoking. Methods: Adult smokers with minimal ENDS history were randomized in a 2:1 ratio to receive product for 3 weeks ( n = 46), or not ( n = 22). Changes in nicotine delivery (16 vs. 24 mg), midway through the study allowed a compelling opportunity to examine two ENDS products compared with the control group. Primary outcomes, assessed via daily diaries during sampling period and in-person laboratory visits over 4 months, included uptake and usage of ENDS, cessation-related outcomes, and exposure to smoke constituents. Results: All ENDS participants tried product at least once, with 48% of 24 mg and 30% of 16 mg using their assigned product for the entire sampling period. Within the 24 mg ENDs group, 57% made an independent purchase of ENDS, versus 28% of 16 mg, and 14% of control participants ( P = 0.01). Smokers in both ENDS groups significantly reduced their smoking, whereas control participants did not ( P = 0.03). Cessation behaviors (quit attempts, biologically verified abstinence) numerically but not statistically favored ENDS participants. Conclusions: Results suggest that cigarette smokers are willing to use ENDS with trends toward reduced cigarette smoking and positive changes in cessation-related behaviors. Impact: Randomized, naturalistic trials such as presented herein are needed to understand the population impact of e-cigarettes. Cancer Epidemiol Biomarkers Prev; 26(12); 1795-803. ©2017 AACR . ©2017 American Association for Cancer Research.

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

    Science.gov (United States)

    Yang, Chiu-Ling; Chen, Chung-Hey

    2018-01-01

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

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

    Science.gov (United States)

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

    2018-06-01

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

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

    Science.gov (United States)

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

    2014-02-01

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

  2. Clinical effects of probiotics containing Bacillus species on gingivitis: a pilot randomized controlled trial.

    Science.gov (United States)

    Alkaya, B; Laleman, I; Keceli, S; Ozcelik, O; Cenk Haytac, M; Teughels, W

    2017-06-01

    Lactobacillus spp. and bifidobacteria are the most frequently used probiotics in oral health research. However, although probiotic effects have been suggested for other genera, such as bacilli, no trials are available to describe the effect of bacilli probiotics on gingivitis in humans. The aim of the present study was to evaluate the clinical effects of a bacilli-containing toothpaste, a mouthrinse and a toothbrush cleaner versus a placebo in patients with generalized gingivitis. In this double-blind placebo-controlled randomized clinical trial, nonsmoking, systemically healthy patients with generalized gingivitis were included. They used a placebo or an experimental probiotic Bacillus subtilis-, Bacillus megaterium- and Bacillus pumulus-containing toothpaste, mouthrinse and toothbrush cleaner for 8 wk. Primary outcome measures of interest were plaque and gingivitis index, and the secondary outcome measures were pocket probing depth and bleeding on probing. Twenty male and 20 female patients were randomized over the two groups. All participants could be included in the final analysis. Although plaque and gingivitis indices were significantly reduced after 8 wk, no intergroup differences could be found at any time point. Also, for the secondary outcome measure, intragroup but no intergroup differences could be detected. No harm or unintended effects were reported by the patients after using the study products. This study did not show any statistically significant differences between a placebo and a bacilli-containing toothpaste, mouthrinse and toothbrush cleaner on gingivitis parameters. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  3. A Pilot Randomized Controlled Trial to Promote Immunosuppressant Adherence in Adult Kidney Transplant Recipients.

    Science.gov (United States)

    Cukor, Daniel; Ver Halen, Nisha; Pencille, Melissa; Tedla, Fasika; Salifu, Moro

    2017-01-01

    Nonadherence to immunosuppressant medication is a prevalent practice among kidney transplant recipients and has been associated with increased risk for graft failure and economic burden. The aim of this pilot study was to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription as measured by telephone pill counts among kidney transplant recipients. Thirty-three adult transplant recipients were less than 98% adherent to tacrolimus prescription based on 3 telephone pill counts and were randomized either to the 2-session cognitive-behavioral adherence promotion program or to standard care. The curriculum was developed from an iterative process with transplant recipients into a 2-session group program that provided psychoeducation, addressed barriers to adherence, fostered motivation to improve adherence behavior, and discussed cultural messages on adherence behavior. The intervention group displayed significantly higher levels of adherence when compared to the control group (t = 2.2, p = 0.04) and. similarly, when the amount of change was compared between the groups, the intervention group showed more change than the control condition (F (22,1) = 12.005, p = 0.003). Tacrolimus trough concentration levels were used as a secondary measure of adherence and, while there were no significant between-group differences for mean trough concentration levels, the variability in the trough levels did significantly decrease over time indicating more consistent pill-taking behavior in the intervention group. There is preliminary support for the pilot program as a successful intervention in helping patients with their immunosuppressant medication. © 2016 S. Karger AG, Basel.

  4. 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; Phillips, Russell S

    2013-07-01

    The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. This was a randomized controlled trial. Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects were patients with metastatic cancer. There were three interventions: massage therapy, no-touch intervention, and usual care. Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. 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. 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.

  5. A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial.

    Science.gov (United States)

    Cevallos, Myriam; Züllig, Stephanie; Christen, Andri; Meier, Brigitte E; Goetz, Martin; Coslovsky, Michael; Trelle, Sven

    2015-12-01

    Several countries are working to adapt clinical trial regulations to align the approval process to the level of risk for trial participants. The optimal framework to categorize clinical trials according to risk remains unclear, however. Switzerland is the first European country to adopt a risk-based categorization procedure in January 2014. We assessed how accurately and consistently clinical trials are categorized using two different approaches: an approach using criteria set forth in the new law (concept) or an intuitive approach (ad hoc). This was a randomized controlled trial with a method-comparison study nested in each arm. We used clinical trial protocols from eight Swiss ethics committees approved between 2010 and 2011. Protocols were randomly assigned to be categorized in one of three risk categories using the concept or the ad hoc approach. Each protocol was independently categorized by the trial's sponsor, a group of experts and the approving ethics committee. The primary outcome was the difference in categorization agreement between the expert group and sponsors across arms. Linear weighted kappa was used to quantify agreements, with the difference between kappas being the primary effect measure. We included 142 of 231 protocols in the final analysis (concept=78; ad hoc=64). Raw agreement between the expert group and sponsors was 0.74 in the concept and 0.78 in the ad hoc arm. Chance-corrected agreement was higher in the ad hoc (kappa: 0.34 (95% confidence interval=0.10-0.58)) than in the concept arm (0.27 (0.06-0.50)), but the difference was not significant (p=0.67). The main limitation was the large number of protocols excluded from the analysis mostly because they did not fit with the clinical trial definition of the new law. A structured risk categorization approach was not better than an ad hoc approach. Laws introducing risk-based approaches should provide guidelines, examples and templates to ensure correct application. © The Author(s) 2015.

  6. 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

  7. Increasing patient involvement in the diabetic foot pathway: a pilot randomized controlled trial.

    Science.gov (United States)

    McBride, E; Hacking, B; O'Carroll, R; Young, M; Jahr, J; Borthwick, C; Callander, A; Berrada, Z

    2016-11-01

    This pilot study aimed to explore whether the use of an intervention to increase shared decision-making (Decision Navigation) increased decision self-efficacy and foot-treatment adherence in patients with a diabetic foot ulcer. Fifty-six patients with a diabetic foot ulcer were randomized to receive Decision Navigation (N = 30) or usual care (N = 26). Primary outcomes included decision self-efficacy, adherence to foot treatment as reported by the participant and adherence to foot treatment as reported by the clinician. Secondary outcomes included foot ulcer healing rate, health-related quality of life, decision conflict and decision regret. Despite participants rating Decision Navigation as very helpful, mixed analyses of variance revealed no differences in decision self-efficacy or adherence between those receiving Decision Navigation and those receiving usual care. There were no differences between groups with regards to the secondary outcomes, with the exception of decision conflict which increased over time (12 weeks) for those receiving Decision Navigation. An intervention that facilitated patient involvement in treatment decisions did not have any impact on decisional confidence or adherence to foot treatment. This does not provide support for the suggestion that personalized care can improve health-related outcomes at this progressed stage of the patient's disease trajectory. We suggest that the diabetic foot population may benefit from interventions aimed at increasing motivation to engage with care pathways, centred on challenging personal controllability beliefs. © 2016 Diabetes UK.

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

    Science.gov (United States)

    Whitley, Julie Anne; Rich, Bonnie L

    2008-12-01

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

  9. A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy.

    Science.gov (United States)

    Advani, Pragati; Brewster, Abenaa M; Baum, George P; Schover, Leslie R

    2017-08-01

    A randomized pilot trial evaluated the hypothesis that early intervention lessens sexual dysfunction in the first year on aromatase inhibitors. A secondary aim was comparing the efficacy of two vaginal moisturizers. Fifty-seven postmenopausal women with early stage breast cancer starting aromatase inhibitors were randomized to three treatment groups. All received a handout on managing sexual and other side effects. The Usual Care group received no additional therapy. The Active Treatment groups received a 6-month supply of a vaginal moisturizer (hyaluronic acid-based in Active Group-H and prebiotic in Active Group-P) and a vaginal lubricant and dilator, plus access to an educational website and phone coaching. Questionnaires completed at baseline, 6, and 12 months included the Female Sexual Function Index (FSFI), Menopausal Sexual Interest Questionnaire (MSIQ), Female Sexual Distress Scale-Revised (FSDS-R), and a menopausal symptom scale. Forty-nine women (86%) provided follow-up data. Mean age was 59 and 77% were non-Hispanic Caucasian. Sexual function was impaired at baseline, but remained stable over 12 months for all groups. The combined active treatment group had less dyspareunia (P = 0.07) and sexual distress (P = 0.02) at 6 months than the Usual Care group. At 6 months, the Active-H group improved significantly more than the Active-P group on FSFI total score (P = 0.04). Sexual counseling helped women maintain stable sexual function on aromatase inhibitors. Active intervention resulted in better outcomes at 6 months. This promising pilot trial suggests a need for more research on preventive counseling to maintain sexual function during aromatase inhibitor treatment.

  10. 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.

  11. Dexamphetamine improves upper extremity outcome during rehabilitation after stroke: a pilot randomized controlled trial.

    Science.gov (United States)

    Schuster, Corina; Maunz, Gerd; Lutz, Karin; Kischka, Udo; Sturzenegger, Rolf; Ettlin, Thierry

    2011-10-01

    For early inpatient stroke rehabilitation, the effectiveness of amphetamine combined with physiotherapy varies across studies. To investigate whether the recovery of activities of daily living (ADL, primary outcome) and motor function (secondary outcome) can be improved by dexamphetamine added to physiotherapy. In a double-blind, placebo-controlled trial, 16 patients, from 918 who were screened, were randomized to the experimental group (EG, dexamphetamine + physiotherapy) or control group (CG, placebo + physiotherapy). Both groups received multidisciplinary inpatient rehabilitation. Dexamphetamine (10 mg oral) or placebo was administered 2 days per week before physiotherapy. ADL and motor function were measured using the Chedoke-McMaster Stroke Assessment (CMSA) twice during baseline, every week during the 5-week treatment period, and at follow-up 1 week, 6 months, and 12 months after intervention. The majority of ineligible patients had too little paresis, were on anticoagulants, or had a stroke >60 days prior to entry. Participants (EG, n = 7, age 70.3 ± 10 years, 5 women, 37.9 ± 9 days after stroke; CG, n = 9, age 65.2 ± 17 years, 3 women, 40.3 ± 9 days after stroke) did not differ at baseline except for the leg subscale. Analysis of variance from baseline to 1 week follow-up revealed significant improvements in favor of EG for subscales ADL (P = .023) and arm function (P = .020) at end of treatment. No adverse events were detected. In this small trial that was based on prior positive trials, significant gains in ADL and arm function suggest that the dose and timing of dexamphetamine can augment physiotherapy. Effect size calculation suggests inclusion of at least 25 patients per group in future studies.

  12. Evaluation of a “Just-in-Time” Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial

    Science.gov (United States)

    Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

    2017-01-01

    Context Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. Objective To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Design Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Main Outcome Measures Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Results Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p Just-in-time” nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care. PMID:28746019

  13. Evaluation of a "Just-in-Time" Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

    2017-01-01

    Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p Just-in-time" nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care.

  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 fall injury rates. A definitive randomized controlled trial analysing the effect of Pilates in older people would be feasible and is warranted given the acceptability and potential positive effects of Pilates on fall injuries and fall risk factors. The protocol for this study is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1262000224820). © The Author(s) 2015.

  15. An 8-week stress management program in pathological gamblers: a pilot randomized controlled trial.

    Science.gov (United States)

    Linardatou, C; Parios, A; Varvogli, L; Chrousos, G; Darviri, C

    2014-09-01

    Stress plays a major role at the onset and relapse of pathological gambling (PG), but at the same time it can also be the aftermath of gambling behavior, thus revealing a reciprocal relationship. Although the role of stress has been well-documented, there is a paucity of studies investigating the effect of an adjunctive stress management program on PG. In this 8-week parallel randomized waitlist controlled trial pathological gamblers, already in the gamblers anonymous (GA) group, were assigned randomly in two groups, with the intervention group (n = 22) receiving an additional stress management program (consisting of education on diet and exercise, stress coping methods, relaxation breathing -RB- and progressive muscle relaxation -PMR). Self-reported measures were used in order to evaluate stress, depression, anxiety, sleep quality/disturbances, life-satisfaction and daily routine. The statistical analyses for the between group differences concerning the main psychosocial study outcomes revealed a statistically significant amelioration of stress, depression, anxiety symptoms and an increase of life-satisfaction and a better daily routine in participants of the intervention group. We hope that these will encourage researchers and clinicians to adopt stress management in their future work. Copyright © 2014 Elsevier Ltd. All rights reserved.

  16. Effect of tranexamic acid on gross hematuria: A pilot randomized clinical trial study.

    Science.gov (United States)

    Moharamzadeh, Payman; Ojaghihaghighi, Seyedhossein; Amjadi, Mohsen; Rahmani, Farzad; Farjamnia, Arezoo

    2017-12-01

    Local forms of the tranexamic acid have been effective in treating many haemorrhagic cases. So that the aim of the current study is to assess the effectiveness of local tranexamic acid in controlling painless hematuria in patients referred to the emergency department. This is a randomized, double-blind clinical trial study, which was conducted on 50 patients with complaints of painless lower urinary tract bleeding during June 2014 and August 2015. The patients were randomly divided into two groups of 25 people each, one group receiving tranexamic acid and the other given a placebo. During bladder irrigation, local tranexamic acid and the placebo were injected into the bladder via Foley catheter. Patients were examined over 24h in terms of the amount of normal saline serum used for irrigation, level of hemoglobin, and blood in urine. In this study it was observed that consumption of tranexamic acid significantly decreased the volume of used serum for bladder irrigation (P=0.041) and the microscopic status of urine decreased significantly in terms of the hematuria after 24h (P=0.026). However, the rate of packed cell transfusion and drop in hemoglobin levels showed no significant difference in both groups of patients (P˃0.05). The results of this study showed that tranexamic acid could significantly reduce the volume of required serum for bladder irrigation to clear urine, but it had no significant effect on the drop in serum hemoglobin levels. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. A pilot randomized controlled trial of aerobic exercise as an adjunct to OCD treatment.

    Science.gov (United States)

    Abrantes, Ana M; Brown, Richard A; Strong, David R; McLaughlin, Nicole; Garnaat, Sarah L; Mancebo, Maria; Riebe, Deborah; Desaulniers, Julie; Yip, Agustin G; Rasmussen, Steven; Greenberg, Benjamin D

    2017-11-01

    The purpose of the current study was to conduct a randomized controlled trial testing the efficacy of aerobic exercise for decreasing OCD symptom severity, other mental health outcomes, and increasing exercise behaviors and cardiorespiratory fitness among individuals with OCD. Fifty-six patients (64% female; mean age=38.8years) with OCD and a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of 16 or greater despite engaging in OCD treatment were randomized to 12-weeks of supervised plus home-based moderate-intensity aerobic exercise (AE; n=28) or to 12-weeks of health education sessions (HE; n=28). Random intercepts mixed models examined differences between conditions at post-treatment. Though no difference between conditions on outcomes was observed, both AE and HE showed significant reduction in OCD symptom severity, depression and anxiety at post-treatment. Relative to HE, significant increases were noted in amount of exercise and cardiorespiratory fitness for those in the AE condition. At post-treatment, 30.4% of the AE condition (7 of 23) were treatment-responders (using the commonly accepted measure of 35% symptom reduction from baseline). In the HE condition, 7.7% of the sample (2 of 26) met this criterion at post-treatment. The results of this preliminary study suggest that exercise and health-focused interventions may be beneficial adjuncts to existing OCD treatment. Future studies with larger samples are needed to more definitively answer questions the efficacy of AE for reducing OCD symptoms and improving related clinical outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Sudha Prathikanti

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

  19. 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

  20. 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

  1. Couple-Based Psychosexual Support Following Prostate Cancer Surgery: Results of a Feasibility Pilot Randomized Control Trial.

    Science.gov (United States)

    Robertson, Jane; McNamee, Phillip; Molloy, Gerry; Hubbard, Gill; McNeill, Alan; Bollina, Prasad; Kelly, Daniel; Forbat, Liz

    2016-08-01

    Surgery for prostate cancer can result in distressing side effects such as sexual difficulties, which are associated with lower levels of dyadic functioning. The study developed and tested an intervention to address sexual, relational, and emotional aspects of the relationship after prostate cancer by incorporating elements of family systems theory and sex therapy. To develop and test the feasibility and acceptability of relational psychosexual treatment for couples with prostate cancer, determine whether a relational-psychosexual intervention is feasible and acceptable for couples affected by prostate cancer, and determine the parameters for a full-scale trial. Forty-three couples were recruited for this pilot randomized controlled trial and received a six-session manual-based psychosexual intervention or usual care. Outcomes were measured before, after, and 6 months after the intervention. Acceptability and feasibility were established from recruitment and retention rates and adherence to the manual. The primary outcome measurement was the sexual bother subdomain of the Expanded Prostate Cancer Index Composite. The Hospital Anxiety and Depression Scale and the 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) were used to measure emotional and relational functioning, respectively. The intervention was feasible and acceptable. The trial achieved adequate recruitment (38%) and retention (74%) rates. The intervention had a clinically and statistically significant effect on sexual bother immediately after the intervention. Small decreases in anxiety and depression were observed for the intervention couples, although these were not statistically significant. Practitioners reported high levels of adherence to the manual. The clinically significant impact on sexual bother and positive feedback on the study's feasibility and acceptability indicate that the intervention should be tested in a multicenter trial. The SCORE-15 lacked specificity for this

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

    Directory of Open Access Journals (Sweden)

    Alfredo D. Oliveira-Filho

    2014-12-01

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

  3. 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.

  4. Sodium bicarbonate infusion in patients undergoing orthotopic liver transplantation: a single center randomized controlled pilot trial.

    Science.gov (United States)

    Weinberg, Laurence; Broad, Jeremy; Pillai, Param; Chen, Guangjun; Nguyen, Micheline; Eastwood, Glenn M; Scurrah, Nick; Nikfarjam, Mehrdad; Story, David; McNicol, Larry; Bellomo, Rinaldo

    2016-05-01

    Liver transplantation-associated acute kidney injury (AKI) carries significant morbidity and mortality. We hypothesized that sodium bicarbonate would reduce the incidence and/or severity of liver transplantation-associated AKI. In this double-blinded pilot RCT, adult patients undergoing orthotopic liver transplantation were randomized to an infusion of either 8.4% sodium bicarbonate (0.5 mEq/kg/h for the first hour; 0.15 mEq/kg/h until completion of surgery); (n = 30) or 0.9% sodium chloride (n = 30). AKI within the first 48 h post-operatively. There were no significant differences between the two treatment groups with regard to baseline characteristics, model for end-stage liver disease and acute physiology and chronic health evaluation (APACHE) II scores, and pre-transplantation renal function. Intra-operative factors were similar for duration of surgery, blood product requirements, crystalloid and colloid volumes infused and requirements for vasoactive therapy. Eleven patients (37%) in the bicarbonate group and 10 patients (33%) in the sodium chloride group developed a post-operative AKI (p = 0.79). Bicarbonate infusion attenuated the degree of immediate post-operative metabolic acidosis; however, this effect dissipated by 48 h. There were no significant differences in ventilation hours, ICU or hospital length of stay, or mortality. The intra-operative infusion of sodium bicarbonate did not decrease the incidence of AKI in patients following orthotopic liver transplantation. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    Science.gov (United States)

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

    2015-06-01

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

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

    Science.gov (United States)

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

    2016-12-01

    To assess the safety and efficacy of short-term meal replacement therapy followed by topiramate for body mass index (BMI) reduction in adolescents with severe obesity. Adolescents (ages 12-18 years) with severe obesity (BMI ≥1.2 times the 95th percentile or BMI ≥35 kg/m 2 ) were recruited for this double-blind, randomized, placebo-controlled trial. Participants completed 4 weeks of meal replacement therapy followed by randomization (1:1) to either 24 weeks of topiramate 75 mg/day or placebo. Mean changes were compared between groups. Thirty adolescents (mean age 15.2 ± 1.7 years, mean BMI 40.3 ± 4.6 kg/m 2 ) completed the meal replacement phase and were randomized; 21 completed the study. The difference in mean percent change in BMI between the topiramate and placebo groups was not significant (-1.9%; 95% CI: -5.2% to +1.5%; P = 0.291). Significant improvements in visceral fat and very-low-density lipoprotein cholesterol were observed in the topiramate compared with the placebo group. There were no concerning changes in neurocognitive function or bone health. In this pilot study, 4 weeks of meal replacement therapy followed by 24 weeks of low-dose topiramate compared with meal replacement therapy alone did not result in significant BMI reduction for adolescents with severe obesity. © 2016 The Obesity Society.

  7. Repetitive transcranial magnetic stimulation versus botulinum toxin injection in chronic migraine prophylaxis: a pilot randomized trial

    Directory of Open Access Journals (Sweden)

    Shehata HS

    2016-10-01

    Full Text Available Hatem S Shehata, Eman H Esmail, Ahmad Abdelalim, Shaimaa El-Jaafary, Alaa Elmazny, Asmaa Sabbah, Nevin M Shalaby Neurology Department, Faculty of Medicine, Cairo University, Cairo, Egypt Background: Chronic migraine is a prevalent disabling disease, with major health-related burden and poor quality of life. Long-term use of preventive medications carries risk of side effects. Objectives: The aim of this study was to compare repetitive transcranial magnetic stimulation (rTMS to botulinum toxin-A (BTX-A injection as preventive therapies for chronic migraine. Methods: A pilot, randomized study was conducted on a small-scale sample of 29 Egyptian patients with chronic migraine, recruited from Kasr Al-Aini teaching hospital outpatient clinic and diagnosed according to ICHD-III (beta version. Patients were randomly assigned into two groups; 15 patients received BTX-A injection following the Phase III Research Evaluating Migraine Prophylaxis Therapy injection paradigm and 14 patients were subjected to 12 rTMS sessions delivered at high frequency (10 Hz over the left motor cortex (MC, M1. All the patients were requested to have their 1-month headache calendar, and they were subjected to a baseline 25-item (beta version Henry Ford Hospital Headache Disability Inventory (HDI, Headache Impact Test (HIT-6, and visual analogue scale assessment of headache intensity. The primary efficacy measures were headache frequency and severity; secondary measures were 25-item HDI, HIT-6, and number of acute medications. Follow-up visits were scheduled at weeks 4, 6, 8, 10, and 12 after baseline visit. Results: A reduction in all outcome measures was achieved in both the groups. However, this improvement was more sustained in the BTX-A group, and both the therapies were well tolerated. Conclusion: BTX-A injection and rTMS have favorable efficacy and safety profiles in chronic migraineurs. rTMS is of comparable efficacy to BTX-A injection in chronic migraine

  8. A pilot randomized, controlled trial of metformin versus insulin in women with type 2 diabetes mellitus during pregnancy.

    Science.gov (United States)

    Refuerzo, Jerrie S; Gowen, Rose; Pedroza, Claudia; Hutchinson, Maria; Blackwell, Sean C; Ramin, Susan

    2015-02-01

    Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus (T2DM). The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM. A pilot randomized, controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy. The primary outcome was glycemic control measured with hemoglobin A1c metformin and 11 received insulin. All women in both groups achieved glycemic control by delivery (HgbA1c: metformin 5.96 ± 5.88 vs. insulin 6.34 ± 0.92%). There were similar rates of cesarean delivery, birth weights, neonatal intensive care unit admissions, respiratory distress syndrome, and neonatal dextrose treatment between groups. There was one case of fetal macrosomia in the insulin group, one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy. In this pilot study, glycemic control was achieved in women who received metformin and insulin. Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  9. Pilot Randomized Controlled Trial of Titrated Subcutaneous Ketamine in Older Patients with Treatment-Resistant Depression.

    Science.gov (United States)

    George, Duncan; Gálvez, Verònica; Martin, Donel; Kumar, Divya; Leyden, John; Hadzi-Pavlovic, Dusan; Harper, Simon; Brodaty, Henry; Glue, Paul; Taylor, Rohan; Mitchell, Philip B; Loo, Colleen K

    2017-11-01

    To assess the efficacy and safety of subcutaneous ketamine for geriatric treatment-resistant depression. Secondary aims were to examine if repeated treatments were safe and more effective in inducing or prolonging remission than a single treatment. In this double-blind, controlled, multiple-crossover study with a 6-month follow-up (randomized controlled trial [RCT] phase), 16 participants (≥60 years) with treatment-resistant depression who relapsed after remission or did not remit in the RCT were administered an open-label phase. Up to five subcutaneous doses of ketamine (0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg) were administered in separate sessions (≥1 week apart), with one active control (midazolam) randomly inserted (RCT phase). Twelve ketamine treatments were given in the open-label phase. Mood, hemodynamic, and psychotomimetic outcomes were assessed by blinded raters. Remitters in each phase were followed for 6 months. Seven of 14 RCT-phase completers remitted with ketamine treatment. Five remitted at doses below 0.5 mg/kg. Doses ≥ 0.2 mg/kg were significantly more effective than midazolam. Ketamine was well tolerated. Repeated treatments resulted in higher likelihood of remission or longer time to relapse. Results provide preliminary evidence for the efficacy and safety of ketamine in treating elderly depressed. Dose titration is recommended for optimizing antidepressant and safety outcomes on an individual basis. Subcutaneous injection is a practical method for giving ketamine. Repeated treatments may improve remission rates (clinicaltrials.gov; NCT01441505). Copyright © 2017 American Association for Geriatric Psychiatry. All rights reserved.

  10. Supplemental vitamin D and physical performance in COPD: a pilot randomized trial

    Directory of Open Access Journals (Sweden)

    Bjerk SM

    2013-02-01

    Full Text Available Sonja M Bjerk,1 Bradley D Edgington,1 Thomas S Rector,1,2 Ken M Kunisaki1,21University of Minnesota, 2Minneapolis VA Health Care System, Minneapolis, MN, USABackground: Low 25-hydroxyvitamin D (25[OH]D levels, commonly observed in chronic obstructive pulmonary disease (COPD, are associated with muscle weakness in elderly populations, and vitamin D supplementation appears to improve muscle strength and decrease falls in older individuals. We tested the effect of vitamin D supplementation on physical performance in patients with COPD.Methods: Patients were randomized to daily cholecalciferol (2000 IU or placebo for 6 weeks. The primary outcome was the 6-week change in Short Physical Performance Battery (SPPB score. Secondary outcomes included changes in the St George’s Respiratory Questionnaire (SGRQ score, and serum 25(OHD.Results: Thirty-six participants (mean age 68 years, all Caucasian males, mean forced expiratory volume in one second 33% of predicted completed the study. Despite an increase in 25(OHD levels in the intervention arm to a mean of 32.6 ng/mL (versus 22.1 ng/mL in the placebo arm, there was no difference in improvements in either SPPB scores (0.3 point difference; 95% confidence interval -0.8 to 1.5; P = 0.56 or SGRQ scores (2.3 point difference; 95% confidence interval -2.3 to 6.9; P = 0.32.Conclusion: Among patients with severe COPD, 2000 IU of daily vitamin D for 6 weeks increased 25(OHD to a level widely considered as normal. However, compared with placebo, short-term vitamin D supplementation had no discernible effect on a simple measure of physical performance.Keywords: chronic obstructive pulmonary disease, randomized controlled trial, vitamin D, skeletal muscle strength

  11. Sensory Barrage Stimulation in the Treatment of Elbow Spasticity: A Crossover Double Blind Randomized Pilot Trial.

    Science.gov (United States)

    Slovak, Martin; Chindo, Joseph; Nair, Krishnan Padmakumari Sivaraman; Reeves, Mark L; Heller, Ben; Barker, Anthony T

    2016-02-01

    To assess the feasibility of using a novel form of multichannel electrical stimulation, termed Sensory Barrage Stimulation (SBS) for the treatment of spasticity affecting the elbow flexor muscles and to compare this with conventional single-channel TENS stimulation. Altogether ten participants with spasticity of the flexor muscles of the elbow of Grade 2 or above on the Modified Ashworth Scale (MAS) were recruited to this crossover double blind randomized trial. The participants received two intervention sessions (SBS and TENS), one week apart in a randomized order. Both interventions were applied over the triceps brachii on the affected arm for a duration of 60 minutes. Spasticity was measured using the MAS. Secondary outcome measures were self-reported change in spasticity, measured on a visual analog scale (VAS, 0-100), and therapist-rated strength of elbow extension and strength of elbow flexion. Measurements were taken immediately before each intervention was applied, immediately after the intervention, and one hour after the intervention. Immediately after stimulation spasticity showed a significant reduction for both TENS and SBS groups assessed by MAS -0.9 ± 0.2 vs. -1.1 ± 0.2 and by VAS -15 ± 3 vs. -31 ± 8. For SBS this improvement in MAS was still present at one hour after the stimulation, but not for TENS. Altogether seven SBS responders and four TENS responders were identified. This study demonstrates the feasibility and practicality of applying the new concept of SBS. Promising results indicate it causes a reduction in spasticity. © 2015 International Neuromodulation Society.

  12. Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

    Science.gov (United States)

    Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

    2017-01-01

    Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible

  13. Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial.

    Science.gov (United States)

    Hunger, Christina; Hilzinger, Rebecca; Koch, Theresa; Mander, Johannes; Sander, Anja; Bents, Hinrich; Schweitzer, Jochen

    2016-03-31

    Social anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT. This article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes. The study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of

  14. Feasibility and Efficacy of an mHealth Game for Managing Anxiety: "Flowy" Randomized Controlled Pilot Trial and Design Evaluation.

    Science.gov (United States)

    Pham, Quynh; Khatib, Yasmin; Stansfeld, Stephen; Fox, Simon; Green, Tobias

    2016-02-01

    Meeting the complex needs of patients with chronic common mental health disorders (CMHDs) may be the greatest challenge facing organized medical practice. On the basis of a well-established and proven theoretical foundation for controlled respiration as a behavioral intervention for CMHDs, as well as preliminary evidence that gamification can improve health outcomes through increasing patient engagement, this randomized controlled pilot study evaluated the feasibility and clinical efficacy of a mobile health game called "Flowy" ( www.flowygame.com ) that digitally delivered breathing retraining exercises for anxiety, panic, and hyperventilation symptom management. We designed an unblinded, Web-based, parallel-group randomized controlled trial focusing on feasibility, clinical efficacy, and design proof of concept. In the intervention condition (n = 31), participants received free access to "Flowy" for 4 weeks. In the control condition (n = 32), participants were placed on a waitlist for 4 weeks before being offered free access to "Flowy." Online measurements using psychological self-report questionnaires were made at 2 and 4 weeks post-baseline. At trial conclusion, participants found "Flowy" acceptable as an anxiety management intervention. "Flowy" engaged participants sufficiently to endorse proactive gameplay. Intent-to-treat analysis revealed a reduction in anxiety, panic, and self-report hyperventilation scores in both trial arms, with the intervention arm experiencing greater quality of life. Participants perceived "Flowy" as a fun and useful intervention, proactively used "Flowy" as part of their care, and would recommend "Flowy" to family and friends. Our results suggest that a digital delivery of breathing retraining exercises through a mobile health game can manage anxiety, panic, and hyperventilation symptoms associated with CMHDs.

  15. Reflexology in the management of chemotherapy induced peripheral neuropathy: A pilot randomized controlled trial.

    Science.gov (United States)

    Kurt, Seda; Can, Gulbeyaz

    2018-02-01

    The current experimental study aimed to evaluate the effectiveness of reflexology on the management of symptoms and functions of chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients. This study was conducted as a randomized controlled trial in 60 patients (30 experimental and 30 control patients) who had chemotherapy-induced Grade II-IV peripheral neuropathy complaints from July 2013 to November 2015. Data were collected using the patient identification form, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC-CIPN-20) form, and BPI (used for related chemotherapy-induced peripheral neuropathy symptoms). The majority of the patients were being treated for gastrointestinal or breast cancer and were primarily receiving Eloxatine- or taxane-based treatment. It was found that reflexology applications did not lead to differences in either group in terms of peripheral neuropathy severity and incidence (p > 0.05) and only led to improvement in sensory functions in the experimental group (p Peripheral neuropathy, reflexology, chemotherapy, EORTC QLQ-CIPN-20, BPI. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2016-09-07

    to investigate feasibility, safety and efficacy of home-based side-alternating whole body vibration (sWBV) to improve motor function in toddlers with cerebral palsy (CP). Randomized controlled trial including 24 toddlers with CP (mean age 19 months (SD±3.1); 13 boys). 14 weeks sWBV with ten 9-minute sessions weekly (non-individualized). Group A started with sWBV, followed by 14 weeks without; in group B this order was reversed. Feasibility (≥70% adherence) and adverse events were recorded; efficacy evaluated with the Gross Motor Function Measure (GMFM-66), Pediatric Evaluation of Disability Inventory (PEDI), at baseline (T0), 14 (T1) and 28 weeks (T2). Developmental change between T0 and T1 was similar in both groups; change scores in group A and B: GMFM-66 2.4 (SD±2.1) and 3.3 (SD±2.9) (p=0.412); PEDI mobility 8.4 (SD±6.6) and 3.5 (SD±9.2) (p=0.148), respectively. In two children muscle tone increased post-sWBV. 24 children received between 67 and 140 sWBV sessions, rate of completed sessions ranged from 48 to 100% and no dropouts were observed. A 14-week home-based sWBV intervention was feasible and safe in toddlers with CP, but was not associated with improvement in gross motor function.

  17. Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

    2016-06-02

    The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

  20. 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

  1. Results of a randomized controlled pilot trial of intravascular renal denervation for management of treatment-resistant hypertension.

    Science.gov (United States)

    Jacobs, Lotte; Persu, Alexandre; Huang, Qi-Fang; Lengelé, Jean-Philippe; Thijs, Lutgarde; Hammer, Frank; Yang, Wen-Yi; Zhang, Zhen-Yu; Renkin, Jean; Sinnaeve, Peter; Wei, Fang-Fei; Pasquet, Agnès; Fadl Elmula, Fadl Elmula M; Carlier, Marc; Elvan, Arif; Wunder, Cora; Kjeldsen, Sverre E; Toennes, Stefan W; Janssens, Stefan; Verhamme, Peter; Staessen, Jan A

    2017-12-01

    Previous trials of catheter-based renal-artery denervation (RDN) as treatment modality in resistant hypertension (rHT) generated unconvincing results. In the Investigator-Steered Project on Intravascular Denervation for Management of Treatment-Resistant Hypertension (INSPiRED; NCT01505010), we optimized selection and management of rHT patients. With ethical clearance to randomize 18 patients, three Belgian hypertension centers screened 29 rHT patients on treatment with ≥3 drugs, of whom 17 after optimization of treatment (age efficacy endpoint, and 2.5 mL/min/1.73 m 2 (+1.5 vs. -1.1 mL/min/1.73 m 2 ; P = .86) for eGFR, the primary safety endpoint. At 6 month, ECG voltages and the number of prescribed drugs (P ≤ .036) were lower in RDN patients, but quality of life and adherence, captured by questionnaire and urine analysis were similar in both groups. Changes in BP and adherence were unrelated. No major complications occurred. The INSPiRED pilot suggests that RDN with the EnligHTN ™ system is effective and safe and generated insights useful for the design of future RDN trials.

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

    Science.gov (United States)

    Wang, Ying; Tong, Lili; Pak, Youngju; Andalibi, Ali; LaPage, Janine A.; Adler, Sharon G.

    2016-01-01

    Background We tested minocycline as an anti-proteinuric adjunct to renin-angiotensin-aldosterone system inhibitors (RAASi) in diabetic nephropathy (DN) and measured urinary biomarkers to evaluate minocycline’s biological effects. Methods Design: Prospective, single center, randomized, placebo-controlled, intention-to-treat pilot trial. Inclusion. Type 2 diabetes/DN; Baseline creatinine clearance > 30 mL/min; proteinuria ≥ 1.0 g/day; Age ≥30 years; BP minocycline patients (6 month P:Cr ÷ Baseline P:Cr, 0.85 vs. 0.92) was not significant (p = 0.27). Creatinine clearance did not differ in the 2 groups. Urine IL-6:Cr (p = 0.03) and osteoprotegerin/Cr (p = 0.046) decrements were significant. Minocycline modified the relationship between urine IL-6 and proteinuria, suggesting a protective biological effect. Conclusions Although the decline in U P:Cr in minocycline patients was not statistically significant, the significant differences in urine IL-6 and osteoprotegerin suggest that minocycline may confer cytoprotection in patients with DN, providing a rationale for further study. Trial Registration Clinicaltrials.gov NCT01779089 PMID:27019421

  3. Feasibility and acceptability of a beverage intervention for Hispanic adults: a protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Morrill, Kristin E; Aceves, Benjamin; Valdez, Luis A; Thomson, Cynthia A; Hakim, Iman A; Bell, Melanie L; Martinez, Jessica A; Garcia, David O

    2018-02-09

    -reactive protein (hs-CRP). This pilot study will provide important feasibility, safety, and early efficacy data necessary to design a larger, adequately-powered randomized controlled trial. NCT02911753 ( ClinicalTrials.gov ). Registered September 19, 2016. Last updated November 1, 2017.

  4. Enhancing trunk stability in acute poststroke subjects using physioball exercise and proprioceptive neuromuscular facilitation technique: A pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ravichandran Hariharasudhan

    2016-01-01

    Full Text Available Background: Stroke is one of the leading causes of death and disability worldwide. Poststroke, most survivors experience trunk control impairment and instability. Previous works on exercise on an unstable surface to improve trunk stability in nonstroke population had proven effective. Thus, physioball exercises (PBEs in poststroke subjects may be useful in the recovery of trunk stability and thereby reduce disability. We hypothesize that PBE is feasible and effective in enhancing trunk stability. Aims: To test the feasibility and successful implementation of conducting a randomized controlled study to assess the clinical effectiveness of PBE and proprioceptive neuromuscular facilitation (PNF technique to enhance trunk control in poststroke subjects. Methods: This study was conducted in a stroke unit of Global Hospitals and Health City, Chennai, India. Thirty patients with the first onset of stroke within 40 days of stroke duration, lesion to one side, and ability to sit independently with or without arm support for 15 days were recruited. All thirty poststroke subjects were randomized either into PBE group or PNF group, and outcome assessors involved in the trail were blinded to allocation. PBE group performed task-oriented activities on an unstable surface and PNF group were treated with PNF-specific trunk stability exercise program for 4 weeks (30 min/day, 5 times/week. Trunk impairment scale (TIS was used as a main outcome measure. Results: Data were analyzed using Wilcoxon signed rank sum test and Mann–Whitney U-test for intra- and inter-group comparison. The baseline characteristics between both groups were statistically nonsignificant. Within groups, there were significant improvements between baseline and at 4 weeks in the measure of TIS. In addition, PBE group showed a significant increase in trunk control (mean 2.33, 95% confidence interval 1.14-3.52, P = 0.002 than the PNF subject. Conclusion: This pilot randomized controlled trial

  5. Mobile Phone Multilevel and Multimedia Messaging Intervention for Breast Cancer Screening: Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Hee; Ghebre, Rahel; Le, Chap; Jang, Yoo Jeong; Sharratt, Monica; Yee, Douglas

    2017-11-07

    Despite the increasing breast cancer incidence and mortality rates, Korean American immigrant women have one of the lowest rates of breast cancer screening across racial groups in the United States. Mobile health (mHealth), defined as the delivery of health care information or services through mobile communication devices, has been utilized to successfully improve a variety of health outcomes. This study adapted the principles of mHealth to advance breast cancer prevention efforts among Korean American immigrant women, an underserved community. Using a randomized controlled trial design, 120 Korean American women aged 40 to 77 years were recruited and randomly assigned to either the mMammogram intervention group (n=60) to receive culturally and personally tailored multilevel and multimedia messages through a mobile phone app along with health navigator services or the usual care control group (n=60) to receive a printed brochure. Outcome measures included knowledge, attitudes, and beliefs about breast cancer screening, readiness for mammography, and mammogram receipt. The feasibility and acceptability of the mMammogram intervention was also assessed. The intervention group showed significantly greater change on scores of knowledge of breast cancer and screening guidelines (P=.01). The intervention group also showed significantly greater readiness for mammography use after the intervention compared with the control group. A significantly higher proportion of women who received the mMammogram intervention (75%, 45/60) completed mammograms by the 6-month follow-up compared with the control group (30%, 18/60; Pservice was a feasible, acceptable, and effective intervention mechanism to promote breast cancer screening in Korean American immigrant women. A flexible, easily tailored approach that relies on recent technological advancements can reach underserved and hard-to-recruit populations that bear disproportionate cancer burdens. Clinicaltrials.gov NCT01972048;

  6. A randomized prospective pilot trial of Web-delivered epilepsy stigma reduction communications in young adults.

    Science.gov (United States)

    Sajatovic, Martha; Herrmann, Lynn K; Van Doren, Jamie R; Tatsuoka, Curtis; Welter, Elisabeth; Perzynski, Adam T; Bukach, Ashley; Needham, Kelley; Liu, Hongyan; Berg, Anne T

    2017-11-01

    Epilepsy is a common neurological condition that is often associated with stigmatizing attitudes and negative stereotypes among the general public. This randomized controlled trial (RCT) tested two new communication approaches targeting epilepsy stigma versus an education-alone approach. Two brief stigma-reduction videos were developed, informed by community stakeholder input; one highlighted role competency in people with epilepsy; the other highlighted social inclusion of people with epilepsy. A control video was also developed. A Web-based survey using a prospective RCT design compared effects of experimental videos and control on acceptability, perceived impact, epilepsy knowledge, and epilepsy stigma. Epilepsy knowledge and stigma were measured with the Epilepsy Knowledge Questionnaire (EKQ) and Attitudes and Beliefs about Living with Epilepsy (ABLE), respectively. A total of 295 participants completed the study. Mean age was 23.1 (standard deviation = 3.27) years; 59.0% were male, and 71.4% were white. Overall, respondents felt videos impacted their epilepsy attitudes. EKQ scores were similar across videos, with a trend for higher knowledge in experimental videos versus control (p = 0.06). The role competency and control videos were associated with slightly better perceived impact on attitudes. There were no differences between videos on ABLE scores (p = 0.568). There were subgroup differences suggesting that men, younger individuals, whites, and those with personal epilepsy experience had more stigmatizing attitudes. This RCT tested communication strategies to improve knowledge and attitudes about epilepsy. Although this initial effort will require follow-up, we have demonstrated the acceptability, feasibility, and potential of novel communication strategies to target epilepsy stigma, and a Web-based approach for assessing them. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  7. The effect of acupuncture on psychosocial outcomes for women experiencing infertility: a pilot randomized controlled trial.

