Background: Young adult veterans who served after the September 11 attacks on the United States in 2001 (ie, post-9/11) are at heightened risk for experiencing behavioral health distress and disorders including hazardous drinking, posttraumatic stress disorder, and depression. These veterans often face significant barriers to behavioral health treatment, and reaching them through brief mobile phone-based interventions may help reduce drinking and promote treatment engagement.
Objective: Following a successful pilot study, this randomized controlled trial (RCT) aims to further test the efficacy of a brief (ie, single session) mobile phone-delivered personalized normative feedback intervention enhanced with content to promote treatment engagement.
Methods: We will conduct an RCT with 800 post-9/11 young adult veterans (aged 18 to 40 years) with potentially hazardous drinking and who have not recently received treatment for any behavioral health problems. Participants will be randomly assigned to the personalized intervention or a control condition with resources for seeking care. The personalized normative feedback module in the intervention focuses on the correction of misperceived norms of peer alcohol use and uses empirically informed approaches to increase motivation to address alcohol use and co-occurring behavioral health problems. Past 30-day drinking, alcohol-related consequences, and treatment-seeking behaviors will be assessed at baseline and 3, 6, 9, and 12 months post intervention. Sex, barriers to care, posttraumatic stress disorder, depression, and severity of alcohol use disorder symptoms will be explored as potential moderators of outcomes.
Results: We expect recruitment to be completed within 6 months, with data collection taking 12 months for each enrolled participant. Analyses will begin within 3 months of the final data collection point (ie, 12 months follow-up).
Conclusions: This RCT will evaluate the efficacy of a novel intervention for non-treatment-seeking veterans who struggle with hazardous drinking and possible co-occurring behavioral health problems. This intervention has the potential to improve veteran health outcomes and overcome significant barriers to treatment.
Trial registration: ClinicalTrials.gov NCT04244461; https://clinicaltrials.gov/study/NCT04244461.
International registered report identifier (irrid): DERR1-10.2196/59993.
Background: Diabetes is a growing concern worldwide, particularly in low- and middle-income countries (LMICs). Type 2 diabetes mellitus constitutes a significant proportion of cases and is associated with debilitating microvascular complications. Type 2 diabetes mellitus is steadily increasing among the LMICs where many barriers to health care exist. Thus, task shifting to community health workers (CHWs) has been proposed as a solution to improve diabetes management in these settings. However, CHWs often lack the necessary training to manage diabetes effectively. Thus, a systematic review is required to present evidence of the highest degree for this intervention.
Objective: This study aims to establish the protocols for a systemic review.
Methods: Using the Participants Intervention Comparator Outcome Time Study Design (PICOTS) framework, this study outlines a systematic review aiming to evaluate the impact of training programs for CHWs in diabetes management in LMICs. Quantitative studies focusing on CHWs, diabetes training, focusing on diabetes management outcomes like hemoglobin A1c levels and fasting blood glucose levels, between January 2000 and December 2023 and found on databases such as PubMed, Ovid MEDLINE, Evidence Based Medicine Reviews, BASE, Google Scholar, and Web of Science will be included. We will include randomized controlled trials but will also include observational studies if we find less than 5 randomized controlled trials. An author committee consisting of 3 reviewers will be formed, where 2 reviewers will conduct the review independently while the third will resolve all disputes. The Cochrane Methods Risk of Bias Tool 2 will be used for assessing the risk of bias and the Grading of Recommendations, Assessment, Development and Evaluation approach for the meta-analysis and narrative synthesis analysis will be used. The results will be presented in a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram.
Results: The review will begin in May 2024 and conclude in 3 months.
Conclusions: The review will synthesize existing evidence and provide insights into the effectiveness of such programs, informing future research and practice in diabetes care in LMICs.
Trial registration: PROSPERO CRD42022341717; https://tinyurl.com/jva2hpdr.
International registered report identifier (irrid): PRR1-10.2196/57313.