    Science.gov (United States)

    Smith, Caroline A; Ussher, Jane M; Perz, Janette; Carmady, Bridget; de Lacey, Sheryl

    2011-10-01

    The study objectives were to examine the effectiveness of acupuncture for reducing infertility-related stress. The study design was a randomized controlled trial of acupuncture compared with a wait-list control. The study was conducted at The University of Western Sydney. Thirty-two (32) women aged 20-45 years, with a diagnosis of infertility, or a history of unsuccessfully trying to conceive for 12 months or more, were the subjects of the study. Women received six sessions of acupuncture over 8 weeks. The primary outcomes were infertility self-efficacy, anxiety, and infertility-related stress. The women's experience of infertility and acupuncture is also reported. At the end of the 8-week intervention, women in the acupuncture group reported significant changes on two domains on the Fertility Problem Inventory with less social concern (mean difference [MD] -3.75, 95% confidence interval [CI] -7.58 to 0.84, p=0.05), and less relationship concern (MD -3.66, 95% CI -6.80 to -0.052, p=0.02). There were also trends toward a reduction of infertility stress on other domains, and a trend toward improved self-efficacy (MD 11.9, 95% CI -2.20 to 26.0, p=0.09) and less anxiety (MD -2.54, 95% CI -5.95 to 0.86, p=0.08) in the acupuncture group compared with the wait-list control. Women described the experience and impact of acupuncture as positive relating to a sense of relaxation and time out, the engagement with the practitioner, and an intervention that had very few negative side-effects. Changes were also perceived after treatment with women describing a physical and psychologic sense of relaxation and calmness, and a changed perspective in relation to coping. Acupuncture may be a useful intervention to assist with the reduction of infertility-related stress. Further research is justified.

  8. Traditionally vs sonographically coached pushing in second stage of labor: a pilot randomized controlled trial.

    Science.gov (United States)

    Bellussi, F; Alcamisi, L; Guizzardi, G; Parma, D; Pilu, G

    2018-03-13

    To investigate the usefulness of visual biofeedback using transperineal ultrasound to improve coached pushing during the active second stage of labor in nulliparous women. This was a randomized controlled trial of low-risk nulliparous women in the active second stage of labor. Patients were allocated to either coached pushing aided by visual demonstration on transperineal ultrasound of the progress of the fetal head (sonographic coaching) or traditional coaching. Patients in both groups were coached by an obstetrician for the first 20 min of the active second stage of labor and, subsequently, the labor was supervised by a midwife. Primary outcomes were duration of the active second stage and increase in the angle of progression at the end of the coaching process. Secondary outcomes included the incidence of operative delivery and complications of labor. Forty women were recruited into the study. Those who received sonographic coaching had a shorter active phase of the second stage (30 min (interquartile range (IQR), 24-42 min) vs 45 min (IQR, 39-55 min); P = 0.01) and a greater increase in the angle of progression (13.5° (IQR, 9-20°) vs 5° (IQR, 3-9.5°); P = 0.01) in the first 20 min of the active second stage of labor than did those who had traditional coaching. No differences were found in the secondary outcomes between the two groups. Our preliminary data suggest that transperineal ultrasound may be a useful adjunct to coached pushing during the active second stage of labor. Further studies are required to confirm these findings and better define the benefits of this approach. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

  9. A pilot randomized controlled trial of mindfulness-based stress reduction for caregivers of family members with dementia.

    Science.gov (United States)

    Brown, Kirk Warren; Coogle, Constance L; Wegelin, Jacob

    2016-11-01

    The majority of care for those with Alzheimer's disease and other age-related dementias is provided in the home by family members. To date, there is no consistently effective intervention for reducing the significant stress burden of many family caregivers. The present pilot randomized controlled trial tested the efficacy of an adapted, eight-week mindfulness-based stress reduction (MBSR) program, relative to a near structurally equivalent, standard social support (SS) control condition for reducing caregiver stress and enhancing the care giver-recipient relationship. Thirty-eight family caregivers were randomized to MBSR or SS, with measures of diurnal salivary cortisol, and perceived stress, mental health, experiential avoidance, caregiver burden, and relationship quality collected pre- and post-intervention and at three-month follow-up. MBSR participants reported significantly lower levels of perceived stress and mood disturbance at post-intervention relative to SS participants. At three-month follow-up, participants in both treatment conditions reported improvements on several psychosocial outcomes. At follow-up, there were no condition differences on these outcomes, nor did MBSR and SS participants differ in diurnal cortisol response change over the course of the study. Both MBSR and SS showed stress reduction effects, and MBSR showed no sustained neuroendocrine and psychosocial advantages over SS. The lack of treatment condition differences could be attributable to active ingredients in both interventions, and to population-specific and design factors.

  10. 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.

  11. Controller adherence following hospital discharge in high risk children: A pilot randomized trial of text message reminders.

    Science.gov (United States)

    Kenyon, Chén C; Gruschow, Siobhan M; Quarshie, William O; Griffis, Heather; Leach, Michelle C; Zorc, Joseph J; Bryant-Stephens, Tyra C; Miller, Victoria A; Feudtner, Chris

    2018-02-13

    To assess the feasibility of a mobile health, inhaled corticosteroid (ICS) adherence reminder intervention and to characterize adherence trajectories immediately following severe asthma exacerbation in high-risk urban children with persistent asthma. Children aged 2-13 with persistent asthma were enrolled in this pilot randomized controlled trial during an asthma emergency department (ED) visit or hospitalization. Intervention arm participants received daily text message reminders for 30 days, and both arms received electronic sensors to measure ICS use. Primary outcomes were feasibility of sensor use and text message acceptability. Secondary outcomes included adherence to prescribed ICS regimen and 30-day adherence trajectories. Group-based trajectory modeling was used to examine adherence trajectories. Forty-one participants (mean age 5.9) were randomized to intervention (n = 21) or control (n = 20). Overall, 85% were Black, 88% had public insurance, and 51% of the caregivers had a high school education or less. Thirty-two participant families (78%) transmitted medication adherence data; of caregivers who completed the acceptability survey, 25 (96%) chose to receive daily reminders beyond that study interval. Secondary outcome analyses demonstrated similar average daily adherence between groups (intervention = 36%; control = 32%, P = 0.73). Three adherence trajectories were identified with none ever exceeding 80% adherence. Within a high-risk pediatric cohort, electronic monitoring of ICS use and adherence reminders delivered via text message were feasible for most participants, but there was no signal of effect. Adherence trajectories following severe exacerbation were suboptimal, demonstrating an important opportunity for asthma care improvement.

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

    Directory of Open Access Journals (Sweden)

    S. Daisy Kosa

    2017-03-01

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

  13. Adult Congenital Heart Disease-Coping And REsilience (ACHD-CARE): Rationale and methodology of a pilot randomized controlled trial.

    Science.gov (United States)

    Kovacs, Adrienne H; Bandyopadhyay, Mimi; Grace, Sherry L; Kentner, Amanda C; Nolan, Robert P; Silversides, Candice K; Irvine, M Jane

    2015-11-01

    One-third of North American adults with congenital heart disease (CHD) have diagnosable mood or anxiety disorders and most do not receive mental health treatment. There are no published interventions targeting the psychosocial needs of patients with CHD of any age. We describe the development of a group psychosocial intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD and the design of a study protocol to determine the feasibility of a potential full-scale randomized controlled trial (RCT). Drawing upon our quantitative and qualitative research, we developed the Adult CHD-Coping And REsilience (ACHD-CARE) intervention and designed a feasibility study that included a 2-parallel arm non-blinded pilot RCT. Eligible participants (CHD, age ≥ 18 years, no planned surgery, symptoms suggestive of a mood and/or anxiety disorder) were randomized to the ACHD-CARE intervention or Usual Care (1:1 allocation ratio). The group intervention was delivered during eight 90-minute weekly sessions. Feasibility will be assessed in the following domains: (i) process (e.g. recruitment and retention), (ii) resources, (iii) management, (iv) scientific outcomes, and (v) intervention acceptability. This study underscores the importance of carefully developing and testing the feasibility of psychosocial interventions in medical populations before moving to full-scale clinical trials. At study conclusion, we will be poised to make one of three determinations for a full-scale RCT: (1) feasible, (2) feasible with modifications, or (3) not feasible. This study will guide the future evaluation and provision of psychosocial treatment for adults with CHD. Copyright © 2015. Published by Elsevier Inc.

  14. Nurse-delivered counselling intervention for parental HIV disclosure: Results from a pilot randomized controlled trial in China

    Science.gov (United States)

    Simoni, Jane M.; Yang, Joyce P.; Shiu, Cheng-Shi; Chen, Wei-ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

    2016-01-01

    Objective The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. Design This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. Setting The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants Participants were 20 HIV-positive outpatients with at least one child (13–25 years old) who was unaware of the parent’s HIV diagnosis. Intervention The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Main outcome measure(s) Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. Results In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a ‘large’ effect size. Conclusion Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy. PMID:26049544

  15. Effects of guided imagery on blood pressure in pregnant women with hypertension: a pilot randomized controlled trial.

    Science.gov (United States)

    Moffatt, Faith Wight; Hodnett, Ellen; Esplen, Mary Jane; Watt-Watson, Judy

    2010-12-01

    Hypertension occurs in nearly 10 percent of pregnancies, and is associated with higher risk of infant and maternal morbidity and mortality than in normal pregnancies. Previous studies have suggested that relaxation therapies reduce blood pressure in nonpregnant adults. The objectives of this pilot randomized trial were to provide preliminary evidence of whether relaxation by means of guided imagery would reduce blood pressure in hypertensive pregnant women, and to assess the feasibility of a larger trial. A total of 69 pregnant women with hypertension were randomized to periods of guided imagery or of quiet rest, twice daily for 4 weeks or until delivery, whichever came first. Daytime ambulatory mean arterial pressure, systolic and diastolic blood pressure, and anxiety were measured weekly for up to 4 weeks. Women allocated to guided imagery had lower mean arterial pressure elevations over time than those allocated to quiet rest (guided imagery: M = 1.58 mmHg, SD = 7.63; quiet rest: M = 5.93 mmHg, SD = 6.55; t = 2.36, p = 0.02). However, when adjusted for baseline mean arterial pressure and gestation, the effect was not significant (p = 0.14). Numbers of women prescribed antihypertensive medication postrandomization were similar (guided imagery: n = 16; quiet rest: n = 13, χ(2) = 0.74, p = 0.46). There was also no evidence of an effect on women's anxiety. Nearly 90 percent (n = 26) of the guided imagery group indicated that they would use it again. Further rigorous study is warranted to determine effects of guided imagery on maternal blood pressure and perinatal health outcomes. © 2010, Copyright the Authors. Journal compilation © 2010, Wiley Periodicals, Inc.

  16. Nurse-delivered counselling intervention for parental HIV disclosure: results from a pilot randomized controlled trial in China.

    Science.gov (United States)

    Simoni, Jane M; Yang, Joyce P; Shiu, Cheng-Shi; Chen, Wei-Ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

    2015-06-01

    The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis. The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size. Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.

  17. 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.

  18. Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Jose M Trigo

    Full Text Available The current lack of pharmacological treatments for cannabis use disorder (CUD warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC/ 25 mg/ml cannabidiol (CBD, Sativex® can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants.Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT. Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time.Medication was well tolerated and no serious adverse events (SAEs were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS. There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS. Cannabis use was reduced in the nabiximols (70.5% and placebo groups (42.6%. Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores.Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.

  19. Nabiximols combined with motivational enhancement/cognitive behavioral therapy for the treatment of cannabis dependence: A pilot randomized clinical trial.

    Science.gov (United States)

    Trigo, Jose M; Soliman, Alexandra; Quilty, Lena C; Fischer, Benedikt; Rehm, Jürgen; Selby, Peter; Barnes, Allan J; Huestis, Marilyn A; George, Tony P; Streiner, David L; Staios, Gregory; Le Foll, Bernard

    2018-01-01

    The current lack of pharmacological treatments for cannabis use disorder (CUD) warrants novel approaches and further investigation of promising pharmacotherapy. We previously showed that nabiximols (27 mg/ml Δ9-tetrahydrocannabinol (THC)/ 25 mg/ml cannabidiol (CBD), Sativex®) can decrease cannabis withdrawal symptoms. Here, we assessed in a pilot study the tolerability and safety of self-titrated nabiximols vs. placebo among 40 treatment-seeking cannabis-dependent participants. Subjects participated in a double blind randomized clinical trial, with as-needed nabiximols up to 113.4 mg THC/105 mg CBD or placebo daily for 12 weeks, concurrently with Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). Primary outcome measures were tolerability and abstinence, secondary outcome measures were days and amount of cannabis use, withdrawal, and craving scores. Participants received up to CDN$ 855 in compensation for their time. Medication was well tolerated and no serious adverse events (SAEs) were observed. Rates of adverse events did not differ between treatment arms (F1,39 = 0.205, NS). There was no significant change in abstinence rates at trial end. Participants were not able to differentiate between subjective effects associated with nabiximols or placebo treatments (F1,40 = 0.585, NS). Cannabis use was reduced in the nabiximols (70.5%) and placebo groups (42.6%). Nabiximols reduced cannabis craving but no significant differences between the nabiximols and placebo groups were observed on withdrawal scores. Nabiximols in combination with MET/CBT was well tolerated and allowed for reduction of cannabis use. Future clinical trials should explore the potential of high doses of nabiximols for cannabis dependence.

  20. Practical Telemedicine for Veterans with Persistently Poor Diabetes Control: A Randomized Pilot Trial.

    Science.gov (United States)

    Crowley, Matthew J; Edelman, David; McAndrew, Ann T; Kistler, Susan; Danus, Susanne; Webb, Jason A; Zanga, Joseph; Sanders, Linda L; Coffman, Cynthia J; Jackson, George L; Bosworth, Hayden B

    2016-05-01

    Telemedicine-based diabetes management improves outcomes versus clinic care but is seldom implemented by healthcare systems. In order to advance telemedicine-based management as a practical option for veterans with persistent poorly controlled diabetes mellitus (PPDM) despite clinic-based care, we evaluated a comprehensive telemedicine intervention that we specifically designed for delivery using existing Veterans Health Administration (VHA) clinical staffing and equipment. We conducted a 6-month randomized trial among 50 veterans with PPDM; all maintained hemoglobin A1c (HbA1c) levels continuously >9.0% for >1 year despite clinic-based management. Participants received usual care or a telemedicine intervention combining telemonitoring, medication management, self-management support, and depression management; existing VHA clinical staff delivered the intervention. Using linear mixed models, we examined HbA1c, diabetes self-care (measured by the Self-Care Inventory-Revised questionnaire), depression, and blood pressure. At baseline, the model-estimated common HbA1c intercept was 10.5%. By 6 months, estimated HbA1c had improved by 1.3% for intervention participants and 0.3% for usual care (estimated difference, -1.0%, 95% confidence interval [CI], -2.0%, 0.0%; p = 0.050). Intervention participants' diabetes self-care (estimated difference, 7.0; 95% CI, 0.1, 14.0; p = 0.047), systolic blood pressure (-7.7 mm Hg; 95% CI, -14.8, -0.6; p = 0.035), and diastolic blood pressure (-5.6 mm Hg; 95% CI, -9.9, -1.2; p = 0.013) were improved versus usual care by 6 months. Depressive symptoms were similar between groups. A comprehensive telemedicine intervention improved outcomes among veterans with PPDM despite clinic-based care. Because we specifically designed this intervention with scalability in mind, it may represent a practical, real-world strategy to reduce the burden of poor diabetes control among veterans.

  1. Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Stephenson, Rob; Metheny, Nicholas; Sharma, Akshay; Sullivan, Stephen; Riley, Erin

    2017-11-28

    Transgender and gender nonconforming people experience some of the highest human immunodeficiency virus (HIV) rates in the United States, and experience many structural and behavioral barriers that may limit their engagement in HIV testing, prevention, and care. Evidence suggests that transgender and gender nonconforming youth (TY) are especially vulnerable to acquiring HIV, yet there is little research on TY and few services are targeted towards HIV testing, prevention, and care for this population. Telehealth presents an opportunity to mitigate some structural barriers that TY experience in accessing HIV testing, allowing TY to engage in HIV testing and counseling in a safe and nonjudgmental space of their choosing. Project Moxie is an HIV prevention intervention that pairs the use of HIV self-testing with remote video-based counseling and support from a trained, gender-affirming counselor. This study aims to offer a more positive HIV testing and counseling experience, with the goal of improving HIV testing frequency. Project Moxie involves a pilot randomized controlled trial (RCT) of 200 TY aged 15-24 years, who are randomized on a 1:1 basis to control or intervention arms. The aim is to examine whether the addition of counseling provided via telehealth, coupled with home-based HIV testing, can create gains in routine HIV testing among TY over a six-month follow-up period. This study implements a prospective pilot RCT of 200 TY recruited online. Participants in the control arm will receive one HIV self-testing kit and will be asked to report their results via the study's website. Participants in the experimental arm will receive one HIV self-testing kit and will test with a remotely-located counselor during a prescheduled video-counseling session. Participants are assessed at baseline, and at three and six months posttesting. Project Moxie was launched in June 2017 and recruitment is ongoing. As of August 21, 2017, the study had enrolled 130 eligible

  2. Body composition influenced by progressive elastic band resistance exercise of sarcopenic obesity elderly women: a pilot randomized controlled trial.

    Science.gov (United States)

    Huang, Shih-Wei; Ku, Jan-Wen; Lin, Li-Fong; Liao, Chun-De; Chou, Lin-Chuan; Liou, Tsan-Hon

    2017-08-01

    Sarcopenia involves age-related decreases in muscle strength and muscle mass, leading to frailty and disability in elderly people. When combined with obesity, it is defined as sarcopenic obesity (SO), which can result in more functional limitations and metabolic disorders than either disorder alone. The aim of this study was to investigate body composition changes after elastic band resistance training in elderly women with SO. Randomized single-blinded (assessor blinded) controlled pilot trial. Academic medical center. Thirty-five elderly (>60 years old) women with SO. This pilot randomized controlled trial focused on elderly women with SO. The study group underwent progressive elastic band resistance training for 12 weeks (3 times per week). The control group received only a 40-minute lesson about the exercise concept. Dual-energy X-ray absorptiometry was performed before and after intervention to evaluate body composition. Mann-Whitney U and Wilcoxon signed rank tests were used to analyze the differences within and between these groups. In total, 35 elderly women with SO were enrolled and divided into study (N.=18) and control groups (N.=17). No difference was observed in age, biochemical parameters, or Body Mass Index between both groups. After the intervention, the fat proportion of body composition in the right upper extremity (P=0.03), left upper extremity (P=0.04), total fat (P=0.035), and fat percentage (P=0.012) had decreased, and bone mineral density (BMD) (P=0.026), T-score (P=0.028), and Z-score (P=0.021) had increased in the study group. Besides, statistical difference was observed in outcome measurements of right upper extremity (P=0.013), total fat (P=0.023), and fat percentage (P=0.012) between the groups. Our study demonstrated that progressive elastic band resistance exercise can reduce fat mass and increase BMD in elderly women with SO, and that this exercise program is feasible for this demographic. Additional studies with larger sample sizes

  3. How should the impact of different presentations of treatment effects on patient choice be evaluated? A pilot randomized trial.

    Directory of Open Access Journals (Sweden)

    Cheryl Carling

    Full Text Available BACKGROUND: Different presentations of treatment effects can affect decisions. However, previous studies have not evaluated which presentations best help people make decisions that are consistent with their own values. We undertook a pilot study to compare different methods for doing this. METHODS AND FINDINGS: We conducted an Internet-based randomized trial comparing summary statistics for communicating the effects of statins on the risk of coronary heart disease (CHD. Participants rated the relative importance of treatment consequences using visual analogue scales (VAS and category rating scales (CRS with five response options. We randomized participants to either VAS or CRS first and to one of six summary statistics: relative risk reduction (RRR and five absolute measures of effect: absolute risk reduction, number needed to treat, event rates, tablets needed to take, and natural frequencies (whole numbers. We used logistic regression to determine the association between participants' elicited values and treatment choices. 770 participants age 18 or over and literate in English completed the study. In all, 13% in the VAS-first group failed to complete their VAS rating, while 9% of the CRS-first group failed to complete their scoring (p = 0.03. Different ways of weighting the elicited values had little impact on the analyses comparing the different presentations. Most (51% preferred the RRR compared to the other five summary statistics (1% to 25%, p = 0.074. However, decisions in the group presented the RRR deviated substantially from those made in the other five groups. The odds of participants in the RRR group deciding to take statins were 3.1 to 5.8 times that of those in the other groups across a wide range of values (p = 0.0007. Participants with a scientific background, who were more numerate or had more years of education were more likely to decide not to take statins. CONCLUSIONS: Internet-based trials comparing different presentations

  4. Effect of continuous oral suctioning on the development of ventilator-associated pneumonia: a pilot randomized controlled trial.

    Science.gov (United States)

    Chow, Meyrick C M; Kwok, Shu-Man; Luk, Hing-Wah; Law, Jenny W H; Leung, Bartholomew P K

    2012-11-01

    Both continuous and intermittent aspiration of subglottic secretions by means of specially designed endotracheal tubes containing a separate dorsal lumen that opens into the subglottic region have been shown to be useful in reducing ventilator-associated pneumonia (VAP). However, the high cost of these tubes restricts their use. The aim of this pilot randomized controlled trial was to test the effect of a low-cost device (saliva ejector) for continuous oral suctioning (COS) on the incidence of VAP in patients receiving mechanical ventilation. The study was conducted in the six-bed medical-surgical ICU of a hospital with over 400 beds that provides comprehensive medical services to the public. The design of this study was a parallel-group randomized controlled trial. While both the experimental and control groups used the conventional endotracheal tube, the saliva ejector was only applied to patients assigned to the experimental group. The device was put between the patient's cheek and teeth, and then connected to 100mmHg of suction for the continuous drainage of saliva. Fourteen patients were randomized to receive COS and 13 patients were randomized to the control group. The two groups were similar in demographics, reasons for intubation, co-morbidity, and risk factors for acquiring VAP. VAP was found in 3 patients (23.1%; 71 episodes of VAP per 1000 ventilation days) receiving COS and in 10 patients (83.3%; 141 episodes of VAP per 1000 ventilation days) in the control group (relative risk, 0.28; 95% confidence interval, 0.10-0.77; p=0.003). The duration of mechanical ventilation in the experimental group was 3.2 days (SD 1.3), while that in the control group was 5.9 days (SD 2.8) (p=0.009); and the length of ICU stay was 4.8 days (SD 1.6) versus 9.8 days (SD 6.3) for the experimental and control groups, respectively (p=0.019). Continuous clearance of oral secretion by the saliva ejector may have an important role to play in reducing the rate of VAP, decreasing the

  5. ATG-Fresenius or daclizumab induction therapy in immunologically high risk kidney recipients: a prospective randomized pilot trial.

    Science.gov (United States)

    Kim, Min Jeong; Tsinalis, Dimitrios; Franz, Stefan; Binet, Isabelle; Gürke, Lorenz; Mihatsch, Michael J; Steiger, Jürg; Thiel, Gilbert; Dickenmann, Michael

    2008-01-01

    Despite all the advantages in the immunosuppressive therapy, kidney transplantation in immunologically high risk patients remains a challenge. Ideally, an induction therapy should provide maximal graft protection, while adverse events rate and costs remain as low as possible. Immunologically high risk kidney recipients with CDC-PRA ł 25% within the last 3 years, a positive B-cell CDC-crossmatch or graft loss due to rejection within 3 years following a prior transplantation, were randomized 1:1 to receive ATG-Fresenius (ATG-F) (9 mg/kg day 0; 3 mg/kg day 1-4) or Daclizumab therapy (1 mg/kg day 0, 14, 28, 42, 56) in a pilot study. Additional immunosuppression consisted of cyclosporine, mycophenolate mofetil, and steroids. 11 patients were included in each group. The patient (90% in ATG-F; 100% in Daclizumab) and graft survival (censored for death) (100% in ATG-F; 90% in Daclizumab) and the mean creatinine concentration at 24 months (139+/-68 mol/l in ATG-F; 176+/-103 mol/l in Daclizumab) were similar in both groups. More severe graft rejections (3 vascular rejections in Daclizumab) and adverse events (5.3/patient in ATG-F; 6.7/patient in Daclizumab) were observed in the Daclizumab group. The costs for hospitalization/ day within 24 months were lower in ATG-F (2.32+/-3.51 USD vs. 12.25+/-9.75 USD; p=0.02) resulting in an average cost-difference of more than 10'435 USD /patient. In this pilot trial, both treatments were comparably successful regarding graft and patient outcome.

  6. Neuroimaging Correlates of Post-Stroke Aphasia Rehabilitation in a Pilot Randomized Trial of Constraint-Induced Aphasia Therapy.

    Science.gov (United States)

    Nenert, Rodolphe; Allendorfer, Jane B; Martin, Amber M; Banks, Christi; Ball, Angel; Vannest, Jennifer; Dietz, Aimee R; Szaflarski, Jerzy P

    2017-07-18

    BACKGROUND Recovery from post-stroke aphasia is a long and complex process with an uncertain outcome. Various interventions have been proposed to augment the recovery, including constraint-induced aphasia therapy (CIAT). CIAT has been applied to patients suffering from post-stroke aphasia in several unblinded studies to show mild-to-moderate linguistic gains. The aim of the present study was to evaluate the neuroimaging correlates of CIAT in patients with chronic aphasia related to left middle cerebral artery stroke. MATERIAL AND METHODS Out of 24 patients recruited in a pilot randomized blinded trial of CIAT, 19 patients received fMRI of language. Eleven of them received CIAT (trained) and eight served as a control group (untrained). Each patient participated in three fMRI sessions (before training, after training, and 3 months later) that included semantic decision and verb generation fMRI tasks, and a battery of language tests. Matching healthy control participants were also included (N=38; matching based on age, handedness, and sex). RESULTS Language testing showed significantly improved performance on Boston Naming Test (BNT; paphasia with no specific effect from CIAT training.

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

    International Nuclear Information System (INIS)

    Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

    2013-01-01

    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.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  9. 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.

  10. 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.

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

    Directory of Open Access Journals (Sweden)

    Andrew M. Busch

    2017-04-01

    Full Text Available Abstract Background Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS. The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC. Methods Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up. Results Fifty-nine participants (28 BAT-CS, 31 SC were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41–3.93 for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42–3.82 for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03. At 24-weeks, effect sizes for mood and stress outcomes ranged from η2 partial of.07–.11, with significant between treatment effects for positive affect, negative affect, and stress. Conclusions The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted. Trial registration NCT01964898 . First received by clinicaltrials.gov October 15, 2013.

  12. 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

  13. Internet-Based Guided Self-Help for Vaginal Penetration Difficulties: Results of a Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Zarski, Anna-Carlotta; Berking, Matthias; Fackiner, Christina; Rosenau, Christian; Ebert, David Daniel

    2017-02-01

    Difficulties with vaginal penetration can severely affect a woman's desire to have sexual intercourse, her sexual and general well-being, or her partnership. However, treatment opportunities for vaginismus are scarce. To evaluate the efficacy of an internet-based guided self-help intervention for vaginismus in a randomized controlled pilot trial. Seventy-seven women with vaginismus (primary inclusion criterion = no intercourse ≥ 6 months) were randomly assigned to an intervention group (IG) and a waitlist control group (WCG). The intervention consisted of 10 sessions involving psychoeducation, relaxation exercises, sensate focus, and gradual exposure with dilators. Participants received written feedback on completed sessions from an eCoach. The primary outcome was successful sexual intercourse. Secondary outcomes were non-intercourse penetration, fear of coitus, sexual functioning, and dyadic coping. Self-reported assessments were scheduled at baseline, 10 weeks, and 6 months. More participants (10 of 40, 34.48%) in the IG had intercourse compared with those in the WCG (6 of 37, 20.69%) at least once at 10 weeks or 6 months (odds ratio = 2.02). The difference was not significant (χ 2 1  = 1.38, P = .38), but in the IG, there was a significant increase in intercourse penetration from baseline to 6 months (d = 0.65). No such increase was found in the WCG (d = 0.21). There were significant between-group effects concerning non-intercourse penetration (self-insertion of a finger or dilator or insertion by the partner) in favor of the IG. Fear of coitus and dyadic coping significantly decreased in the IG. Overall satisfaction with the training was high. This randomized controlled trial showed promising effects of an internet-based intervention by increasing participants' ability to have intercourse and non-intercourse penetration while experiencing high treatment satisfaction. The WCG also showed improvement, although participants had vaginismus for an average

  14. Interpersonal Mindfulness Informed by Functional Analytic Psychotherapy: Findings from a Pilot Randomized Trial

    Science.gov (United States)

    Bowen, Sarah; Haworth, Kevin; Grow, Joel; Tsai, Mavis; Kohlenberg, Robert

    2012-01-01

    Functional Analytic Psychotherapy (FAP; Kohlenberg & Tsai, 1991) aims to improve interpersonal relationships through skills intended to increase closeness and connection. The current trial assessed a brief mindfulness-based intervention informed by FAP, in which an interpersonal element was added to a traditional intrapersonal mindfulness…

  15. Pilot Randomized trial of Fibrinogen in Trauma Haemorrhage (PRooF-iTH)

    DEFF Research Database (Denmark)

    Steinmetz, Jacob; Henriksen, Hanne Hee; Sørensen, Anne Marie

    2016-01-01

    bleeding related to trauma, so scientific guardians will co-sign the informed consent form. Next of kin and the patients’ general practitioner or the patients will co-sign as soon as possible.This trial will test whether immediate pre-emptive fibrinogen concentrate administered to adult trauma patients...

  16. Early physical training and psycho-educational intervention for patients undergoing coronary artery bypass grafting. The SheppHeart randomized 2 × 2 factorial clinical pilot trial

    DEFF Research Database (Denmark)

    Højskov, Ida E; Moons, Philip; Hansen, Niels V

    2015-01-01

    BACKGROUND: Patients undergoing coronary artery bypass graft surgery often experience a range of problems and symptoms such as immobility, pain and insufficient sleep. Results from trials investigating testing in-hospital physical exercise or psychological intervention have been promising. However......, no randomized clinical trials have tested a comprehensive rehabilitation programme consisting of both physical exercise and psycho-education in the early rehabilitation phase. AIMS: The aims of the present SheppHeart pilot randomized clinical trial were to evaluate the feasibility of patient recruitment......, patient acceptance of the intervention, safety and tolerability of the intervention. METHODS AND DESIGN: Sixty patients admitted for coronary artery bypass graft were randomized 1:1:1:1 to: 1) physical exercise plus usual care, or 2) psycho-educational intervention plus usual care, or 3) physical exercise...

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

    Science.gov (United States)

    Lizis, Pawel; Kobza, Wojciech

    2017-06-23

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

  18. Training cognitive flexibility in patients with anorexia nervosa: a pilot randomized controlled trial of cognitive remediation therapy.

    Science.gov (United States)

    Brockmeyer, Timo; Ingenerf, Katrin; Walther, Stephan; Wild, Beate; Hartmann, Mechthild; Herzog, Wolfgang; Bents, Hinrich; Friederich, Hans-Christoph

    2014-01-01

    Inefficient cognitive flexibility is considered a neurocognitive trait marker involved in the development and maintenance of anorexia nervosa (AN). Cognitive Remediation Therapy (CRT) is a specific treatment targeting this cognitive style. The aim of this study was to investigate the feasibility and efficacy (by estimating the effect size) of specifically tailored CRT for AN, compared to non-specific cognitive training. A prospective, randomized controlled, superiority pilot trial was conducted. Forty women with AN receiving treatment as usual (TAU) were randomized to receive either CRT or non-specific neurocognitive therapy (NNT) as an add-on. Both conditions comprised 30 sessions of computer-assisted (21 sessions) and face-to-face (9 sessions) training over a 3-week period. CRT focused specifically on cognitive flexibility. NNT was comprised of tasks designed to improve attention and memory. The primary outcome was performance on a neuropsychological post-treatment assessment of cognitive set-shifting. Data available from 25 treatment completers were analyzed. Participants in the CRT condition outperformed participants in the NNT condition in cognitive set-shifting at the end of the treatment (p = 0.027; between-groups effect size d = 0.62). Participants in both conditions showed high treatment acceptance. This study confirms the feasibility of CRT for AN, and provides a first estimate of the effect size that can be achieved using CRT for AN. Furthermore, the present findings corroborate that neurocognitive training for AN should be tailored to the specific cognitive inefficiencies of this patient group. Copyright © 2013 Wiley Periodicals, Inc.

  19. 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.

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

    Science.gov (United States)

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

    2010-07-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

  2. 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.

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

    Science.gov (United States)

    Prins, Jan C M; Stubbe, Janine H; van Meeteren, Nico L U; Scheffers, Frans A; van Dongen, Martien C J M

    2011-05-01

    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. A pilot version of an intended prospective randomized controlled clinical trial was conducted. A total of 19 patients with an acute tear in the gastrocnemius muscle were randomly allocated to either active or control treatment. The intervention consisted of the repeated application of crushed ice. Primary outcome measures were functional capacity and reconvalescence time. Secondary outcome measures were pain and work absenteeism. The number of patients we could include within the 6-hour time window and dropping out from the pilot study were regarded as indicators of the feasibility of ice therapy. A total of 16 patients were excluded from the study because diagnosis was not made within 6 hours after onset of the complaint. The 19 patients included completed the treatment. For functional capacity, reconvalescence time, work absenteeism and pain relief, no significant differences between the intervention and control group were found. The execution of a randomized controlled trial on ice therapy for acute gastrocnemius tear is feasible though quite an enterprise. First, it is recommended to improve the recruitment processes. Second, power analysis demands inclusion of 396 participants. Preliminary effectiveness in our limited-sized trial indicates that the use of ice is not beneficial for people who receive ice therapy.

  4. Reducing approach bias to achieve smoking cessation: A pilot randomized placebo-controlled trial

    NARCIS (Netherlands)

    Baird, S.O.; Rinck, M.; Rosenfield, D.; Davis, M.L.; Fisher, J.R.; Becker, E.S.; Powers, M.B.; Smits, J.A.J.

    2017-01-01

    This study aimed to provide a preliminary test of the efficacy of a brief cognitive bias modification program for reducing approach bias in adult smokers motivated to quit. Participants were 52 smokers who were randomly assigned to four sessions of approach bias modification training (AAT) or sham

  5. 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…

  6. Randomized Controlled Trial for Early Intervention for Autism: A Pilot Study of the Autism 1-2-3 Project

    Science.gov (United States)

    Wong, Virginia C. N.; Kwan, Queenie K.

    2010-01-01

    We piloted a 2-week "Autism-1-2-3" early intervention for children with autism and their parents immediately after diagnosis that targeted at (1) eye contact, (2) gesture and (3) vocalization/words. Seventeen children were randomized into the Intervention (n = 9) and Control (n = 8) groups. Outcome measures included the Autism Diagnostic…

  7. 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…

  8. Feasibility of a Preventive Parenting Intervention for Very Preterm Children at 18 Months Corrected Age: A Randomized Pilot Trial

    NARCIS (Netherlands)

    Flierman, Monique; Koldewijn, Karen; Meijssen, Dominique; van Wassenaer-Leemhuis, Aleid; Aarnoudse-Moens, Cornelieke; van Schie, Petra; Jeukens-Visser, Martine

    2016-01-01

    To evaluate the feasibility and potential efficacy of an age-appropriate additional parenting intervention for very preterm born toddlers. In a randomized controlled pilot study, 60 of 94 eligible very preterm born children who had received a responsive parenting intervention in their first year

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

    Science.gov (United States)

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

    2017-01-01

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

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

    NARCIS (Netherlands)

    Acarturk, C.; Konuk, E.; Cetinkaya, M.; Senay, I.; Sijbrandij, M.; Cuijpers, P.; Aker, T.

    2015-01-01

    Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating

  11. Overcoming Therapeutic Inertia in Multiple Sclerosis Care: A Pilot Randomized Trial Applying the Traffic Light System in Medical Education

    Directory of Open Access Journals (Sweden)

    Gustavo Saposnik

    2017-08-01

    Full Text Available BackgroundPhysicians often do not initiate or intensify treatments when clearly warranted, a phenomenon known as therapeutic inertia (TI. Limited information is available on educational interventions to ameliorate knowledge-to-action gaps in TI.ObjectivesTo evaluate the feasibility and efficacy of an educational intervention compared to usual care among practicing neurologists caring for patients with multiple sclerosis (MS.MethodsWe conducted a pilot double-blind, parallel-group, randomized clinical trial. Inclusion criteria included neurologists who are actively involved in managing MS patients. Participants were exposed to 20 simulated case-scenarios (10 cases at baseline, and 10 cases post-randomization to usual care vs. educational intervention of relapsing–remitting MS with moderate or high risk of disease progression. The educational intervention employed a traffic light system (TLS to facilitate decisions, allowing participants to easily recognize high-risk scenarios requiring treatment escalation. We also measured differences between blocks to invoke decision fatigue. The control group responded as they would do in their usual clinical practice not exposed to the educational intervention. The primary feasibility outcome was the proportion of participants who completed the study and the proportion of participants who correctly identified a high-risk case-scenario with the “red traffic light.” Secondary outcomes included decision fatigue (defined as an increment of TI in the second block of case-scenarios compared to the first block and the efficacy of the educational intervention measured as a reduction in TI for MS treatment.ResultsOf 30 neurologists invited to be part of the study, the participation rate was 83.3% (n = 25. Of the 25 participants, 14 were randomly assigned to the control group and 11 to the intervention group. TI was present in 72.0% of participants in at least one case scenario. For the primary feasibility

  12. Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial.

    Science.gov (United States)

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

    2013-07-18

    The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean weekly pain score of ≥ 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit. The result

  13. 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

    -parametric statistics were calculated. RESULTS: The trial ran from January 2010 to October 2011. We analyzed 111 complete video-recordings (54 active, 57 sham). Chiropractor interactions differed between the treatment groups in 7 categories. Active participants received more interactions with clinical information (8 vs....... 4) or explanations (3.5 vs. 1) than sham participants within the therapeutic domain. Active participants received more directions (63 vs. 58) and adjusting instrument thrusts (41.5 vs. 23) in the procedural domain and more optimistic (2.5 vs. 0) or neutral (7.5 vs. 5) outcome statements...... 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...

  14. A randomized pilot trial of a videoconference couples communication intervention for advanced GI cancer.

    Science.gov (United States)

    Porter, Laura S; Keefe, Francis J; Baucom, Donald H; Olsen, Maren; Zafar, S Yousuf; Uronis, Hope

    2017-07-01

    This study aims to test the feasibility and preliminary efficacy of a couple-based communication intervention for advanced GI cancer delivered via videoconference. Thirty-two couples were randomly assigned to either couples communication skills training (CCST) or an education comparison intervention, both delivered via videoconference. Participation was limited to couples who reported communication difficulties at screening. Patients and partners completed measures of relationship functioning and individual functioning at baseline and post-intervention. Eighty-eight percent of randomized dyads completed all six sessions and reported high levels of satisfaction with the intervention. Between-group effect sizes suggested that the CCST intervention led to improvements in relationship satisfaction for patients and partners and to improvements in intimacy and communication for patients. A couples-based communication intervention delivered via videoconference is feasible and acceptable in the context of advanced cancer. Preliminary findings suggest that the intervention shows promise in contributing to enhanced relationship functioning. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  15. Effect of a stress management program on subjects with neck pain: A pilot randomized controlled trial.

    Science.gov (United States)

    Metikaridis, T Damianos; Hadjipavlou, Alexander; Artemiadis, Artemios; Chrousos, George; Darviri, Christina

    2016-05-20

    Studies have shown that stress is implicated in the cause of neck pain (NP). The purpose of this study is to examine the effect of a simple, zero cost stress management program on patients suffering from NP. This study is a parallel-type randomized clinical study. People suffering from chronic non-specific NP were chosen randomly to participate in an eight week duration program of stress management (N= 28) (including diaphragmatic breathing, progressive muscle relaxation) or in a no intervention control condition (N= 25). Self-report measures were used for the evaluation of various variables at the beginning and at the end of the eight-week monitoring period. Descriptive and inferential statistic methods were used for the statistical analysis. At the end of the monitoring period, the intervention group showed a statistically significant reduction of stress and anxiety (p= 0.03, p= 0.01), report of stress related symptoms (p= 0.003), percentage of disability due to NP (p= 0.000) and NP intensity (p= 0.002). At the same time, daily routine satisfaction levels were elevated (p= 0.019). No statistically significant difference was observed in cortisol measurements. Stress management has positive effects on NP patients.

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

    Science.gov (United States)

    Nixon, Reginald D V

    2012-12-01

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

  17. PROMOTING GROSS MOTOR SKILLS IN TODDLERS: THE ACTIVE BEGINNINGS PILOT CLUSTER RANDOMIZED TRIAL.

    Science.gov (United States)

    Veldman, Sanne L C; Okely, Anthony D; Jones, Rachel A

    2015-12-01

    This study examined the feasibility, acceptability, and potential efficacy of a gross motor skill program for toddlers. An 8-wk. skills program in which children practiced three skills was implemented for 10 min. daily in two randomly designated childcare centers. Two other centers served as the control group. Recruitment and retention rates were collected for feasibility. Data on professional development, children's participation, program duration, and appropriateness of the lessons were collected for acceptability, and the Test of Gross Motor Development-2 and Get Skilled, Get Active (total of 28 points) were used to look at the potential efficacy. The participants were 60 toddlers (M age=2.5 yr., SD=0.4; n=29 boys), and the retention rate was 95%. Overall participation was 76%, and educators rated 98% of the lessons as appropriate. Compared with the control group, the intervention group showed significantly greater improvements in motor skills (pmotor skills among toddlers.

  18. 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)…

  19. Neointimal hyperplasia after silverhawk atherectomy versus percutaneous transluminal angioplasty (PTA) in femoropopliteal stent reobstructions: a controlled, randomized pilot trial.

    Science.gov (United States)

    Brodmann, Marianne; Rief, Peter; Froehlich, Harald; Dorr, Andreas; Gary, Thomas; Eller, Philipp; Hafner, Franz; Deutschmann, Hannes; Seinost, Gerald; Pilger, Ernst

    2013-02-01

    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.

  20. Body weight-supported treadmill training vs. overground walking training for persons with chronic stroke: a pilot randomized controlled trial.

    Science.gov (United States)

    Combs-Miller, Stephanie A; Kalpathi Parameswaran, Anu; Colburn, Dawn; Ertel, Tara; Harmeyer, Amanda; Tucker, Lindsay; Schmid, Arlene A

    2014-09-01

    To compare the effects of body weight-supported treadmill training and overground walking training when matched for task and dose (duration/frequency/intensity) on improving walking function, activity, and participation after stroke. Single-blind, pilot randomized controlled trial with three-month follow-up. University and community settings. A convenience sample of participants (N = 20) at least six months post-stroke and able to walk independently were recruited. Thirty-minute walking interventions (body weight-supported treadmill training or overground walking training) were administered five times a week for two weeks. Intensity was monitored with the Borg Rating of Perceived Exertion Scale at five-minute increments to maintain a moderate training intensity. Walking speed (comfortable/fast 10-meter walk), walking endurance (6-minute walk), spatiotemporal symmetry, and the ICF Measure of Participation and ACTivity were assessed before, immediately after, and three months following the intervention. The overground walking training group demonstrated significantly greater improvements in comfortable walking speed compared with the body weight-supported treadmill training group immediately (change of 0.11 m/s vs. 0.06 m/s, respectively; p = 0.047) and three months (change of 0.14 m/s vs. 0.08 m/s, respectively; p = 0.029) after training. Only the overground walking training group significantly improved comfortable walking speed (p = 0.001), aspects of gait symmetry (p = 0.032), and activity (p = 0.003) immediately after training. Gains were maintained at the three-month follow-up (p training was more beneficial than body weight-supported treadmill training at improving self-selected walking speed for the participants in this study. © The Author(s) 2014.

  1. Narrative exposure therapy versus interpersonal psychotherapy. A pilot randomized controlled trial with Rwandan genocide orphans.

    Science.gov (United States)

    Schaal, Susanne; Elbert, Thomas; Neuner, Frank

    2009-01-01

    The aim of the present study was to evaluate the efficacy of treatment modules for trauma spectrum disorders in a sample of Rwandan genocide orphans. Twenty-six orphans (originally 27) who presented with posttraumatic stress disorder (PTSD) at first assessment continued to meet a PTSD DSM-IV diagnosis 6 months after their initial assessment. They were offered participation in a controlled treatment trial. A group adaptation of interpersonal psychotherapy (IPT, n = 14) was compared to individual narrative exposure therapy (NET, n = 12). The last NET session involved guided mourning. Each treatment program consisted of 4 weekly sessions. Main outcome measures were diagnostic status and symptoms of PTSD and depression assessed before treatment, at 3 months post-test and at 6 months follow-up using the Clinician-Administered PTSD Scale, Mini-International Neuropsychiatric Interview, and Hamilton Rating Scale. At post-test, there were no significant group differences between NET and IPT on any of the examined outcome measures. At 6-month follow-up, only 25% of NET, but 71% of IPT participants still fulfilled PTSD criteria. There was a significant time x treatment interaction in the severity of PTSD [Wilks' Lambda = 0.75, F(2,23) = 3.93; p < 0.05] and depression symptoms [Wilks' Lambda = 0.23, F(2,23) = 3.40; p = 0.05]. At follow-up, NET participants were significantly more improved than IPT participants with respect to both the severity of symptoms of PTSD and depression. Individual NET in combination with group-based mourning comprises an effective treatment for traumatized survivors who have to bear the loss of loved ones and have been suffering from symptoms of PTSD and depression. Copyright 2009 S. Karger AG, Basel.

  2. Effects of adjunctive exercise on physiological and psychological parameters in depression: a randomized pilot trial.

    Science.gov (United States)

    Kerling, Arno; Tegtbur, Uwe; Gützlaff, Elke; Kück, Momme; Borchert, Luise; Ates, Zeynep; von Bohlen, Anne; Frieling, Helge; Hüper, Katja; Hartung, Dagmar; Schweiger, Ulrich; Kahl, Kai G

    2015-05-15

    Major depressive disorder (MDD) is associated with decreased physical activity and increased rates of the metabolic syndrome (MetS), a risk factor for the development of type 2 diabetes and cardiovascular disorders. Exercise training has been shown to improve cardiorespiratory fitness and metabolic syndrome factors. Therefore, our study aimed at examining whether patients receiving an exercise program as an adjunct to inpatient treatment will benefit in terms of physiological and psychological factors. Fourty-two inpatients with moderate to severe depression were included. Twenty-two patients were randomized to additional 3x weekly exercise training (EXERCISE) and compared to treatment as usual (TAU). Exercise capacity was assessed as peak oxygen uptake (VO2peak), ventilatory anaerobic threshold (VAT) and workload expressed as Watts (W). Metabolic syndrome was defined according to NCEP ATPIII panel criteria. After 6 weeks of treatment, cardiorespiratory fitness (VO2peak, VAT, Watt), waist circumference and HDL cholesterol were significantly improved in EXERCISE participants. Treatment response expressed as ≥50% MADRS reduction was more frequent in the EXERCISE group. Adjunctive exercise training in depressed inpatients improves physical fitness, MetS factors, and psychological outcome. Given the association of depression with cardiometablic disorders, exercise training is recommended as an adjunct to standard antidepressant treatment. Copyright © 2015 Elsevier B.V. All rights reserved.

  3. Safety and improvement of movement function after stroke with atomoxetine: A pilot randomized trial

    Science.gov (United States)

    Ward, Andrea; Carrico, Cheryl; Powell, Elizabeth; Westgate, Philip M.; Nichols, Laurie; Fleischer, Anne; Sawaki, Lumy

    2016-01-01

    Background: Intensive, task-oriented motor training has been associated with neuroplastic reorganization and improved upper extremity movement function after stroke. However, to optimize such training for people with moderate-to-severe movement impairment, pharmacological modulation of neuroplasticity may be needed as an adjuvant intervention. Objective: Evaluate safety, as well as improvement in movement function, associated with motor training paired with a drug to upregulate neuroplasticity after stroke. Methods: In this double-blind, randomized, placebo-controlled study, 12 subjects with chronic stroke received either atomoxetine or placebo paired with motor training. Safety was assessed using vital signs. Upper extremity movement function was assessed using Fugl-Meyer Assessment, Wolf Motor Function Test, and Action Research Arm Test at baseline, post-intervention, and 1-month follow-up. Results: No significant between-groups differences were found in mean heart rate (95% CI, –12.4–22.6; p = 0.23), mean systolic blood pressure (95% CI, –1.7–29.6; p = 0.21), or mean diastolic blood pressure (95% CI, –10.4–13.3; p = 0.08). A statistically significant between-groups difference on Fugl-Meyer at post-intervention favored the atomoxetine group (95% CI, 1.6–12.7; p = 0.016). Conclusion: Atomoxetine combined with motor training appears safe and may optimize motor training outcomes after stroke. PMID:27858723

  4. Oral language supports early literacy: a pilot cluster randomized trial in disadvantaged schools.

    Science.gov (United States)

    Snow, Pamela C; Eadie, Patricia A; Connell, Judy; Dalheim, Brenda; McCusker, Hugh J; Munro, John K

    2014-10-01

    This study examined the impact of teacher professional development aimed at improving the capacity of primary teachers in disadvantaged schools to strengthen children's expressive and receptive oral language skills and early literacy success in the first 2 years of school. Fourteen low-SES schools in Victoria, Australia were randomly allocated to a research (n = 8) or control arm (n = 6), resulting in an initial sample of 1254 students, (n = 602 in research arm and n = 652 in control arm). The intervention comprised 6 days of teacher and principal professional development (delivered by language and literacy experts), school-based continuing contact with the research team and completion by one staff member of each research school of a postgraduate unit on early language and literacy. Schools in the control arm received standard teaching according to state auspiced curriculum guidelines. Full data were available on 979 students at follow-up (time 2). Students in the research arm performed significantly better on Test of Language Development: Primary (Fourth Edition) sub-tests (p ≤ .002) and the Reading Progress Test (F = 10.4(1); p = .001) than students in the control arm at time 2. Narrative scores were not significantly different at time 2, although students in research schools showed greater gains. Findings provide "proof of concept" for this approach, and are discussed with respect to implications for teacher professional development and pre-service education concerning the psycholinguistic competencies that underpin the transition to literacy.

  5. A pilot randomized trial of a cognitive reappraisal obesity prevention program.

    Science.gov (United States)

    Stice, Eric; Yokum, Sonja; Burger, Kyle; Rohde, Paul; Shaw, Heather; Gau, Jeff M

    2015-01-01

    Evaluate a selective obesity prevention program promoting use of cognitive reappraisals to reduce reward region response and increase inhibitory region response to high-fat/high-sugar foods and reduce intake of fat and sugar to prevent blunted reward region response to intake of such foods. Young adults at risk for future weight gain by virtue of weight concerns (N=148) were randomized to this new prevention program (Minding Health), an alternative prevention program promoting participant-driven gradual reductions in caloric intake and increases in physical activity (Healthy Weight), or an obesity education video control condition, completing assessments at pre-, post-, and 6-month follow-up. A subset of Minding Health and control participants completed an fMRI scan at pre- and post-assessing neural response to images of high-fat/sugar foods and to receipt and anticipated receipt of a high-fat/sugar food. Minding Health participants showed significantly greater reductions in body fat than controls and caloric intake from fat and sugar than Healthy Weight participants. Minding Health participants also showed greater activation of an inhibitory control region and reduced activation of an attention/expectation region in response to palatable food images relative to pretest and controls. However, Healthy Weight participants showed greater reductions in BMI and eating disorder symptoms than Minding Health participants. Although the Minding Health intervention produced some of the hypothesized effects, it did not produce lasting reductions in body fat or BMI and showed limited effects on neural responsivity, implying it will be vital to increase the efficacy of this new prevention program. Copyright © 2014 Elsevier Inc. All rights reserved.

  6. A Pilot Randomized, Single Blind, Placebo-Controlled Trial of Traditional Acupuncture for Vasomotor Symptoms and Mechanistic Pathways of Menopause

    Science.gov (United States)

    Painovich, Jeannette M.; Shufelt, Chrisandra L.; Azziz, Ricardo; Yang, Yuching; Goodarzi, Mark O.; Braunstein, Glenn D.; Karlan, Beth Y.; Stewart, Paul M.; Merz, C. Noel Bairey

    2011-01-01

    Objective To conduct a pilot study for feasibility of planning a definitive clinical trial comparing traditional acupuncture (TA) to sham acupuncture (SA) and waiting control (WC) on menopause related vasomotor symptoms (VMS), quality of life (QOL), and the hypothalamic-pituitary-adrenal (HPA) axis in peri and post-menopausal women. Methods Thirty-three peri and post-menopausal women with at least 7 VMS daily were randomized to TA, SA or WC. The TA and SA groups were given three treatments per week for 12 weeks. Outcomes included the number and severity of VMS, MENQOL questionnaire, Beck Depression Inventory, Spielberg State-Trait Anxiety Instrument, Pittsburgh Quality Sleep Index, 24 hour urine cortisol and metabolites, and ACTH stimulation testing. Results Both TA and SA groups demonstrated improved VMS trends compared to WC (Δ −3.5±3.00 vs. −4.1±3.79 vs. −1.2±2.4, respectively, p=.20), and significantly improved MENQOL vasomotor scores (Δ − 1.5±2.02 vs. −1.8±1.52 vs. 0.3±0.64, respectively, p=.04). There were no psychosocial group differences. Exit 24-hour urinary measures were lower in the TA vs the SA or WC in total cortisol metabolites (4,658.9±1,670.9 vs 7,735.8±3,747.9 vs 5,166.0±2,234.5, p=0.03, respectively) and DHEA (41.4±27.46, 161.2±222.77, 252.4±385.40, respectively, p=0.05). The ACTH stimulation cortisol response data also trended in the hypothesized direction (p=0.17). Conclusion Both TA and SA reduce VMS frequency and severity and improve VMS-related quality of life compared to WC; however, TA alone may impact the HPA axis. This association is viewed as preliminary and hypothesis-generating and should be explored in a large clinical trial. PMID:21968279

  7. Patient-centered professional practice models for managing low back pain in older adults: a pilot randomized controlled trial.

    Science.gov (United States)

    Goertz, Christine M; Salsbury, Stacie A; Long, Cynthia R; Vining, Robert D; Andresen, Andrew A; Hondras, Maria A; Lyons, Kevin J; Killinger, Lisa Z; Wolinsky, Fredric D; Wallace, Robert B

    2017-10-13

    Low back pain is a debilitating condition for older adults, who may seek healthcare from multiple providers. Few studies have evaluated impacts of different healthcare delivery models on back pain outcomes in this population. The purpose of this study was to compare clinical outcomes of older adults receiving back pain treatment under 3 professional practice models that included primary medical care with or without chiropractic care. We conducted a pilot randomized controlled trial with 131 community-dwelling, ambulatory older adults with subacute or chronic low back pain. Participants were randomly allocated to 12 weeks of individualized primary medical care (Medical Care), concurrent medical and chiropractic care (Dual Care), or medical and chiropractic care with enhanced interprofessional collaboration (Shared Care). Primary outcomes were low back pain intensity rated on the numerical rating scale and back-related disability measured with the Roland-Morris Disability Questionnaire. Secondary outcomes included clinical measures, adverse events, and patient satisfaction. Statistical analyses included mixed-effects regression models and general estimating equations. At 12 weeks, participants in all three treatment groups reported improvements in mean average low back pain intensity [Shared Care: 1.8; 95% confidence interval (CI) 1.0 to 2.6; Dual Care: 3.0; 95% CI 2.3 to 3.8; Medical Care: 2.3; 95% CI 1.5 to 3.2)] and back-related disability (Shared Care: 2.8; 95% CI 1.6 to 4.0; Dual Care: 2.5; 95% CI 1.3 to 3.7; Medical Care: 1.5; 95% CI 0.2 to 2.8). No statistically significant differences were noted between the three groups on the primary measures. Participants in both models that included chiropractic reported significantly better perceived low back pain improvement, overall health and quality of life, and greater satisfaction with healthcare services than patients who received medical care alone. Professional practice models that included primary care and

  8. The effect of offering different numbers of colorectal cancer screening test options in a decision aid: a pilot randomized trial

    Directory of Open Access Journals (Sweden)

    Brenner Alison RT

    2008-01-01

    Full Text Available Abstract Background Decision aids can improve decision making processes, but the amount and type of information that they should attempt to communicate is controversial. We sought to compare, in a pilot randomized trial, two colorectal cancer (CRC screening decision aids that differed in the number of screening options presented. Methods Adults ages 48–75 not currently up to date with screening were recruited from the community and randomized to view one of two versions of our previously tested CRC screening decision aid. The first version included five screening options: fecal occult blood test (FOBT, sigmoidoscopy, a combination of FOBT and sigmoidoscopy, colonoscopy, and barium enema. The second discussed only the two most frequently selected screening options, FOBT and colonoscopy. Main outcomes were differences in screening interest and test preferences between groups after decision aid viewing. Patient test preference was elicited first without any associated out-of-pocket costs (OPC, and then with the following costs: FOBT-$10, sigmoidoscopy-$50, barium enema-$50, and colonoscopy-$200. Results 62 adults participated: 25 viewed the 5-option decision aid, and 37 viewed the 2-option version. Mean age was 54 (range 48–72, 58% were women, 71% were White, 24% African-American; 58% had completed at least a 4-year college degree. Comparing participants that viewed the 5-option version with participants who viewed the 2-option version, there were no differences in screening interest after viewing (1.8 vs. 1.9, t-test p = 0.76. Those viewing the 2-option version were somewhat more likely to choose colonoscopy than those viewing the 5-option version when no out of pocket costs were assumed (68% vs. 46%, p = 0.11, but not when such costs were imposed (41% vs. 42%, p = 1.00. Conclusion The number of screening options available does not appear to have a large effect on interest in colorectal cancer screening. The effect of offering differing

  9. 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

  10. The Smartphone Peer Physical Activity Counseling (SPPAC) Program for Manual Wheelchair Users: Protocol of a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Best, Krista L; Routhier, François; Sweet, Shane N; Arbour-Nicitopoulos, Kelly P; Borisoff, Jaimie F; Noreau, Luc; Martin Ginis, Kathleen A

    2017-04-26

    Physical activity (PA) must be performed regularly to accrue health benefits. However, the majority of manual wheelchair users do not meet PA recommendations. Existing community-based PA programs for manual wheelchair users appear to work, but effect sizes are small and retention is low. Existing PA programs may not fully implement some psychosocial factors that are strongly linked with PA (eg, autonomy). The use of peers and mobile phone technology in the Smartphone Peer PA Counseling (SPPAC) program represents a novel approach to cultivating a PA-supportive environment for manual wheelchair users. The primary objective is to compare change in objective PA between the experimental (SPPAC) and control groups from baseline to postintervention (10 weeks) and follow-up (3 months). Changes in and relationships between subjective PA, wheelchair skills, motivation, self-efficacy (for overcoming barriers to PA for manual wheelchair use), satisfaction of psychological needs for PA, and satisfaction with PA participation will be explored (secondary outcome). Program implementation will be explored (tertiary objective). A total of 38 community-living manual wheelchair users (≥18 years) will be recruited in a randomized controlled trial (RCT). Participants in both the control and experimental groups will receive existing PA guidelines. Participants in the experimental group will also receive the SPPAC program: 14 sessions (~30 min) over a 10-week period delivered by a peer trainer using a mobile phone. PA activities will be based on individuals' preferences and goals. Implementation of important theoretical variables will be enforced through a peer-trainer checklist. Outcomes for objective PA (primary) and subjective PA, wheelchair skills, motivation, self-efficacy, satisfaction of psychological needs, and satisfaction with participation will be collected at three time points (baseline, postintervention, follow-up). Multiple imputations will be used to treat missing data. A

  11. Web-based nursing intervention for self-management of pain after cardiac surgery: pilot randomized controlled trial.

    Science.gov (United States)

    Martorella, Géraldine; Côté, José; Racine, Mélanie; Choinière, Manon

    2012-12-14

    Most adults undergoing cardiac surgery suffer from moderate to severe pain for up to 6 days after surgery. Individual barriers and attitudes regarding pain and its relief make patients reluctant to report their pain and ask for analgesic medication, which results in inadequate pain management. More innovative educational interventions for postoperative pain relief are needed. We developed a Web-based nursing intervention to influence patient's involvement in postoperative pain management. The intervention (SOULAGE-TAVIE) includes a preoperative 30-minute Web-based session and 2 brief face-to-face postoperative booster sessions. The Web application generates reflective activities and tailored educational messages according to patients' beliefs and attitudes. The messages are transmitted through videos of a virtual nurse, animations, stories, and texts. The aim of this single-blinded pilot randomized trial was to investigate the preliminary effects of a virtual nursing intervention (SOULAGE-TAVIE) to improve pain relief in patients undergoing cardiac surgery. Participants (N = 60) were adults scheduled for their first cardiac surgery. They were randomly assigned to the experimental group using SOULAGE-TAVIE (n = 30) or the control group using usual care, including an educational pamphlet and postoperative follow-up (n = 30). Data were collected through questionnaires at the time of admission and from day 1 to day 7 after surgery with the help of a blinded research assistant. Outcomes were pain intensity, pain interference with daily activities, patients' pain barriers, tendency to catastrophize in face of pain, and analgesic consumption. The two groups were comparable at baseline across all demographic measures. Results revealed that patients in the experimental group did not experience less intense pain, but they reported significantly less pain interference when breathing/coughing (P = .04). A severe pain interference with breathing/coughing (pain ranked ≥ 7

  12. Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

    Science.gov (United States)

    Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

    2017-11-09

    Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs

  13. Management of ocular trauma in emergency (MOTE trial: A pilot randomized double-blinded trial comparing topical amethocaine with saline in the outpatient management of corneal trauma

    Directory of Open Access Journals (Sweden)

    Ting Joseph

    2009-01-01

    Full Text Available Background: It is unclear whether local anesthetic eye drops can be safely used for the topical anesthesia of patients with minor corneal injury who are discharged from the emergency department (ED. Objectives: To assess whether topical 0.4% amethocaine self-administered to a maximum recommended frequency of once every hour for 36-48 h is safe in the management of uncomplicated corneal injury in patients discharged from the ED. Patients and Methods: A pilot randomized double-blinded trial comparing topical 0.4% amethocaine with topical normal saline. Results: Forty-seven subjects were recruited, with 22 randomized to receive amethocaine and 25 to receive placebo (normal saline . Baseline characteristics, including corneal injury type, were similar in both groups. There were no significant functional or clinical adverse sequelae in the majority of enrolled patients who could be contacted at 2 weeks (17/22 for amethocaine and 21/25 for placebo. Follow-up for the primary study outcome was suboptimal, with only 7/22 from the amethocaine group and 9/25 from the saline group presenting for 36-48 h review; there was a statistically nonsignificant trend for persistence of the corneal defect in the amethocaine group as compared with the saline group (2/7 and 1/9, respectively. Conclusion: Compared with saline drops, amethocaine eye drops are not definitely safe but they are effective for topical analgesia in minor corneal injury. Until further definitive studies, topical nonsteroidal agents or long-lasting artificial tears may be preferred for the topical analgesia of minor corneal injury. Return for corneal re-evaluation will necessarily remain suboptimal in an otherwise self-limiting condition, leading to a bias even if study recruitment is good.

  14. Behavioral intervention to reduce opioid overdose among high-risk persons with opioid use disorder: A pilot randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Phillip Oliver Coffin

    Full Text Available The United States is amidst an opioid epidemic, including synthetic opioids that may result in rapid death, leaving minimal opportunity for bystander rescue. We pilot tested a behavioral intervention to reduce the occurrence of opioid overdose among opioid dependent persons at high-risk for subsequent overdose.We conducted a single-blinded randomized-controlled trial of a repeated dose motivational interviewing intervention (REBOOT to reduce overdose versus treatment as usual, defined as information and referrals, over 16 months at the San Francisco Department of Public Health from 2014-2016. Participants were 18-65 years of age, had opioid use disorder by Structured Clinical Interview, active opioid use, opioid overdose within 5 years, and prior receipt of naloxone kits. The intervention was administered at months 0, 4, 8, and 12, preceded by the assessment which was also administered at month 16. Dual primary outcomes were any overdose event and number of events, collected by computer-assisted personal interview, as well as any fatal overdose events per vital records.A total of 78 persons were screened and 63 enrolled. Mean age was 43 years, 67% were born male, 65% White, 17% African-American, and 14% Latino. Ninety-two percent of visits and 93% of counseling sessions were completed. At baseline, 33.3% of participants had experienced an overdose in the past four months, with a similar mean number of overdoses in both arms (p = 0.95; 29% overdosed during follow-up. By intention-to-treat, participants assigned to REBOOT were less likely to experience any overdose (incidence rate ratio [IRR] 0.62 [95%CI 0.41-0.92, p = 0.019 and experienced fewer overdose events (IRR 0.46, 95%CI 0.24-0.90, p = 0.023, findings that were robust to sensitivity analyses. There were no differences between arms in days of opioid use, substance use treatment, or naloxone carriage.REBOOT reduced the occurrence of any opioid overdose and the number of overdoses

  15. Test-based exclusion diets in gastro-esophageal reflux disease patients: a randomized controlled pilot trial.

    Science.gov (United States)

    Caselli, Michele; Zuliani, Giovanni; Cassol, Francesca; Fusetti, Nadia; Zeni, Elena; Lo Cascio, Natalina; Soavi, Cecilia; Gullini, Sergio

    2014-12-07

    To investigate the clinical response of gastro-esophageal reflux disease (GERD) symptoms to exclusion diets based on food intolerance tests. A double blind, randomized, controlled pilot trial was performed in 38 GERD patients partially or completely non-responders to proton pump inhibitors (PPI) treatment. Fasting blood samples from each patients were obtained; leukocytotoxic test was performed by incubating the blood with a panel of 60 food items to be tested. The reaction of leukocytes (rounding, vacuolization, lack of movement, flattening, fragmentation or disintegration of cell wall) was then evaluated by optical microscopy and rated as follows: level 0 = negative, level 1 = slightly positive, level 2 = moderately positive, and level 3 = highly positive. A "true" diet excluding food items inducing moderate-severe reactions, and a "control" diet including them was developed for each patient. Then, twenty patients received the "true" diet and 18 the "control" diet; after one month (T1) symptoms severity was scored by the GERD impact scale (GIS). Hence, patients in the "control" group were switched to the "true" diet, and symptom severity was re-assessed after three months (T2). At baseline (T0) the mean GIS global score was 6.68 (range: 5-12) with no difference between "true" and control group (6.6 ± 1.19 vs 6.7 ± 1.7). All patients reacted moderately/severely to at least 1 food (range: 5-19), with a significantly greater number of food substances inducing reaction in controls compared with the "true" diet group (11.6 vs 7.0, P < 0.001). Food items more frequently involved were milk, lettuce, brewer's yeast, pork, coffee, rice, sole asparagus, and tuna, followed by eggs, tomato, grain, shrimps, and chemical yeast. At T1 both groups displayed a reduction of GIS score ("true" group 3.3 ± 1.7, -50%, P = 0.001; control group 4.9 ± 2.8, -26.9%, P = 0.02), although the GIS score was significantly lower in "true" vs "control" group (P = 0.04). At T2, after the diet

  16. Parent Training with High-Risk Immigrant Chinese Families: A Pilot Group Randomized Trial Yielding Practice-Based Evidence

    Science.gov (United States)

    Lau, Anna S.; Fung, Joey J.; Ho, Lorinda Y.; Liu, Lisa L.; Gudino, Omar G.

    2011-01-01

    We studied the efficacy and implementation outcomes of a culturally responsive parent training (PT) program. Fifty-four Chinese American parents participated in a wait-list controlled group randomized trial (32 immediate treatment, 22 delayed treatment) of a 14-week intervention designed to address the needs of high-risk immigrant families.…

  17. Brief Report: Pilot Randomized Controlled Trial of Reciprocal Imitation Training for Teaching Elicited and Spontaneous Imitation to Children with Autism

    Science.gov (United States)

    Ingersoll, Brooke

    2010-01-01

    Children with autism exhibit significant deficits in imitation skills. Reciprocal Imitation Training (RIT), a naturalistic imitation intervention, was developed to teach young children with autism to imitate during play. This study used a randomized controlled trial to evaluate the efficacy of RIT on elicited and spontaneous imitation skills in 21…

  18. Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial

    NARCIS (Netherlands)

    Bom, T. van der; Winter, M.M.; Bouma, B.J.; Groenink, M.; Vliegen, H.W.; Pieper, P.G.; Dijk, A.P.J. van; Sieswerda, G.T.; Roos-Hesselink, J.W.; Zwinderman, A.H.; Mulder, B.J.

    2013-01-01

    BACKGROUND: The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. METHODS AND RESULTS: We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared

  19. Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial

    NARCIS (Netherlands)

    van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

    2013-01-01

    The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared with placebo in patients with a

  20. Effect of Valsartan on Systemic Right Ventricular Function A Double-Blind, Randomized, Placebo-Controlled Pilot Trial

    NARCIS (Netherlands)

    van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

    2013-01-01

    Background-The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. Methods and Results-We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared

  1. 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

  2. Recruitment methods and costs for a randomized, placebo-controlled trial of chiropractic care for lumbar spinal stenosis: a single-site pilot study.

    Science.gov (United States)

    Cambron, Jerrilyn A; Dexheimer, Jennifer M; Chang, Mabel; Cramer, Gregory D

    2010-01-01

    The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis. This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives. Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was $40 740 or $679 per randomized patient. The costs per randomization were highest for direct mail ($995 per randomization) and lowest for newspaper/magazine advertising ($558 per randomization). Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial. Copyright 2010 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  3. A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music.

    Science.gov (United States)

    Rennick, Janet E; Stremler, Robyn; Horwood, Linda; Aita, Marilyn; Lavoie, Tanya; Majnemer, Annette; Antonacci, Marie; Knox, Alyssa; Constantin, Evelyn

    2018-04-13

    To examine the feasibility and acceptability of a PICU Soothing intervention using touch, reading, and music. Nonblinded, pilot randomized controlled trial. The PICU and medical-surgical wards of one Canadian pediatric hospital. Twenty PICU patients age 2-14 years old and their parents, randomized to an intervention group (n = 10) or control group (n = 10). PICU Soothing consisted of: 1) parental comforting (touch and reading), followed by 2) a quiet period with music via soft headbands, administered once daily throughout hospitalization. Acceptability and feasibility of the intervention and methods were assessed via participation rates, observation, measurement completion rates, semistructured interviews, and telephone calls. Psychological well-being was assessed using measures of distress, sleep, and child and parent anxiety in the PICU, on the wards and 3 months post discharge. Forty-four percent of parents agreed to participate. Seventy percent and 100% of intervention group parents responded positively to comforting and music, respectively. Most intervention group parents (70%) and all nurses felt children responded positively. All nurses found the intervention acceptable and feasible. Measurement completion rates ranged from 70% to 100%. Pilot data suggested lower intervention group child and parent anxiety after transfer to hospital wards. PICU Soothing is acceptable and feasible to conduct. Results support the implementation of a full-scale randomized controlled trial to evaluate intervention effectiveness.

  4. Early physical training and psycho-educational intervention for patients undergoing coronary artery bypass grafting. The SheppHeart randomized 2 × 2 factorial clinical pilot trial.

    Science.gov (United States)

    Højskov, Ida E; Moons, Philip; Hansen, Niels V; Greve, Helle; Olsen, Dorte Bæk; Cour, Søren La; Glud, Christian; Winkel, Per; Lindschou, Jane; Egerod, Ingrid; Christensen, Anne Vinggaard; Berg, Selina Kikkenborg

    2016-10-01

    Patients undergoing coronary artery bypass graft surgery often experience a range of problems and symptoms such as immobility, pain and insufficient sleep. Results from trials investigating testing in-hospital physical exercise or psychological intervention have been promising. However, no randomized clinical trials have tested a comprehensive rehabilitation programme consisting of both physical exercise and psycho-education in the early rehabilitation phase. The aims of the present SheppHeart pilot randomized clinical trial were to evaluate the feasibility of patient recruitment, patient acceptance of the intervention, safety and tolerability of the intervention. Sixty patients admitted for coronary artery bypass graft were randomized 1:1:1:1 to: 1) physical exercise plus usual care, or 2) psycho-educational intervention plus usual care, or 3) physical exercise and psycho-educational plus usual care, or 4) usual care alone during a four week period after surgery. The acceptability of trial participation was 67% during the three month recruitment period. In the physical exercise groups, patients complied with 59% of the total expected training sessions during hospitalization. Nine patients (30%) complied with >75% and nine patients (30%) complied with 50% of the planned exercise sessions. Eleven patients (42%) participated in ⩾75% of the four consultations and six patients (23%) participated in 50% of the psycho-educational programme. Comprehensive phase one rehabilitation combining physical exercise and psycho-education in coronary artery bypass graft patients shows reasonably high inclusion, feasibility and safety. © The European Society of Cardiology 2015.

  5. Feasibility of a Psychosocial Rehabilitation Intervention to Enhance the Involvement of Relatives in Cancer Rehabilitation: Pilot Study for a Randomized Controlled Trial

    DEFF Research Database (Denmark)

    L, Ledderer; KI, Cour; O, Mogensen

    2013-01-01

    . We developed an innovative rehabilitation program to be offered to the patient and a relative as a pair. Objective The aim of the present pilot study was to examine the feasibility of the intervention in a randomized controlled trial (RCT) and to evaluate the impact on quality of life. Methods...... significant difference was observed between the intervention and the control group. Pairs reported that the time of inclusion was inconvenient and that rehabilitation ought to meet their changing needs. Conclusions The pilot study showed that it may be difficult to conduct an RCT of a psychosocial...... rehabilitation intervention for pairs, and difficulties with inclusion and drop out have to be addressed. Interventions need to be carefully developed and tested before evaluating an effect in a large-scale study....

  6. Recruitment to and pilot results of the PACES randomized trial of physical exercise during adjuvant chemotherapy for colon cancer.

    Science.gov (United States)

    van Waart, Hanna; Stuiver, Martijn M; van Harten, Wim H; Geleijn, Edwin; de Maaker-Berkhof, Marianne; Schrama, Jolanda; Geenen, Maud M; Meerum Terwogt, Jetske M; van den Heiligenberg, Simone M; Hellendoorn-van Vreeswijk, Jeannette A J H; Sonke, Gabe S; Aaronson, Neil K

    2018-01-01

    We report the recruitment rate, reasons for and factors influencing non-participation, and descriptive results of a randomized controlled trial of two different exercise programs for patients with colon cancer undergoing adjuvant chemotherapy. Participants were randomized to a low-intensity, home-based program (Onco-Move), a moderate- to high-intensity, combined supervised resistance and aerobic exercise program (OnTrack), or Usual Care. Non-participants provided reasons for non-participation and were asked to complete a questionnaire assessing behavioral and attitudinal variables. Trial participants completed performance-based and self-reported outcome measures prior to randomization, at the end of chemotherapy, and at the 6-month follow-up. Twenty-three of 63 referred patients agreed to participate in the trial. All 40 non-participants provided reasons for non-participation. Forty-five percent of the non-participants completed the questionnaire. Those who did not want to exercise had higher fatigue scores at baseline and a more negative attitude toward exercise. Compliance to both programs was high and no adverse events occurred. On average, the colon cancer participants were able to maintain or improve their physical fitness levels and maintain or decrease their fatigue levels during chemotherapy and follow-up. Recruitment of patients with colon cancer to a physical exercise trial during adjuvant chemotherapy proved to be difficult, underscoring the need to develop more effective strategies to increase participation rates. Both home-based and supervised programs are safe and feasible in patients with colon cancer undergoing chemotherapy. Effectiveness needs to be established in a larger trial. Netherlands Trial Register - NTR2159.

  7. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT: study protocol and design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kruger Peter

    2011-03-01

    Full Text Available Abstract Background Swine origin influenza A/H1N1 infection (H1N1 emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes. Methods/Design A multi-national, pilot randomized controlled trial (RCT of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM, waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to

  8. Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial

    Directory of Open Access Journals (Sweden)

    Uchenna Okafor

    2017-02-01

    Full Text Available Abstract Background The HIV prevalence among female populations involved in sex work in Nigeria has heightened interest in HIV prevention programming for this sub-population with brothel-based female sex workers (BB FSWs having a prevalence of 27.4%, six times higher than the prevalence in the general population. Methods/design The clusters in the randomized pilot trial will be brothels and female sex workers (FSWs residing in the brothels will be the participants of the study. The participants will receive free condom distribution as well as HIV prevention messages on condom use and negotiation skills to increase self-efficacy in handling social and gender power plays within their environment. Twelve brothels will be randomized into experimental and control conditions with a minimum total sample size of 200 participants. Recruitment of participants will be carried out from within the brothels. The control condition will receive a standard intervention consisting of a minimum of six interactive sessions with peer educators (PE engaging their peers through group discussions and one on one interaction using pre-designed HIV prevention messages. The experimental condition will receive the standard intervention as well as interactive sessions with the brothel leadership (chairladies and brothel managers to facilitate consistent condom use and appropriate condom use policies, conditions, and messaging. Both interventions will be delivered over a maximum period of 16 weeks, and male and female condoms will be distributed during the intervention. Quantitative assessments will be carried out at baseline and at 16 weeks follow-up, and the pilot findings will inform feasibility of and sample size estimation for a phase III trial. The primary outcomes measured are recruitment rate attrition rate and adherence to the intervention. Consistent condom use outcomes by FSWs within the brothel with all partner types and enhanced self-efficacy for condom

  9. Development and piloting of a food-based intervention to increase vitamin E intake in pregnant women in a randomized controlled trial.

    Science.gov (United States)

    Clark, Julia; Holgan, Nikki; Craig, Leone; Morgan, Heather; Danielian, Peter; Devereux, Graham

    2016-11-01

    Low maternal vitamin E intake during pregnancy is associated with childhood asthma and a trial is required to test whether increasing maternal vitamin E intake reduces childhood asthma. This study investigated whether such a trial is possible using food to increase vitamin E intake. Three soup varieties with enhanced vitamin E content (16-19 mg/can) from food ingredients were developed. Near identical retail versions (vitamin E 1-4 mg/can) acted as placebo. In a pilot double-blind randomized controlled trial, pregnant women were randomized 1:1 to enhanced or placebo soups (three tins/week) from 12 weeks gestation to delivery. Vitamin E intake was quantified at 12, 20, and 34 weeks gestation. Qualitative interviews were conducted. 59 women were randomized (29 enhanced, 30 placebo), 28 completed the trial, (15 enhanced, 13 placebo). In women completing the trial, vitamin E intake of the placebo group remained unchanged; 7.09 mg/d (95% CI 5.41-8.77) at 12 weeks, 6.41 mg/d (5.07-7.75) at 20 weeks, and 6.67 mg/d (5.38-7.96) at 34 weeks gestation; vitamin E intake of the enhanced group increased from 6.50 mg/d (5.21-7.79) at 12 weeks to 14.9 mg/d (13.3-16.4) at 20 weeks and 15.2 mg/d (12.9-17.5) at 34 weeks, P  clear guidance on improving adherence. Although 31 women withdrew at median 19 weeks gestation (interquartile range 16-25), the intervention was consumed by women for 80% of weeks between 12 and 34 weeks gestation and for 63% of weeks between 12 weeks gestation and delivery. In a pilot double-blind randomized controlled trial (RCT) it is possible to increase maternal vitamin E intake using food ingredients, a further food product is required to improve adherence.

  10. Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial.

    Science.gov (United States)

    Okafor, Uchenna; Crutzen, Rik; Okekearu, Ifeanyi; Adebajo, Sylvia; Uzoh, Adaora; Awo, Egbe Aneotah; Chima, Chukwuemeka; Agwagwa, Ogechukwu; van den Borne, Bart

    2017-01-01

    The HIV prevalence among female populations involved in sex work in Nigeria has heightened interest in HIV prevention programming for this sub-population with brothel-based female sex workers (BB FSWs) having a prevalence of 27.4%, six times higher than the prevalence in the general population. The clusters in the randomized pilot trial will be brothels and female sex workers (FSWs) residing in the brothels will be the participants of the study. The participants will receive free condom distribution as well as HIV prevention messages on condom use and negotiation skills to increase self-efficacy in handling social and gender power plays within their environment. Twelve brothels will be randomized into experimental and control conditions with a minimum total sample size of 200 participants. Recruitment of participants will be carried out from within the brothels. The control condition will receive a standard intervention consisting of a minimum of six interactive sessions with peer educators (PE) engaging their peers through group discussions and one on one interaction using pre-designed HIV prevention messages. The experimental condition will receive the standard intervention as well as interactive sessions with the brothel leadership (chairladies and brothel managers) to facilitate consistent condom use and appropriate condom use policies, conditions, and messaging. Both interventions will be delivered over a maximum period of 16 weeks, and male and female condoms will be distributed during the intervention. Quantitative assessments will be carried out at baseline and at 16 weeks follow-up, and the pilot findings will inform feasibility of and sample size estimation for a phase III trial. The primary outcomes measured are recruitment rate attrition rate and adherence to the intervention. Consistent condom use outcomes by FSWs within the brothel with all partner types and enhanced self-efficacy for condom negotiation with all partner types will be the primary

  11. Effects of periodontal treatment on lung function and exacerbation frequency in patients with chronic obstructive pulmonary disease and chronic periodontitis: a 2-year pilot randomized controlled trial.

    Science.gov (United States)

    Zhou, Xuan; Han, Jing; Liu, Zhiqiang; Song, Yiqing; Wang, Zuomin; Sun, Zheng

    2014-06-01

    To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease (COPD) patients with chronic periodontitis (CP). In a pilot randomized controlled trial, 60 COPD patients with CP were randomly assigned to receive scaling and root planing (SRP) treatment, supragingival scaling treatment, or oral hygiene instructions only with no periodontal treatment. We evaluated their periodontal indexes, respiratory function, and COPD exacerbations at baseline, 6 months, 1, and 2 years. Compared with the control group, measurements of periodontal indexes were significantly improved in patients in two treatment groups at 6-month, 1-year, and 2-year follow-up (all p periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. Pilot Randomized Trial Comparing Intersession Scheduling of Biofeedback Results to Individuals with Chronic Pain: Influence on Psychologic Function and Pain Intensity.

    Science.gov (United States)

    Weeks, Douglas L; Whitney, Anthony A; Tindall, Angelique G; Carter, Gregory T

    2015-10-01

    The objective of this study was to compare the effectiveness of two biofeedback schedules on long-term improvement in physical and psychologic reactivity to chronic nonmalignant pain. This study is a prospective, randomized pilot trial. Twenty adults with chronic pain engaged in heart rate variability (HRV) biofeedback training for nine sessions with HRV presented visually. Two groups, formed by random assignment, were compared: The faded feedback group received concurrent visual HRV biofeedback in session 1, with the amount of biofeedback systematically reduced for ensuing sessions so that, by session 9, the participants were controlling HRV without external feedback. The full feedback group received visual HRV biofeedback continuously across all sessions. Outcome measures assessed at baseline, immediately after the program, and 3 mos after the program included pain intensity, fear-avoidance beliefs, and self-report physical functioning. Use of biofeedback skills was also assessed 3 mos after the program. Nominal variables were analyzed with χ. Continuous measures were analyzed with repeated-measures analyses of variance. The faded feedback schedule resulted in greater use of biofeedback skills at 3 mos and improved pain intensity and fear-avoidance beliefs after the program and at 3 mos. Physical functioning did not differ between groups. Systematically reducing the frequency of external visual feedback during HRV biofeedback training was associated with reduced reactivity to chronic pain. Results of this pilot study should be confirmed with a larger randomized study.

  13. An observer-blinded randomized controlled pilot trial comparing localized immersion psoralen-ultraviolet A with localized narrowband ultraviolet B for the treatment of palmar hand eczema.

    Science.gov (United States)

    Brass, D; Fouweather, T; Stocken, D D; Macdonald, C; Wilkinson, J; Lloyd, J; Farr, P M; Reynolds, N J; Hampton, P J

    2017-12-13

    Hand eczema is a common inflammatory dermatosis that causes significant patient morbidity. Previous studies comparing psoralen-ultraviolet A (PUVA) with narrowband ultraviolet B (NB-UVB) have been small, nonrandomized and retrospective. To conduct an observer-blinded randomized controlled pilot study using validated scoring criteria to compare immersion PUVA with NB-UVB for the treatment of chronic hand eczema unresponsive to topical steroids. Sixty patients with hand eczema unresponsive to clobetasol propionate 0·05% were randomized to receive either immersion PUVA or NB-UVB twice weekly for 12 weeks with assessments at intervals of 4 weeks. The primary outcome measure was the proportion of patients achieving 'clear' or 'almost clear' Physician's Global Assessment (PGA) response at 12 weeks. Secondary outcome measures included assessment of the modified Total Lesion and Symptom Score (mTLSS) and the Dermatology Life Quality index (DLQI). In both treatment arms, 23 patients completed the 12-week assessment for the primary outcome measure. In the PUVA group, five patients achieved 'clear' and eight 'almost clear' [intention-to-treat (ITT) response rate 43%]. In the NB-UVB group, two achieved 'clear' and five 'almost clear' (ITT response rate 23%). For the secondary outcomes, median mTLSS scores were similar between groups at baseline (PUVA 9·5, NB-UVB 9) and at 12 weeks (PUVA 3, NB-UVB 4). Changes in DLQI were similar, with improvements in both groups. In this randomized pilot trial recruitment was challenging. After randomization, there were acceptable levels of compliance and safety in each treatment schedule, but lower levels of retention. Using validated scoring systems - PGA, mTLSS and DLQI - as measures of treatment response, the trial demonstrated that both PUVA and NB-UVB reduced the severity of chronic palmar hand eczema. © 2017 British Association of Dermatologists.

  14. Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial.

    Science.gov (United States)

    Michel, Patrik; Ntaios, George; Reichhart, Marc; Schindler, Christian; Bogousslavsky, Julien; Maeder, Philip; Meuli, Reto; Wintermark, Max

    2012-06-01

    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(3) in the treatment arm and 29 (8-105) cm(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.

  15. Perfusion-CT guided intravenous thrombolysis in patients with unknown-onset stroke: a randomized, double-blind, placebo-controlled, pilot feasibility trial

    International Nuclear Information System (INIS)

    Michel, Patrik; Ntaios, George; Reichhart, Marc; Schindler, Christian; Bogousslavsky, Julien; Maeder, Philip; Meuli, Reto; Wintermark, Max

    2012-01-01

    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 3 in the treatment arm and 29 (8-105) cm 3 in the placebo arm. This pilot study shows that a randomized PCT-guided thrombolysis trial in patients with stroke of unknown onset may be feasible if issues such as treatment delays and reliable identification of tissue at risk of infarction tissue are resolved. Safety and efficiency of such an approach need to be established. (orig.)

  16. Interaction and efficacy of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: A study protocol for a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Kim Yoon-Bum

    2011-03-01

    Full Text Available Abstract Background In consideration of patients seeking to use traditional Chinese medicine, an evidence-based potentiality for safe and effective use of herbal medicine and acupuncture in treatment of acne vulgaris has been suggested. However, despite common use of a combination of herbal medicine and acupuncture in clinical practice, the current level of evidence is insufficient to draw a conclusion for an interaction and efficacy of herbal medicine and acupuncture. Therefore, considering these methodological flaws, this study was designed to assess the interaction and efficacy of an available herbal medicine, Keigai-rengyo-to extract (KRTE, and acupuncture for treatment of acne using the 2 × 2 factorial design and the feasibility of a large clinical trial. Methods/Design A randomized, assessor single blinded, 2 × 2 factorial pilot trial will be conducted. Forty four participants with acne vulgaris will be randomized into one of four groups: waiting list group (WL, KRTE only group (KO, acupuncture only group (AO, and KRTE and acupuncture combined treatment group (KA. After randomization, a total of 8 sessions of acupuncture treatment will be performed twice a week in the AO- and KA groups, respectively. Patients in the KO- and KA groups will be prescribed KRTE 3 times a day at a dose of 7.4 g after meals for 4 weeks. The following outcome measurements will be used in examination of subjects: the mean percentage change and the count change of inflammatory and non-inflammatory acne lesions, the Skindex 29, visual analogue scale (VAS and investigator global assessment (IGA from baseline to the end of the trial. Trial Registration The trial is registered with the Clinical Research Information Service (CRiS, Republic of Korea: KCT0000071.

  17. Improving depression and enhancing resilience in family dementia caregivers: a pilot randomized placebo-controlled trial of escitalopram.

    Science.gov (United States)

    Lavretsky, Helen; Siddarth, Prabha; Irwin, Michael R

    2010-02-01

    This study examined the potential of an antidepressant drug, escitalopram, to improve depression, resilience to stress, and quality of life in family dementia caregivers in a randomized placebo-controlled double-blinded trial. Forty family caregivers (43-91 years of age, 25 children and 15 spouses; 26 women) who were taking care of their relatives with Alzheimer disease were randomized to receive either escitalopram 10 mg/day or placebo for 12 weeks. Severity of depression, resilience, burden, distress, quality of life, and severity of care-recipient's cognitive and behavioral disturbances were assessed at baseline and over the course of the study. The Hamilton Depression Rating Scale scores at baseline ranged between 10 and 28. The groups were stratified by the diagnosis of major and minor depression. Most outcomes favored escitalopram over placebo. The severity of depression improved, and the remission rate was greater with the drug compared with placebo. Measures of anxiety, resilience, burden, and distress improved on escitalopram compared with placebo. Among caregivers, this small randomized controlled trial found that escitalopram use resulted in improvement in depression, resilience, burden and distress, and quality of life. Our results need to be confirmed in a larger sample.