Unstructured: Background: Cognitive impairment is one of the major diseases facing the aging society. The progressive decline of cognitive function will lead to the decline or even loss of life, work and social ability. Exercise and behavioral stimulation can increase neurotransmitters in the brain and improve overall health and cognitive function. Reactivity training can mobilize neuromuscular function and induce changes in brain plasticity, which may effectively improve cognitive dysfunction and delay the occurrence and development of Alzheimer's disease, but the evidence of its effectiveness is still limited. Methods: This study is a single-center, open-label, controlled clinical trial. Seventy-eight participants will be recruited for the study, including an equal number of athletes, average healthy college students, and average older adults in the community. Subjects will receive two weeks of visual-motor response training. The primary outcome of this study was to assess the imaging difference of functional magnetic resonance imaging (fMRI) at 2 weeks. Secondary outcomes are acousto-optic response time, Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Mini-mental State Examination (MMSE), Activity of Daily Living Scale (ADL), Subjective Cognitive Decline Questionnaire-9 (SCD-Q9), 10-word memory test and safety. Results: The study was approved by the Shanghai Clinical Research Ethics Committee on January 2, 2024 (ethical reference: SECCR/2023-162-01). As of February 31, 2024, we have recruited 53 participants. We expect to complete recruitment in April 2024 and expect to complete the collection and analysis of study data in July 2024. Discussion: The purpose of this study is to compare improvements in brain perceptual motor functional characteristics and cognitive levels in different populations by response ability training, and to explore the efficacy and safety of exercise-based non- pharmacological therapies in improving cognitive function. Other potential benefits include understanding the functional differences and perceptual characteristics of the brain's perceptual-motor system between athletes and the general population, and exploring the adaptability of the brain for acquiring skills during training in competitive sports, thus providing an evidence base for early sports talent development and broader youth development. Trial registration: Chinese Clinical Trial Registry ID: ChiCTR2400079602. Registered 8 Jan 2024, Available at: www.chictr.org.cn/showproj.html?proj=215669 Abbreviations: AD=Alzheimer's disease (AD), DMC=data Monitoring Committee, fMRI=functional magnetic resonance imaging.
Background: One strategy to prevent adverse effects resulting from chemotherapy treatment is to perform physical exercises during treatment. However, there is still no consensus on the best type and intensity of exercise, nor when it should be started. Most studies have been carried out in patients with breast cancer, usually a few weeks after starting chemotherapy, on an outpatient basis 2 to 3 times a week. The main differences in our study are that we carried out physical training in hospitalized patients undergoing a cycle of chemotherapy for cancer treatment and that this training was carried out 5 times a week and was not restricted to a specific type of cancer.
Objective: We aimed to evaluate the effects of aerobic training on symptoms related to chemotherapy (nausea, vomiting, asthenia, and sensation of weakness), fatigue, mobility, clinical complications, and length of hospital stay of patients during the drug treatment cycle. We also evaluated patient satisfaction with the proposed intervention, the adverse effects of aerobics training, and the cost-effectiveness of this intervention.
Methods: This is a controlled and randomized trial with blinded evaluation that will include 94 hospitalized patients with cancer for 1 or more cycles of chemotherapy. The intervention group will perform aerobic training during a cycle of chemotherapy. The control group will receive a booklet with guidelines for staying active during the hospitalization period. The groups will be compared using a linear mixed model for fatigue, mobility, and chemotherapy-related symptoms before and after the intervention. The length of hospital stay will also be compared between groups using Kaplan-Meier survival analysis. The incidence of complications will be compared using the χ2 test. Cost-effectiveness and cost-utility analyses will be performed for the impact of exercise and quality-adjusted life years with the EQ-5D-3L-21 quality of life trials. The implementation variables (acceptability, suitability, and feasibility) will be evaluated by frequencies.
Results: The clinical trial registration was approved in March 2023. Recruitment and data collection for the trial are ongoing, and the results of this study are likely to be published in late 2025.
Conclusions: Chemotherapy has side effects that negatively impact the quality of life of patients with cancer. Aerobic exercise can reduce these side effects in a simple and inexpensive way. The field of work of physical therapists could be expanded to oncology if the intervention works.
Trial registration: Registro Brasileiro de Ensaios Clínicos RBR-6b4zwx3; https://tinyurl.com/39c4c7wz.