  18. Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Van Dorn, Richard A; Desmarais, Sarah L; Rade, Candalyn B; Burris, Elizabeth N; Cuddeback, Gary S; Johnson, Kiersten L; Tueller, Stephen J; Comfort, Megan L; Mueser, Kim T

    2017-08-04

    Adults with co-occurring mental and substance use disorders (CODs) are overrepresented in jails. In-custody barriers to treatment, including a lack of evidence-based treatment options and the often short periods of incarceration, and limited communication between jails and community-based treatment agencies that can hinder immediate enrollment into community care once released have contributed to a cycle of limited treatment engagement, unaddressed criminogenic risks, and (re)arrest among this vulnerable and high-risk population. This paper describes a study that will develop research and communication protocols and adapt two evidence-based treatments, dual-diagnosis motivational interviewing (DDMI) and integrated group therapy (IGT), for delivery to adults with CODs across a jail-to-community treatment continuum. Adaptations to DDMI and IGT were guided by the Risk-Need-Responsivity model and the National Institute of Corrections' implementation competencies; the development of the implementation framework and communication protocols were guided by the Evidence-Based Interagency Implementation Model for community corrections and the Inter-organizational Relationship model, respectively. Implementation and evaluation of the protocols and adapted interventions will occur via an open trial and a pilot randomized trial. The clinical intervention consists of two in-jail DDMI sessions and 12 in-community IGT sessions. Twelve adults with CODs and four clinicians will participate in the open trial to evaluate the acceptability and feasibility of, and fidelity to, the interventions and research and communication protocols. The pilot controlled trial will be conducted with 60 inmates who will be randomized to either DDMI-IGT or treatment as usual. A baseline assessment will be conducted in jail, and four community-based assessments will be conducted during a 6-month follow-up period. Implementation, clinical, public health, and treatment preference outcomes will be evaluated

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

    Directory of Open Access Journals (Sweden)

    Kalpana P. Padala

    2017-01-01

    Full Text Available 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 < 0.001 after adjusting for baseline. Conclusion. This study establishes that the Wii-Fit exercise program is efficacious in improving balance in community dwelling older Veterans. This trial is registered with ClinicalTrials.gov Identifier NCT02190045.

  20. Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial.

    Science.gov (United States)

    Sosnoff, Jacob J; Moon, Yaejin; Wajda, Douglas A; Finlayson, Marcia L; McAuley, Edward; Peterson, Elizabeth W; Morrison, Steve; Motl, Robert W

    2015-10-01

    To determine the feasibility of three fall prevention programs delivered over 12 weeks among individuals with multiple sclerosis: (A) a home-based exercise program targeting physiological risk factors; (B) an educational program targeting behavioral risk factors; and (C) a combined exercise-and-education program targeting both factors. Randomized controlled trial. Home-based training with assessments at research laboratory. A total of 103 individuals inquired about the investigation. After screening, 37 individuals with multiple sclerosis who had fallen in the last year and ranged in age from 45-75 years volunteered for the investigation. A total of 34 participants completed postassessment following the 12-week intervention. Participants were randomly assigned into one of four conditions: (1) wait-list control (n = 9); (2) home-based exercise (n = 11); (3) education (n = 9); or (4) a combined exercise and education (n = 8) group. Before and after the 12-week interventions, participants underwent a fall risk assessment as determined by the physiological profile assessment and provided information on their fall prevention behaviors as indexed by the Falls Prevention Strategy Survey. Participants completed falls diaries during the three-months postintervention. A total of 34 participants completed postintervention testing. Procedures and processes were found to be feasible. Overall, fall risk scores were lower in the exercise groups (1.15 SD 1.31) compared with the non-exercise groups (2.04 SD 1.04) following the intervention (p fall prevention behaviors (p > 0.05). Further examination of home-based exercise/education programs for reducing falls in individuals with multiple sclerosis is warranted. A total of 108 participants would be needed in a larger randomized controlled trial.ClinicalTrials.org #NCT01956227. © The Author(s) 2014.

  1. Outcomes of a pilot hand hygiene randomized cluster trial to reduce communicable infections among US office-based employees.

    Science.gov (United States)

    Stedman-Smith, Maggie; DuBois, Cathy L Z; Grey, Scott F; Kingsbury, Diana M; Shakya, Sunita; Scofield, Jennifer; Slenkovich, Ken

    2015-04-01

    To determine the effectiveness of an office-based multimodal hand hygiene improvement intervention in reducing self-reported communicable infections and work-related absence. A randomized cluster trial including an electronic training video, hand sanitizer, and educational posters (n = 131, intervention; n = 193, control). Primary outcomes include (1) self-reported acute respiratory infections (ARIs)/influenza-like illness (ILI) and/or gastrointestinal (GI) infections during the prior 30 days; and (2) related lost work days. Incidence rate ratios calculated using generalized linear mixed models with a Poisson distribution, adjusted for confounders and random cluster effects. A 31% relative reduction in self-reported combined ARI-ILI/GI infections (incidence rate ratio: 0.69; 95% confidence interval, 0.49 to 0.98). A 21% nonsignificant relative reduction in lost work days. An office-based multimodal hand hygiene improvement intervention demonstrated a substantive reduction in self-reported combined ARI-ILI/GI infections.

  2. 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.

  3. Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial.

    Science.gov (United States)

    Cohen, Craig R; Steinfeld, Rachel L; Weke, Elly; Bukusi, Elizabeth A; Hatcher, Abigail M; Shiboski, Stephen; Rheingans, Richard; Scow, Kate M; Butler, Lisa M; Otieno, Phelgona; Dworkin, Shari L; Weiser, Sheri D

    2015-01-01

    Despite advances in treatment of people living with HIV, morbidity and mortality remains unacceptably high in sub-Saharan Africa, largely due to parallel epidemics of poverty and food insecurity. We conducted a pilot cluster randomized controlled trial (RCT) of a multisectoral agricultural and microfinance intervention (entitled Shamba Maisha) designed to improve food security, household wealth, HIV clinical outcomes and women's empowerment. The intervention was carried out at two HIV clinics in Kenya, one randomized to the intervention arm and one to the control arm. HIV-infected patients >18 years, on antiretroviral therapy, with moderate/severe food insecurity and/or body mass index (BMI) loan (~$150) to purchase the farming commodities, 2) a micro-irrigation pump, seeds, and fertilizer, and 3) trainings in sustainable agricultural practices and financial literacy. Enrollment of 140 participants took four months, and the screening-to-enrollment ratio was similar between arms. We followed participants for 12 months and conducted structured questionnaires. We also conducted a process evaluation with participants and stakeholders 3-5 months after study start and at study end. Baseline results revealed that participants at the two sites were similar in age, gender and marital status. A greater proportion of participants at the intervention site had a low BMI in comparison to participants at the control site (18% vs. 7%, p = 0.054). While median CD4 count was similar between arms, a greater proportion of participants enrolled at the intervention arm had a detectable HIV viral load compared with control participants (49% vs. 28%, respectively, p loans, agricultural challenges due to weather patterns, and a challenging partnership with the microfinance institution. We expect the results from this pilot study to provide useful data on the impacts of livelihood interventions and will help in the design of a definitive cluster RCT. This trial is registered at ClinicalTrials

  4. Effects of active/passive interventions on pain, anxiety, and quality of life in women with fibromyalgia: Randomized controlled pilot trial.

    Science.gov (United States)

    Ekici, Gamze; Unal, Edibe; Akbayrak, Turkan; Vardar-Yagli, Naciye; Yakut, Yavuz; Karabulut, Erdem

    2017-01-01

    The authors of this study compared the effects of pilates exercises and connective tissue massage (CTM) on pain intensity; pain-pressure threshold; and tolerance, anxiety, progress, and health-related quality of life in females with fibromyalgia. It was a pilot, assessor masked, randomized controlled trial conducted between January and August of 2013. Twenty-one women with fibromyalgia were randomly assigned to the pilates exercise program (six of whom did not complete the program), and 22 were randomly assigned to CTM (one of whom did not complete this program). Each group received the assigned intervention three times per week during a 4-week period. The Visual Analogue Scale, algometry, State-Trait Anxiety Inventory, Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of treatments. Significant improvements were found in both groups for all parameters. However, the scores for pain-pressure threshold were significantly elevated and the symptoms of anxiety were significantly diminished in the exercise group compared to the massage group. Thus, exercise and massage might be used to provide improvements in women with fibromyalgia. The exercise group showed more advantages than the massage group and thus might be preferred for patients with fibromyalgia. However, an adequately powered trial is required to determine this with certainty.

  5. Randomized controlled pilot trial of mindfulness-based stress reduction for breast and colorectal cancer survivors: effects on cancer-related cognitive impairment.

    Science.gov (United States)

    Johns, Shelley A; Von Ah, Diane; Brown, Linda F; Beck-Coon, Kathleen; Talib, Tasneem L; Alyea, Jennifer M; Monahan, Patrick O; Tong, Yan; Wilhelm, Laura; Giesler, R Brian

    2016-06-01

    Cancer-related cognitive impairment (CRCI) is a common, fatigue-related symptom that disrupts cancer survivors' quality of life. Few interventions for CRCI exist. As part of a randomized pilot study targeting cancer-related fatigue, the effects of mindfulness-based stress reduction (MBSR) on survivors' cognitive outcomes were investigated. Breast and colorectal cancer survivors (n = 71) with moderate-to-severe fatigue were randomized to MBSR (n = 35) or a fatigue education and support (ES; n = 36) condition. The Attentional Function Index (AFI) and the Stroop test were used to assess survivors' cognitive function at baseline (T1), after the 8-week intervention period (T2), and 6 months later (T3) using intent-to-treat analysis. Mediation analyses were performed to explore mechanisms of intervention effects on cognitive functioning. MBSR participants reported significantly greater improvement on the AFI total score compared to ES participants at T2 (d = 0.83, p = 0.001) and T3 (d = 0.55, p = 0.021). MBSR also significantly outperformed ES on most AFI subscales, although both groups improved over time. MBSR produced greater Stroop accuracy rates relative to ES at T2 (r = 0.340, p = 0.005) and T3 (r = 0.280, p = 0.030), with improved accuracy over time only for the MBSR group. There were no significant differences in Stroop reaction time between groups. Improvements in mindfulness mediated the effect of group (e.g., MBSR vs. ES) on AFI total score at T2 and T3. Additional randomized trials with more comprehensive cognitive measures are warranted to definitively assess the efficacy of MBSR for CRCI. This pilot study has important implications for all cancer survivors as it is the first published trial to show that MBSR offers robust and durable improvements in CRCI.

  6. Topiramate for the management of methamphetamine dependence: a pilot randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Rezaei, Farzin; Ghaderi, Ebrahim; Mardani, Roya; Hamidi, Seiran; Hassanzadeh, Kambiz

    2016-06-01

    To date, no medication has been approved as an effective treatment for methamphetamine dependence. Topiramate has attracted considerable attention as a treatment for the dependence on alcohol and stimulants. Therefore, this study aimed to evaluate the effect of topiramate for methamphetamine dependence. This study was a double-blind, randomized, placebo-controlled trial. In the present investigation, 62 methamphetamine-dependent adults were enrolled and randomized into two groups, and received topiramate or a placebo for 10 weeks in escalating doses from 50 mg/day to the target maintenance dose of 200 mg/day. Addiction severity index (ASI) and craving scores were registered every week. The Beck questionnaire was also given to each participant at baseline and every 2 weeks during the treatment. Urine samples were collected at baseline and every 2 weeks during the treatment. Fifty-seven patients completed 10 weeks of the trial. There was no significant difference between both groups in the mean percentage of prescribed capsules taken by the participants. At week six, the topiramate group showed a significantly lower proportion of methamphetamine-positive urine tests in comparison with the placebo group (P = 0.01). In addition, there were significantly lower scores in the topiramate group in comparison with the placebo group in two domains of ASI: drug use severity (P methamphetamine dependence. © 2016 Société Française de Pharmacologie et de Thérapeutique.

  7. A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere's Disease-A Pilot Study.

    Science.gov (United States)

    Kitahara, Tadashi; Okamoto, Hidehiko; Fukushima, Munehisa; Sakagami, Masaharu; Ito, Taeko; Yamashita, Akinori; Ota, Ichiro; Yamanaka, Toshiaki

    2016-01-01

    Meniere's disease, a common inner ear condition, has an incidence of 15-50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere's patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control) traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I management for Meniere's disease. However, avoidance of stress is unrealistic for patients who live in demanding social environments. Our findings in this pilot study suggest that interventions to decrease vasopressin secretion by abundant water intake, tympanic ventilation tubes and sleeping in darkness is feasible in treating Meniere's disease, even though these therapies did not alter reported mental/physical stress levels. ClinicalTrials.gov NCT01099046.

  8. 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

  9. Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system.

    Science.gov (United States)

    Saposnik, G; Mamdani, M; Bayley, M; Thorpe, K E; Hall, J; Cohen, L G; Teasell, R

    2010-02-01

    Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients. Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of > or =3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18-85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period). The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41-83) years. Mean time from stroke onset 25 (range 10-56) days. EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration# NTC692523.

  10. Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.

    Science.gov (United States)

    Gudavalli, M Ram; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Corber, Lance; Patwardhan, Avinash G; Goertz, Christine M

    2015-06-05

    Manual cervical distraction (MCD) is a traction-based therapy performed with a manual contact over the cervical region producing repeating cycles while patients lie prone. This study evaluated a traction force-based minimal intervention for use as an attention-touch control in clinical trials of MCD for patients with chronic neck pain. We conducted a mixed-methods, pilot randomized clinical trial in adults with chronic neck pain. Participants were allocated to three traction force ranges of MCD: low force/minimal intervention (0-20 N), medium force (21-50 N), or high force (51-100 N). Clinicians delivered five treatments over two weeks consisting of three sets of five cycles of MCD at the C5 vertebra and occiput. Traction forces were measured at each treatment. Patient-reported outcomes included a pain visual analogue scale (VAS), Neck Disability Index (NDI), Credibility and Expectancy Questionnaire (CEQ), and adverse effects. A qualitative interview evaluated treatment group allocation perceptions. We randomized 48 participants, allocating an average of five each month. Forty-five participants completed the trial with three participants lost to follow-up. Most participants were women (65%) and white (92%) with a mean (SD) age of 46.8 (12.5) years. Mean traction force values were within the prescribed force ranges for each group at the C5 and occiput levels. Neck pain VAS demonstrated a benefit for high traction force MCD compared to the low force group [adjusted mean difference 15.6; 95% confidence interval (CI) 1.6 to 29.7]. Participants in the medium traction force group demonstrated improvements in NDI compared to the low force group (adjusted mean difference 3.0; 95% CI 0.1 to 5.9), as did participants in the high traction force group (adjusted mean difference 2.7; 95% CI -0.1 to 5.6). CEQ favored the high force group. Most low force participants correctly identified their treatment allocation in the qualitative interview. No serious adverse events were

  11. Recruitment of Participants and Delivery of Online Mental Health Resources for Depressed Individuals Using Tumblr: Pilot Randomized Control Trial.

    Science.gov (United States)

    Kelleher, Erin; Moreno, Megan; Wilt, Megan Pumper

    2018-04-12

    Adolescents and young adults frequently post depression symptom references on social media; previous studies show positive associations between depression posts and self-reported depression symptoms. Depression is common among young people and this population often experiences many barriers to mental health care. Thus, social media may be a new resource to identify, recruit, and intervene with young people at risk for depression. The purpose of this pilot study was to test a social media intervention on Tumblr. We used social media to identify and recruit participants and to deliver the intervention of online depression resources. This randomized pilot intervention identified Tumblr users age 15-23 who posted about depression using the search term "#depress". Eligible participants were recruited via Tumblr messages; consented participants completed depression surveys and were then randomized to an intervention of online mental health resources delivered via a Tumblr message, while control participants did not receive resources. Postintervention online surveys assessed resource access and usefulness and control groups were asked whether they would have liked to receive resources. Analyses included t tests. A total of 25 participants met eligibility criteria. The mean age of the participants was 17.5 (SD 1.9) and 65% were female with average score on the Patient Health Questionnaire-9 of 17.5 (SD 5.9). Among the 11 intervention participants, 36% (4/11) reported accessing intervention resources and 64% (7/11) felt the intervention was acceptable. Among the 14 control participants, only 29% (4/14) of reported that receiving resources online would be acceptable (P=.02). Participants suggested anonymity and ease of use as important characteristics in an online depression resource. The intervention was appropriately targeted to young people at risk for depression, and recruitment via Tumblr was feasible. Most participants in the intervention group felt the social media

  12. Effects of physical therapy on pain and mood in patients with terminal cancer: a pilot randomized clinical trial.

    Science.gov (United States)

    López-Sendín, Nuria; Alburquerque-Sendín, Francisco; Cleland, Joshua A; Fernández-de-las-Peñas, César

    2012-05-01

    The objective of this study was to determine the effects of physical therapy, including massage and exercise, on pain and mood in patients with advanced terminal cancer. The design was a randomized controlled pilot study. Twenty-four (24) patients with terminal cancer were randomly assigned to one of two treatment groups. Group A received a physiotherapy intervention consisting of several massage techniques, mobilizations, and local and global exercises. Group B received a simple hand contact/touch to areas of pain (cervical area, shoulder, interscapular area, heels, and gastrocnemius), which was maintained for the same period of time as the intervention group. All patients received six sessions of 30-35 minutes in duration over a 2-week period. Outcomes were collected at baseline, at 1 week, and at a 2-week follow-up (after treatment completion) by an assessor blinded to the treatment allocation of the participants. Outcomes included the Brief Pain Inventory (BPI, 0-10 scale), Memorial Pain Assessment Card (0-10 scale), and Memorial Symptom Assessment Scale (MSAS Physical, Psychological, 0-4 scale). Baseline between-group differences were assessed with an independent t-test. A two-way repeated-measures analysis of variance was used to examine the effects of the intervention. There were no significant between-group baseline differences (p>0.2). A significant group × time interaction with greater improvements in group A was found for BPI worst pain (F=3.5, p=0.036), BPI pain right now (F=3.94, p=0.027), and BPI index (F=13.2, ppatients with terminal cancer. A sustained effect on pain and psychologic distress existed; however, parameters such as physical distress and the least pain were no greater in the intervention group as compared to the sham.

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

    Science.gov (United States)

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

    2015-01-01

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

  14. Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Vigod, Simone; Dennis, Cindy-Lee; Daskalakis, Zafiris; Murphy, Kellie; Ray, Joel; Oberlander, Tim; Somerton, Sarah; Hussain-Shamsy, Neesha; Blumberger, Daniel

    2014-09-18

    Women with depression in pregnancy are faced with difficult treatment decisions. Untreated, antenatal depression has serious negative implications for mothers and children. While antidepressant drug treatment is likely to improve depressive symptoms, it crosses the placenta and may pose risks to the unborn child. Transcranial direct current stimulation is a focal brain stimulation treatment that improves depressive symptoms within 3 weeks of treatment by inducing changes to brain areas involved in depression, without impacting any other brain areas, and without inducing changes to heart rate, blood pressure or core body temperature. The localized nature of transcranial direct current stimulation makes it an ideal therapeutic approach for treating depression during pregnancy, although it has never previously been evaluated in this population. We describe a pilot randomized controlled trial of transcranial direct current stimulation among women with depression in pregnancy to assess the feasibility of a larger, multicentre efficacy study. Women over 18 years of age and between 14 and 32 weeks gestation can be enrolled in the study provided they meet diagnostic criteria for a major depressive episode of at least moderate severity and have been offered but refused antidepressant medication. Participants are randomized to receive active transcranial direct current stimulation or a sham condition that is administered in 15 30-minute treatments over three weeks. Women sit upright during treatment and receive obstetrical monitoring prior to, during and after each treatment session. Depressive symptoms, treatment acceptability, and pregnancy outcomes are assessed at baseline (prior to randomization), at the end of each treatment week, every four weeks post-treatment until delivery, and at 4 and 12 weeks postpartum. Transcranial direct current stimulation is a novel therapeutic option for treating depression during pregnancy. This protocol allows for assessment of the

  15. 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

  16. Does robot-assisted gait training ameliorate gait abnormalities in multiple sclerosis? A pilot randomized-control trial.

    Science.gov (United States)

    Straudi, S; Benedetti, M G; Venturini, E; Manca, M; Foti, C; Basaglia, N

    2013-01-01

    Gait disorders are common in multiple sclerosis (MS) and lead to a progressive reduction of function and quality of life. Test the effects of robot-assisted gait rehabilitation in MS subjects through a pilot randomized-controlled study. We enrolled MS subjects with Expanded Disability Status Scale scores within 4.5-6.5. The experimental group received 12 robot-assisted gait training sessions over 6 weeks. The control group received the same amount of conventional physiotherapy. Outcomes measures were both biomechanical assessment of gait, including kinematics and spatio-temporal parameters, and clinical test of walking endurance (six-minute walk test) and mobility (Up and Go Test). 16 subjects (n = 8 experimental group, n = 8 control group) were included in the final analysis. At baseline the two groups were similar in all variables, except for step length. Data showed walking endurance, as well as spatio-temporal gait parameters improvements after robot-assisted gait training. Pelvic antiversion and reduced hip extension during terminal stance ameliorated after aforementioned intervention. Robot-assisted gait training seems to be effective in increasing walking competency in MS subjects. Moreover, it could be helpful in restoring the kinematic of the hip and pelvis.

  17. Single-Blind Randomized Controlled Trial of Poly-Herbal Formula Sahatsatara for Acute Low Back Pain: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Thiyapha Verayachankul

    2016-01-01

    Full Text Available Objective: To evaluate the efficacy and safety of poly-herbal formula Sahatsatara (SHT in pain reduction in acute low back pain (LBP patients. Methods: Twenty-nine patients aged 18-65 years with a history of moderate to severe acute LBP ≤3-day (score ≥4 on a 0-10 numeric rating scale [NRS] were enrolled and randomized to receive an ibuprofen (400 mg after meals three times daily or SHT (1,350 mg before meals three times daily for 7 days. The non-inferiority trial margin was set at ±10 percentage points. The outcomes were measured on pain intensity on the 0-10 NRS, disability on the Thai version of the Oswestry disability index [ODI], total analgesic consumption, patient satisfaction, and safety. Results: Fourteen patients and 15 patients were randomly allocated to ibuprofen and SHT groups, respectively. The mean difference in pain intensity and disability between the two groups at day 7 adjusted according to baseline was within ±1 for pain (-0.3; 95% CI, -1.48 to 0.96 and ±10% (-4.9%; 95% CI, -14.86% to 5.02% for the NRS and ODI scores, respectively. One patient in the SHT group and 5 in the ibuprofen group had gastrointestinal irritation, but the difference was not statistically significant. Conclusion: SHT was not inferior to ibuprofen in pain relieving and disability in patients with acute LBP. The result suggests a role for SHT as an alternative analgesic in acute LBP. (Thai Clinical Trials Registry number 20141027001

  18. Attention Measures of Accuracy, Variability, and Fatigue Detect Early Response to Donepezil in Alzheimer's Disease: A Randomized, Double-blind, Placebo-Controlled Pilot Trial.

    Science.gov (United States)

    Vila-Castelar, Clara; Ly, Jenny J; Kaplan, Lillian; Van Dyk, Kathleen; Berger, Jeffrey T; Macina, Lucy O; Stewart, Jennifer L; Foldi, Nancy S

    2018-04-09

    Donepezil is widely used to treat Alzheimer's disease (AD), but detecting early response remains challenging for clinicians. Acetylcholine is known to directly modulate attention, particularly under high cognitive conditions, but no studies to date test whether measures of attention under high load can detect early effects of donepezil. We hypothesized that load-dependent attention tasks are sensitive to short-term treatment effects of donepezil, while global and other domain-specific cognitive measures are not. This longitudinal, randomized, double-blind, placebo-controlled pilot trial (ClinicalTrials.gov Identifier: NCT03073876) evaluated 23 participants newly diagnosed with AD initiating de novo donepezil treatment (5 mg). After baseline assessment, participants were randomized into Drug (n = 12) or Placebo (n = 11) groups, and retested after approximately 6 weeks. Cognitive assessment included: (a) attention tasks (Foreperiod Effect, Attentional Blink, and Covert Orienting tasks) measuring processing speed, top-down accuracy, orienting, intra-individual variability, and fatigue; (b) global measures (Alzheimer's Disease Assessment Scale-Cognitive Subscale, Mini-Mental Status Examination, Dementia Rating Scale); and (c) domain-specific measures (memory, language, visuospatial, and executive function). The Drug but not the Placebo group showed benefits of treatment at high-load measures by preserving top-down accuracy, improving intra-individual variability, and averting fatigue. In contrast, other global or cognitive domain-specific measures could not detect treatment effects over the same treatment interval. The pilot-study suggests that attention measures targeting accuracy, variability, and fatigue under high-load conditions could be sensitive to short-term cholinergic treatment. Given the central role of acetylcholine in attentional function, load-dependent attentional measures may be valuable cognitive markers of early treatment response.

  19. Fluoxetine for Maintenance of Remission and to Improve Quality of Life in Patients with Crohn's Disease: a Pilot Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Mikocka-Walus, Antonina; Hughes, Patrick A; Bampton, Peter; Gordon, Andrea; Campaniello, Melissa A; Mavrangelos, Chris; Stewart, Benjamin J; Esterman, Adrian; Andrews, Jane M

    2017-04-01

    Previous studies have shown that antidepressants reduce inflammation in animal models of colitis. The present trial aimed to examine whether fluoxetine added to standard therapy for Crohn's disease [CD] maintained remission, improved quality of life [QoL] and/or mental health in people with CD as compared to placebo. A parallel randomized double-blind placebo controlled trial was conducted. Participants with clinically established CD, with quiescent or only mild disease, were randomly assigned to receive either fluoxetine 20 mg daily or placebo, and followed for 12 months. Participants provided blood and stool samples and completed mental health and QoL questionnaires. Immune functions were assessed by stimulated cytokine secretion [CD3/CD28 stimulation] and flow cytometry for cell type. Linear mixed-effects models were used to compare groups. Of the 26 participants, 14 were randomized to receive fluoxetine and 12 to placebo. Overall, 14 [54%] participants were male. The mean age was 37.4 [SD=13.2] years. Fluoxetine had no effect on inflammatory bowel disease activity measured using either the Crohn's Disease Activity Index [F(3, 27.5)=0.064, p=0.978] or faecal calprotectin [F(3, 32.5)=1.08, p=0.371], but did have modest effects on immune function. There was no effect of fluoxetine on physical, psychological, social or environmental QoL, anxiety or depressive symptoms as compared to placebo [all p>0.05]. In this small pilot clinical trial, fluoxetine was not superior to placebo in maintaining remission or improving QoL. [ID: ACTRN12612001067864.]. © European Crohn’s and Colitis Organistion (ECCO) 2016.

  20. Rehab-let: touchscreen tablet for self-training impaired dexterity post stroke: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Rand, Debbie; Zeilig, Gabi; Kizony, Rachel

    2015-06-18

    Impaired dexterity of the weaker upper extremity is common post stroke and it is recommended that these individuals practice many repetitions of movement to regain function. However, stroke rehabilitation methods do not achieve the required intensity to be effective. Touchscreen tablet technology may be used as a motivating tool for self-training impaired dexterity of the weaker upper extremity post stroke. Rehab-let is a self-training protocol utilizing game apps on a touchscreen for practicing movement of the weaker upper extremity. We will conduct a pilot randomized controlled trial to assess Rehab-let compared to traditional self-training to improve dexterity of the weaker hand, and to increase self-training time and satisfaction in individuals with subacute stroke. Forty individuals with stroke undergoing subacute rehabilitation will be randomly allocated to Rehab-let or a traditional self-training program using therapeutic aids such as balls, blocks and pegs. All participants will be requested to perform self-training for 60 minutes a day, 5 times a week for 4 weeks. Dexterity assessed by The Nine Hole Peg Test is the main outcome measure. Assessments will be administered pre and post the self-training intervention by assessors blind to the group allocation. The outcomes of this study will inform the design of a fully powered randomized controlled trial to evaluate the effectiveness of Rehab-let. If found to be effective, Rehab-let can be used during subacute rehabilitation to increase treatment intensity and improve dexterity. Potentially, Rehab-let can also be used after discharge and might be ideal for individuals with mild stroke who are often not referred to formal rehabilitation. Current Controlled Trials NCT02136433 registered on 17 September 2014.

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

    Directory of Open Access Journals (Sweden)

    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.

  2. Effects of Brazilian Cardioprotective Diet Program on risk factors in patients with coronary heart disease: a Brazilian Cardioprotective Diet randomized pilot trial

    Directory of Open Access Journals (Sweden)

    Bernardete Weber

    2012-12-01

    Full Text Available OBJECTIVE: To evaluate the effectiveness of the Brazilian Cardioprotective Diet Program in reducing blood pressures, fasting glucose levels and body mass indices in patients with established atherothrombotic disease. METHOD: This randomized controlled pilot trial included outpatients who were over 45 years of age with atherothrombotic cardiovascular disease. Group A, who received the Brazilian Cardioprotective Diet Program, had weekly sessions with dietitians. Groups B and C received the usual dietary therapy that is given to patients with cardiovascular diseases as proposed by the Brazilian guidelines. This diet had the same nutrient profile as that given to Group A, but it was customized by the integration of typical Mediterranean foods. The difference between Groups B and C was the number of sessions with the dietitian. Group B received weekly sessions, while group C only had monthly sessions. ClinicalTrials.gov: NCT 01453166. RESULTS: There was a greater reduction in systolic (7.8% and diastolic (10.8% blood pressures in Group A compared with Group B (2.3% and 7.3%, and Group C (3.9% and 4.9%, respectively. Fasting glucose decreased by 5.3% and 2% in Groups A and B, respectively. Fasting glucose increased by 3.7% in Group C. The BMIs decreased by 3.5% and 3.3% in Groups A and B, respectively. Group C did not present with any changes in BMI. However, none of these data showed statistical differences between the groups, which is methodologically acceptable in pilot trials. CONCLUSIONS: The Brazilian Cardioprotective Diet Program seems to be more effective in reducing blood pressures, fasting glucose levels, weights and BMIs in patients with previous cardiovascular disease compared with the diet that has been proposed by the Brazilian guidelines.

  3. 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.

  4. Metacognitive Interpersonal Therapy in group (MIT-G) for young adults with personality disorders: A pilot randomized controlled trial.

    Science.gov (United States)

    Popolo, Raffaele; MacBeth, Angus; Canfora, Flaviano; Rebecchi, Daniela; Toselli, Cecilia; Salvatore, Giampaolo; Dimaggio, Giancarlo

    2018-04-06

    Young adults with personality disorders (PD) other than borderline are in urgent need of validated treatments to help them in managing important life transitions. Therapeutic interventions focused upon social and interpersonal difficulties may facilitate these individuals in maximizing opportunities for employment, forming stable romantic relationships, and belong to social groups. It is also important that they are offered evidence-based, first-line time-limited treatments in order to maximize effectiveness and reduce costs. We developed a 16-session programme of group-based Metacognitive Interpersonal Therapy (MIT-G) including psychoeducation on the main interpersonal motives, an experiential component enabling practice of awareness of mental states; and use of mentalistic knowledge for purposeful problem-solving. We report a feasibility, acceptability, and clinical significance randomized clinical trial. Participants meeting inclusion criteria were randomized to receive MIT-G (n = 10) or waiting list+TAU (n = 10). Dropout rate was low and session attendance high (92.19%). Participants in the MIT-G arm had symptomatic and functional improvements consistent with large effect sizes. In the MIT-G arm similarly large effects were noted for increased capacity to understand mental states and regulate social interactions using mentalistic knowledge. Results were sustained at follow-up. Our findings suggest potential for applying MIT-G in larger samples to further test its effectiveness in reducing PD-related symptoms and problematic social functioning. © 2018 The British Psychological Society.

  5. 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.

  6. Bioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep (TEMPOJIMS)

    Science.gov (United States)

    Monje, Florencio Gil; González-García, Raúl; Little, Christopher B; Mónico, Lisete; Pinho, Mário; Santos, Fábio Abade; Carrapiço, Belmira; Gonçalves, Sandra Cavaco; Morouço, Pedro; Alves, Nuno; Moura, Carla; Wang, Yadong; Jeffries, Eric; Gao, Jin; Sousa, Rita; Neto, Lia Lucas; Caldeira, Daniel; Salvado, Francisco

    2017-01-01

    Background Preclinical trials are essential to test efficacious options to substitute the temporomandibular joint (TMJ) disk. The contemporary absence of an ideal treatment for patients with severe TMJ disorders can be related to difficulties concerning the appropriate study design to conduct preclinical trials in the TMJ field. These difficulties can be associated with the use of heterogeneous animal models, the use of the contralateral TMJ as control, the absence of rigorous randomized controlled preclinical trials with blinded outcomes assessors, and difficulties involving multidisciplinary teams. Objective This study aims to develop a new, reproducible, and effective study design for preclinical research in the TMJ domain, obtaining rigorous data related to (1) identify the impact of bilateral discectomy in black Merino sheep, (2) identify the impact of bilateral discopexy in black Merino sheep, and (3) identify the impact of three different bioengineering TMJ discs in black Merino sheep. Methods A two-phase exploratory randomized controlled preclinical trial with blinded outcomes is proposed. In the first phase, nine sheep are randomized into three different surgical bilateral procedures: bilateral discectomy, bilateral discopexy, and sham surgery. In the second phase, nine sheep are randomized to bilaterally test three different TMJ bioengineering disk implants. The primary outcome is the histological gradation of TMJ. Secondary outcomes are imaging changes, absolute masticatory time, ruminant time per cycle, ruminant kinetics, ruminant area, and sheep weight. Results Previous preclinical studies in this field have used the contralateral unoperated side as a control, different animal models ranging from mice to a canine model, with nonrandomized, nonblinded and uncontrolled study designs and limited outcomes measures. The main goal of this exploratory preclinical protocol is to set a new standard for future preclinical trials in oromaxillofacial surgery

  7. 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.

  8. A Pilot Randomized Controlled Trial of the ACCESS Program: A Group Intervention to Improve Social, Adaptive Functioning, Stress Coping, and Self-Determination Outcomes in Young Adults with Autism Spectrum Disorder

    Science.gov (United States)

    Oswald, Tasha M.; Winder-Patel, Breanna; Ruder, Steven; Xing, Guibo; Stahmer, Aubyn; Solomon, Marjorie

    2018-01-01

    The purpose of this pilot randomized controlled trial was to investigate the acceptability and efficacy of the Acquiring Career, Coping, Executive control, Social Skills (ACCESS) Program, a group intervention tailored for young adults with autism spectrum disorder (ASD) to enhance critical skills and beliefs that promote adult functioning,…

  9. A Double-Blind, Randomized Pilot Trial of Chromium Picolinate for Overweight Individuals with Binge-Eating Disorder: Effects on Glucose Regulation.

    Science.gov (United States)

    Sala, Margarita; Breithaupt, Lauren; Bulik, Cynthia M; Hamer, Robert M; La Via, Maria C; Brownley, Kimberly A

    2017-03-04

    Chromium treatment has been shown to improve glucose regulation in some populations. The purpose of this study was to evaluate whether chromium picolinate (CrPic) supplementation improves glucose regulation in overweight individuals with binge-eating disorder (BED). In this double-blinded randomized pilot trial, participants (N = 24) were randomized to high (HIGH, 1000 mcg/day, n = 8) or moderate (MOD, 600 mcg/day, n = 9) dose of CrPic or placebo (PL, n = 7) for 6 months. Participants completed an oral glucose tolerance test (OGTT) at baseline, 3 months, and 6 months. Fixed effects models were used to estimate mean change in glucose area under the curve (AUC), insulin AUC , and insulin sensitivity index (ISI). Results revealed a significant group and time interaction (p < 0.04) for glucose AUC , with glucose AUC increasing significantly in the PL group (p < 0.02) but decreasing significantly in the MOD group (p < 0.03) at 6 months. Insulin AUC increased significantly over time (main effect, p < 0.02), whereas ISI decreased significantly over time (main effect, p < 0.03). As anticipated, a moderate dose of CrPic was associated with improved glycemic control, whereas PL was associated with decreased glycemic control. It was unexpected that the improved glycemic control seen in the MOD dose group was not seen in the HIGH dose group. However, although participants randomized to the HIGH dose group did not have improved glycemic control, they had better glycemic control than participants randomized to the PL group. These findings support the need for larger trials.

  10. The Happy Older Latinos are Active (HOLA) health promotion and prevention study: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Jimenez, Daniel E; Reynolds, Charles F; Alegría, Margarita; Harvey, Philip; Bartels, Stephen J

    2015-12-18

    Results of previous studies attest to the greater illness burden of common mental disorders (anxiety and depression) in older Latinos and the need for developing preventive interventions that are effective, acceptable, and scalable. Happy Older Latinos are Active (HOLA) is a newly developed intervention that uses a community health worker (CHW) to lead a health promotion program in order to prevent common mental disorders among at-risk older Latinos. This pilot study tests the feasibility and acceptability of delivering HOLA to older, at-risk Latinos. HOLA is a multi-component, health promotion intervention funded by the National Institute of Mental Health (NIMH). This prevention approach will be tested against a fotonovela, an enhanced psychoeducation control condition, in a sample of Latino elderly with minor or subthreshold depression or anxiety. A total of 60 older Latinos (aged 60+) will be randomized to receive HOLA or the fotonovela. The primary outcomes of interest are recruitment, adherence, retention, and acceptability. Data will also be collected on: preemption of incident and recurrent major depression, generalized anxiety, and social phobia; reduction in depression and anxiety symptom severity; physical functioning; sedentary behaviors; social engagement; and self-efficacy. The results of this study could have implications for other high-risk, highly disadvantaged populations. The development of a health promotion intervention designed to prevent common mental disorders could be a means of addressing multiple disparities (for example, mental health outcomes, mental health service use, stigma) among racial/ethnic minority elderly. CLINICALTRIALS. NCT02371954 . Date of registration: 21 January 2015.

  11. Melatonin increases anagen hair rate in women with androgenetic alopecia or diffuse alopecia: results of a pilot randomized controlled trial.

    Science.gov (United States)

    Fischer, T W; Burmeister, G; Schmidt, H W; Elsner, P

    2004-02-01

    In addition to the well-known hormonal influences of testosterone and dihydrotestosterone on the hair cycle, melatonin has been reported to have a beneficial effect on hair growth in animals. The effect of melatonin on hair growth in humans has not been investigated so far. To examine whether topically applied melatonin influences anagen and telogen hair rate in women with androgenetic or diffuse hair loss. A double-blind, randomized, placebo-controlled study was conducted in 40 women suffering from diffuse alopecia or androgenetic alopecia. A 0.1% melatonin or a placebo solution was applied on the scalp once daily for 6 months and trichograms were performed to assess anagen and telogen hair rate. To monitor effects of treatment on physiological melatonin levels, blood samples were taken over the whole study period. Melatonin led to a significantly increased anagen hair rate in occipital hair in women with androgenetic hair loss compared with placebo (n=12; P=0.012). For frontal hair, melatonin gave a significant increase in the group with diffuse alopecia (n=28; P=0.046). The occipital hair samples of patients with diffuse alopecia and the frontal hair counts of those with androgenetic alopecia also showed an increase of anagen hair, but differences were not significant. Plasma melatonin levels increased under treatment with melatonin, but did not exceed the physiological night peak. To the authors' knowledge, this pilot study is the first to show that topically applied melatonin might influence hair growth in humans in vivo. The mode of action is not known, but the effect might result from an induction of anagen phase.

  12. An evidence-based walking program among older people with knee osteoarthritis: the PEP (participant exercise preference) pilot randomized controlled trial.

    Science.gov (United States)

    Loew, Laurianne; Brosseau, Lucie; Kenny, Glen P; Durand-Bush, Natalie; Poitras, Stéphane; De Angelis, Gino; Wells, George A

    2017-07-01

    Knee osteoarthritis is a common joint problem leading to an increase of pain and a loss of function in older individuals. The main objective of this study was to evaluate if a participant who was randomly assigned to his preferred group improved his adherence to an effective walking program compared to a participant who did not receive his preferred group. This was a 9-month pilot randomized clinical trial, based on a patient treatment preferences design. The 69 eligible participants had a diagnosis of knee osteoarthritis. Participants were randomized to one of two groups: a supervised community-based or unsupervised walking program, based on the Ottawa Panel guidelines. At 6 months, participants who expressed a preference, either for the supervised or unsupervised program, and who were assigned to their preferred choice of program showed significantly higher adherence to walking sessions (supervised 60.7 ± 12.3%, P walking program, while ensuring the maintenance of clinical benefits of walking, among older adults susceptible to avoid or not properly engage in physical activity.

  13. 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.

  14. Flutamide versus a cyproterone acetate-ethinyl estradiol combination in moderate acne: a pilot randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Adalatkhah H

    2011-07-01

    Full Text Available Hassan Adalatkhah1, Farhad Pourfarzi2, Homayoun Sadeghi-Bazargani31Department of Dermatology, 2Department of Social Medicine, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil; 3Statistics and Epidemiology Department, Faculty of Health and Nutrition, Tabriz University of Medical Sciences, Tabriz, IranBackground: The use of oral flutamide is rarely investigated in acne therapy. The aim of this study was to compare the efficacy of oral flutamide with that of a cyproterone-estradiol combination in treating acne lesions.Methods: A randomized clinical trial enrolled patients with moderate acne into two equal groups to receive either oral flutamide or the cyproterone-estradiol combination for 6 months. Lesion count, Acne Severity Index, and Global Acne Grading system (GAGS scores were used to assess improvement in acne lesions. The dichotomous measurement scale for primary endpoint assessment was defined as improvement from moderate to mild acne based on GAGS score. Patient satisfaction and dermal fat were also assessed. Intention to treat and per protocol analyses were done, reporting related effect sizes.Results: Both treatments resulted in substantial improvement in acne lesions. Although flutamide seemed to have higher efficacy, an intention to treat analysis did not find the two treatment protocols to be different. The relative risk in intention to treat analysis was 1.8 (95% confidence interval [CI] 0.89–1.6, and was 1.33 (95% CI 1.03–1.72 for the per protocol analysis. The number needed to treat for flutamide compared with the cyproterone-estradiol combination was 7.7 and 4.2 in the intention to treat and per protocol analyses, respectively.Conclusion: Flutamide appears to be more effective than a cyproterone-estradiol combination in some aspects of acne treatment, but this requires confirmation in a larger trial.Keywords: acne vulgaris, flutamide, cyproterone acetate, ethinyl estradiol, androgen antagonists

  15. Promoting Physical Activity in Low-Active Adolescents via Facebook: A Pilot Randomized Controlled Trial to Test Feasibility.

    Science.gov (United States)

    Wójcicki, Thomas R; Grigsby-Toussaint, Diana; Hillman, Charles H; Huhman, Marian; McAuley, Edward

    2014-10-30

    The World Wide Web is an effective method for delivering health behavior programs, yet major limitations remain (eg, cost of development, time and resource requirements, limited interactivity). Social media, however, has the potential to deliver highly customizable and socially interactive behavioral interventions with fewer constraints. Thus, the evaluation of social media as a means to influence health behaviors is warranted. The objective of this trial was to examine and demonstrate the feasibility of using an established social networking platform (ie, Facebook) to deliver an 8 week physical activity intervention to a sample of low-active adolescents (N=21; estimated marginal mean age 13.48 years). Participants were randomized to either an experimental (ie, Behavioral) or attentional control (ie, Informational) condition. Both conditions received access to a restricted-access, study-specific Facebook group where the group's administrator made two daily wall posts containing youth-based physical activity information and resources. Primary outcomes included physical activity as assessed by accelerometry and self-report. Interactions and main effects were examined, as well as mean differences in effect sizes. Analyses revealed significant improvements over time on subjectively reported weekly leisure-time physical activity (F1,18=8.426, P=.009, η2 = .319). However, there was no interaction between time and condition (F1,18=0.002, P=.968, η2 = .000). There were no significant time or interaction effects among the objectively measured physical activity variables. Examination of effect sizes revealed moderate-to-large changes in physical activity outcomes. Results provide initial support for the feasibility of delivery of a physical activity intervention to low-active adolescents via social media. Whether by employing behavioral interventions via social media can result in statistically meaningful changes in health-related behaviors and outcomes remains to be

  16. A Pilot Randomized Controlled Trial of a Holistic Needs Assessment Questionnaire in a Supportive and Palliative Care Service.