International registered report identifier (irrid): DERR1-10.2196/60828.
Background: It is recommended that children should avoid eating dinner, being physically active, or using screens in the hour before bed to ensure good sleep health. However, the evidence base behind these guidelines is weak and limited to cross-sectional studies using questionnaires.
Objective: The aim of this randomized crossover trial was to use objective measures to experimentally determine whether recommendations to improve sleep by banning electronic media, physical activity, or food intake in the hour before bed, impact sleep quantity and quality in the youth.
Methods: After a baseline week to assess usual behavior, 72 children (10-14.9 years old) will be randomized to four conditions, which are (1) avoid all 3 behaviors, (2) use screens for at least 30 minutes, (3) be physically active for at least 30 minutes, and (4) eat a large meal, during the hour before bed on days 5 to 7 of weeks 2 to 5. Families can choose which days of the week they undertake the intervention, but they must be the same days for each intervention week. Guidance on how to undertake each intervention will be provided. Interventions will only be undertaken during the school term to avoid known changes in sleep during school holidays. Intervention adherence and shuteye latency (time from getting into bed until attempting sleep) will be measured by wearable and stationary PatrolEyes video cameras (StuntCams). Sleep (total sleep time, sleep onset, and wake after sleep onset) will be measured using actigraphy (baseline, days 5 to 7 of each intervention week). Mixed effects regression models with a random effect for participants will be used to estimate mean differences (95% CI) for conditions 2 to 4 compared with condition 1.
Results: Recruitment started in March 2024, and is anticipated to finish in April 2025. Following data analysis, we expect that results will be available later in 2026.
Conclusions: Using objective measures, we will be able to establish if causal relationships exist between prebedtime behaviors and sleep in children. Such information is critical to ensure appropriate and achievable sleep guidelines.
Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12624000206527; https://tinyurl.com/3kcjmfnj.
International registered report identifier (irrid): DERR1-10.2196/63692.
Background: Osteoarthritis of the hip joint is an increasing functional and health-related problem. The most common surgical treatment is hip replacement to reduce pain and improve function. Rehabilitation after total hip arthroplasty (THA) is not regulated in Austria and mostly depends on the patient's own initiative and possibilities. Functional deficits, such as valgus thrust of the leg, functional Trendelenburg gait, or Duchenne limp, are characteristic symptoms before and, due to the performance learning effect prior to surgery, also after the operation. Addressing these deficits is possible through neuromuscular-focused exercise therapy. The efficacy of such therapy relies significantly on the quality of performance, the frequency of exercise, and the duration of engagement. Enhancing sustainability is achievable through increased motivation and real-time feedback (RTF) on exercise execution facilitated by digital feedback systems.
Objective: This study will be performed to quantify the medium-term effectiveness of digital home exercise feedback systems on functional performance following THA.
Methods: A clinical trial with a cluster-randomized, 2-arm, parallel-group design with an 8-week intervention phase and subsequent follow-ups at 3 and 6 months postsurgery will be conducted. Feedback during exercising will be provided through a blended-care program, combining a supervised group exercise program with a self-developed digital feedback system for home exercise. In total, 70 patients will be recruited for baseline. The primary outcome parameters will be the frontal knee range of motion, pelvic obliquity, and lateral trunk lean. Secondary outcomes will be the sum scores of patient-reported outcomes and relevant kinematic, kinetic, and spatiotemporal parameters.
Results: The trial started in January 2024, and the first results are anticipated to be published by June 2025. RTF-supported home exercise is expected to improve exercise execution quality and therapeutic adherence compared to using paper instructions for excise guidance.
Conclusions: The anticipated findings of this study aim to offer new insights into the effect of a blended-care program incorporating digital RTF on exercise therapy after unilateral THA, in addition to knowledge on the functional status 3 and 6 months postsurgery, for further improvement in the development of rehabilitation guidelines following THA.
Trial registration: ClinicalTrials.gov: NCT06161194; https://clinicaltrials.gov/study/NCT06161194.
International registered report identifier (irrid): PRR1-10.2196/59755.
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