    Science.gov (United States)

    Ahmed, Nisar; Hughes, Philippa; Winslow, Michelle; Bath, Peter A; Collins, Karen; Noble, Bill

    2015-11-01

    At present, there is no widely used systematic evidence-based holistic approach to assessment of patients' supportive and palliative care needs. To determine whether the use of a holistic needs assessment questionnaire, Sheffield Profile for Assessment and Referral for Care (SPARC), will lead to improved health care outcomes for patients referred to a palliative care service. This was an open, pragmatic, randomized controlled trial. Patients (n = 182) referred to the palliative care service were randomized to receive SPARC at baseline (n = 87) or after a period of two weeks (waiting-list control n = 95). Primary outcome measure is the difference in score between Measure Yourself Concerns and Wellbeing (MYCAW) patient-nominated Concern 1 on the patient self-scoring visual analogue scale at baseline and the two-week follow-up. Secondary outcomes include difference in scores in the MYCAW, EuroQoL (EQ-5D), and Patient Enablement Instrument (PEI) scores at Weeks 2, 4, and 6. There was a significant association between change in MYCAW score and whether the patients were in the intervention or control group (χ(2)trend = 5.51; degrees of freedom = 1; P = 0.019). A higher proportion of patients in the control group had an improvement in MYCAW score from baseline to Week 2: control (34 of 70 [48.6%]) vs. intervention (19 of 66 [28.8%]). There were no significant differences (no detectable effect) between the control and intervention groups in the scores for EQ-5D and Patient Enablement Instrument at 2-, 4-, or 6-week follow-up. This trial result identifies a potential negative effect of SPARC in specialist palliative care services, raising questions that standardized holistic needs assessment questionnaires may be counterproductive if not integrated with a clinical assessment that informs the care plan. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  17. 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.

  18. A Double-Blind Randomized Controlled Pilot Trial of N-Acetylcysteine in Veterans with PTSD and Substance Use Disorders

    Science.gov (United States)

    Back, Sudie E.; McCauley, Jenna L.; Korte, Kristina J.; Gros, Daniel F.; Leavitt, Virginia; Gray, Kevin M.; Hamner, Mark B.; DeSantis, Stacia M.; Malcolm, Robert; Brady, Kathleen T.; Kalivas, Peter W.

    2016-01-01

    Objective The antioxidant N-Acetylcysteine (NAC) is being increasingly investigated as a therapeutic agent in the treatment of substance use disorders. Preclinical and clinical findings suggest that NAC normalizes extracellular glutamate by restoring the activity of glutamate transporters and antiporters in the nucleus accumbens. This study explored the efficacy of NAC in the treatment of post-traumatic stress disorder (PTSD), which frequently co-occurs with substance use disorders (SUD) and shares impaired prefrontal cortex regulation of basal ganglia circuitry, in particular at glutamate synapses in the nucleus accumbens. Method Veterans with current PTSD and SUD (N=35) were randomly assigned to receive a double-blind, 8-week course of NAC (2400 mg/day) or placebo plus outpatient group cognitive-behavioral therapy for SUD. Primary outcome measures included PTSD symptoms (Clinician Administered PTSD Scale, PTSD Checklist-Military) and craving (Visual Analogue Scale). Depression (Beck Depression Inventory-II) and substance use (Timeline Follow Back, urine drug screens) were also assessed. Results Participants treated with NAC, as compared to placebo, evidenced significant improvements in PTSD symptoms, craving, and depression. Substance use at the start of treatment was low for both the NAC and placebo groups and no significant between-group differences were observed. NAC was well tolerated and retention was high. Conclusions This is the first randomized controlled trial to investigate NAC as a pharmacological treatment for PTSD. The findings show a significant treatment effect on symptoms of PTSD and drug craving, and provide initial support for the use of NAC in combination with cognitive-behavioral therapy among individuals with co-occurring PTSD and SUD. PMID:27736051

  19. Personalized Digital Interventions Showed no Impact on Risky Drinking in Young Adults: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Davies, Emma L; Lonsdale, Adam J; Hennelly, Sarah E; Winstock, Adam R; Foxcroft, David R

    2017-11-01

    To assess the effectiveness of two personalized digital interventions (OneTooMany and Drinks Meter) compared to controls. Randomized controlled trial (AEARCTR-0,001,082). Volunteers for the study, aged 18-30, were randomly allocated to one of two interventions or one of two control groups and were followed up 4 weeks later. Primary outcomes were AUDIT-C, drinking harms and pre-loading. Drinks Meter provided participants with brief screening and advice for alcohol in addition to normative feedback, information on calories consumed and money spent. OneTooMany presented a series of socially embarrassing scenarios that may occur when drinking, and participants were scored according to if/how recently they had been experienced. The study failed to recruit and obtain sufficient follow-up data to reach a prior estimated power for detecting a difference between groups and there was no indication in the analysable sample of 402 subjects of a difference on the primary outcome measures (Drinks Meter; AUDIT-C IRR = 0.98 (0.89-1.09); Pre-loading IRR = 1.01 (0.95-1.07); Harms IRR = 0.97 (0.79-1.20); OneTooMany; AUDIT-C IRR = 0.96 (0.86-1.07); Pre-loading IRR = 0.99 (0.93-1.06); Harms IRR = 1.16 (0.94-1.43). Further research is needed on the efficacy of such instruments and their ingredients. However, recruitment and follow-up are a challenge. © The Author 2017. Medical Council on Alcohol and Oxford University Press. All rights reserved.

  20. Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial

    Directory of Open Access Journals (Sweden)

    Yakoot Mostafa

    2012-04-01

    Full Text Available Abstract Background Spirulina platensis, a cynobacterium used frequently as a dietary supplement had been found to exhibit many immune-stimulating and antiviral activities. It had been found to activate macrophages, NK cells, T cells, B cells, and to stimulate the production of Interferon gamma (IFN-γ and other cytokines. Natural substances isolated from Spirulina platensis had been found to be potent inhibitors against several enveloped viruses by blocking viral absorption/penetration and some replication stages of progeny viruses after penetration into cells. We aimed to study whether this dietary supplement possesses any therapeutically feasible activity worthy of further larger controlled clinical evaluation. Methods Sixty six patients with chronic hepatitis C virus infection and eligible for inclusion had been randomized to either Spirulina or Silymarin treated groups for a period of six months treatment. The two groups were followed up and blindly compared for early (after 3 months and end of 6 months treatment virological response. The effects of both treatments on each of alanine aminotransferase (ALT, Chronic Liver Disease Questionnaire scores (CLDQ, Arizona Sexual Experience Scale scores (ASEX and the occurrence of any attributable adverse events were also compared. Results Among the 30 patients who had been treated with Spirulina and completed the 6 months protocol, 4 patients (13.3% had a complete end of treatment virological response and 2 patients (6.7% had a partial end of treatment response defined as significant decrease of virus load of at least 2-logs10. Though the proportion of responders in Spirulina group was greater than in the Silymarin group, the difference was not statistically significant at the end of both 6 months (p = 0.12 and 3 months treatment (p = 0.22 by Exact test. Alanine aminotransferase as well as CLDQ and ASEX scores were found to be more significantly improved in Spirulina than in Silymarin treated group

  1. Managing knee osteoarthritis with yoga or aerobic/strengthening exercise programs in older adults: a pilot randomized controlled trial.

    Science.gov (United States)

    Cheung, Corjena; Wyman, Jean F; Bronas, Ulf; McCarthy, Teresa; Rudser, Kyle; Mathiason, Michelle A

    2017-03-01

    Although exercise is often recommended for managing osteoarthritis (OA), limited evidence-based exercise options are available for older adults with OA. This study compared the effects of Hatha yoga (HY) and aerobic/strengthening exercises (ASE) on knee OA. Randomized controlled trial with three arms design was used: HY, ASE, and education control. Both HY and ASE groups involved 8 weekly 45-min group classes with 2-4 days/week home practice sessions. Control group received OA education brochures and weekly phone calls from study staff. Standardized instruments were used to measure OA symptoms, physical function, mood, spiritual health, fear of falling, and quality of life at baseline, 4 and 8 weeks. HY/ASE adherences were assessed weekly using class attendance records and home practice video recordings. Primary analysis of the difference in the change from baseline was based on intent-to-treat and adjusted for baseline values. Eight-three adults with symptomatic knee OA completed the study (84% female; mean age 71.6 ± 8.0 years; mean BMI 29.0 ± 7.0 kg/m 2 ). Retention rate was 82%. Compared to the ASE group at 8 weeks, participants in the HY group had a significant improvement from baseline in perception of OA symptoms (-9.6 [95% CI -15.3, -4]; p = .001), anxiety (-1.4 [95% CI -2.7, -0]; p = .04), and fear of falling (-4.6 [-7.5, -1.7]; p = .002). There were no differences in class/home practice adherence between HY and ASE. Three non-serious adverse events were reported from the ASE group. Both HY and ASE improved symptoms and function but HY may have superior benefits for older adults with knee OA. Trial registration The full trial protocol is available at clinicaltrials.gov (NCT02525341).

  2. Pilot randomized controlled trial of Tuning Relationships with Music: Intervention for parents with a trauma history and their adolescent.

    Science.gov (United States)

    Colegrove, Vivienne M; Havighurst, Sophie S; Kehoe, Christiane E; Jacobsen, Stine L

    2018-05-01

    For parents who have experienced childhood interpersonal trauma, the challenges of parenting an adolescent may trigger memories of abuse, intensifying conflict, resulting in negative cycles of relating and poorer responsiveness to emotions when parenting. This study examined whether Tuning Relationships with Music, a dyadic therapy for parents and adolescents, increased responsive parent-adolescent interactions and parent emotion coaching whilst reducing conflict and adolescent mental health difficulties. Twenty-six parent-adolescent dyads were recruited if parents had a trauma history and the dyad were currently having high levels of conflict. Dyads were randomly allocated into intervention or wait-list control and completed questionnaires and observation assessments at baseline and 4-month post-baseline follow-up. Those allocated to the intervention condition participated in 8 sessions of Tuning Relationships with Music. ANZCTR: 12615000814572. Parents and adolescents reported significant reductions in conflict. Parents in the intervention condition were observed to significantly improve their nonverbal communication, emotional responsiveness and non-reactivity toward their adolescent. Although parents reported they were less dismissive and punitive, and more encouraging of their adolescent's emotions, and both parents and adolescents reported improvements in the adolescent's mental health, these were not statistically significant. Findings suggest Tuning Relationships with Music may assist parents with a history of childhood interpersonal trauma and their adolescent to reduce conflict and increase responsive ways of relating that may positively impact the young person's mental health. Future trials with a larger sample are warranted. Copyright © 2018 Elsevier Ltd. All rights reserved.

  3. 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.

  4. A pilot randomized trial of pentoxifylline for the reduction of periprocedural myocardial injury in patients undergoing elective percutaneous coronary intervention.

    Science.gov (United States)

    Aslanabadi, Naser; Shirzadi, Hamid Reza; Asghari-Soufi, Hossein; Dousti, Samaneh; Ghaffari, Samad; Sohrabi, Bahram; Mashayekhi, Simin Ozar; Hamishehkar, Hadi; Entezari-Maleki, Taher

    2015-02-01

    Periprocedural myocardial injury (PMI) following percutaneous coronary intervention (PCI) has received great attention due to its significant association with mortality and morbidity. Accordingly, cardioprotection during PCI is one of the important therapeutic concerns. Regarding the potential cardiovascular benefits of pentoxifylline this study was performed to evaluate whether the pretreatment pentoxifylline could reduce PMI in patients who are undergoing elective PCI. A randomized clinical trial on 85 patients undergoing elective PCI was performed. The intervention group (n = 41) received 1200 mg pentoxifylline in divided doses plus the standard treatment before PCI, while the control group (n = 44) received the standard treatment. For assessing myocardial damage during PCI, the levels of CK-MB and troponin-I were measured at baseline, 8, and 24 h after the procedure. Then, patients were followed up for a 1-month period regarding the major adverse cardiac effect. Comparing with the control group, no significant change of CK-MB at 8 (p = 0.315) and 24 h (p = 0.896) after PCI was documented in pentoxifylline group. Similarly, no significant change was found in troponin-I at 8 (p = 0.141) and 24 h (p = 0.256) after PCI. This study could not support the pretreatment with pentoxifylline in the prevention of PMI in patients undergoing elective PCI. However, the trend was toward the potential benefit of pentoxifylline.

  5. Benefits of different intensity of aerobic exercise in modulating body composition among obese young adults: a pilot randomized controlled trial.

    Science.gov (United States)

    Chiu, Chih-Hui; Ko, Ming-Chen; Wu, Long-Shan; Yeh, Ding-Peng; Kan, Nai-Wen; Lee, Po-Fu; Hsieh, Jenn-Woei; Tseng, Ching-Yu; Ho, Chien-Chang

    2017-08-24

    The aim of present study was to compare the effects of different aerobic exercise intensities and energy expenditures on the body composition of sedentary obese college students in Taiwan. Forty-eight obese participants [body mass index (BMI) ≥ 27 kg/m 2 , age 18-26 years] were randomized into four equal groups (n = 12): light-intensity training group (LITG), 40%-50% heart rate reserve (HRR); middle-intensity training group (MITG), 50%-70% HRR; high-intensity training group (HITG), 70%-80% HRR; and control group (CG). The aerobic exercise training program was conducted for 60 min per day on a treadmill 3 days per week for 12 weeks. All participant anthropometric data, blood biochemical parameters, and health-related physical fitness components were measured at baseline and after 12 weeks. At baseline, the anthropometric indices did not differ significantly among the four groups (p > 0.05). After 12-week exercise intervention, the HITG and MITG had significantly more changes in body weight, waist circumference (WC), waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR) than the LITG. The changes in BMI and body fat percentage differed among all four groups (p exercise intervention with high energy expenditure can considerably reduce body weight, body fat, WC, WHR, and WHtR, whereas a light-intensity exercise intervention can significantly reduce body weight and body fat. Current Controlled Trials TPECTR09831410900 , registered on 24 th Dec 2009.

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

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    Baldwin, Austin S; Kangas, Julie L; Denman, Deanna C; Smits, Jasper A J; Yamada, Tetsuhiro; Otto, Michael W

    2016-11-01

    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 of 67 previously inactive adults, we compared the effects of a PA prescription emphasizing the maintenance of positive affect to one emphasizing a target heart rate, and tested the extent to which the effect of the affect-guided prescription on PA is moderated by cardiorespiratory fitness (CRF). We found the effect of an affect-guided prescription was significantly moderated by CRF. At one week, for participants with lower CRF (i.e. poor conditioning), the affect-guided prescription resulted in significantly greater change in PA minutes (M = 240.8) than the heart rate-guided prescription (M = 165.7), reflecting a moderate-sized effect (d = .55). For those with higher CRF (i.e. good conditioning), the means were in the opposite direction but not significantly different. At one month, the same pattern emerged but the interaction was not significant. We discuss the implications of these findings for the type of PA prescriptions offered to individuals in need.

  7. Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial.

    Science.gov (United States)

    Sood, Amit; Sharma, Varun; Schroeder, Darrell R; Gorman, Brian

    2014-01-01

    To test the efficacy of a Stress Management and Resiliency Training (SMART) program for decreasing stress and anxiety and improving resilience and quality of life among Department of Radiology physicians. The study was approved by the institutional review board. A total of 26 Department of Radiology physicians were randomized in a single-blind trial to either the SMART program or a wait-list control arm for 12 weeks. The program involved a single 90-min group session in the SMART training with two follow-up phone calls. Primary outcomes measured at baseline and week 12 included the Perceived Stress Scale, Linear Analog Self-Assessment Scale, Mindful Attention Awareness Scale, and Connor-Davidson Resilience Scale. A total of 22 physicians completed the study. A statistically significant improvement in perceived stress, anxiety, quality of life, and mindfulness at 12 weeks was observed in the study arm compared to the wait-list control arm; resilience also improved in the active arm, but the changes were not statistically significant when compared to the control arm. A single session to decrease stress among radiologists using the SMART program is feasible. Furthermore, the intervention afforded statistically significant and clinically meaningful improvement in anxiety, stress, quality of life, and mindful attention. Further studies including larger sample size and longer follow-up are warranted. Copyright © 2014. Published by Elsevier Inc.

  8. Muscle, functional and cognitive adaptations after flywheel resistance training in stroke patients: a pilot randomized controlled trial.

    Science.gov (United States)

    Fernandez-Gonzalo, Rodrigo; Fernandez-Gonzalo, Sol; Turon, Marc; Prieto, Cristina; Tesch, Per A; García-Carreira, Maria del Carmen

    2016-04-06

    Resistance exercise (RE) improves neuromuscular function and physical performance after stroke. Yet, the effects of RE emphasizing eccentric (ECC; lengthening) actions on muscle hypertrophy and cognitive function in stroke patients are currently unknown. Thus, this study explored the effects of ECC-overload RE training on skeletal muscle size and function, and cognitive performance in individuals with stroke. Thirty-two individuals with chronic stroke (≥6 months post-stroke) were randomly assigned into a training group (TG; n = 16) performing ECC-overload flywheel RE of the more-affected lower limb (12 weeks, 2 times/week; 4 sets of 7 maximal closed-chain knee extensions; trained (48.2 %), and the less-affected, untrained limb (28.1 %) increased after training. TG showed enhanced balance (8.9 %), gait performance (10.6 %), dual-task performance, executive functions (working memory, verbal fluency tasks), attention, and speed of information processing. CG showed no changes. ECC-overload flywheel resistance exercise comprising 4 min of contractile activity per week offers a powerful aid to regain muscle mass and function, and functional performance in individuals with stroke. While the current intervention improved cognitive functions, the cause-effect relationship, if any, with the concomitant neuromuscular adaptations remains to be explored. Clinical Trials NCT02120846.

  9. An Open Randomized Pilot Trial on the Differential Effects of Aripiprazole versus Risperidone on Anhedonia and Subjective Well-Being

    NARCIS (Netherlands)

    Liemburg, E.; Aleman, A.; Bous, J.; Hollander, K.; Knegtering, H.

    Introduction: Negative symptoms of schizophrenia often predict an unfavorable clinical outcome. Disturbed dopamine transmission in different brain parts may underlie different aspects of negative symptoms, and the effect of antipsychotics on them may also differ. This pilot study investigated the

  10. The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA) in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Kulason, Kay; Nouchi, Rui; Hoshikawa, Yasushi; Noda, Masafumi; Okada, Yoshinori; Kawashima, Ryuta

    2018-01-01

    Background: There has been little research conducted regarding cognitive treatments for the elderly postsurgical population. Patients aged ≥60 years have an increased risk of postoperative cognitive decline, a condition in which cognitive functions are negatively affected. This cognitive decline can lead to a decline in quality of life. In order to maintain a high quality of life, the elderly postsurgical population may benefit from treatment to maintain and/or improve their cognitive functions. This pilot study investigates the effect of simple calculation and reading aloud (SCRA) cognitive training in elderly Japanese postsurgical patients. Methods: Elderly patients undergoing non-cardiovascular thoracic surgery under general anesthesia were recruited ( n = 12). Subjects were randomly divided into two groups-one that receives 12 weeks of SCRA intervention, and a waitlisted control group. Before and after the intervention, we measured cognitive function [Mini-Mental Status Exam-Japanese (MMSE-J), Frontal Assessment Battery (FAB), computerized Cogstate Brief Battery (CBB)] and emotional state [General Health Questionnaire-12 (GHQ-12), Geriatric Depression Scale (GDS), Quality of Life Scale-5 (QOL-5)]. Results: Group difference analyses using ANCOVA with permutation test showed that the intervention SCRA group had a significant improvement in FAB motor programming sub-score, GDS, and QOL-5 compared to the control group. Within-group analyses using Wilcoxon signed-rank test to compare baseline and follow-up showed that the SCRA intervention group total FAB scores, FAB motor programming sub-scores, and QOL-5 scores were significantly improved. Discussion: This pilot study showed that there are important implications for the beneficial effects of SCRA intervention on cognitive function and emotional state in the postoperative elderly population; however, further investigations are necessary to reach any conclusions. Trial registration: This study was registered with

  11. The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Kay Kulason

    2018-03-01

    Full Text Available Background: There has been little research conducted regarding cognitive treatments for the elderly postsurgical population. Patients aged ≥60 years have an increased risk of postoperative cognitive decline, a condition in which cognitive functions are negatively affected. This cognitive decline can lead to a decline in quality of life. In order to maintain a high quality of life, the elderly postsurgical population may benefit from treatment to maintain and/or improve their cognitive functions. This pilot study investigates the effect of simple calculation and reading aloud (SCRA cognitive training in elderly Japanese postsurgical patients.Methods: Elderly patients undergoing non-cardiovascular thoracic surgery under general anesthesia were recruited (n = 12. Subjects were randomly divided into two groups—one that receives 12 weeks of SCRA intervention, and a waitlisted control group. Before and after the intervention, we measured cognitive function [Mini-Mental Status Exam-Japanese (MMSE-J, Frontal Assessment Battery (FAB, computerized Cogstate Brief Battery (CBB] and emotional state [General Health Questionnaire-12 (GHQ-12, Geriatric Depression Scale (GDS, Quality of Life Scale-5 (QOL-5].Results: Group difference analyses using ANCOVA with permutation test showed that the intervention SCRA group had a significant improvement in FAB motor programming sub-score, GDS, and QOL-5 compared to the control group. Within-group analyses using Wilcoxon signed-rank test to compare baseline and follow-up showed that the SCRA intervention group total FAB scores, FAB motor programming sub-scores, and QOL-5 scores were significantly improved.Discussion: This pilot study showed that there are important implications for the beneficial effects of SCRA intervention on cognitive function and emotional state in the postoperative elderly population; however, further investigations are necessary to reach any conclusions.Trial registration: This study was

  12. 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

  13. Effectiveness of school-based humanistic counselling for psychological distress in young people: Pilot randomized controlled trial with follow-up in an ethnically diverse sample.

    Science.gov (United States)

    Pearce, Peter; Sewell, Ros; Cooper, Mick; Osman, Sarah; Fugard, Andrew J B; Pybis, Joanne

    2017-06-01

    The aim of this study was to pilot a test of the effectiveness of school-based humanistic counselling (SBHC) in an ethnically diverse group of young people (aged 11-18 years old), with follow-up assessments at 6 and 9 months. Pilot randomized controlled trial, using linear-mixed effect modelling and intention-to-treat analysis to compare changes in levels of psychological distress for participants in SBHC against usual care (UC). ISRCTN44253140. In total, 64 young people were randomized to either SBHC or UC. Participants were aged between 11 and 18 (M = 14.2, SD = 1.8), with 78.1% of a non-white ethnicity. The primary outcome was psychological distress at 6 weeks (mid-therapy), 12 weeks (end of therapy), 6-month follow-up and 9-month follow-up. Secondary measures included emotional symptoms, self-esteem and attainment of personal goals. Recruitment and retention rates for the study were acceptable. Participants in the SBHC condition, as compared with participants in the UC condition, showed greater reductions in psychological distress and emotional symptoms, and greater improvements in self-esteem, over time. However, at follow-up, only emotional symptoms showed significant differences across groups. The study adds to the pool of evidence suggesting that SBHC can be tested and that it brings about short-term reductions in psychological and emotional distress in young people, across ethnicities. However, there is no evidence of longer-term effects. School-based humanistic counselling can be an effective means of reducing the psychological distress experienced by young people with emotional symptoms in the short term. The short-term effectiveness of school-based humanistic counselling is not limited to young people of a White ethnicity. There is no evidence that school-based humanistic counselling has effects beyond the end of therapy. © 2016 The British Psychological Society.

  14. Effective therapy to reduce edema after total knee arthroplasty Multi-layer compression therapy or standard therapy with cool pack - a randomized controlled pilot trial

    Science.gov (United States)

    Stocker, Brigitta; Babendererde, Christine; Rohner-Spengler, Manuela; Müller, Urs W; Meichtry, André; Luomajoki, Hannu

    2018-02-01

    Background: After total knee arthroplasty (TKA) efficient control and reduction of postoperative edema is of great importance. Aim: The aim of this pilot study (EKNZ 2014 – 225 DRKS00006271) was to investigate the effectiveness of multi-layer compression therapy (MLCT) to reduce edema in the early period after surgery compared to the standard treatment with Cool Pack. Methods: In this randomized controlled pilot trial, sixteen patients after TKA were randomized into an intervention group (IG) or a control group (CG). Circumferential measurements were used to assess edema. Secondary outcomes were range of motion (ROM), pain (numeric rating scale, NRS) and function as measured with the fast Self Paced Walking Test (fSPWT). Results: Clinically relevant differences in edema reduction between the two groups were found in the early postoperative period and at the six weeks follow up. Six days postoperatively the group time interaction (IE) in favor of the IG were −3.8 cm (95 % CI: −5.1; −2.4) when measured 10 cm proximal to the joint space and −2.7 cm (CI: −4.1; −1.3) when measured 5 cm proximally. We further observed differences in secondary outcomes in favor of the CG. Six days postoperatively the IE for knee flexion was –8.3 ° (CI: −22.0; 5.4) and for the fSPWT it was 12.8 seconds (CI: −16.4; 41.3). Six weeks postoperatively these differences diminished. Conclusions: The findings suggest that MLCT could be an alternative treatment to reduce postoperative edema in patients after total knee arthroplasty. Eventually possible negative effects on early knee flexion and function must be considered.

  15. Are Anti-Stigma Films a Useful Strategy for Reducing Weight Bias Among Trainee Healthcare Professionals? Results of a Pilot Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Judy Anne Swift

    2013-03-01

    Full Text Available Background: Weight bias is an important clinical issue that the educators of tomorrow's healthcare professionals cannot afford to ignore. This study, therefore, aimed to pilot a randomized controlled trial of the effects of educational films designed to reduce weight stigmatization toward obese patients on trainee dietitians' and doctors' attitudes. Methods: A pre-post experimental design with a 6-week follow-up, which consisted of an intervention group (n = 22 and a control group (n = 21, was conducted to assess the efficacy of brief anti-stigma films in reducing weight bias, and to test whether future, larger-scale studies among trainee healthcare professionals are feasible. Results: Participants at baseline demonstrated weight bias, on both implicit and explicit attitude measures, as well as strong beliefs that obesity is under a person's control. The intervention films significantly improved explicit attitudes and beliefs toward obese people, and participant evaluation was very positive. The intervention did not significantly improve implicit anti-fat bias. Conclusion: The current study suggests both that it is possible to conduct a substantive trial of the effects of educational films designed to reduce weight stigma on a larger cohort of trainee healthcare professionals, and that brief educational interventions may be effective in reducing stigmatizing attitudes in this population.

  16. A randomized, placebo controlled pilot trial of botulinum toxin for paratonic rigidity in people with advanced cognitive impairment.

    Directory of Open Access Journals (Sweden)

    Galit Kleiner-Fisman

    Full Text Available Evaluate safety and efficacy of Incobotulinumtoxin A in elderly patients with dementia and paratonia.University-affiliated hospital, spasticity management Clinic.Ten subjects were enrolled.1 severe cognitive impairment 2 diagnosis of Alzheimer's disease, vascular dementia, or frontotemporal dementia, and 3 score >3 on the paratonic assessment instrument, with posture in an arm(s interfering with provision of care.1 alternate etiologies for increased tone and 2 injection with botulinum toxin within the 6 months preceding the study.Single center, randomized, double blind, placebo-controlled, crossover trial with two treatment cycles of 16 weeks. Assessments occurred at 2, 6, 12 and16 weeks following injections. Subjects received up to 300 U of Incobotulinumtoxin A in arm(s.Primary outcome measure was the modified caregiver burden scale (mCBS; exploratory secondary outcome measures were also performed. Analysis of variance and mixed modeling techniques were used to evaluate treatment effects.Incobotulinumtoxin A treatment produced significant improvement in mCBS total score -1.11 (-2.04 to -0.18 (Treatment effect and 95% CI, dressing sub-score -0.36 (-0.59 to 0.12, and cleaning under the left and right armpits sub-score -0.5 (-0.96 to -0.04, -0.41 (-0.79 to -0.04 respectively. PROM in the left and right elbow increased by 27.67 degrees (13.32-42.02 and 22.07 degrees (9.76-34.39 respectively. PROM in the left and right shoulder increased by 11.92 degrees (5.46-18.38 and 8.58 degrees (3.73-13.43 respectively. No significant treatment effect was found for GAS, VAS and PAINAD scales or change in time to perform care. No adverse drug reactions occurred.Administration of Incobotulinumtoxin A in elderly people with advanced dementia and paratonia may be an efficacious and safe treatment to increase range of motion and reduce functional burden. Further studies are needed to confirm results.ClinicalTrials.Gov NCT02212119.

  17. 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

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

    Science.gov (United States)

    Shin, Kyung-Min; Kim, Joo-Hee; Lee, Seunghoon; Shin, Mi-Suk; Kim, Tae-Hun; Park, Hyo-Ju; Lee, Min-Hee; Hong, Kwon-Eui; Lee, Seungdeok; Choi, Sun-Mi

    2013-06-14

    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. 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-test and ANCOVA (P <0.05). The

  19. A Web-based self-management exercise and diet intervention for breast cancer survivors: pilot randomized controlled trial.

    Science.gov (United States)

    Lee, Myung Kyung; Yun, Young Ho; Park, Hyeoun-Ae; Lee, Eun Sook; Jung, Kyung Hae; Noh, Dong-Young

    2014-12-01

    Regular exercise and dietary practices have been shown to affect the health-related quality of life (HRQOL) and survival of breast cancer patients. The current study aimed to investigate whether the WSEDI was a feasible and primarily effective method for promoting exercise and dietary behaviours for breast cancer patients. A 12-week randomized, controlled trial. Oncology outpatient treatment clinics at 3 university hospitals and 1 National Cancer Center in South Korea. Fifty-nine breast cancer patients who had received curative surgery and completed primary cancer treatment within 12 months prior to the study and who had been diagnosed with stage 0-III cancers within 2 years prior to the study were recruited. Participants were randomly assigned to either the intervention group, which used a Web-based self-management exercise and diet intervention program incorporating transtheoretical model (TTM)-based strategies (n=29), or to the control group, which used a 50-page educational booklet on exercise and diet (n=28). The intervention efficacy was measured at the baseline and 12 weeks via a Web-based survey that addressed the promotion of exercise and consumption of 5 servings of fruits and vegetables (F&V) per day, dietary quality, HRQOL, anxiety, depression, fatigue, motivational readiness, and self-efficacy. The proportion of subjects who performed at least moderate-intensity aerobic exercise for at least 150 min per week; ate 5 servings of F&V per day; and had overall improvements in dietary quality, physical functioning and appetite loss (HRQOL), fatigue, and motivational readiness was greater in the intervention group than in the control group. The self-efficacy with respect to exercise and F&V consumption was greater in the intervention group than in the control group. A Web-based program that targets changes in exercise and dietary behaviours might be effective for breast cancer survivors if the TTM theory has been used to inform the program strategy, although

  20. Pilot study of a social network intervention for heroin users in opiate substitution treatment: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Day, Edward; Copello, Alex; Seddon, Jennifer L; Christie, Marilyn; Bamber, Deborah; Powell, Charlotte; George, Sanju; Ball, Andrew; Frew, Emma; Freemantle, Nicholas

    2013-08-19

    Research indicates that 3% of people receiving opiate substitution treatment (OST) in the UK manage to achieve abstinence from all prescribed and illicit drugs within 3 years of commencing treatment, and there is concern that treatment services have become skilled at engaging people but not at helping them to enter a stage of recovery and drug abstinence. The National Treatment Agency for Substance Misuse recommends the involvement of families and wider social networks in supporting drug users' psychological treatment, and this pilot randomized controlled trial aims to evaluate the impact of a social network-focused intervention for patients receiving OST. In this two-site, early phase, randomized controlled trial, a total of 120 patients receiving OST will be recruited and randomized to receive one of three treatments: 1) Brief Social Behavior and Network Therapy (B-SBNT), 2) Personal Goal Setting (PGS) or 3) treatment as usual. Randomization will take place following baseline assessment. Participants allocated to receive B-SBNT or PGS will continue to receive the same treatment that is routinely provided by drug treatment services, plus four additional sessions of either intervention. Outcomes will be assessed at baseline, 3 and 12 months. The primary outcome will be assessment of illicit heroin use, measured by both urinary analysis and self-report. Secondary outcomes involve assessment of dependence, psychological symptoms, social satisfaction, motivation to change, quality of life and therapeutic engagement. Family members (n = 120) of patients involved in the trial will also be assessed to measure the level of symptoms, coping and the impact of the addiction problem on the family member at baseline, 3 and 12 months. This study will provide experimental data regarding the feasibility and efficacy of implementing a social network intervention within routine drug treatment services in the UK National Health Service. The study will explore the impact of the

  1. 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

  2. Piloting relationship education for female same-sex couples: Results of a small randomized waitlist-control trial.

    Science.gov (United States)

    Whitton, Sarah W; Scott, Shelby B; Dyar, Christina; Weitbrecht, Eliza M; Hutsell, David W; Kuryluk, Amanda D

    2017-10-01

    Relationship education represents a promising, nonstigmatizing approach to promoting the health and stability of same-sex couples. A new culturally sensitive adaptation of relationship education was developed specifically for female same-sex couples (The Strengthening Same-Sex Relationships Program, Female version; SSSR-F). SSSR-F includes adaptations of evidence-based strategies to build core relationship skills (e.g., communication skills training) as well as new content to address unique challenges faced by this population (e.g., discrimination; low social support). A small randomized waitlist-control trial (N = 37 couples) was conducted to evaluate program feasibility, acceptability, and efficacy. Three proximal outcomes targeted by SSSR-F (communication, perceived stress, social support) and 3 distal outcomes (global relationship satisfaction, instability, and confidence) were assessed at pre- and posttreatment and 3-month follow-up. Results of multilevel models accounting for nonindependence in dyadic data indicated statistically significant program effects on positive and negative couple communication, relationship satisfaction, and relationship confidence and small, nonsignificant program effects on stress, social support, and relationship instability. Analyses of follow-up data suggest maintenance of effects on the proximal but not the distal outcomes. Ratings of program satisfaction were high. Overall, findings support the feasibility, acceptability, and initial efficacy of SSSR-F, highlighting the potential value of culturally sensitive relationship education for same-sex couples. Continued efforts are needed to increase sustainability of program effects on global relationship quality over time. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  3. A pilot randomized trial of levator injections versus physical therapy for treatment of pelvic floor myalgia and sexual pain.

    Science.gov (United States)

    Zoorob, Dani; South, Mary; Karram, Mickey; Sroga, Julie; Maxwell, Rose; Shah, Aparna; Whiteside, James

    2015-06-01

    Our aim was to determine the effects of pelvic floor physical therapy (PT) and levator-directed trigger-point injections (LTPI) on sexual function and levator-related pelvic pain. A randomized trial among women with pelvic floor myalgia (PFM) was performed wherein participants received either PT or LTPI. Pain was assessed and 1 month posttreatment completion. Levator-based pain was assessed using a numeric rating scale (NRS) and the Patient Global Impression of Improvement (PGI-I) scale. Sexual function was assessed using the Female Sexual Function Index (FSFI). Twenty-nine women completed the study (17 had PT, 12 had LTPI). Both groups reported reduction in vaginal pain: mean NRS change from baseline of 4.47 [standard deviation (SD) 2.12) for PT and 4.67 (SD 1.72) for LTPI (p = 0.8)]. A >50 % improvement in NRS was documented among 59 % of women receiving PT and 58 % receiving LTPI (p = 1.0). Consistent with NRS scores, mean PGI-I score was 2.50 (SD 1.17) for PT and 2.17 (SD 1.01) for LTPI (p = 0.5). Mean change in FSFI favored PT [PT +8.87 (SD 5.60), LTPI +4.00 (SD 5.24), p = 0.04], reflecting improvement in the sexual pain domain favoring PT (p = 0.02). However, the time in weeks to effect improvement favored LTPI if controlling for the degree of change in NRS (p = 0.01) and FSFI (p = 0.01). Vaginal myalgia and sex-related pain improved with pelvic floor PT and LTPI. Time-to-effect improvement and significance of therapy are dependent on treatment type.

  4. Effects of the Tailored Activity Program in Brazil (TAP-BR) for Persons With Dementia: A Randomized Pilot Trial.

    Science.gov (United States)

    Novelli, Marcia M P C; Machado, Styfany C B; Lima, Gabriela B; Cantatore, Lais; Sena, Barbara P; Rodrigues, Renata S; Rodrigues, Camila I B; Canon, Mariana B F; Piersol, Catherine V; Nitrini, Ricardo; Yassuda, Monica S; Gitlin, Laura N

    2018-04-25

    The objectives of this study were to evaluate the effects of the Tailored Activity Program-Brazilian version (TAP-BR), on behavioral symptoms and the quality of life (QOL) in persons with dementia, as well as on their caregivers, and on caregiver burden. A 2-group randomized controlled trial with 30 dyads was conducted: the experimental group (n=15) received TAP-BR over 4 months, and a wait-list control group (n=15) received usual care. Dyads were recruited from the community of Santos City, Brazil. For persons with dementia, 50% were female individuals, the average age was 81.37 (±7.57), and the educational level was 9.97 (±5.32) years. For caregivers, 83.33% were female, the average age was 65.97 (±10.13), and the educational level was 12.10 (±4.44) years. At posttest, in comparison with the wait-list control group, experimental group caregivers reported greater reductions in number (P<0.001; Cohen d=0.93), frequency (P<0.001; Cohen d=1.12), and intensity (P<0.001; Cohen d=0.77) of the behavioral psychological symptoms of dementia, and caregiver distress (P<0.001; Cohen d=0.87). Caregivers also reported improvement in their own QOL (P<0.05; Cohen d=0.57) and that of the person with dementia (P<0.01; Cohen d=0.56); no differences were found in the ratings of QOL by the person with dementia themselves. The results provide compelling evidence that the TAP-BR is an effective strategy to support dementia caregivers in other cultures (cross-validation).

  5. 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

  6. Cognitive-behavioral therapy for sleep disturbance in patients undergoing peritoneal dialysis: a pilot randomized controlled trial.

    Science.gov (United States)

    Chen, Hung-Yuan; Chiang, Chih-Kang; Wang, Hsi-Hao; Hung, Kuan-Yu; Lee, Yue-Joe; Peng, Yu-Sen; Wu, Kwan-Dun; Tsai, Tun-Jun

    2008-08-01

    Greater than 50% of dialysis patients experience sleep disturbances. Cognitive-behavioral therapy (CBT) is effective for treating chronic insomnia, but its effectiveness has never been reported in peritoneal dialysis (PD) patients and its association with cytokines is unknown. We investigated the effectiveness of CBT in PD patients by assessing changes in sleep quality and inflammatory cytokines. Randomized control study with parallel-group design. 24 PD patients with insomnia in a tertiary medical center without active medical and psychiatric illness were enrolled. The intervention group (N = 13) received CBT from a psychiatrist for 4 weeks and sleep hygiene education, whereas the control group (N = 11) received only sleep hygiene education. Primary outcomes were changes in the Pittsburgh Sleep Quality Index and Fatigue Severity Scale scores, and secondary outcomes were changes in serum interleukin 6 (IL-6), IL-1beta, IL-18, and tumor necrosis factor alpha levels during the 4-week trial. Median percentages of change in global Pittsburgh Sleep Quality Index scores were -14.3 (interquartile range, -35.7 to - 6.3) and -1.7 (interquartile range, -7.6 to 7.8) in the intervention and control groups, respectively (P = 0.3). Median percentages of change in global Fatigue Severity Scale scores were -12.1 (interquartile range, -59.8 to -1.5) and -10.5 (interquartile range, -14.3 to 30.4) in the intervention and control groups, respectively (P = 0.04). Serum IL-1beta level decreased in the intervention group, but increased in the control group (P = 0.04). There were no significant differences in changes in other cytokines. This study had a small number of participants and short observation period, and some participants concurrently used hypnotics. CBT may be effective for improving the quality of sleep and decreasing fatigue and inflammatory cytokine levels. CBT can be an effective nonpharmacological therapy for PD patients with sleep disturbances.

  7. Experimental pain ratings and reactivity of cortisol and soluble tumor necrosis factor-α receptor II following a trial of hypnosis: Results of a randomized controlled pilot study

    Science.gov (United States)

    Goodin, Burel R.; Quinn, Noel B.; Kronfli, Tarek; King, Christopher D.; Page, Gayle G.; Haythornthwaite, Jennifer A.; Edwards, Robert R.; Stapleton, Laura M.; McGuire, Lynanne

    2011-01-01

    Objective Current evidence supports the efficacy of hypnosis for reducing the pain associated with experimental stimulation and various acute and chronic conditions; however, the mechanisms explaining how hypnosis exerts its effects remain less clear. The hypothalamic-pituitary-adrenal (HPA) axis and pro-inflammatory cytokines represent potential targets for investigation given their purported roles in the perpetuation of painful conditions; yet, no clinical trials have thus far examined the influence of hypnosis on these mechanisms. Design Healthy participants, highly susceptible to the effects of hypnosis, were randomized to either a hypnosis intervention or a no-intervention control. Using a cold pressor task, assessments of pain intensity and pain unpleasantness were collected prior to the intervention (Pre) and following the intervention (Post) along with pain-provoked changes in salivary cortisol and the soluble receptor of tumor necrosis factor-α (sTNFαRII). Results Compared to the no-intervention control, data analyses revealed that hypnosis significantly reduced pain intensity and pain unpleasantness. Hypnosis was not significantly associated with suppression of cortisol or sTNFαRII reactivity to acute pain from Pre to Post; however, the effect sizes for these associations were medium-sized. Conclusions Overall, the findings from this randomized controlled pilot study support the importance of a future large-scale study on the effects of hypnosis for modulating pain-related changes of the HPA axis and pro-inflammatory cytokines. PMID:22233394

  8. A pilot randomized trial assessing the effects of autogenic training in early stage cancer patients in relation to psychological status and immune system responses.

    Science.gov (United States)

    Hidderley, Margaret; Holt, Martin

    2004-03-01

    Autogenic training (AT) is a type of meditation usually used for reducing stress. This pilot study describes how AT was used on a group of early stage cancer patients and the observed effect on stress-related behaviours and immune system responses. This was a randomized trial with 31 early stage breast cancer women, having received a lumpectomy and adjuvant radiotherapy. The women were randomized into two groups. Group 1 received a home visit only. Group 2 received a home visit and 2 months' weekly Autogenic training. At the beginning and end of the 2 monthly periods, the Hospital Anxiety and Depression Scale (HADS) and T and B cell markers were measured to give an indication of changes in immune system responses and measurement of anxiety and depression. At the end of the study, HADS scores and T and B cell markers remained similar in the women who did not receive AT. The women receiving AT showed a strong statistical difference for an improvement in their HADS scores and those women observed in a meditative state as opposed to a relaxed state were found to have an increase in their immune responses. This study suggests AT as a powerful self-help therapy.

  9. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial.

    Science.gov (United States)

    Ferraz, Daniel Dominguez; Trippo, Karen Valadares; Duarte, Gabriel Pereira; Neto, Mansueto Gomes; Bernardes Santos, Kionna Oliveira; Filho, Jamary Oliveira

    2018-05-01

    To compare the effects of functional training, bicycle exercise, and exergaming on walking capacity of elderly with Parkinson disease (PD). A pilot randomized, controlled, single-blinded trial. A state reference health care center for elderly, a public reference outpatient clinic for the elderly. Elderly individuals (≥60 years of age; N=62) with idiopathic PD (stage 2 to 3 of modified Hoehn and Yahr staging scale) according to the London Brain Bank. The participants were randomly assigned to three groups. Group 1 (G1) participated in functional training (n=22); group 2 (G2) performed bicycle exercise (n=20), and group 3 (G3) trained with Kinect Adventures (Microsoft, Redmond, WA) exergames (n=20). The primary outcome measure was the 6-minute walk test (6MWT); secondary outcome measures were the 10-m walk test (10MWT), sitting-rising test (SRT), body mass index, Parkinson Disease Questionnaire-39, World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), and 15-item Geriatric Depression Scale. All groups showed significant improvements in 6MWT (G1 P=.008; G2 P=.001; G3 P=.005), SRT (G1 Ptraining had similar outcomes compared with functional training and bicycle exercise. The three physical exercise modalities presented significant improvements on walking capacity, ability to stand up and sit, and functionality of the participants. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  10. Pacing, Conventional Physical Activity and Active Video Games to Increase Physical Activity for Adults with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Ferrar, Katia Elizabeth; Smith, Ashleigh E; Davison, Kade

    2017-08-01

    Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious illness of biological origin characterized by profound physical and cognitive exhaustion and postexertion malaise. Pacing is a common strategy used to manage available energy and complete activities of daily living; yet little research has investigated this as a strategy to increase physical activity levels. Typically, people living with ME/CFS are faced by unique barriers to physical activity participation and are less physically active than healthy peers. As such they are at increased risk of physical inactivity-related health consequences. Active video games may be a feasible and acceptable avenue to deliver physical activity intervention by overcoming many of the reported barriers to participation. The primary objective of this pilot study is to determine the feasibility and acceptability of active video games to increase physical activity levels of people with ME/CFS. The secondary aims are to explore the preliminary effectiveness of pacing and active video gaming to pacing alone and pacing plus conventional physical activity to increase the physical activity levels of adults with ME/CFS and explore the relationship between physical activity and cumulative inflammatory load (allostatic load). This study will use a mixed method design, with a 3-arm pilot randomized controlled trial, exit interviews, and collection of feasibility and process data. A total of 30 adults with ME/CFS will be randomized to receive either (1) pacing, (2) pacing and conventional physical activity, or (3) pacing and active video gaming. The intervention duration will be 6 months, and participants will be followed up for 6 months postintervention completion. The intervention will be conducted in the participant's home, and activity intensity will be determined by continuously monitored heart rate and ratings of perceived exertion. Feasibility and acceptability and process data will be collected during and at the end

  11. 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%…

  12. 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

  13. 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

  14. Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial.

    Science.gov (United States)

    Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Robinson, David B; Szturm, Tony

    2013-03-09

    Significant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand. With modest evidence on the therapeutic effectiveness of conventional hand exercises, a task-oriented training program via real life object manipulations has been developed for people with arthritis. An innovative, computer-based gaming platform that allows a broad range of common objects to be seamlessly transformed into therapeutic input devices through instrumentation with a motion-sense mouse has also been designed. Personalized objects are selected to target specific training goals such as graded finger mobility, strength, endurance or fine/gross dexterous functions. The movements and object manipulation tasks that replicate common situations in everyday living will then be used to control and play any computer game, making practice challenging and engaging. The ongoing study is a 6-week, single-center, parallel-group, equally allocated and assessor-blinded pilot randomized controlled trial. Thirty people with rheumatoid arthritis or osteoarthritis affecting the hand will be randomized to receive either conventional hand exercises or the task-oriented training. The purpose is to determine a preliminary estimation of therapeutic effectiveness and feasibility of the task-oriented training program. Performance based and self-reported hand function, and exercise compliance are the study outcomes. Changes in outcomes (pre to post intervention) within each group will be assessed by paired Student t test or Wilcoxon signed-rank test and between groups (control versus experimental) post intervention using unpaired Student t test or Mann-Whitney U test. The study findings will inform decisions on the feasibility, safety and completion rate and will also provide preliminary data on the treatment effects of the task

  15. Incidence and severity of gingival invaginations associated with early versus late initiation of orthodontic space closure after tooth extraction : A multicenter pilot and randomized controlled trial.

    Science.gov (United States)

    Reichert, Christoph; Kutschera, Eric; Plötz, Christina; Scharf, Sven; Gölz, Lina; Fimmers, Rolf; Fuhrmann, Christine; Wahl, Gerhard; Braumann, Bert; Jäger, Andreas

    2017-09-01

    Gingival invaginations are a common side effect of orthodontic extraction-space closure. The timing of initiating the closure of an extraction space varies greatly in clinical practice. In this multicenter pilot and randomized controlled trial, we prospectively investigated whether initiating space closure in the early stage of wound healing would benefit the incidence and severity of invaginations developing in the extraction sites. A total of 368 patients were screened for indications to extract at least one mandibular premolar. Those recruited were randomly assigned to one of two treatment arms: initiation of space closure either 2-4 weeks (arm A) or ≥12 weeks (arm B) after tooth extraction. Clinical data regarding treatment process and periodontal tissue response were recorded during and after space closure and analyzed by a specialized biometrics unit. The study was performed under continuous surveillance by an independent study control center. A total of 74 extraction sites were analyzed. Regarding the incidence of gingival invaginations, there were no significant intergroup differences [p = 0.13; group A comprising 37/44 (84.1%) and group B 29/30 (96.7%) invaginated sites]. The same was true based on either maxillary (p = 0.52) or mandibular (p = 0.21) sites only, and the severity of the invaginations did not differ between the treatment arms. As to the incidence and severity of gingival invaginations, we did not notice any statistically significant differences between the two timeframes. Our data do, however, provide a basis to identify additional confounders and to improve the accuracy of case-load estimations for future trials.

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

    Science.gov (United States)

    Gajecki, Mikael; Johansson, Magnus; Blankers, Matthijs; Sinadinovic, Kristina; Stenlund-Gens, Erik; Berman, Anne H.

    2016-01-01

    Background 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. Methods 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. Results 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). Conclusion Self-help programs for problematic alcohol use can be more

  17. Topical Mannitol Reduces Capsaicin-Induced Pain: Results of a Pilot-Level, Double-Blind, Randomized Controlled Trial.

    Science.gov (United States)

    Bertrand, Helene; Kyriazis, Marylene; Reeves, K Dean; Lyftogt, John; Rabago, David

    2015-11-01

    Capsaicin specifically activates, and then gradually exhausts, the transient receptor potential vanilloid type 1 (TRPV1) receptor, a key receptor in neuropathic pain. Activation of the TRPV-1 receptor is accompanied by burning pain. A natural substance or medication that can reduce the burning pain resulting from capsaicin application may have therapeutic potential in neuropathic pain. To assess the pain-relieving effects of a mannitol-containing cream in a capsaicin-based pain model. Randomized, placebo-controlled, double-blind clinical trial. Outpatient pain clinic. Twenty-five adults with pain-free lips. Capsaicin .075% cream was applied to both halves of each participant's upper lip, inducing pain via stimulation of the transient receptor potential vanilloid 1 (TRPV1, capsaicin) receptor, then removed after 5 minutes or when participants reported a burning pain of 8/10, whichever came first. A cream containing mannitol and the same cream without mannitol (control) were then immediately applied, 1 on each side of the lip, in an allocation-masked manner. Participants self-recorded a numeric rating scale (NRS, 0-10) pain score for each side of the lip per minute for 10 minutes. A t-test was performed to evaluate the pain score change from baseline between each side of the lip at each recording. Area under the curve (AUC) analysis was used to determine the overall difference between groups. Participants reached a capsaicin-induced pain level of 7.8 ± 1.0 points in 3.3 ± 1.6 minutes that was equal on both sides of the lip. Both groups reported progressive diminution of pain over the 10-minute study period. However, participants reported significantly reduced pain scores on the mannitol cream half-lip compared to control at 3 through 10 minutes (P < .05) and in AUC analysis (P < .001). Mannitol cream reduced self-reported pain scores in a capsaicin pain model more rapidly than a control cream, potentially via a TRPV1 receptor effect. Copyright © 2015 American

  18. Effects of home-based exercise on pre-dialysis chronic kidney disease patients: a randomized pilot and feasibility trial.

    Science.gov (United States)

    Hiraki, Koji; Shibagaki, Yugo; Izawa, Kazuhiro P; Hotta, Chiharu; Wakamiya, Akiko; Sakurada, Tsutomu; Yasuda, Takashi; Kimura, Kenjiro

    2017-06-17

    Only a few research is available on the effects of home-based exercise training on pre-dialysis chronic kidney disease (CKD) patients. Therefore, we aimed to elucidate the effect of home-based exercise therapy on kidney function and arm and leg muscle strength in pre-dialysis CKD patients. Thirty-six male stage 3-4 pre-dialysis CKD patients (age, 68.7 ± 6.8 years; estimated glomerular filtration rate (eGFR), 39.0 ± 11.6 ml/min/1.73 m 2 ) who were being treated as outpatients were included. The subjects were randomly assigned to an exercise intervention group (Ex group: 18) and a control group (C group: 18). The Ex group wore accelerometer pedometers and were instructed to perform home-based aerobic and resistance exercises, such as brisk walking for 30 min per day, for 12 months. The C group subjects wore accelerometer pedometers but received no exercise therapy guidance; the number of steps covered during normal daily activities was recorded for the C group. The outcome measures were changes in kidney function and handgrip and knee extension muscle strength. Values at the baseline (T1) and 12 months later (T2) were compared. There were no significant differences in baseline characteristics between the two groups; however, the C group was more physically active than the Ex group. Eight subjects dropped out, and 28 subjects (14 in each group) were included in the final analysis. Physical activity increased significantly only in the Ex group. Grip strength (F = 7.0, p = 0.01) and knee extension muscle strength (F = 14.3, p < 0.01) were found to improve only in the Ex group. Further, the changes in eGFR were not significantly different between the two groups (F = 0.01, p = 0.93). Home-based exercise therapy for pre-dialysis CKD patients was feasible and improved arm and leg muscle strength without affecting kidney function. UMIN Clinical Trials Registry ( UMIN000005091 ). Registered 2/15/2011.

  19. A mobile phone-based program to promote healthy behaviors among adults with prediabetes: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Griauzde, Dina H; Kullgren, Jeffrey T; Liestenfeltz, Brad; Richardson, Caroline; Heisler, Michele

    2018-01-01

    Rates of participation in Diabetes Prevention Programs (DPPs) are low. This may be due, in part, to low levels of autonomous motivation (i.e., motivation that arises from internal sources and sustains healthy behaviors over time) to prevent type 2 diabetes (T2DM) among many individuals with prediabetes. Mobile health (mHealth) technologies that incorporate principles from the Self-Determination Theory offer an effective and scalable approach to increase autonomous motivation levels. One promising mobile phone-based application is JOOL Health, which aims to help users connect certain health behaviors (e.g., sleep and diet) with personal values in specific life domains (e.g., family and work). The first aim of this study is to estimate whether JOOL Health can increase autonomous motivation to prevent T2DM among individuals with prediabetes who declined DPP participation. The second aim of this pilot study is to examine the intervention's feasibility and acceptability. This is a 12-week, three-arm pilot randomized controlled trial. We will recruit 105 individuals with prediabetes who did not engage in a DPP despite invitation from their health plan to participate in face-to-face or web-based programs at no out-of-pocket-cost. Participants will be randomized to one of three study arms: (1) a group that receives information on prediabetes, evidence-based strategies to decrease progression to T2DM, and a list of resources for mHealth tools for monitoring diet, physical activity, and weight (comparison group); (2) a group that receives the JOOL Health application; and (3) a group that receives the JOOL Health application as well as a Fitbit activity tracker and wireless-enabled scale. Our primary outcome is change in autonomous motivation to prevent T2DM (measured using the Treatment Self-Regulation Questionnaire). We will also collect data related to the intervention's feasibility (recruitment and retention rates) and acceptability (adherence and qualitative experience

  20. 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

  1. A pilot randomized clinical trial testing integrated 12-Step facilitation (iTSF) treatment for adolescent substance use disorder.

    Science.gov (United States)

    Kelly, John F; Kaminer, Yifrah; Kahler, Christopher W; Hoeppner, Bettina; Yeterian, Julie; Cristello, Julie V; Timko, Christine

    2017-12-01

    The integration of 12-Step philosophy and practices is common in adolescent substance use disorder (SUD) treatment programs, particularly in North America. However, although numerous experimental studies have tested 12-Step facilitation (TSF) treatments among adults, no studies have tested TSF-specific treatments for adolescents. We tested the efficacy of a novel integrated TSF. Explanatory, parallel-group, randomized clinical trial comparing 10 sessions of either motivational enhancement therapy/cognitive-behavioral therapy (MET/CBT; n = 30) or a novel integrated TSF (iTSF; n = 29), with follow-up assessments at 3, 6 and 9 months following treatment entry. Out-patient addiction clinic in the United States. Adolescents [n = 59; mean age = 16.8 (1.7) years; range = 14-21; 27% female; 78% white]. The iTSF integrated 12-Step with motivational and cognitive-behavioral strategies, and was compared with state-of-the-art MET/CBT for SUD. Primary outcome: percentage days abstinent (PDA); secondary outcomes: 12-Step attendance, substance-related consequences, longest period of abstinence, proportion abstinent/mostly abstinent, psychiatric symptoms. Primary outcome: PDA was not significantly different across treatments [b = 0.08, 95% confidence interval (CI) = -0.08 to 0.24, P = 0.33; Bayes' factor = 0.28). during treatment, iTSF patients had substantially greater 12-Step attendance, but this advantage declined thereafter (b = -0.87; 95% CI = -1.67 to 0.07, P = 0.03). iTSF did show a significant advantage at all follow-up points for substance-related consequences (b = -0.42; 95% CI = -0.80 to -0.04, P Step meeting attendance was associated significantly with longer abstinence during (r = 0.39, P = 0.008), and early following (r = 0.30, P = 0.049), treatment. Compared with motivational enhancement therapy/cognitive-behavioral therapy (MET/CBT), in terms of abstinence, a novel integrated 12-Step facilitation treatment for adolescent

  2. A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder.

    Science.gov (United States)

    Bikic, Aida; Christensen, Torben Østergaard; Leckman, James F; Bilenberg, Niels; Dalsgaard, Søren

    2017-08-01

    The purpose of this trial was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with attention-deficit/hyperactivity disorder (ADHD). Eighteen adolescents with ADHD were randomized to treatment or control intervention for 7 weeks. Outcome measures were cognitive test, symptom, and motivation questionnaires. SBT and Tetris were feasible as home-based interventions, and participants' compliance was high, but participants perceived both interventions as not very interesting or helpful. There were no significant group differences on cognitive and ADHD-symptom measures after intervention. Pre-post intra-group measurement showed that the SBT had a significant beneficial effect on sustained attention, while the active placebo had significant beneficial effects on working memory, both with large effect sizes. Although no significant differences were found between groups on any measure, there were significant intra-group changes for each group.

  3. 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 Health Organization limits for low risk (1-10 TTCs/100 mL), respectively, compared with 0.9% and 7.3% for control group samples. Overall, prevalence of diarrhea was 60% less among households using filters than among control households (odds ratio = 0.40, 95% confidence interval = 0.25, 0.63, P < 0.0001). However, the microbiologic performance and protective effect of the filters was not uniform throughout the study communities, suggesting the need to consider the circumstances of the particular setting before implementing this intervention.

  4. Biking for Health: Results of a Pilot Randomized Controlled Trial Examining the Impact of a Bicycling Intervention on Lower-Income Adults.

    Science.gov (United States)

    Bernstein, Rebecca; Schneider, Robert; Welch, Whitney; Dressel, Anne; DeNomie, Melissa; Kusch, Jennifer; Sosa, Mirtha

    2017-08-01

    This pilot study tested the efficacy of a bicycling intervention targeting inactive, low-income, overweight adults on reducing perceived barriers to bicycling, increasing physical activity, and improving health. A nonblinded 2-site randomized controlled trial was conducted in Milwaukee, Wisconsin, in summer 2015. Participants included members from 1 largely Latino community and a second primarily African American neighborhood. A certified bicycling instructor led a 12-week bicycling intervention. Outcome measures including biking-related attitudes, self-reported physical activity, fitness as measured by the 6-minute step test, and biometric data were collected at baseline, 12 weeks, and 20 weeks. Thirty-eight participants completed the study. Barriers to bicycling declined significantly among intervention group participants at 12 weeks with some declines persisting to 20 weeks. Bicycling for leisure or non work transportation increased significantly more in the intervention than control group from baseline to 12 weeks but this difference attenuated by 20 weeks. Both groups increased their fitness between baseline and 12 weeks, with a trend towards greater gains in the bicycling intervention group. No significant change in biometric measurements was seen at either 12 weeks or 20 weeks. Despite the small study size, this bicycling intervention decreased perceived barriers to bicycling and increased bicycling activity in low-income minority participants. These findings support a larger-scale study to measure fitness and health changes from bicycling interventions.

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

    Science.gov (United States)

    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) 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 data was collected by administering the Youth Self Report (YSR), a modified Spielberger State-Trait Anxiety Inventory, and the Cognitive and Affective Mindfulness Measure -Revised before and after 6 weeks of meditation or active control condition. Both meditators and active controls decreased significantly on the YSR Internalizing Problems, Externalizing Problems, and Attention Problems subscales but did not differ in the extent of their improvements. Both groups also showed comparable improvements on measures in affect. Meditators were significantly less likely to develop suicidal ideation or thoughts of self-harm than controls. Improvements in affect were correlated with increases in mindfulness in meditators but not controls. These results suggest that mindfulness training may yield both unique and nonspecific benefits that are shared by other novel activities. PMID:24930819

  6. 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

  7. High-speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Levinger, Pazit; Dunn, Jeremy; Bifera, Nancy; Butson, Michael; Elias, George; Hill, Keith D

    2017-08-18

    The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined. This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA. The results of this study will improve understanding

  8. Print versus a culturally-relevant Facebook and text message delivered intervention to promote physical activity in African American women: a randomized pilot trial.

    Science.gov (United States)

    Joseph, Rodney P; Keller, Colleen; Adams, Marc A; Ainsworth, Barbara E

    2015-03-27

    African American women report insufficient physical activity and are disproportionally burdened by associated disease conditions; indicating the need for innovative approaches to promote physical activity in this underserved population. Social media platforms (i.e. Facebook) and text messaging represent potential mediums to promote physical activity. This paper reports the results of a randomized pilot trial evaluating a theory-based (Social Cognitive Theory) multi-component intervention using Facebook and text-messages to promote physical activity among African American women. Participants (N = 29) were randomly assigned to receive one of two multi-component physical activity interventions over 8 weeks: a culturally-relevant, Social Cognitive Theory-based, intervention delivered by Facebook and text message (FI) (n = 14), or a non-culturally tailored print-based intervention (PI) (n = 15) consisting of promotion brochures mailed to their home. The primary outcome of physical activity was assessed by ActiGraph GT3X+ accelerometers. Secondary outcomes included self-reported physical activity, physical activity-related psychosocial variables, and participant satisfaction. All randomized participants (N = 29) completed the study. Accelerometer measured physical activity showed that FI participants decreased sedentary time (FI = -74 minutes/week vs. PI = +118 minute/week) and increased light intensity (FI = +95 minutes/week vs. PI = +59 minutes/week) and moderate-lifestyle intensity physical activity (FI = + 27 minutes/week vs. PI = -34 minutes/week) in comparison to PI participants (all P's  .05). Results of secondary outcomes showed that in comparison to the PI, FI participants self-reported greater increases in moderate-to-vigorous physical activity (FI = +62 minutes/week vs. PI = +6 minutes/week; P = .015) and had greater enhancements in self-regulation for physical activity (P program to a friend

  9. 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

    Pseudomonas aeruginosa forms biofilms in the cystic fibrosis lung. Quorum sensing (QS) controls biofilm maturation, immune evasion, antibiotic tolerance and virulence factor production. Garlic shows QS inhibitory activity in vitro and in animal models. We report the first clinical trial in man of...

  10. A Randomized Controlled Trial of Acceptance-Based Behavior Therapy and Cognitive Therapy for Test Anxiety: A Pilot Study

    Science.gov (United States)

    Brown, Lily A.; Forman, Evan M.; Herbert, James D.; Hoffman, Kimberly L.; Yuen, Erica K.; Goetter, Elizabeth M.

    2011-01-01

    Many university students suffer from test anxiety that is severe enough to impair performance. Given mixed efficacy results of previous cognitive-behavior therapy (CBT) trials and a theoretically driven rationale, an acceptance-based behavior therapy (ABBT) approach was compared to traditional CBT (i.e., Beckian cognitive therapy; CT) for the…

  11. 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

  12. 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.

  13. Effects of dual-task balance training on postural performance in patients with Multiple Sclerosis: a double-blind, randomized controlled pilot trial.

    Science.gov (United States)

    Monjezi, Saeideh; Negahban, Hossein; Tajali, Shirin; Yadollahpour, Nava; Majdinasab, Nastaran

    2017-02-01

    To investigate the effects of dual-task balance training on postural performance in patients with multiple sclerosis as compared with single-task balance training. Double-blind, pretest-posttest, randomized controlled pilot trial. Local Multiple Sclerosis Society. A total of 47 patients were randomly assigned to two equal groups labeled as single-task training and dual-task training groups. All patients received supervised balance training sessions, 3 times per week for 4 weeks. The patients in the single-task group performed balance activities, alone. However, patients in dual-task group practiced balance activities while simultaneously performing cognitive tasks. The 10-Meter Walk Test and Timed Up-and-Go under single-task and dual-task conditions, in addition to Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment were assessed pre-, and post intervention and also 6-weeks after the end of intervention. Only 38 patients completed the treatment plan. There was no difference in the amount of improvement seen between the two study groups. In both groups there was a significant effect of time for dual-10 Meter Walk Test (F 1, 36 =11.33, p=0.002) and dual-Timed Up-and-Go (F 1, 36 =14.27, p=0.001) but not for their single-tasks. Moreover, there was a significant effect of time for Activities-specific Balance Confidence, Berg Balance Scale, and Functional Gait Assessment ( Ppilot study did not show more benefits from undertaking dual-task training than single-task training. A power analysis showed 71 patients per group would be needed to determine whether there was a clinically relevant difference for dual-task gait speed between the groups.

  14. 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.

  15. Effects of Functional Fascial Taping on pain and function in patients with non-specific low back pain: a pilot randomized controlled trial.

    Science.gov (United States)

    Chen, Shu-Mei; Alexander, Ron; Lo, Sing Kai; Cook, Jill

    2012-10-01

    To compare the short-term and medium-term effect of Functional Fascial Taping to placebo taping on pain and function in people with non-specific low back pain. A pilot randomized controlled trial with a 2-week intervention, and 2-, 6- and 12-week follow-up. Individuals with non-specific low back pain recruited from local communities. Forty-three participants with non-specific low back pain for more than 6 weeks were randomized into either Functional Fascial Taping group (n = 21) or placebo group (n = 22). The intervention group was treated with Functional Fascial Taping while the control group was treated with placebo taping. Both groups received four treatments over 2 weeks. Worst and average pain and function were assessed at baseline, after the 2-week intervention, and at 6 and 12 weeks follow-up. The Functional Fascial Taping group demonstrated significantly greater reduction in worst pain compared to placebo group after the 2-week intervention (P = 0.02, effect size = 0.74; 95% confidence interval 0.11-1.34). A higher proportion of participants in Functional Fascial Taping group attained the minimal clinically important difference in worst pain (P = 0.007) and function (P = 0.007) than those in placebo group after the 2-week intervention. There were no significant differences in either group's disability rating or clinically important difference in average pain at any time. Functional Fascial Taping reduced worst pain in patients with non-acute non-specific low back pain during the treatment phase. No medium-term differences in pain or function were observed.

  16. A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design.

    Science.gov (United States)

    Asfar, Taghrid; Caban-Martinez, Alberto J; McClure, Laura A; Ruano-Herreria, Estefania C; Sierra, Danielle; Gilford Clark, G; Samano, Daniel; Dietz, Noella A; Ward, Kenneth D; Arheart, Kristopher L; Lee, David J

    2018-04-01

    Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers. This paper describes the intervention development and the design, methods, and data analysis plans for an ongoing cluster pilot two-arm randomized controlled trial comparing an Enhanced Care worksite cessation program to Standard Care. Fourteen construction sites will be randomized to either Enhanced Care or Standard Care and 126 participants (63/arm) will be recruited. In both arms, recruitment and intervention delivery occur around "food trucks" that regularly visit the construction sites. Participants at Enhanced Care sites will receive the developed intervention consisting of a single face-to-face group counseling session, 2 phone calls, and a fax referral to Florida tobacco quitline (QL). Participants at Standard Care sites will receive a fax referral to the QL. Both groups will receive eight weeks of nicotine replacement treatment and two follow-up assessments at three and six months. Feasibility outcomes are estimated recruitment yield, barriers to delivering the intervention onsite, and rates of adherence/compliance to the intervention, follow-ups, and QL enrollment. Efficacy outcomes are point-prevalence and prolonged abstinence rates at six month follow-up confirmed by saliva cotinine <15 ng/ml. Copyright © 2018. Published by Elsevier Inc.

  17. A pilot randomized clinical trial of intermittent occlusion therapy liquid crystal glasses versus traditional patching for treatment of moderate unilateral amblyopia.

    Science.gov (United States)

    Wang, Jingyun; Neely, Daniel E; Galli, Jay; Schliesser, Joshua; Graves, April; Damarjian, Tina G; Kovarik, Jessica; Bowsher, James; Smith, Heather A; Donaldson, Dana; Haider, Kathryn M; Roberts, Gavin J; Sprunger, Derek T; Plager, David A

    2016-08-01

    To compare the effectiveness of intermittent occlusion therapy (IO therapy) using liquid crystal glasses and continuous occlusion therapy using traditional adhesive patches for treating amblyopia. Children 3-8 years of age with previously untreated, moderate, unilateral amblyopia (visual acuity of 20/40 to 20/100 in the amblyopic eye) were enrolled in this randomized controlled trial. Amblyopia was associated with strabismus, anisometropia, or both. All subjects had worn any optimal refractive correction for at least 12 weeks without improvement. Subjects were randomized into two treatment groups: a 4-hour IO therapy group with liquid crystal glasses (Amblyz), set at 30-second opaque/transparent intervals (occluded 50% of wear time), and a 2-hour continuous patching group (occluded 100% of wear time). For each patient, visual acuity was measured using ATS-HOTV before and after 12 weeks of treatment. Data from 34 patients were available for analysis. Amblyopic eye visual acuity improvement from baseline was 0.15 ± 0.12 logMAR (95% CI, 0.09-0.15) in the IO therapy group (n = 19) and 0.15 ± 0.11 logMAR (95% CI, 0.1-0.15) in the patching group (n = 15). In both groups improvement was significant, but the difference between groups was not (P = 0.73). No adverse effects were reported. In this pilot study, IO therapy with liquid crystal glasses is not inferior to adhesive patching and is a promising alternative treatment for children 3-8 years of age with moderate amblyopia. Copyright © 2016 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

  18. Effects of a lighter, smaller football on acute match injuries in adolescent female football: a pilot cluster-randomized controlled trial.

    Science.gov (United States)

    Zebis, Mette K; Thorborg, Kristian; Andersen, Lars L; Møller, Merete; Christensen, Karl B; Clausen, Mikkel B; Hölmich, Per; Wedderkopp, Niels; Andersen, Thomas B; Krustrup, Peter

    2018-05-01

    The high injury incidence during match-play in female adolescent football is a major concern. In football, males and females play matches with the same football size. No studies have investigated the effect of football size on injury incidence in female adolescent football. Thus, the aim of the present study was to investigate the effects of introducing a lighter, smaller football on the injury pattern in female adolescent football. We conducted a pilot cluster randomized controlled trial including 26 football teams representing 346 adolescent female football players (age 15-18 years). The teams were randomized to a new lighter, smaller football (INT, N.=12 teams) or a traditional FIFA size 5 football (CON, N.=14 teams) during a full match-season. Acute time-loss injuries and football-exposure during match-play were reported weekly by text-message questions and verified subsequently by telephone interview. In total, 46 acute time-loss injuries were registered (5 severe injuries), yielding an incidence rate of 15.2 injuries per 1000 hours of match-play (95% CI: 8.5-27.2) in INT and 18.6 injuries per 1000 hours of match-play (95% CI: 14.0-24.8) in CON. The estimated 22% greater injury incidence rate risk (IRR: 1.22 [95% CI: 0.64-2.35]) in the CON group was not significant. With an IRR of 1.22, a future RCT main study would need to observe 793 acute time-loss injuries during match-play, in order to have a power of 80%. A large-scaled RCT is required to definitively test for beneficial or harmful effects of a lighter, smaller football in adolescent female football.

  19. Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P Study, a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rejeski W Jack

    2011-05-01

    Full Text Available Abstract Background The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial. Methods SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA and/or cognitive training intervention (CT in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment. Results Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004, the interventions produced marked changes in cognitive and physical performance measures (p≤0.05, and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01. Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome or 2,000 participants (categorical outcome. Conclusions Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible. Trial Registration Clinicaltrials.gov Identifier: NCT00688155

  20. My Team of Care Study: A Pilot Randomized Controlled Trial of a Web-Based Communication Tool for Collaborative Care in Patients With Advanced Cancer.

    Science.gov (United States)

    Voruganti, Teja; Grunfeld, Eva; Jamieson, Trevor; Kurahashi, Allison M; Lokuge, Bhadra; Krzyzanowska, Monika K; Mamdani, Muhammad; Moineddin, Rahim; Husain, Amna

    2017-07-18

    The management of patients with complex care needs requires the expertise of health care providers from multiple settings and specialties. As such, there is a need for cross-setting, cross-disciplinary solutions that address deficits in communication and continuity of care. We have developed a Web-based tool for clinical collaboration, called Loop, which assembles the patient and care team in a virtual space for the purpose of facilitating communication around care management. The objectives of this pilot study were to evaluate the feasibility of integrating a tool like Loop into current care practices and to capture preliminary measures of the effect of Loop on continuity of care, quality of care, symptom distress, and health care utilization. We conducted an open-label pilot cluster randomized controlled trial allocating patients with advanced cancer (defined as stage III or IV disease) with ≥3 months prognosis, their participating health care team and caregivers to receive either the Loop intervention or usual care. Outcome data were collected from patients on a monthly basis for 3 months. Trial feasibility was measured with rate of uptake, as well as recruitment and system usage. The Picker Continuity of Care subscale, Palliative care Outcomes Scale, Edmonton Symptom Assessment Scale, and Ambulatory and Home Care Record were patient self-reported measures of continuity of care, quality of care, symptom distress, and health services utilization, respectively. We conducted a content analysis of messages posted on Loop to understand how the system was used. Nineteen physicians (oncologists or palliative care physicians) were randomized to the intervention or control arms. One hundred twenty-seven of their patients with advanced cancer were approached and 48 patients enrolled. Of 24 patients in the intervention arm, 20 (83.3%) registered onto Loop. In the intervention and control arms, 12 and 11 patients completed three months of follow-up, respectively. A mean

  1. Evaluation of a spirituality informed e-mental health tool as an intervention for major depressive disorder in adolescents and young adults - a randomized controlled pilot trial.

    Science.gov (United States)

    Rickhi, Badri; Kania-Richmond, Ania; Moritz, Sabine; Cohen, Jordan; Paccagnan, Patricia; Dennis, Charlotte; Liu, Mingfu; Malhotra, Sonya; Steele, Patricia; Toews, John

    2015-12-24

    Depression in adolescents and young adults is a major mental health condition that requires attention. Research suggests that approaches that include spiritual concepts and are delivered through an online platform are a potentially beneficial approach to treating/managing depression in this population. The purpose of this study was to evaluate the effectiveness of an 8-week online spirituality informed e-mental health intervention (the LEAP Project) on depression severity, and secondary outcomes of spiritual well-being and self-concept, in adolescents and young adults with major depressive disorder of mild to moderate severity. A parallel group, randomized, waitlist controlled, assessor-blinded clinical pilot trial was conducted in Calgary, Alberta, Canada. The sample of 62 participants with major depressive disorder (DSM-IV-TR) was defined by two age subgroups: adolescents (ages 13 to 18 years; n = 31) and young adults (ages 19 to 24 years; n = 31). Participants in each age subgroup were randomized into the study arm (intervention initiated upon enrolment) or the waitlist control arm (intervention initiated after an 8-week wait period). Comparisons were made between the study and waitlist control arms at week 8 (the point where study arm had completed the intervention and the waitlist control arm had not) and within each arm at four time points over 24-week follow-up period. At baseline, there was no statistical difference between study and waitlist participants for both age subgroups for all three outcomes of interest. After the intervention, depression severity was significantly reduced; comparison across arms at week 8 and over time within each arm and both age subgroups. Spiritual well-being changes were not significant, with the exception of an improvement over time for the younger participants in the study arm (p = 0.01 at week 16 and p = 0.0305 at week 24). Self-concept improved significantly for younger participants immediately after the

  2. A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity

    DEFF Research Database (Denmark)

    Kingston, Jessica; Chadwick, Paul; Meron, Daniel

    2007-01-01

    Objective: To investigate the effect of mindfulness training on pain tolerance, psychological well-being, physiological activity, and the acquisition of mindfulness skills. Methods: Forty-two asymptomatic University students participated in a randomized, single-blind, active control pilot study. ...

  3. Reiki therapy for postoperative oral pain in pediatric patients: pilot data from a double-blind, randomized clinical trial.

    Science.gov (United States)

    Kundu, Anjana; Lin, Yuting; Oron, Assaf P; Doorenbos, Ardith Z

    2014-02-01

    To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

  4. Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound.

    Science.gov (United States)

    Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

    2016-08-01

    Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era in which tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesized that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (arm 1) vs SLNB (arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Sixty-eight subjects were enrolled in the pilot phase of the trial (34 subjects in arm 1, no further staging; 32 subjects in arm 2, SLNB; and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40 to 80 years) in arm 1 and 59 years (range 31 to 81 years) in arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1 to 32 months). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (>2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  5. Pilot randomized trial of a volitional help sheet-based tool to increase leisure time physical activity in breast cancer survivors.

    Science.gov (United States)

    Chapman, Janine; Fletcher, Chloe; Flight, Ingrid; Wilson, Carlene

    2018-05-16

    To develop and test a volitional help sheet-based tool to improve physical activity in breast cancer survivors compared to a standard self-generated implementation intention intervention. Pilot randomized trial conducted online over 3 months. Participants were randomized to an online volitional help sheet (n = 50) or implementation intention (n = 51) intervention. Measures were taken at baseline, 1 and 3 months. The main outcome measure was moderate-strenuous leisure time physical activity. Secondary outcomes were health-related quality of life and mood. Participants exposed to the volitional help sheet and implementation intention interventions showed similar effects after 1 month, with both groups reporting a significant increase in moderate-strenuous physical activity. After 3 months, the initial increase in physical activity was maintained by the volitional help sheet group, but not the implementation intention group. Improvements were also found for negative affect and emotional quality of life. While both interventions show promise in promoting physical activity in breast cancer survivors, the volitional help sheet may be more effective for facilitating lasting change and emotional well-being. Findings suggest that the volitional help sheet may have potential to offer a cost-effective contribution to consumer-led tertiary preventive health. Future research should test these initial findings in a definitive trial. Statement of contribution What is already known on this subject? Physical activity is important for optimizing health in breast cancer survivors. Despite this, physical activity in this cohort remains low. Theory-based strategies are needed to help breast cancer survivors independently manage and maintain regular physical activity over the long term. What does this study add? Online planning interventions can improve physical activity in breast cancer survivors. Volitional help sheets, but not implementation intentions, show sustained

  6. 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

  7. Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial.

    Science.gov (United States)

    Dawson, Jacqueline K; Dorff, Tanya B; Todd Schroeder, E; Lane, Christianne J; Gross, Mitchell E; Dieli-Conwright, Christina M

    2018-04-03

    Prostate cancer patients on androgen deprivation therapy (ADT) experience adverse effects such as lean mass loss, known as sarcopenia, fat gain, and changes in cardiometabolic factors that increase risk of metabolic syndrome (MetS). Resistance training can increase lean mass, reduce body fat, and improve physical function and quality of life, but no exercise interventions in prostate cancer patients on ADT have concomitantly improved body composition and MetS. This pilot trial investigated 12 weeks of resistance training on body composition and MetS changes in prostate cancer patients on ADT. An exploratory aim examined if a combined approach of training and protein supplementation would elicit greater changes in body composition. Prostate cancer patients on ADT were randomized to resistance training and protein supplementation (TRAINPRO), resistance training (TRAIN), protein supplementation (PRO), or control stretching (STRETCH). Exercise groups (EXE = TRAINPRO, TRAIN) performed supervised exercise 3 days per week for 12 weeks, while non-exercise groups (NoEXE = PRO, STRETCH) performed a home-based stretching program. TRAINPRO and PRO received 50 g⋅day - 1 of whey protein. The primary outcome was change in lean mass assessed through dual energy x-ray absorptiometry. Secondary outcomes examined changes in sarcopenia, assessed through appendicular skeletal mass (ASM) index (kg/m 2 ), body fat %, strength, physical function, quality of life, MetS score and the MetS components of waist circumference, blood pressure, glucose, high-density lipoprotein-cholesterol, and triglyceride levels. A total of 37 participants were randomized; 32 participated in the intervention (EXE n = 13; NoEXE n = 19). At baseline, 43.8% of participants were sarcopenic and 40.6% met the criteria for MetS. Post-intervention, EXE significantly improved lean mass (d = 0.9), sarcopenia prevalence (d = 0.8), body fat % (d = 1.1), strength (d = 0.8-3.0), and

  8. A Pilot Randomized Controlled Trial of a New Supplementary Food Designed to Enhance Cognitive Performance during Prevention and Treatment of Malnutrition in Childhood.

    Science.gov (United States)

    Roberts, Susan B; Franceschini, Maria Angela; Krauss, Amy; Lin, Pei-Yi; de Sa, Augusto Braima; Có, Raimundo; Taylor, Salima; Brown, Carrie; Chen, Oliver; Johnson, Elizabeth J; Pruzensky, William; Schlossman, Nina; Balé, Carlito; Wu, Kuan-Cheng Tony; Hagan, Katherine; Saltzman, Edward; Muentener, Paul

    2017-11-01

    Cognitive impairment associated with childhood malnutrition and stunting is generally considered irreversible. The aim was to test a new nutritional supplement for the prevention and treatment of moderate-acute malnutrition (MAM) focused on enhancing cognitive performance. An 11-wk, village-randomized, controlled pilot trial was conducted in 78 children aged 1-3 or 5-7 y living in villages in Guinea-Bissau. The supplement contained 291 kcal/d for young children and 350 kcal/d for older children and included 5 nutrients and 2 flavan-3-ol-rich ingredients not present in current food-based recommendations for MAM. Local bakers prepared the supplement from a combination of locally sourced items and an imported mix of ingredients, and it was administered by community health workers 5 d/wk. The primary outcome was executive function abilities at 11 wk. Secondary outcomes included additional cognitive measures and changes in z scores for weight (weight-for-age) and height (height-for-age) and hemoglobin concentrations at 11 wk. An index of cerebral blood flow (CBF) was also measured at 11 wk to explore the use of this measurement as a biological index of cognitive impairment. There were no significant differences in any outcome between groups at baseline. There was a beneficial effect of random assignment to the supplement group on working memory at 11 wk in children aged 1-3 y ( P < 0.05). This difference contrasted with no effect in older children and was not associated with faster growth rate. In addition, CBF correlated with task-switching performance ( P < 0.05). These preliminary data suggest that cognitive impairment can be monitored with measurement of CBF. In addition, the findings provide preliminary data that suggest that it may be possible to improve poor cognitive performance in young children through changes in the nutritional formulation of supplementary foods used to prevent and treat MAM. Powered studies of the new supplement formulation are needed. This

  9. Lessons learned from recruiting socioeconomically disadvantaged smokers into a pilot randomized controlled trial to explore the role of Exercise Assisted Reduction then Stop (EARS) smoking.

    Science.gov (United States)

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

    2015-02-12

    Research is needed on what influences recruitment to smoking reduction trials, and how to increase their reach. The present study aimed to i) assess the feasibility of recruiting a disadvantaged population, ii) examine the effects of recruitment methods on participant characteristics, iii) identify resource requirements for different recruitment methods, and iv) to qualitatively assess the acceptability of recruitment. This was done as part of a pilot two-arm trial of the effectiveness of a novel behavioral support intervention focused on increasing physical activity and reducing smoking, among disadvantaged smokers not wishing to quit. Smokers were recruited through mailed invitations from three primary care practices (62 participants) and one National Health Stop Smoking Service (SSS) database (31 participants). Six other participants were recruited via a variety of other community-based approaches. Data were collected through questionnaires, field notes, work sampling, and databases. Chi-squared and t-tests were used to compare baseline characteristics of participants. We randomized between 5.1 and 11.1% of those invited through primary care and SSS, with associated researcher time to recruit one participant varying from 18 to 157 minutes depending on time and intensity invested.Only six participants were recruited through a wide variety of other community-based approaches, with an associated researcher time of 469 minutes to recruit one participant. Targets for recruiting a disadvantaged population were met, with 91% of the sample in social classes C2 to E (NRS social grades, UK), and 41% indicating mental health problems. Those recruited from SSS were more likely to respond to an initial letter, had used cessation aids before, and had attempted to quit in the past year. Overall, initial responders were more likely to be physically active than those who were recruited via follow-up telephone calls. No other demographics or behaviour characteristics were

  10. A randomized pilot trial comparing videoconference versus face-to-face delivery of behavior therapy for childhood tic disorders.

    Science.gov (United States)

    Himle, Michael B; Freitag, Malinda; Walther, Michael; Franklin, Shana A; Ely, Laura; Woods, Douglas W

    2012-09-01

    Comprehensive Behavioral Intervention for Tics (CBIT) has been shown to be effective for reducing tics in children with chronic tic disorder. Unfortunately, there remain significant barriers to dissemination. The aim of the current study was to examine the effectiveness of CBIT delivered over videoconference. Twenty children were randomly assigned to receive CBIT over videoconference or via traditional face-to-face delivery. Results show that both treatment delivery modalities resulted in significant tic reduction with no between group differences. Furthermore, acceptability and therapist-client alliance ratings were strong for both groups. Together, these results suggest that videoconference is a viable option for disseminating CBIT. Copyright © 2012 Elsevier Ltd. All rights reserved.

  11. 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

  12. Effects of online group exercises for older adults on physical, psychological and social wellbeing: a randomized pilot trial

    Directory of Open Access Journals (Sweden)

    Marcos Baez

    2017-04-01

    Social group. However, online social interactions have shown to be correlated to the decrease in loneliness in the Social group. Conclusion The results indicate that technology-supported online group-exercising which conceals individual differences in physical skills is effective in motivating and enabling individuals who are less fit to train as much as fitter individuals. This not only indicates the feasibility of training together despite differences in physical skills but also suggests that online exercise might reduce the effect of skills on adherence in a social context. However, results from this pilot are limited to a small sample size and therefore are not conclusive. Longer term interventions with more participants are instead recommended to assess impacts on wellbeing and behavior change.

  13. Effects of online group exercises for older adults on physical, psychological and social wellbeing: a randomized pilot trial.

    Science.gov (United States)

    Baez, Marcos; Khaghani Far, Iman; Ibarra, Francisco; Ferron, Michela; Didino, Daniele; Casati, Fabio

    2017-01-01

    have shown to be correlated to the decrease in loneliness in the Social group. The results indicate that technology-supported online group-exercising which conceals individual differences in physical skills is effective in motivating and enabling individuals who are less fit to train as much as fitter individuals. This not only indicates the feasibility of training together despite differences in physical skills but also suggests that online exercise might reduce the effect of skills on adherence in a social context. However, results from this pilot are limited to a small sample size and therefore are not conclusive. Longer term interventions with more participants are instead recommended to assess impacts on wellbeing and behavior change.

  14. The effect of autogenic training on salivary immunoglobulin A in surgical patients with breast cancer: a randomized pilot trial.

    Science.gov (United States)

    Minowa, Chika; Koitabashi, Kikuyo

    2014-11-01

    Psychological stress among breast cancer patients can inhibit immune function and contribute to disease progression. We investigated the effects of autogenic training (AT), a relaxation method for reducing stress, on salivary immunoglobulin A (sIgA) in breast cancer surgery patients. Thirty patients scheduled to undergo breast cancer surgery were randomly assigned to an AT or control group (usual care). Patients in the AT group underwent training for 7 days after surgery. Salivary IgA and heart rate variability were assessed on the day before surgery, and on the third and seventh postoperative days. Levels of sIgA were significantly higher on the seventh postoperative day in the AT group (n = 7) compared to the control group (n = 7) (p = 0.049). These findings suggest that AT may improve immune function in breast surgery patients. Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. Development of an Exergame to Deliver a Sustained Dose of High-Intensity Training: Formative Pilot Randomized Trial.

    Science.gov (United States)

    McBain, Thomas; Weston, Matthew; Crawshaw, Paul; Haighton, Catherine; Spears, Iain

    2018-03-27

    Sport science can play a critical role in reducing health inequalities. The inverse relationship between life expectancy, cardiorespiratory fitness, and socioeconomic status could be addressed by performing high-intensity training (HIT), delivered in a class salient and accessible approach. Commercially available exergames have shown encouraging compliance rates but are primarily designed for entertainment purposes rather than focusing on health-related outcomes. A serious game tailored toward delivering an exercise stimulus, while reducing the aversive protocols associated with HIT, could be beneficial to engage and improve health outcomes in socially deprived males. The aims of this study were to develop an exergame capable of delivering HIT and evaluate the effect on selected health outcomes in men recruited in regions of socioeconomic deprivation. We conducted an exploratory trial in our target population, and participants were allocated to intervention (n=14) or control groups (n=10) by third-party minimization. The intervention was a 6-week training program consisting of three sessions of exergaming per week. The sessions involved a structured warm-up, then brief intermittent repetitions in the form of boxing rounds (10 s, 20 s, and 30 s) against their peers with a work/rest ratio of 0.25. Retention to the intervention was 87.5% (21/24). Over the duration of the intervention, session attendance was 67.5% (170/252); repetition mean and peak heart rates (% of maximal) and session ratings of perceived exertion (AU, arbitrary units) were 86.3 (5.4%), 89.9 (6.1%), and 7.5 (2.2 AU), respectively. The effect of the intervention, when compared with the control, was a likely small beneficial improvement in predicted maximum oxygen consumption (VO 2 max, 3.0; 90% confidence limits ±2.6%). Effects on body mass, waist circumference, and blood pressure were either trivial or unclear. Over the 6-week intervention, the exergame delivered a consistent and sustained dose of

  16. Feasibility and acceptability of a nursing intervention with family caregiver on self-care among heart failure patients: a randomized pilot trial.

    Science.gov (United States)

    Cossette, Sylvie; Belaid, Hayet; Heppell, Sonia; Mailhot, Tanya; Guertin, Marie-Claude

    2016-01-01

    Self-care practices in heart failure (HF) contribute to quality of life, symptom stabilization, and extended life expectancy. However, adherence to practices such as liquid and salt restriction or symptom monitoring require high motivation on a daily basis. The aim was to assess the feasibility, acceptability, and potential effectiveness of a nursing intervention with family caregivers, aimed at improving self-care practice of HF patients. This pilot study involved 32 HF patient-caregiver dyads (16/group) randomized to an experimental (EG) or control group (CG). The intervention, based on the Self-Determination Theory, was designed to enhance patients' autonomy and motivation in self-care practices, by involving their caregivers' support. Five encounters were planned with the EG dyads-two face-to-face during hospitalization and three by telephone after discharge. The feasibility of delivering the protocol was evaluated as well as the acceptability of the intervention. The potential effectiveness of the intervention was assessed based on patient outcomes, including general self-care management and self-care specific to HF, perceived competence to manage HF, autonomous motivation (A-motivation, external extrinsic motivation, internal extrinsic motivation, and intrinsic motivation), and perceived support from the caregiver. Caregiver outcomes included level of support provided to the patient. Despite recruitment challenges, the intervention was feasible, with 12 of the 16 dyads receiving all 5 encounters delivered per protocol. The 4 other dyads received the two hospital encounters, but at least 1 of the 3 post-discharge planned telephone encounters was not feasible because the patients had been re-hospitalized or was deceased. Participant's satisfaction with the intervention was high. Outcomes favoring the EG include self-care specific to HF, internal extrinsic motivation, intrinsic motivation, and caregiver's feeling that they provide a higher level of support

  17. An alcohol-focused intervention versus a healthy living intervention for problem drinkers identified in a general hospital setting (ADAPTA): study protocol for a randomized, controlled pilot trial.

    Science.gov (United States)

    Watson, Judith; Tober, Gillian; Raistrick, Duncan; Mdege, Noreen; Dale, Veronica; Crosby, Helen; Godfrey, Christine; Lloyd, Charlie; Toner, Paul; Parrott, Steve

    2013-04-30

    Alcohol misuse is a major cause of premature mortality and ill health. Although there is a high prevalence of alcohol problems among patients presenting to general hospital, many of these people are not help seekers and do not engage in specialist treatment. Hospital admission is an opportunity to steer people towards specialist treatment, which can reduce health-care utilization and costs to the public sector and produce substantial individual health and social benefits. Alcohol misuse is associated with other lifestyle problems, which are amenable to intervention. It has been suggested that the development of a healthy or balanced lifestyle is potentially beneficial for reducing or abstaining from alcohol use, and relapse prevention. The aim of the study is to test whether or not the offer of a choice of health-related lifestyle interventions is more acceptable, and therefore able to engage more problem drinkers in treatment, than an alcohol-focused intervention. This is a pragmatic, randomized, controlled, open pilot study in a UK general hospital setting with concurrent economic evaluation and a qualitative component. Potential participants are those admitted to hospital with a diagnosis likely to be responsive to addiction interventions who score equal to or more than 16 on the Alcohol Use Disorders Identification Test (AUDIT). The main purpose of this pilot study is to evaluate the acceptability of two sorts of interventions (healthy living related versus alcohol focused) to the participants and to assess the components and processes of the design. Qualitative research will be undertaken to explore acceptability and the impact of the approach, assessment, recruitment and intervention on trial participants and non-participants. The effectiveness of the two treatments will be compared at 6 months using AUDIT scores as the primary outcome measure. There will be additional economic, qualitative and secondary outcome measurements. Development of the study was a

  18. Effectiveness of the Virtual Reality System Toyra on Upper Limb Function in People with Tetraplegia: A Pilot Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    I. Dimbwadyo-Terrer

    2016-01-01

    Full Text Available The aim of this study was to investigate the effects of a virtual reality program combined with conventional therapy in upper limb function in people with tetraplegia and to provide data about patients’ satisfaction with the virtual reality system. Thirty-one people with subacute complete cervical tetraplegia participated in the study. Experimental group received 15 sessions with Toyra® virtual reality system for 5 weeks, 30 minutes/day, 3 days/week in addition to conventional therapy, while control group only received conventional therapy. All patients were assessed at baseline, after intervention, and at three-month follow-up with a battery of clinical, functional, and satisfaction scales. Control group showed significant improvements in the manual muscle test (p = 0,043, partial η2 = 0,22 in the follow-up evaluation. Both groups demonstrated clinical, but nonsignificant, changes to their arm function in 4 of the 5 scales used. All patients showed a high level of satisfaction with the virtual reality system. This study showed that virtual reality added to conventional therapy produces similar results in upper limb function compared to only conventional therapy. Moreover, the gaming aspects incorporated in conventional rehabilitation appear to produce high motivation during execution of the assigned tasks. This trial is registered with EudraCT number 2015-002157-35.

  19. Effectiveness of the Virtual Reality System Toyra on Upper Limb Function in People with Tetraplegia: A Pilot Randomized Clinical Trial.

    Science.gov (United States)

    Dimbwadyo-Terrer, I; Gil-Agudo, A; Segura-Fragoso, A; de los Reyes-Guzmán, A; Trincado-Alonso, F; Piazza, S; Polonio-López, B

    2016-01-01

    The aim of this study was to investigate the effects of a virtual reality program combined with conventional therapy in upper limb function in people with tetraplegia and to provide data about patients' satisfaction with the virtual reality system. Thirty-one people with subacute complete cervical tetraplegia participated in the study. Experimental group received 15 sessions with Toyra(®) virtual reality system for 5 weeks, 30 minutes/day, 3 days/week in addition to conventional therapy, while control group only received conventional therapy. All patients were assessed at baseline, after intervention, and at three-month follow-up with a battery of clinical, functional, and satisfaction scales. Control group showed significant improvements in the manual muscle test (p = 0,043, partial η (2) = 0,22) in the follow-up evaluation. Both groups demonstrated clinical, but nonsignificant, changes to their arm function in 4 of the 5 scales used. All patients showed a high level of satisfaction with the virtual reality system. This study showed that virtual reality added to conventional therapy produces similar results in upper limb function compared to only conventional therapy. Moreover, the gaming aspects incorporated in conventional rehabilitation appear to produce high motivation during execution of the assigned tasks. This trial is registered with EudraCT number 2015-002157-35.

  20. 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

  1. Parahippocampectomy as a New Surgical Approach to Mesial Temporal Lobe Epilepsy Caused By Hippocampal Sclerosis: A Pilot Randomized Comparative Clinical Trial.

    Science.gov (United States)

    Alonso-Vanegas, Mario Arturo; Freire Carlier, Iván D; San-Juan, Daniel; Martínez, Alma Rosa; Trenado, Carlos

    2018-02-01

    The parahippocampal gyrus plays an important role in the epileptogenic pathways of mesial temporal lobe epilepsy caused by hippocampal sclerosis (mTLE-HS); its resection could prevent epileptic seizures with fewer complications. This study evaluates the initial efficacy and safety of anterior temporal lobectomy (ATL), selective amygdalohipppocampectomy (SAH), and parahippocampectomy (PHC) surgical approaches in mTLE-HS. A randomized comparative pilot clinical trial (2008-2011) was performed that included patients with mTLE-HS who underwent ATL, trans-T3 SAH, and trans-T3 PHC. Their sociodemographic characteristics, visual field profiles, verbal and visual memory profiles, and Engel scale outcome at baseline and at 1 and 5 years are described, using descriptive statistics along with parametric and nonparametric tests. Forty-three patients with a mean age of 35.2 years (18-56 years), 65% female, were analyzed: 14 underwent PHC, 14 ATL, and 15 SAH. The following percentages refer to those patients who were seizure free (Engel class IA) at 1-year and 5-year follow-up, respectively: 42.9% PHC, 71.4% ATL, and 60% SAH (P = 0.304); 28.6% PHC, 50% ATL, and 53.3% SAH (P = 0.353). Postoperative visual field deficits were 0% PHC, 85.7% ATL, and 46.7% SAH (P = 0.001). Verbal and/or visual memory worsening were present in 21.3% PHC, 42.8% ATL, and 33.4% SAH (P = 0.488) and preoperative and postoperative visual memory scores were significantly different in the SAH group only (P = 0.046). PHC, ALT, and SAH show a preliminary similar efficacy in short-term seizure-free rates in patients with mTLE-HS. However, PHC efficacy in the long-term decreases compared with the other surgical techniques. PHC does not produce postoperative visual field deficits. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. A randomized waitlist-controlled pilot trial of voice over Internet protocol-delivered behavior therapy for youth with chronic tic disorders.

    Science.gov (United States)

    Ricketts, Emily J; Goetz, Amy R; Capriotti, Matthew R; Bauer, Christopher C; Brei, Natalie G; Himle, Michael B; Espil, Flint M; Snorrason, Ívar; Ran, Dagong; Woods, Douglas W

    2016-04-01

    Comprehensive Behavioral Intervention for Tics (CBIT) has been shown to be efficacious for chronic tic disorders (CTDs), but utilization is limited by a lack of treatment providers and perceived financial and time burden of commuting to treatment. A promising alternative to in-person delivery is voice over Internet protocol (VoIP), allowing for remote, real-time treatment delivery to patients' homes. However, little is known about the effectiveness of VoIP for CTDs. Therefore, the present study examined the preliminary efficacy, feasibility, and acceptability of VoIP-delivered CBIT (CBIT-VoIP). Twenty youth (8-16 years) with CTDs participated in a randomized, waitlist-controlled pilot trial of CBIT-VoIP. The main outcome was pre- to post-treatment change in clinician-rated tic severity (Yale Global Tic Severity Scale). The secondary outcome was clinical responder rate (Clinical Global Impressions - Improvement Scale), assessed using ratings of 'very much improved' or 'much improved' indicating positive treatment response. Intention-to-treat analyses with the last observation carried forward were performed. At post-treatment (10-weeks), significantly greater reductions in clinician-rated, (F(1,18) = 3.05, p tic severity, (F(1,18) = 6.37, p < 0.05, partial η(2 )= 0.26) were found in CBIT-VoIP relative to waitlist. One-third (n = 4) of those in CBIT-VoIP were considered treatment responders. Treatment satisfaction and therapeutic alliance were high. CBIT can be delivered via VoIP with high patient satisfaction, using accessible, low-cost equipment. CBIT-VoIP was generally feasible to implement, with some audio and visual challenges. Modifications to enhance treatment delivery are suggested. © The Author(s) 2015.

  3. PPAR-gamma agonist pioglitazone modifies craving intensity and brain white matter integrity in patients with primary cocaine use disorder: a double-blind randomized controlled pilot trial.

    Science.gov (United States)

    Schmitz, Joy M; Green, Charles E; Hasan, Khader M; Vincent, Jessica; Suchting, Robert; Weaver, Michael F; Moeller, F Gerard; Narayana, Ponnada A; Cunningham, Kathryn A; Dineley, Kelly T; Lane, Scott D

    2017-10-01

    Pioglitazone (PIO), a potent agonist of PPAR-gamma, is a promising candidate treatment for cocaine use disorder (CUD). We tested the effects of PIO on targeted mechanisms relevant to CUD: cocaine craving and brain white matter (WM) integrity. Feasibility, medication compliance and tolerability were evaluated. Two-arm double-blind randomized controlled proof-of-concept pilot trial of PIO or placebo (PLC). Single-site out-patient treatment research clinic in Houston, TX, USA. Thirty treatment-seeking adults, 18 to 60 years old, with CUD. Eighteen participants (8 = PIO; 10 = PLC) completed diffusion tensor imaging (DTI) of WM integrity at pre-/post-treatment. Study medication was dispensed at thrice weekly visits along with once-weekly cognitive behavioral therapy for 12 weeks. Measures of target engagement mechanisms of interest included cocaine craving assessed by the Brief Substance Craving Scale (BSCS), the Obsessive Compulsive Drug Use Scale (OCDUS), a visual analog scale (VAS) and change in WM integrity. Feasibility measures included number completing treatment, medication compliance (riboflavin detection) and tolerability (side effects, serious adverse events). Target engagement change in mechanisms of interest, defined as a ≥ 0.75 Bayesian posterior probability of an interaction existing favoring PIO over PLC, was demonstrated on measures of craving (BSCS, VAS) and WM integrity indexed by fractional anisotropy (FA) values. Outcomes indicated greater decrease in craving and greater increase in FA values in the PIO group. Feasibility was demonstrated by high completion rates among those starting treatment (21/26 = 80%) and medication compliance (≥ 80%). There were no reported serious adverse events for PIO. Compared with placebo, patients receiving pioglitazone show a higher likelihood of reduced cocaine craving and improved brain white matter integrity as a function of time in treatment. Pioglitazone shows good feasibility as a treatment for cocaine

  4. Effects of Flipped Learning Using Online Materials in a Surgical Nursing Practicum: A Pilot Stratified Group-Randomized Trial.

    Science.gov (United States)

    Lee, Myung Kyung; Park, Bu Kyung

    2018-01-01

    This study examined the effect of flipped learning in comparison to traditional learning in a surgical nursing practicum. The subjects of this study were 102 nursing students in their third year of university who were scheduled to complete a clinical nursing practicum in an operating room or surgical unit. Participants were randomly assigned to either a flipped learning group (n = 51) or a traditional learning group (n = 51) for the 1-week, 45-hour clinical nursing practicum. The flipped-learning group completed independent e-learning lessons on surgical nursing and received a brief orientation prior to the commencement of the practicum, while the traditional-learning group received a face-to-face orientation and on-site instruction. After the completion of the practicum, both groups completed a case study and a conference. The student's self-efficacy, self-leadership, and problem-solving skills in clinical practice were measured both before and after the one-week surgical nursing practicum. Participants' independent goal setting and evaluation of beliefs and assumptions for the subscales of self-leadership and problem-solving skills were compared for the flipped learning group and the traditional learning group. The results showed greater improvement on these indicators for the flipped learning group in comparison to the traditional learning group. The flipped learning method might offer more effective e-learning opportunities in terms of self-leadership and problem-solving than the traditional learning method in surgical nursing practicums.

  5. 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.

  6. Impact of sleep deprivation on anaesthesia residents' non-technical skills: a pilot simulation-based prospective randomized trial.

    Science.gov (United States)

    Neuschwander, A; Job, A; Younes, A; Mignon, A; Delgoulet, C; Cabon, P; Mantz, J; Tesniere, A

    2017-07-01

    Sleep deprivation is common in anaesthesia residents, but its impact on performance remains uncertain. Non-technical skills (team working, situation awareness, decision making, and task management) are key components of quality of care in anaesthesia, particularly in crisis situations occurring in the operating room. The impact of sleep deprivation on non-technical skills is unknown. We tested the hypothesis that in anaesthesia residents sleep deprivation is associated with impaired non-technical skills. Twenty anaesthesia residents were randomly allocated to undergo a simulation session after a night shift [sleep-deprived (SLD) group, n =10] or after a night of rest [rested (R) group, n =10] from January to March 2015. The simulated scenario was a situation of crisis management in the operating room. The primary end point was a composite score of anaesthetists' non-technical skills (ANTS) assessed by two blinded evaluators. Non-technical skills were significantly impaired in the SLD group [ANTS score 12.2 (interquartile range 10.5-13)] compared with the R group [14.5 (14-15), P technical skills of anaesthesia residents in a simulated anaesthesia intraoperative crisis scenario. NCT02622217. © The Author 2017. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  7. Development and Pilot Randomized Control Trial of a Drama Program to Enhance Well-being Among Older Adults.

    Science.gov (United States)

    Moore, Raeanne C; Straus, Elizabeth; Dev, Sheena I; Parish, Steven M; Sueko, Seema; Eyler, Lisa T

    2017-02-01

    Develop a novel theatre-based program and test its feasibility, tolerability, and preliminary efficacy for improving empathy/compassion and well-being among older adults. Thirteen older adults were randomized to a 6-week Drama Workshop (DW) program or time-equivalent Backstage Pass (BP) control condition. Pre- and post-treatment measures included empathy, compassion, and mood scales. Additional post-treatment measures included self-rated change in empathy/compassion, confidence, and affect. Participants also rated their mood/affect after each session. The program was successfully completed and well-liked. No pre-to-post-treatment changes in empathy/compassion or mood symptoms were found in either group. Compared to BP, DW weekly ratings indicated higher levels of anxiety and lower happiness; however, the DW program had higher self-ratings of positive change in self-esteem, confidence, and happiness post-treatment. While the DW may not promote empathy/compassion and was personally challenging during the program, engagement in dramatic exercises and rehearsing and performing a dramatic piece was seen by participants as a positive growth experience, as indicated by the post-treatment ratings of enhanced self-esteem, confidence and happiness. Thus, such a program might be useful for counteracting some of the potential negative aspects of aging, including reduced self-efficacy due to physical limitations and negative affect due to losses.

  8. Cognitive and motor dual task gait training improve dual task gait performance after stroke - A randomized controlled pilot trial.

    Science.gov (United States)

    Liu, Yan-Ci; Yang, Yea-Ru; Tsai, Yun-An; Wang, Ray-Yau

    2017-06-22

    This study investigated effects of cognitive and motor dual task gait training on dual task gait performance in stroke. Participants (n = 28) were randomly assigned to cognitive dual task gait training (CDTT), motor dual task gait training (MDTT), or conventional physical therapy (CPT) group. Participants in CDTT or MDTT group practiced the cognitive or motor tasks respectively during walking. Participants in CPT group received strengthening, balance, and gait training. The intervention was 30 min/session, 3 sessions/week for 4 weeks. Three test conditions to evaluate the training effects were single walking, walking while performing cognitive task (serial subtraction), and walking while performing motor task (tray-carrying). Parameters included gait speed, dual task cost of gait speed (DTC-speed), cadence, stride time, and stride length. After CDTT, cognitive-motor dual task gait performance (stride length and DTC-speed) was improved (p = 0.021; p = 0.015). After MDTT, motor dual task gait performance (gait speed, stride length, and DTC-speed) was improved (p = 0.008; p = 0.008; p = 0.008 respectively). It seems that CDTT improved cognitive dual task gait performance and MDTT improved motor dual task gait performance although such improvements did not reach significant group difference. Therefore, different types of dual task gait training can be adopted to enhance different dual task gait performance in stroke.

  9. A pilot randomized control trial to evaluate pelvic floor muscle training for urinary incontinence among gynecologic cancer survivors.

    Science.gov (United States)

    Rutledge, Teresa L; Rogers, Rebecca; Lee, Sang-Joon; Muller, Carolyn Y

    2014-01-01

    We previously reported high rates of urinary incontinence among gynecologic cancer survivors and aimed to evaluate the effectiveness of a simple intervention for treatment of urinary incontinence in this population. We recruited 40 gynecologic cancer survivors who reported urinary incontinence on a validated questionnaire. Women were randomized to either pelvic floor muscle training/behavioral therapy (treatment group) or usual care (control group). The primary outcome measure, assessed at 12 weeks post intervention, was a 40% difference in the validated Patient Global Impression of Improvement (PGI-I) score. Fisher's exact test was used to identify differences between groups for frequency data; two-sample t-test was conducted for continuous measurements. Mean age of this cohort was 57 (range: 37-79). The majority of the survivors had uterine cancer (60%), 18% had received radiation therapy, 95% had received surgical therapy, and 35% had received chemotherapy. At three months, 80% of the treatment and 40% of the control group reported that their urinary incontinence was "much better" or "very much better" as evaluated by the Patient Global Impression of Improvement scale (p=0.02). Brink's scores were significantly improved in the treatment group as compared to those of the controls (pgynecologic cancer survivors, it is often under-assessed and undertreated. We found a simple intervention that included pelvic floor muscle training and behavioral therapy, which significantly improved cancer survivor's urinary incontinence. © 2013.

  10. Assessing the National Cancer Institute's SmokefreeMOM Text-Messaging Program for Pregnant Smokers: Pilot Randomized Trial.

    Science.gov (United States)

    Abroms, Lorien C; Chiang, Shawn; Macherelli, Laura; Leavitt, Leah; Montgomery, Margaret

    2017-10-03

    Automated text messages on mobile phones have been found to be effective for smoking cessation in adult smokers. This study aims to test the acceptability and feasibility of SmokefreeMOM, a national smoking cessation text-messaging program for pregnant smokers. Participants were recruited from prenatal care and randomized to receive SmokefreeMOM (n=55), an automated smoking cessation text-messaging program, or a control text message quitline referral (n=44). Participants were surveyed by phone at baseline and at 1 month and 3 months after enrollment. Results indicate that the SmokefreeMOM program was highly rated overall and rated more favorably than the control condition in its helpfulness at 3-month follow-up (Pmessaging at both 1-month and 3-month follow-ups (Pmessages, and few participants unsubscribed from the program. There were no significant differences between groups on the use of extra treatment resources or on smoking-related outcomes. However, at the 3-month follow-up, some outcomes favored the intervention group. SmokefreeMOM is acceptable for pregnant smokers. It is recommended that SmokefreeMOM be further refined and evaluated. Clinicaltrials.gov NCT02412956; https://clinicaltrials.gov/ct2/show/NCT02412956 (Archived by WebCite at http://www.webcitation.org/6tcmeRnbC). ©Lorien C Abroms, Shawn Chiang, Laura Macherelli, Leah Leavitt, Margaret Montgomery. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 03.10.2017.

  11. Core stabilization exercise with real-time feedback for chronic hemiparetic stroke: a pilot randomized controlled trials.

    Science.gov (United States)

    Chung, Eunjung; Lee, Byoung-Hee; Hwang, Sujin

    2014-01-01

    The purpose of this study was to examine the feasibility of core stabilization exercise with real-time feedback on balance and gait function in patients with chronic hemiparetic stroke. Nineteen stroke subjects were enrolled in this study. The patients were randomly divided into the experimental (n = 10) and control groups (n = 9). Subjects in the experimental group performed core stabilization exercise with real-time feedback training for 30 minutes per day during a period of six weeks. Subjects in the control group performed core stabilization exercise during the same period. This study assessed the kinematic parameters using a portable walkway system, and timed up-and-go test. Gait velocity showed significantly greater improvement in the experimental group (7.3 ± 5.0 sec) than in the control group (-0.7 ± 10.6). Stride length showed significantly greater increase in the experimental group (13.2 ± 7.9 on the affected side and 12.6 ± 8.0 on the less affected side) than the control group (3.5 ± 8.7 on the affected side and 3.4 ± 8.5 on the less affected side). After training, change in results on the timed up and go test was significantly greater in the experimental group than in the control group. Core stabilization exercise using real-time feedback produces greater improvement in gait performance in chronic hemiparetic stroke patients than core stabilization exercise only.

  12. [DONG's extraordinary acupoints for the ovarian function of polycystic ovary syndrome:a randomized controlled pilot trial].

    Science.gov (United States)

    Cao, Yu; Zhang, Li; Zhao, Danyang; Liu, Zhishun

    2017-07-12

    To preliminary assess the efficacy of DONG 's extraordinary acupoints for the ovarian function of polycystic ovary syndrome. Fifty-six patients were randomized into an acupuncture group and a western medication group. In the acupuncture group, the acupoints were Fuke, Huanchao, Tianhuang (Yinlingquan, SP 9), Renhuang (Sanyinjiao, SP 6), Guanyuan (CV 4), Zigong (EX-CA 1). The treatment was used twice a week for continuous 12 weeks. In the western medication group, patients were given diane-35 for 3 menstrual cycles, once a day for 21 days with 7 days between the two sessions. The ratio of luteinizing hormone/flitropin (LH/FSH) was taken as the primary index, while the secondary indices were serum testosterone (T), FSH, LH, body mass index (BMI), the condition of ovary and menstruation. ①After treatment, the ratio of LH/FSH declined in both the two groups ( P 0.05). ②T, LH and BMI dropped in the two groups ( P 0.05). ③The size of ovary did not change significantly after treatment in the two groups (both P >0.05), but the reduction degree of ovary size of the acupuncture group was larger than that of the western medication group ( P ovary number of more than 10 foliiculi in single ovary in the acupuncture group reduced compared with that before treatment ( P ovary number with the above feature was not significantly different between the two groups ( P >0.05). ④The times and days of menstruation within 3 months increased significantly in the two groups (all P 0.05). DONG 's extraordinary acupoints could improve the ovarian function of polycystic ovary syndrome, whose effect is similar as diane-35.

  13. 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.

  14. Effects of interactive metronome therapy on cognitive functioning after blast-related brain injury: a randomized controlled pilot trial.

    Science.gov (United States)

    Nelson, Lonnie A; Macdonald, Margaret; Stall, Christina; Pazdan, Renee

    2013-11-01

    We report preliminary findings on the efficacy of interactive metronome (IM) therapy for the remediation of cognitive difficulties in soldiers with persisting cognitive complaints following blast-related mild-to-moderate traumatic brain injury (TBI). Forty-six of a planned sample of 50 active duty soldiers with persistent cognitive complaints following a documented history of blast-related TBI of mild-to-moderate severity were randomly assigned to receive either standard rehabilitation care (SRC) or SRC plus a 15-session standardized course of IM therapy. Primary outcome measures were Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Index Scores. Secondary outcome measures included selected subtests from the Delis-Kaplan Executive Functioning System (Trail Making Test and Color-Word Interference) and the Wechsler Adult Intelligence Scale-Fourth Edition (Symbol Search, Digit-Symbol Coding, Digit Span, and Letter-Number Sequencing) as well as the Integrated Visual and Auditory Continuous Performance Test. Significant group differences (SRC vs. IM) were observed for RBANS Attention (p = .044), Immediate Memory (p = .019), and Delayed Memory (p = .031) indices in unadjusted analyses, with the IM group showing significantly greater improvement at Time 2 than the SRC group, with effect sizes in the medium-to-large range in the adjusted analyses for each outcome (Cohen's d = 0.511, 0.768, and 0.527, respectively). Though not all were statistically significant, effects in 21 of 26 cognitive outcome measures were consistently in favor of the IM treatment group (binomial probability = .00098). The addition of IM therapy to SRC appears to have a positive effect on neuropsychological outcomes for soldiers who have sustained mild-to-moderate TBI and have persistent cognitive complaints after the period for expected recovery has passed. PsycINFO Database Record (c) 2013 APA, all rights reserved.

  15. The effects of video-game training on broad cognitive transfer in multiple sclerosis: A pilot randomized controlled trial.

    Science.gov (United States)

    Janssen, Alisha; Boster, Aaron; Lee, HyunKyu; Patterson, Beth; Prakash, Ruchika Shaurya

    2015-01-01

    Multiple sclerosis (MS) is a neurodegenerative disease of the central nervous system that results in diffuse nerve damage and associated physical and cognitive impairments. Of the few comprehensive rehabilitation options that exist for populations with lower baseline cognitive functioning, those that have been successful at eliciting broad cognitive improvements have focused on a multimodal training approach, emphasizing complex cognitive processing that utilizes multiple domains simultaneously. The current study sought to determine the feasibility of an 8-week, hybrid-variable priority training (HVT) program, with a secondary aim to assess the success of this training paradigm at eliciting broad cognitive transfer effects. Capitalizing on the multimodal training modalities offered by the Space Fortress platform, we compared the HVT strategy-based intervention with a waitlist control group, to primarily assess skill acquisition and secondarily determine presence of cognitive transfer. Twenty-eight participants met inclusionary criteria for the study and were randomized to either training or waitlist control groups. To assess broad transfer effects, a battery of neuropsychological tests was administered pre- and post-intervention. The results indicated an overall improvement in skill acquisition and evidence for the feasibility of the intervention, but a lack of broad transfer to tasks of cognitive functioning. Participants in the training group, however, did show improvements on a measure of spatial short-term memory. The current investigation provided support for the feasibility of a multimodal training approach, using the HVT strategy, within the MS population, but lacked broad transfer to multiple domains of cognitive functioning. Future improvements to obtain greater cognitive transfer efficacy would include a larger sample size, a longer course of training to evoke greater game score improvement, the inclusion of only cognitively impaired individuals, and

  16. Effects of dance on motor functions, cognitive functions, and mental symptoms of Parkinson's disease: a quasi-randomized pilot trial.

    Science.gov (United States)

    Hashimoto, Hiroko; Takabatake, Shinichi; Miyaguchi, Hideki; Nakanishi, Hajime; Naitou, Yasuo

    2015-04-01

    To examine the effectiveness of dance on motor functions, cognitive functions, and mental symptoms of Parkinson's disease (PD). This study employed a quasi-randomised, between-group design. Dance, PD exercise, and all assessments were performed in community halls in different regions of Japan. Forty-six mild-moderate PD patients participated. Six PD patient associations that agreed to participate in the study were randomly assigned to a dance group, PD exercise group, or non-intervention group. The dance and PD exercise groups performed one 60-min session per week for 12 weeks. Control group patients continued with their normal lives. All groups were assessed before and after the intervention. We used the Timed Up-and-Go Test (TUG) and Berg Balance Scale (BBS) to assess motor function, the Frontal Assessment Battery at bedside (FAB) and Mental Rotation Task (MRT) to assess cognitive function, and the Apathy Scale (AS) and Self-rating Depression Scale (SDS) to assess mental symptoms of PD. The Unified Parkinson's Disease Rating Scale (UPDRS) was used for general assessment of PD. When comparing results before and after intervention, the dance group showed a large effect in TUG time (ES=0.65, p=0.006), TUG step number (ES=0.66, p=0.005), BBS (ES=0.75, p=0.001), FAB (ES=0.77, p=0.001), MRT response time (ES=0.79, pmental symptoms in PD patients. General symptoms in PD also improved. Dance is an effective method for rehabilitation in PD patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Repetitive transcranial magnetic stimulation in cervical dystonia: effect of site and repetition in a randomized pilot trial.

    Directory of Open Access Journals (Sweden)

    Sarah Pirio Richardson

    Full Text Available Dystonia is characterized by abnormal posturing due to sustained muscle contraction, which leads to pain and significant disability. New therapeutic targets are needed in this disorder. The objective of this randomized, sham-controlled, blinded exploratory study is to identify a specific motor system target for non-invasive neuromodulation and to evaluate this target in terms of safety and tolerability in the cervical dystonia (CD population. Eight CD subjects were given 15-minute sessions of low-frequency (0.2 Hz repetitive transcranial magnetic stimulation (rTMS over the primary motor cortex (MC, dorsal premotor cortex (dPM, supplementary motor area (SMA, anterior cingulate cortex (ACC and a sham condition with each session separated by at least two days. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS score was rated in a blinded fashion immediately pre- and post-intervention. Secondary outcomes included physiology and tolerability ratings. The mean change in TWSTRS severity score by site was 0.25 ± 1.7 (ACC, -2.9 ± 3.4 (dPM, -3.0 ± 4.8 (MC, -0.5 ± 1.1 (SHAM, and -1.5 ± 3.2 (SMA with negative numbers indicating improvement in symptom control. TWSTRS scores decreased from Session 1 (15.1 ± 5.1 to Session 5 (11.0 ± 7.6. The treatment was tolerable and safe. Physiology data were acquired on 6 of 8 subjects and showed no change over time. These results suggest rTMS can modulate CD symptoms. Both dPM and MC are areas to be targeted in further rTMS studies. The improvement in TWSTRS scores over time with multiple rTMS sessions deserves further evaluation.

  18. A web-based training program using cognitive behavioral therapy to alleviate psychological distress among employees: randomized controlled pilot trial.

    Science.gov (United States)

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

    2014-12-02

    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. 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. 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. 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 initially exhibited clinically

  19. [Comparison of efficacy on functional constipation treated with electroacupuncture of different acupoint prescriptions: a randomized controlled pilot trial].

    Science.gov (United States)

    Wu, Jia-Ni; Zhang, Bi-Ying; Zhu, Wen-Zeng; Du, Ruo-Sang; Liu, Zhi-Shun

    2014-06-01

    To evaluate preliminarily the efficacy on functional constipation treated with electroacupuncture of different acupoint prescriptions. One hundred and four patients were randomized into a front-mu and back-shu points group (19 cases), a he-sea points group (34 cases), a he-sea, front-mu and back-shu points group (26 cases) and a western medication control group (25 cases). In the front-mu and back-shu points group, electroacupuncture was applied at bilateral Tianshu (ST 25) and Dachangshu (BL 25). In the he-sea points group, electroacupuncture was applied at bilateral Quchi (LI 11) and Shangjuxu (ST 37). In the he-sea, front-mu and back-shu points group, electroacupuncture was applied at unilateral Tianshu (ST 25), Dachangshu (BL 25), Quchi (LI 11) and Shangjuxu (ST 37). In the three groups above, the treatment was given 5 times a week in the first two weeks and 3 times a week in the next two weeks. In the western medication control group, mosapride citrate tablets were prescribed for oral administration, 1 table (5 mg) each time, 3 times a day, continuously for 4 weeks. The period of research was 9 weeks, including 1 week for baseline evaluation, 4 weeks for treatment and 4 weeks for follow-up. The weekly defecation frequency was taken as primary index, while the defecation difficulty and life quality score were taken as the secondary indices for the efficacy evaluation after treatment and in follow-up. According to the intention-to-treat (ITT) analytic principle, 104 cases were all enrolled in the final analysis. (1) After treatment, the weekly frequency of defecation was all increased significantly in the four groups (P electroacupuncture groups was similar to that of western medication control group (P > 0.05). In follow-up, the increasing effect on the weekly frequency of defecation was maintained in the he-sea points group (P 0.05). (2) After treatment, defecation difficulty was relieved in the he-sea points group, the he-sea, front-mu and back-shu points

  20. Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial

    Science.gov (United States)

    Chan, Ching Han Helen; Lai, Chi-Keung Jonah; Chan, Wai Fung Vivian; Wang, Man Ping; Li, Ho Cheung William; Chan, Sophia Siu Chee; Lam, Tai-Hing

    2015-01-01

    Background Quit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence. Objective Our aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently. Methods This was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days. Results Fewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators’ posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants’ posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant. Conclusions The intervention via the WhatsApp social group was effective in reducing

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

    Science.gov (United States)

    Lee, Tih-Shih; Quek, Shin Yi; Goh, Siau Juinn Alexa; Phillips, Rachel; Guan, Cuntai; Cheung, Yin Bun; Feng, Lei; Wang, Chuan Chu; Chin, Zheng Yang; Zhang, Haihong; Lee, Jimmy; Ng, Tze Pin; Krishnan, K Ranga Rama

    2015-01-01

    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. Thirty-nine elderly participants were randomized into intervention (n=21) and wait-list 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 about any adverse events experienced after each session as a safety measure. The training was deemed easily usable and acceptable by senior users. The median difference in the change scores pre- and post-training of the modified RBANS total score was 8.0 (95% confidence interval [CI]: 0.0-16.0, P=0.042) higher in the intervention arm than waitlist control, while the mean difference was 9.0 (95% CI: 1.7-16.2, P=0.017). Ten (30.3%) participants reported a total of 16 adverse events - all of which were graded "mild" except for one graded "moderate". Our BCI training system shows potential in improving cognition in both English- and Chinese-speaking elderly, and deserves further evaluation in a Phase III trial. Overall, participants

  2. An mHealth Pain Coping Skills Training Intervention for Hematopoietic Stem Cell Transplantation Patients: Development and Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Somers, Tamara J; Kelleher, Sarah A; Dorfman, Caroline S; Shelby, Rebecca A; Fisher, Hannah M; Rowe Nichols, Krista; Sullivan, Keith M; Chao, Nelson J; Samsa, Gregory P; Abernethy, Amy P; Keefe, Francis J

    2018-03-19

    Pain is a challenge for patients following hematopoietic stem cell transplantation (HCT). This study aimed to develop and test the feasibility, acceptability, and initial efficacy of a Web-based mobile pain coping skills training (mPCST) protocol designed to address the needs of HCT patients. Participants had undergone HCT and reported pain following transplant (N=68). To guide intervention development, qualitative data were collected from focus group participants (n=25) and participants who completed user testing (n=7). After their input was integrated into the mPCST intervention, a pilot randomized controlled trial (RCT, n=36) was conducted to examine the feasibility, acceptability, and initial efficacy of the intervention. Measures of acceptability, pain severity, pain disability, pain self-efficacy, fatigue, and physical disability (self-report and 2-min walk test [2MWT]) were collected. Participants in the focus groups and user testing provided qualitative data that were used to iteratively refine the mPCST protocol. Focus group qualitative data included participants' experiences with pain following transplant, perspectives on ways to cope with pain, and suggestions for pain management for other HCT patients. User testing participants provided feedback on the HCT protocol and information on the use of videoconferencing. The final version of the mPCST intervention was designed to bridge the intensive outpatient (1 in-person session) and home settings (5 videoconferencing sessions). A key component of the intervention was a website that provided personalized messages based on daily assessments of pain and activity. The website also provided intervention materials (ie, electronic handouts, short videos, and audio files). The intervention content included pain coping advice from other transplant patients and instructions on how to apply pain coping skills while engaging in meaningful and leisure activities. In the RCT phase of this research, HCT patients (n=36

  3. Providing patients with information about disease-modifying anti-rheumatic drugs: Individually or in groups? A pilot randomized controlled trial comparing adherence and satisfaction.

    Science.gov (United States)

    Homer, Dawn; Nightingale, Peter; Jobanputra, Paresh

    2009-06-01

    Communicating information about disease-modifying anti-rheumatic drugs (DMARDs) before patients start treatment is a key role for some rheumatology clinical nurse specialists. This is done in our unit to promote understanding of the risks and benefits of drug therapy and encourage timely and reliable use of DMARDs. Information is routinely provided individually but this can lead to delays in starting treatment because of limited nursing resources. In this randomized trial we tested the feasibility of giving patients, who were about to start on a DMARD, information about the drug in groups and compared this with information given individually. Adults with a clinical diagnosis of rheumatoid arthritis or psoriatic arthritis who were referred to the nursing team for counselling about starting on methotrexate, sulfasalazine or leflunomide were included. Patients who had previously taken a DMARD were not excluded and those consenting were randomized to receive drug information individually or in groups (of three to six patients). We provided all patients with written materials about the relevant drug and discussed the risks and benefits of drug use verbally. Patients allocated to group counselling received this intervention in a teaching room, with a slide presentation. The primary outcome was adherence with medication use, ascertained by pill counts, self-report diaries and prescription dispensation. Secondary outcomes included satisfaction with information about medicines (SIMS) by questionnaire; time taken to provide information; adherence to scheduled hospital appointments and blood monitoring schedules; and DMARD continuation rates at four and twelve months. Of 127 eligible patients referred for counselling about DMARDs, 62 consented to take part: 32 were randomized to receive drug information individually and 30 to receiving it in groups. Patients allocated to the two different interventions were comparable for age and diagnoses at baseline but more patients

  4. Dose-ranging pilot randomized trial of amino acid mixture combined with physical activity promotion for reducing abdominal fat in overweight adults

    Directory of Open Access Journals (Sweden)

    Sasai H

    2017-07-01

    Full Text Available Hiroyuki Sasai,1–3,* Keisuke Ueda,4,5,* Takehiko Tsujimoto,6,7 Hiroyuki Kobayashi,1 Chiaki Sanbongi,4 Shuji Ikegami,4 Yoshio Nakata1 1Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, 2Japan Society for the Promotion of Science, Chiyoda, Tokyo, 3Department of Life Sciences, Graduate School of Arts and Sciences, The University of Tokyo, Meguro, Tokyo, 4Food Science Research Laboratories, Meiji Co., Ltd., Odawara, Kanagawa, 5Graduate School of Comprehensive Human Sciences, 6Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Ibaraki, 7Faculty of Human Sciences, Shimane University, Matsue, Shimane, Japan *These authors contributed equally to this work Objective: The objective of this study was to determine the effective dose of an amino acid mixture comprising arginine, alanine, and phenylalanine combined with physical activity promotion in reducing abdominal fat among overweight adults.Methods: A 12-week randomized, double-blind, placebo-controlled, dose-ranging, pilot trial was conducted in Mito, Japan, from January through April 2016, and the data were analyzed from May through November 2016. The study participants were 35 overweight adults, aged 20–64 years, with no regular exercise habit. Participants were randomly assigned to high-dose (3,000 mg/d, n=9, medium-dose (1,500 mg/d, n=9, low-dose (750 mg/d, n=8, or placebo (0 mg/d, n=9 groups, and the test beverage containing the amino acid mixture or placebo was administered for 12 weeks. All participants maintained a physically active lifestyle during the study period through monthly physical activity promotion sessions and smartphone-based self-monitoring with wearable trackers. Primary outcomes were changes in abdominal total, subcutaneous, and visceral fat areas, assessed by computed tomography.Results: Of the 35 enrolled participants, 32 completed the 12-week follow-up visit. The intention-to-treat analysis revealed that the changes in abdominal total fat

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

    OpenAIRE

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

    2017-01-01

    Background 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. Methods A randomized pilot study with participant blinding was conducted. Feasibility outcomes included recruitment and compliance rate....

  6. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  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. The effect of balance training on postural control in people with multiple sclerosis using the CAREN virtual reality system: a pilot randomized controlled trial.

    Science.gov (United States)

    Kalron, Alon; Fonkatz, Ilia; Frid, Lior; Baransi, Hani; Achiron, Anat

    2016-03-01

    Multiple sclerosis (MS) is a multi-focal progressive disorder of the central nervous system often resulting in diverse clinical manifestations. Imbalance appears in most people with multiple sclerosis (PwMS). A popular balance training tool is virtual reality (VR) with several advantages including increased compliance and user satisfaction. Therefore, the aim of this pilot RCT (Trial registration number, date: ISRCTN14425615, 21/01/2016) was to examine the efficacy of a 6-week VR balance training program using the computer assisted rehabilitation environment (CAREN) system (Motek Medical BV, Amsterdam, Netherlands) on balance measures in PwMS. Results were compared with those of a conventional balance exercise group. Secondary aims included the impact of this program on the fear of falling. Thirty-two PwMS were equally randomized into the VR intervention group or the control group. Each group received balance training sessions for 6 consecutive weeks, two sessions per week, 30 min sessions. Clinical balance tests and instrumented posturography outcome measures were collected upon initiation of the intervention programs and at termination. Final analysis included 30 patients (19 females, 11 males; mean age, (S.D.) = 45.2 (11.6) years; mean EDSS (S.D.) = 4.1 (1.3), mean disease duration (S.D.) = 11.0 (8.9) years). Both groups showed a main effect of time on the center of pressure (CoP) path length with eyes open (F = 5.278, P = .024), sway rate with eyes open (F = 5.852, P = .035), Functional Reach Test (F = 20.841, P = .001), Four Square Step Test (F = 9.011, P = .031) and the Fear of Falls self-reported questionnaire (F = 17.815, P = .023). In addition, significant differences in favor of the VR program were observed for the group x time interactions of the Functional Reach Test (F = 10.173, P = .009) and fear of falling (F = 6.710, P = .021). We demonstrated that balance training based on the

  9. A Pilot Randomized Controlled Trial of a Technology-Based Approach for Preventing Excess Weight Gain during Pregnancy among Women with Overweight

    Directory of Open Access Journals (Sweden)

    Ariana M. Chao

    2017-11-01

    Full Text Available ObjectiveOverweight/obesity and excess weight gain during pregnancy are associated with adverse maternal and neonatal outcomes. Few interventions have been effective in limiting gestational weight gain among women with overweight or obesity. This pilot, randomized clinical trial compared treatment as usual (TAU to a lifestyle modification program delivered via phone for the prevention of excess gestational weight gain in women who had overweight or obesity.MethodsParticipants included 41 pregnant women with a body mass index (BMI ≥ 25 kg/m2 (mean age = 28.7 ± 5.8 years; mean pre-gravid BMI = 31.2 ± 6.2 kg/m2; 54% black, 39% white. The intervention group (n = 20 received weekly telephone counseling sessions and used WiFi scales to monitor their weight from weeks 16 to 36 of pregnancy. We compared differences in weight and birth outcomes for the intervention vs. the TAU group (n = 21.ResultsThe intervention and TAU groups did not differ with respect to: gestational weight gain (15.5 ± 5.3 vs. 13.3 ± 6.8 kg, respectively; proportion gaining above the 2009 Institute of Medicine recommended weight range (83 vs. 70%; and weight gain from pre-pregnancy weight to 6 weeks postpartum (4.8 ± 4.6 vs. 3.0 ± 5.5 kg. Other birth and health outcomes also did not differ.ConclusionA telemedicine intervention designed to decrease logistical burden on participants was not more successful in reducing excessive weight gain during pregnancy as compared to TAU. Future studies should examine more intensive forms of remote treatment beginning earlier in pregnancy as well as interventions promoting a healthy weight prior to pregnancy.

  10. Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Cheung, Yee Tak Derek; Chan, Ching Han Helen; Lai, Chi-Keung Jonah; Chan, Wai Fung Vivian; Wang, Man Ping; Li, Ho Cheung William; Chan, Sophia Siu Chee; Lam, Tai-Hing

    2015-10-22

    Quit attempters often have episodes of smoking relapse before they eventually quit. Interactive text messaging through mobile phones has been shown to increase abstinence. This service can be potentially applied on the platform of a social networking service to help quitters maintain abstinence. Our aim was to determine if the group discussion and reminders via the WhatsApp or Facebook social group were effective to prevent smoking relapse in quitters who had stopped smoking recently. This was a single-blinded, parallel, 3-arm pilot cluster randomized controlled trial allocating recent quitters, who had completed an 8-week treatment and reported abstinence for at least 7 days, to WhatsApp (n=42), Facebook (n=40), and a control group (n=54). The 2 intervention groups participated in a 2-month online group discussion with either WhatsApp or Facebook moderated by a trained smoking cessation counselor and received a self-help booklet on smoking cessation. The control group only received the booklet. The primary outcome was the 2- and 6-month relapse rates, defined as the proportion of participants who smoked at least 5 cigarettes in 3 consecutive days. Fewer participants in the WhatsApp group (17%, 7/42) reported relapse than the control group (42.6%, 23/54) at 2-month (OR 0.27, 95% CI 0.10-0.71) and 6-month (40.5%, 17/42 vs 61.1%, 33/54; OR 0.43, 95% CI 0.19-0.99) follow-ups. The Facebook group (30.0%, 12/40) had an insignificantly lower relapse rate than the control group (42.6%, 23/54) at 2-month (OR 0.58, 95% CI 0.24-1.37) and 6-month (52.5%, 13/40 vs 61.1%, 33/54; OR 0.70, 95% CI 0.31-1.61) follow-ups. The WhatsApp social groups had more moderators' posts (median 60, IQR 25 vs median 32, IQR 7; P=.05) and participants' posts (median 35, IQR 50 vs median 6, IQR 9; P=.07) than their Facebook counterparts, but the difference was insignificant. The intervention via the WhatsApp social group was effective in reducing relapse probably because of enhanced discussion and

  11. 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.

  12. Effects of exercise and nutrition on postural balance and risk of falling in elderly people with decreased bone mineral density : randomized controlled trial pilot study

    NARCIS (Netherlands)

    Swanenburg, Jaap; de Bruin, Eling Douwe; Stauffacher, Marguerite; Mulder, Theo; Uebelhart, Daniel

    Objective: To compare the effect of calcium/vitamin D supplements with a combination of calcium/vitamin D supplements and exercise/protein on risk of failing and postural balance. Design: Randomized clinical trial. Setting: University hospital physiotherapy department. Subjects: Twenty-four

  13. A Randomized Controlled Trial of Simulation-Based Teaching versus Traditional Instruction in Medicine: A Pilot Study among Clinical Medical Students

    Science.gov (United States)

    Gordon, James A.; Shaffer, David W.; Raemer, Daniel B.; Pawlowski, John; Hurford, William E.; Cooper, Jeffrey B.

    2006-01-01

    Objective: To compare simulator-based teaching with traditional instruction among clinical medical students. Methods: Randomized controlled trial with written pre-post testing. Third-year medical students (n = 38) received either a myocardial infarction (MI) simulation followed by a reactive airways disease (RAD) lecture, or a RAD simulation…

  14. 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

    , but higher anxiety was associated with recent and total number of shocks. The small pilot study suggested that a simple program of CBT might lower moderate-high anxiety with lasting effects to 1 year and supports the need for a larger trial to validate these results. CLINICAL TRIAL REGISTRATION: Clinical......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...... 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...

  15. Mobile Technology in E-Learning for Undergraduate Medical Education on Emergent Otorhinolaryngology–Head and Neck Surgery Disorders: Pilot Randomized Controlled Trial

    Science.gov (United States)

    Lee, Li-Ang; Wang, Shu-Ling; Chao, Yi-Ping; Tsai, Ming-Shao; Hsin, Li-Jen; Kang, Chung-Jan; Fu, Chia-Hsiang; Chao, Wei-Chieh; Huang, Chung-Guei; Li, Hsueh-Yu

    2018-01-01

    Background The use of mobile technology in e-learning (M-TEL) can add new levels of experience and significantly increase the attractiveness of e-learning in medical education. Whether an innovative interactive e-learning multimedia (IM) module or a conventional PowerPoint show (PPS) module using M-TEL to teach emergent otorhinolaryngology–head and neck surgery (ORL-HNS) disorders is feasible and efficient in undergraduate medical students is unknown. Objective The aim of this study was to compare the impact of a novel IM module with a conventional PPS module using M-TEL for emergent ORL-HNS disorders with regard to learning outcomes, satisfaction, and learning experience. Methods This pilot study was conducted at an academic teaching hospital and included 24 undergraduate medical students who were novices in ORL-HNS. The cognitive style was determined using the Group Embedded Figures Test. The participants were randomly allocated (1:1) to one of the two groups matched by age, sex, and cognitive style: the IM group and the PPS group. During the 100-min learning period, the participants were unblinded to use the IM or PPS courseware on a 7-inch tablet. Pretests and posttests using multiple-choice questions to evaluate knowledge and multimedia situational tests to evaluate competence were administered. Participants evaluated their satisfaction and learning experience by the AttrakDiff2 questionnaire, and provided feedback about the modules. Results Overall, the participants had significant gains in knowledge (median of percentage change 71, 95% CI 1-100, P<.001) and competence (median of percentage change 25, 95% CI 0-33, P=.007) after 100 min of learning. Although there was no significant difference in knowledge gain between the two groups (median of difference of percentage change 24, 95% CI −75 to 36; P=.55), competence gain was significantly lower in the IM group compared with the PPS group (median of difference of percentage change −41, 95% CI −67 to

  16. 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

  17. Comparison between self-formulation and compounded-formulation dexamethasone mouth rinse for oral lichen planus: a pilot, randomized, cross-over trial.

    Science.gov (United States)

    Hambly, Jessica L; Haywood, Alison; Hattingh, Laetitia; Nair, Raj G

    2017-08-01

    There is a lack of appropriate, commercially-available topical corticosteroid formulations for use in oral lichen planus (OLP) and oral lichenoid reaction. Current therapy includes crushing a dexamethasone tablet and mixing it with water for use as a mouth rinse. This formulation is unpleasant esthetically and to use in the mouth, as it is a bitter and gritty suspension, resulting in poor compliance. Thus, the present study was designed to formulate and pilot an effective, esthetically-pleasing formulation. A single-blinded, cross-over trial was designed with two treatment arms. Patients were monitored for 7 weeks. Quantitative and qualitative data was assessed using VAS, numeric pain scales, the Treatment Satisfaction Questionnaire for Medication-9, and thematic analysis to determine primary patient-reported outcomes, including satisfaction, compliance, quality of life, and symptom relief. Nine patients completed the pilot trial. Data analysis revealed the new compounded formulation to be superior to existing therapy due to its convenience, positive contribution to compliance, patient-perceived faster onset of action, and improved symptom relief. Topical dexamethasone is useful in the treatment of OLP. When carefully formulated into a compounded mouth rinse, it improves patient outcomes. © 2016 John Wiley & Sons Australia, Ltd.

  18. Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

    2017-01-28

    Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a

  19. The Efficacy of Treatment of Different Intervention Programs for Patellofemoral Pain Syndrome–A Single Blinded Randomized Clinical Trial. Pilot Study

    Directory of Open Access Journals (Sweden)

    Feazadeh Avraham

    2007-01-01

    Full Text Available Patello-femoral pain syndrome (PFPS is a common knee joint disability. The integration of hip soft tissue regimens are not always emphasized, although current literature implies that there is a significant relationship between the two and there is a lack of randomized clinical trials to substantiate this relationship in clinical practice. A randomized controlled assessor blinded trial was designed to explore different rehabilitation programs related to PFPS. The study was conducted at RAZIEL institute of physical therapy, Netania, Israel with a total of 30 consecutive patients (mean age 35y, diagnosed with PFPS. All patients were randomly allocated into 3 groups. Group I conventional knee rehabilitation program. Included quadriceps strengthening and Trans Electric Neuromuscular Stimulation (TENS. Group II hip oriented rehabilitation program. included stretching, Hip external rotators strengthening and TENS. Group III a combination of the two above programs. Pain and function were documented on initial of the program and again 3 weeks later, on the completion. Pain was assessed by a numeric visual analogue scale (VAS; function was assessed by Patello-femoral joint evaluation scale (PFJES (0-100 points. At end of trial, all groups showed significant improvements in VAS and PFJES (p<0.0001; these improvements did not vary significantly between the 3 groups. The conclusions were that the explored different rehabilitation programs showed a similar beneficial effect.

  20. Blood pressure and endothelial function in healthy, pregnant women after acute and daily consumption of flavanol-rich chocolate: a pilot, randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Several randomized clinical trials (RCTs) indicate that flavanol-rich chocolate has beneficial effects on flow-mediated dilation (FMD) and blood pressure (BP). However, no RCTs have evaluated these outcomes in pregnant women. The objective of this 2-group, parallel, double-blind RCT was to examine the effects of flavanol-rich chocolate on FMD and BP in pregnant women with normal BP. Methods Forty-four healthy, pregnant women were randomized to the high-flavanol (n = 23) or low-flavanol (n = 21) chocolate consumption for 12 weeks. At randomization (0, 60, 120 and 180 min after a single 40-g dose of chocolate), 6 and 12 weeks after daily 20-g chocolate intake, we evaluated plasma concentrations of flavanols and theobromine, as well as the FMD and BP. Results Plasma epicatechin was significantly increased (p chocolate compared to low-flavanol chocolate. Theobromine concentrations were significantly higher 180 min and 12 weeks after the intake of experimental chocolate or low-flavanol chocolate (p chocolate to an equivalent placebo during pregnancy and demonstrate higher plasma epicatechin and theobromine concentration in the intervention group after acute ingestion Trial registration ClinicalTrials.gov Identifier: NCT01659060 PMID:23565841

  1. Mobile Technology in E-Learning for Undergraduate Medical Education on Emergent Otorhinolaryngology-Head and Neck Surgery Disorders: Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Lee, Li-Ang; Wang, Shu-Ling; Chao, Yi-Ping; Tsai, Ming-Shao; Hsin, Li-Jen; Kang, Chung-Jan; Fu, Chia-Hsiang; Chao, Wei-Chieh; Huang, Chung-Guei; Li, Hsueh-Yu; Chuang, Cheng-Keng

    2018-03-08

    The use of mobile technology in e-learning (M-TEL) can add new levels of experience and significantly increase the attractiveness of e-learning in medical education. Whether an innovative interactive e-learning multimedia (IM) module or a conventional PowerPoint show (PPS) module using M-TEL to teach emergent otorhinolaryngology-head and neck surgery (ORL-HNS) disorders is feasible and efficient in undergraduate medical students is unknown. The aim of this study was to compare the impact of a novel IM module with a conventional PPS module using M-TEL for emergent ORL-HNS disorders with regard to learning outcomes, satisfaction, and learning experience. This pilot study was conducted at an academic teaching hospital and included 24 undergraduate medical students who were novices in ORL-HNS. The cognitive style was determined using the Group Embedded Figures Test. The participants were randomly allocated (1:1) to one of the two groups matched by age, sex, and cognitive style: the IM group and the PPS group. During the 100-min learning period, the participants were unblinded to use the IM or PPS courseware on a 7-inch tablet. Pretests and posttests using multiple-choice questions to evaluate knowledge and multimedia situational tests to evaluate competence were administered. Participants evaluated their satisfaction and learning experience by the AttrakDiff2 questionnaire, and provided feedback about the modules. Overall, the participants had significant gains in knowledge (median of percentage change 71, 95% CI 1-100, Plearning. Although there was no significant difference in knowledge gain between the two groups (median of difference of percentage change 24, 95% CI -75 to 36; P=.55), competence gain was significantly lower in the IM group compared with the PPS group (median of difference of percentage change -41, 95% CI -67 to -20; P=.008). However, the IM group had significantly higher scores of satisfaction (difference 2, 95% CI 2-4; P=.01), pragmatic quality

  2. 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

  3. 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.

  4. USE OF NEUROFEEDBACK AND MINDFULNESS TO ENHANCE RESPONSE TO HYPNOSIS TREATMENT IN INDIVIDUALS WITH MULTIPLE SCLEROSIS: Results From a Pilot Randomized Clinical Trial.

    Science.gov (United States)

    Jensen, Mark P; Battalio, Samuel L; Chan, Joy F; Edwards, Karlyn A; Day, Melissa A; Sherlin, Leslie H; Ehde, Dawn M

    2018-01-01

    This pilot study evaluated the possibility that 2 interventions hypothesized to increase slower brain oscillations (e.g., theta) may enhance the efficacy of hypnosis treatment, given evidence that hypnotic responding is associated with slower brain oscillations. Thirty-two individuals with multiple sclerosis and chronic pain, fatigue, or both, were randomly assigned to 1 of 2 interventions thought to increase slow wave activity (mindfulness meditation or neurofeedback training) or no enhancing intervention, and then given 5 sessions of self-hypnosis training targeting their presenting symptoms. The findings supported the potential for both neurofeedback and mindfulness to enhance response to hypnosis treatment. Research using larger sample sizes to determine the generalizability of these findings is warranted.

  5. A pilot randomized controlled trial of on-line interventions to improve sleep quality in adults after mild or moderate traumatic brain injury.

    Science.gov (United States)

    Theadom, Alice; Barker-Collo, Suzanne; Jones, Kelly; Dudley, Margaret; Vincent, Norah; Feigin, Valery

    2018-05-01

    To explore feasibility and potential efficacy of on-line interventions for sleep quality following a traumatic brain injury (TBI). A two parallel-group, randomized controlled pilot study. Community-based. In all, 24 participants (mean age: 35.9 ± 11.8 years) who reported experiencing sleep difficulties between 3 and 36 months after a mild or moderate TBI. Participants were randomized to receive either a cognitive behaviour therapy or an education intervention on-line. Both interventions were self-completed for 20-30 minutes per week over a six-week period. The Pittsburgh Sleep Quality Index assessed self-reported sleep quality with actigraphy used as an objective measure of sleep quality. The CNS Vital Signs on-line neuropsychological test assessed cognitive functioning and the Rivermead Post-concussion Symptoms and Quality of Life after Brain Injury questionnaires were completed pre and post intervention. Both programmes demonstrated feasibility for use post TBI, with 83.3% of participants completing the interventions. The cognitive behaviour therapy group experienced significant reductions ( F = 5.47, p = 0.04) in sleep disturbance (mean individual change = -4.00) in comparison to controls post intervention (mean individual change = -1.50) with a moderate effect size of 1.17. There were no significant group differences on objective sleep quality, cognitive functioning, post-concussion symptoms or quality of life. On-line programmes designed to improve sleep are feasible for use for adults following mild-to-moderate TBI. Based on the effect size identified in this pilot study, 128 people (64 per group) would be needed to determine clinical effectiveness.

  6. Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.

    Science.gov (United States)

    Doiron-Cadrin, Patrick; Kairy, Dahlia; Vendittoli, Pascal-André; Lowry, Véronique; Poitras, Stéphane; Desmeules, François

    2016-12-15

    The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs. This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis. ClinicalTrials.gov: NCT02636751.

  7. Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit).

    Science.gov (United States)

    Naughton, Felix; Cooper, Sue; Foster, Katharine; Emery, Joanne; Leonardi-Bee, Jo; Sutton, Stephen; Jones, Matthew; Ussher, Michael; Whitemore, Rachel; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim

    2017-07-01

    To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. Sixteen antenatal clinics in England. Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

  8. Effectiveness of Parent-Child Mediation in Improving Family Functioning and Reducing Adolescent Problem Behavior: Results from a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Tucker, Joan S; Edelen, Maria Orlando; Huang, Wenjing

    2017-03-01

    Parent-child mediation programs are intended to resolve or manage disputes and improve family functioning, but rigorous evaluations of their effectiveness are lacking. Families referred to a community-based mediation program (N = 111) were randomized to an intervention or wait-list control group, and completed three surveys over a 12-week period. With the exception of parent-reported child delinquency (which decreased more in the intervention group), this evaluation provides little support for the short-term effectiveness of parent-child mediation for improving family functioning and reducing child problem behaviors in general. Given that this is the first randomized controlled trial of a parent-child mediation program, additional evaluations involving larger samples and longer follow-ups are needed before firm conclusions can be drawn about the effectiveness of this intervention.

  9. Effectiveness of Parent-Child Mediation in Improving Family Functioning and Reducing Adolescent Problem Behavior: Results from a Pilot Randomized Controlled Trial

    Science.gov (United States)

    Tucker, Joan S.; Edelen, Maria Orlando; Huang, Wenjing

    2016-01-01

    Parent-child mediation programs are intended to resolve or manage disputes and improve family functioning, but rigorous evaluations of their effectiveness are lacking. Families referred to a community-based mediation program (N=111) were randomized to an intervention or wait-list control group, and completed three surveys over a 12-week period. With the exception of parent-reported child delinquency (which decreased more in the intervention group), this evaluation provides little support for the short-term effectiveness of parent-child mediation for improving family functioning and reducing child problem behaviors in general. Given that this is the first randomized controlled trial of a parent-child mediation program, additional evaluations involving larger samples and longer follow-ups are needed before firm conclusions can be drawn about the effectiveness of this intervention. PMID:26762375

  10. Reducing stigma among healthcare providers to improve mental health services (RESHAPE): protocol for a pilot cluster randomized controlled trial of a stigma reduction intervention for training primary healthcare workers in Nepal.

    Science.gov (United States)

    Kohrt, Brandon A; Jordans, Mark J D; Turner, Elizabeth L; Sikkema, Kathleen J; Luitel, Nagendra P; Rai, Sauharda; Singla, Daisy R; Lamichhane, Jagannath; Lund, Crick; Patel, Vikram

    2018-01-01

    Non-specialist healthcare providers, including primary and community healthcare workers, in low- and middle-income countries can effectively treat mental illness. However, scaling-up mental health services within existing health systems has been limited by barriers such as stigma against people with mental illness. Therefore, interventions are needed to address attitudes and behaviors among non-specialists. Aimed at addressing this gap, RE ducing S tigma among H ealthc A re P roviders to Improv E mental health services (RESHAPE) is an intervention in which social contact with mental health service users is added to training for non-specialist healthcare workers integrating mental health services into primary healthcare. This protocol describes a mixed methods pilot and feasibility study in primary care centers in Chitwan, Nepal. The qualitative component will include key informant interviews and focus group discussions. The quantitative component consists of a pilot cluster randomized controlled trial (c-RCT), which will establish parameters for a future effectiveness study of RESHAPE compared to training as usual (TAU). Primary healthcare facilities (the cluster unit, k  = 34) will be randomized to TAU or RESHAPE. The direct beneficiaries of the intervention are the primary healthcare workers in the facilities ( n  = 150); indirect beneficiaries are their patients ( n  = 100). The TAU condition is existing mental health training and supervision for primary healthcare workers delivered through the Programme for Improving Mental healthcarE (PRIME) implementing the mental health Gap Action Programme (mhGAP). The primary objective is to evaluate acceptability and feasibility through qualitative interviews with primary healthcare workers, trainers, and mental health service users. The secondary objective is to collect quantitative information on health worker outcomes including mental health stigma (Social Distance Scale), clinical knowledge (mh

  11. 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

    2017-01-01

    Background 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. Objective 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. Methods 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. Results 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

  12. The Preliminary Effects of Massage and Inhalation Aromatherapy on Chemotherapy-Induced Acute Nausea and Vomiting: A Quasi-Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Zorba, Pinar; Ozdemir, Leyla

    2017-04-20

    Despite pharmacological treatment, chemotherapy-induced nausea and vomiting (CINV) are observed in patients. This quasi-randomized controlled pilot study evaluated the feasibility and preliminary effects of massage and inhalation aromatherapies on chemotherapy-induced acute nausea/vomiting. Seventy-five patients with breast cancer were randomly grouped into 1 of 3 groups: massage (n = 25), inhalation (n = 25), and control (n = 25). The patients in the massage group received 20-minute aromatherapy foot massage, whereas those in the inhalation group received 3-minute inhalation aromatherapy before their second, third, and fourth chemotherapy cycles. The control group underwent only the routine treatment. A nausea, vomiting, and retching patient follow-up form was used to evaluate nausea severity by visual analog scale and frequency of vomiting and retching. The incidence of nausea and retching was significantly higher in the control group than in the other groups in the third and fourth chemotherapy cycles (P aromatherapy groups than in the control group. Nausea and retching incidence was reduced in the aromatherapy groups compared with that in the control group. Nonpharmacological approaches are recommended for managing CINV. Massage and inhalation aromatherapy seems promising regarding the management of CINV.

  13. A pilot randomized controlled trial of the Occupational Goal Intervention method for the improvement of executive functioning in patients with treatment-resistant schizophrenia.

    Science.gov (United States)

    Vizzotto, Adriana D B; Celestino, Diego L; Buchain, Patricia C; Oliveira, Alexandra M; Oliveira, Graça M R; Di Sarno, Elaine S; Napolitano, Isabel C; Elkis, Helio

    2016-11-30

    Schizophrenia is a chronic disabling mental disorder that involves impairments in several cognitive domains, especially in executive functions (EF), as well as impairments in functional performance. This is particularly true in patients with Treatment-Resistant Schizophrenia (TRS). The aim of this study was to test the efficacy of the Occupational Goal Intervention (OGI) method for the improvement of EF in patients with TRS. In this randomized, controlled, single-blind pilot study, 25 TRS patients were randomly assigned to attend 30 sessions of either OGI or craft activities (control) over a 15-week period and evaluated by the Behavioural Assessment of the Dysexecutive Syndrome (BADS) as the primary outcome and the Direct Assessment of Functional Status (DAFS-BR) as well as the Independent Living Skills Survey (ILSS-BR) as secondary outcomes, all adapted for the Brazilian population. The Positive and Negative Syndrome Scale (PANSS) was used for monitoring symptom severity. Results showed significant statistical differences, favoring the OGI group in terms of improvement on the BADS, both in subtests (Action Program and Key Search) and the total score. Improvements in EFs were observed by families in various dimensions as measured by different subtests of the ILSS-BR inventory. The OGI group showed no significant results in secondary outcomes (DAFS-BR) except in terms of improvement of communication skills. Although preliminary, our results indicate that the OGI method is efficacious and effective for patients with TRS. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  14. Two-Arm Randomized Pilot Intervention Trial to Decrease Sitting Time and Increase Sit-To-Stand Transitions in Working and Non-Working Older Adults.

    Directory of Open Access Journals (Sweden)

    Jacqueline Kerr

    Full Text Available Excessive sitting has been linked to poor health. It is unknown whether reducing total sitting time or increasing brief sit-to-stand transitions is more beneficial. We conducted a randomized pilot study to assess whether it is feasible for working and non-working older adults to reduce these two different behavioral targets.Thirty adults (15 workers and 15 non-workers age 50-70 years were randomized to one of two conditions (a 2-hour reduction in daily sitting or accumulating 30 additional brief sit-to-stand transitions per day. Sitting time, standing time, sit-to-stand transitions and stepping were assessed by a thigh worn inclinometer (activPAL. Participants were assessed for 7 days at baseline and followed while the intervention was delivered (2 weeks. Mixed effects regression analyses adjusted for days within participants, device wear time, and employment status. Time by condition interactions were investigated.Recruitment, assessments, and intervention delivery were feasible. The 'reduce sitting' group reduced their sitting by two hours, the 'increase sit-to-stand' group had no change in sitting time (p < .001. The sit-to-stand transition group increased their sit-to-stand transitions, the sitting group did not (p < .001.This study was the first to demonstrate the feasibility and preliminary efficacy of specific sedentary behavioral goals.clinicaltrials.gov NCT02544867.

  15. A Double-Blind, Randomized, Controlled Pilot Trial of N-Acetylcysteine in Veterans With Posttraumatic Stress Disorder and Substance Use Disorders.

    Science.gov (United States)

    Back, Sudie E; McCauley, Jenna L; Korte, Kristina J; Gros, Daniel F; Leavitt, Virginia; Gray, Kevin M; Hamner, Mark B; DeSantis, Stacia M; Malcolm, Robert; Brady, Kathleen T; Kalivas, Peter W

    2016-11-01

    The antioxidant N-acetylcysteine is being increasingly investigated as a therapeutic agent in the treatment of substance use disorders (SUDs). This study explored the efficacy of N-acetylcysteine in the treatment of posttraumatic stress disorder (PTSD), which frequently co-occurs with SUD and shares impaired prefrontal cortex regulation of basal ganglia circuitry, in particular at glutamate synapses in the nucleus accumbens. Veterans with PTSD and SUD per DSM-IV criteria (N = 35) were randomly assigned to receive a double-blind, 8-week course of N-acetylcysteine (2,400 mg/d) or placebo plus cognitive-behavioral therapy for SUD (between March 2013 and April 2014). Primary outcome measures included PTSD symptoms (Clinician-Administered PTSD Scale, PTSD Checklist-Military) and craving (Visual Analog Scale). Substance use and depression were also assessed. Participants treated with N-acetylcysteine compared to placebo evidenced significant improvements in PTSD symptoms, craving, and depression (β values acetylcysteine was well tolerated, and retention was high. This is the first randomized controlled trial to investigate N-acetylcysteine as a pharmacologic treatment for PTSD and SUD. Although preliminary, the findings provide initial support for the use of N-acetylcysteine in combination with psychotherapy among individuals with co-occurring PTSD and SUD. ClinicalTrials.gov identifier: NCT02499029. © Copyright 2016 Physicians Postgraduate Press, Inc.

  16. Foot shape and its effect on functioning in Royal Australian Air Force recruits. Part 2: Pilot, randomized, controlled trial of orthotics in recruits with flat feet.

    Science.gov (United States)

    Esterman, Adrian; Pilotto, Louis

    2005-07-01

    As part of a larger study of the effect of foot shape on functioning, 47 Royal Australian Air Force recruits with flexible flat feet who were embarking on a 10-week basic training course took part in a randomized controlled trial of orthotic therapy. In particular, recruits were assigned at random to an untreated group or a group that received Australian Orthotics Laboratory, three-quarter-length, flexible, shoe inserts. The groups were assessed at baseline and week 8. Outcome measures included pain, injury, foot health, and quality of life. The untreated group (n = 22) had a greater proportion of heavier recruits than did the treated group (n = 25). There were no significant differences in outcome measures at baseline. Only one-half of the group assigned to orthotic therapy wore the orthotics most or all of the time. At the end of the trial, although the results were not statistically significant, those who were provided with orthotics and wore them had the least lower limb pain and the best general foot health and quality of life. Notably, none of the recruits who wore their orthotics most or all of the time sustained a training injury.

  17. Prevention of hypothermia in patients undergoing orthotopic liver transplantation using the humigard® open surgery humidification system: a prospective randomized pilot and feasibility clinical trial.

    Science.gov (United States)

    Weinberg, Laurence; Huang, Andrew; Alban, Daniel; Jones, Robert; Story, David; McNicol, Larry; Pearce, Brett

    2017-01-23

    Perioperative thermal disturbances during orthotopic liver transplantation (OLT) are common. We hypothesized that in patients undergoing OLT the use of a humidified high flow CO 2 warming system maintains higher intraoperative temperatures when compared to standardized multimodal strategies to maintain thermoregulatory homeostasis. We performed a randomized pilot study in adult patients undergoing primary OLT. Participants were randomized to receive either open wound humidification with a high flow CO 2 warming system in addition to standard care (Humidification group) or to standard care alone (Control group). The primary end point was nasopharyngeal core temperature measured 5 min immediately prior to reperfusion of the donor liver (Stage 3 - 5 min). Secondary endpoints included intraoperative PaCO 2 , minute ventilation and the use of vasoconstrictors. Eleven patients were randomized to each group. Both groups were similar for age, body mass index, MELD, SOFA and APACHE II scores, baseline temperature, and duration of surgery. Immediately prior to reperfusion (Stage 3 - 5 min) the mean (SD) core temperature was higher in the Humidification Group compared to the Control Group: 36.0 °C (0.13) vs. 35.4 °C (0.22), p = 0.028. Repeated measured ANOVA showed that core temperatures over time during the stages of the transplant were higher in the Humidification Group compared to the Control Group (p < 0.0001). There were no significant differences in the ETCO 2 , PaCO 2 , minute ventilation, or inotropic support. The humidified high flow CO 2 warming system was superior to standardized multimodal strategies in maintaining normothermia in patients undergoing OLT. Use of the device was feasible and did not interfere with any aspects of surgery. A larger study is needed to investigate if the improved thermoregulation observed is associated with improved patient outcomes. ACTRN12616001631493 . Retrospectively registered 25 November 2016.

  18. A randomized clinical trial of high eicosapentaenoic acid omega-3 fatty acids and inositol as monotherapy and in combination in the treatment of pediatric bipolar spectrum disorders: a pilot study.

    Science.gov (United States)

    Wozniak, Janet; Faraone, Stephen V; Chan, James; Tarko, Laura; Hernandez, Mariely; Davis, Jacqueline; Woodworth, K Yvonne; Biederman, Joseph

    2015-11-01

    We conducted a 12-week, randomized, double-blind, controlled clinical trial to evaluate the effectiveness and tolerability of high eicosapentaenoic acid (EPA)/docosahexaenoic acid (DHA) omega-3 fatty acids and inositol as monotherapy and in combination in children with bipolar spectrum disorders. Participants were children 5-12 years of age meeting DSM-IV diagnostic criteria for bipolar spectrum disorders (bipolar I or II disorder or bipolar disorder not otherwise specified [NOS]) and displaying mixed, manic, or hypomanic symptoms. Subjects with severe illness were excluded. Subjects were randomized to 1 of 3 treatment arms: inositol plus placebo, omega-3 fatty acids plus placebo, and the combined active treatment of omega-3 fatty acids plus inositol. Data were collected from February 2012 to November 2013. Twenty-four subjects were exposed to treatment (≥ 1 week of study completed) (inositol [n = 7], omega-3 fatty acids [n = 7], and omega-3 fatty acids plus inositol [n =10]). Fifty-four percent of the subjects completed the study. Subjects randomized to the omega-3 fatty acids plus inositol arm had the largest score decrease comparing improvement from baseline to end point with respect to the Young Mania Rating Scale (P < .05). Similar results were found for the Children's Depression Rating Scale (P < .05) and the Brief Psychiatric Rating Scale (P <.05). Results of this pilot randomized, double-blind, controlled trial suggest that the combined treatment of omega-3 fatty acids plus inositol reduced symptoms of mania and depression in prepubertal children with mild to moderate bipolar spectrum disorders. Results should be interpreted in light of limitations, which include exclusion of severely ill subjects, 54% completion rate, and small sample size. ClinicalTrials.gov identifier: NCT01396486. © Copyright 2015 Physicians Postgraduate Press, Inc.

  19. The SHAZ! Project: Results from a Pilot Randomized Trial of a Structural Intervention to Prevent HIV among Adolescent Women in Zimbabwe

    Science.gov (United States)

    Dunbar, Megan S.; Kang Dufour, Mi-Suk; Lambdin, Barrot; Mudekunye-Mahaka, Imelda; Nhamo, Definate; Padian, Nancy S.

    2014-01-01

    Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ!) was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control). The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83)], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62)] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01)], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the intervention model, and

  20. 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

  1. Work-related CBT versus vocational services as usual for unemployed persons with social anxiety disorder: A randomized controlled pilot trial.

    Science.gov (United States)

    Himle, Joseph A; Bybee, Deborah; Steinberger, Edward; Laviolette, Wayne T; Weaver, Addie; Vlnka, Sarah; Golenberg, Zipora; Levine, Debra Siegel; Heimberg, Richard G; O'Donnell, Lisa A

    2014-12-01

    We designed and pilot-tested a group-based, work-related cognitive-behavioral therapy (WCBT) for unemployed individuals with social anxiety disorder (SAD). WCBT, delivered in a vocational service setting by vocational service professionals, aims to reduce social anxiety and enable individuals to seek, obtain, and retain employment. We compared WCBT to a vocational services as usual control condition (VSAU). Participants were unemployed, homeless, largely African American, vocational service-seeking adults with SAD (N = 58), randomized to receive either eight sessions of WCBT plus VSAU or VSAU alone and followed three months post-treatment. Multilevel modeling revealed significantly greater reductions in social anxiety, general anxiety, depression, and functional impairment for WCBT compared to VSAU. Coefficients for job search activity and self-efficacy indicated greater increases for WCBT. Hours worked per week in the follow-up period did not differ between the groups, but small sample size and challenges associated with measuring work hours may have contributed to this finding. Overall, the results of this study suggest that unemployed persons with SAD can be effectively treated with specialized work-related CBT administered by vocational service professionals. Future testing of WCBT with a larger sample, a longer follow-up period, and adequate power to assess employment outcomes is warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.

  2. Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial.

    Science.gov (United States)

    Ferrando, Carlos; Suarez-Sipmann, Fernando; Tusman, Gerardo; León, Irene; Romero, Esther; Gracia, Estefania; Mugarra, Ana; Arocas, Blanca; Pozo, Natividad; Soro, Marina; Belda, Francisco J

    2017-01-01

    Low tidal volume (VT) during anesthesia minimizes lung injury but may be associated to a decrease in functional lung volume impairing lung mechanics and efficiency. Lung recruitment (RM) can restore lung volume but this may critically depend on the post-RM selected PEEP. This study was a randomized, two parallel arm, open study whose primary outcome was to compare the effects on driving pressure of adding a RM to low-VT ventilation, with or without an individualized post-RM PEEP in patients without known previous lung disease during anesthesia. Consecutive patients scheduled for major abdominal surgery were submitted to low-VT ventilation (6 ml·kg-1) and standard PEEP of 5 cmH2O (pre-RM, n = 36). After 30 min estabilization all patients received a RM and were randomly allocated to either continue with the same PEEP (RM-5 group, n = 18) or to an individualized open-lung PEEP (OL-PEEP) (Open Lung Approach, OLA group, n = 18) defined as the level resulting in maximal Cdyn during a decremental PEEP trial. We compared the effects on driving pressure and lung efficiency measured by volumetric capnography. OL-PEEP was found at 8±2 cmH2O. 36 patients were included in the final analysis. When compared with pre-RM, OLA resulted in a 22% increase in compliance and a 28% decrease in driving pressure when compared to pre-RM. These parameters did not improve in the RM-5. The trend of the DP was significantly different between the OLA and RM-5 groups (p = 0.002). VDalv/VTalv was significantly lower in the OLA group after the RM (p = 0.035). Lung recruitment applied during low-VT ventilation improves driving pressure and lung efficiency only when applied as an open-lung strategy with an individualized PEEP in patients without lung diseases undergoing major abdominal surgery. ClinicalTrials.gov NCT02798133.

  3. Exploring synergistic effects of aerobic exercise and mindfulness training on cognitive function in older adults: Protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Salmoirago-Blotcher, Elena; DeCosta, Julie; Harris, Kristie; Breault, Christopher; Dunsiger, Shira; Santos, Claudia; Snyder, Peter

    2018-05-01

    Despite increasing evidence that aerobic exercise and cognitive training improve cognitive function among patients with cognitive impairment and dementia, few studies have focused on the effect of a combination of these approaches. This study will explore whether combining aerobic training (AT) with mindfulness training (MT), an intervention promoting the moment-to-moment awareness of physical sensations, affective states, and thoughts, improves cognitive function in individuals at risk of dementia. The primary objective is to determine the feasibility and acceptability of the intervention(s). The secondary objective is to obtain estimates of effect sizes on cognitive function and on possible mediators. Forty participants with at least 2 risk factors for dementia will be randomized (2 × 2 factorial design) to either AT (3 sessions/week for 12 weeks), MT (1 session/week for 8 weeks), both, or usual care. Assessments of cognitive function (attention, executive function, episodic, and working memory); physical activity (accelerometry), aerobic capacity (6-minute walk test), waist-to-hip ratio, blood pressure, social support (Multidimensional Scale of Perceived Social Support), depression (Hospital Anxiety and Depression Scale), and mindfulness (Five Facets of Mindfulness) will be conducted at baseline, end of treatment, and 6-months postbaseline. Rates of retention, attendance, and program satisfaction will be calculated for each of the 4 groups to determine the feasibility and acceptability of each intervention. This study has full ethical approval by The Miriam Hospital Institutional Review Board and adheres to the Standard Protocol Items: Recommendations for Interventional Trials reporting recommendations. If results from this exploratory, proof-of-concept study support our hypotheses, we will conduct a large randomized controlled trial (RCT) to determine the efficacy of combined MT and AT in improving cognitive function in individuals at risk of dementia

  4. Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Cheon, Chunhoo; Yoo, Jeong-Eun; Yoo, Hwa-Seung; Cho, Chong-Kwan; Kang, Sohyeon; Kim, Mia; Jang, Bo-Hyoung; Shin, Yong-Cheol; Ko, Seong-Gyu

    2017-01-01

    Anorexia occurs in about half of cancer patients and is associated with high mortality rate. However, safe and long-term use of anorexia treatment is still an unmet need. The purpose of the present study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests. Anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group. Sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy. This trial is registered with ClinicalTrials.gov NCT02468141.

  5. A pilot randomized controlled trial of D-cycloserine and distributed practice as adjuvants to constraint-induced movement therapy after stroke.

    Science.gov (United States)

    Nadeau, Stephen E; Davis, Sandra E; Wu, Samuel S; Dai, Yunfeng; Richards, Lorie G

    2014-01-01

    Background. Phase III trials of rehabilitation of paresis after stroke have proven the effectiveness of intensive and extended task practice, but they have also shown that many patients do not qualify, because of severity of impairment, and that many of those who are treated are left with clinically significant deficits. Objective. To test the value of 2 potential adjuvants to normal learning processes engaged in constraint-induced movement therapy (CIMT): greater distribution of treatment over time and the coadministration of d-cycloserine, a competitive agonist at the glycine site of the N-methyl-D-aspartate glutamate receptor. Methods. A prospective randomized single-blind parallel-group trial of more versus less condensed therapy (2 vs 10 weeks) and d-cycloserine (50 mg) each treatment day versus placebo (in a 2 × 2 design), as potential adjuvants to 60 hours of CIMT. Results. Twenty-four participants entered the study, and 22 completed it and were assessed at the completion of treatment and 3 months later. Neither greater distribution of treatment nor treatment with d-cycloserine significantly augmented retention of gains achieved with CIMT. Conclusions. Greater distribution of practice and treatment with d-cycloserine do not appear to augment retention of gains achieved with CIMT. However, concentration of CIMT over 2 weeks ("massed practice") appears to confer no advantage either. © The Author(s) 2014.

  6. Efficacy of cognitive behavioral internet-based therapy in parents after the loss of a child during pregnancy: pilot data from a randomized controlled trial.

    Science.gov (United States)

    Kersting, Anette; Kroker, Kristin; Schlicht, Sarah; Baust, Katja; Wagner, Birgit

    2011-12-01

    The loss of a child during pregnancy can be a traumatic event associated with long-lasting grief and psychological distress. This study examined the efficacy of an internet-based cognitive behavioral therapy program for mothers after pregnancy loss. In a randomized controlled trial with a waiting list control group, 83 participants who had lost a child during pregnancy were randomly allocated either to 5 weeks of internet therapy or to a 5-week waiting condition. Within a manualized cognitive behavioral treatment program, participants wrote ten essays on loss-specific topics. Posttraumatic stress, grief, and general psychopathology, especially depression, were assessed pretreatment, posttreatment, and at 3-month follow-up. Intention-to-treat analyses and completer analyses were performed. Relative to controls, participants in the treatment group showed significant improvements in posttraumatic stress, grief, depression, and overall mental health, but not in anxiety or somatization. Medium to large effect sizes were observed, and the improvement was maintained at 3-month follow-up. This internet-based cognitive behavioral therapy program represents an effective treatment approach with stable effects for women after pregnancy loss. Implementation of the program can thus help to improve the health care provision for mothers in this traumatic loss situation.

  7. The SHAZ! project: results from a pilot randomized trial of a structural intervention to prevent HIV among adolescent women in Zimbabwe.

    Directory of Open Access Journals (Sweden)

    Megan S Dunbar

    Full Text Available Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ! was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control. The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own income [IOR = 2.05 vs. COR = 1.67, p = 0.02]. Additionally, within the Intervention arm there was a lower risk of transactional sex [IOR = 0.64, 95% CI (0.50, 0.83], and a higher likelihood of using a condom with their current partner [IOR = 1.79, 95% CI (1.23, 2.62] over time compared to baseline. There was also evidence of fewer unintended pregnancies among intervention participants [HR = 0.61, 95% CI (0.37, 1.01], although this relationship achieved only marginal statistical significance. Several important challenges in this study included the coordination with vocational training programs, the political and economic instability of the area at the time of the study, and the difficulty in creating a true standard of care control arm. Overall the results of the SHAZ! study suggest important potential for HIV prevention intervention packages that include vocational training and micro-grants, and lessons for further economic livelihoods interventions with adolescent females. Further work is needed to refine the

  8. The SHAZ! project: results from a pilot randomized trial of a structural intervention to prevent HIV among adolescent women in Zimbabwe.

    Science.gov (United States)

    Dunbar, Megan S; Kang Dufour, Mi-Suk; Lambdin, Barrot; Mudekunye-Mahaka, Imelda; Nhamo, Definate; Padian, Nancy S

    2014-01-01

    Adolescent females in Zimbabwe are at high risk for HIV acquisition. Shaping the Health of Adolescents in Zimbabwe (SHAZ!) was a randomized controlled trial of a combined intervention package including life-skills and health education, vocational training, micro-grants and social supports compared to life-skills and health education alone. SHAZ! was originally envisioned as a larger effectiveness trial, however, the intervention was scaled back due to contextual and economic conditions in the country at the time. SHAZ! enrolled 315 participants randomly assigned to study arm within blocks of 50 participants (158 intervention and 157 control). The intervention arm participants showed statistically significant differences from the control arm participants for several outcomes during the two years of follow up including; reduced food insecurity [IOR = 0.83 vs. COR = 0.68, p-0.02], and having their own inco