Feasibility and initial efficacy of a wheelchair exercise-training intervention for persons with multiple sclerosis

对多发性硬化症患者进行轮椅运动训练干预的可行性和初步效果

基本信息

批准号：
10570319
负责人：
Stephanie Silveira Gee
金额：
$ 5.28万
依托单位：
UNIVERSITY OF NORTH TEXAS
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-04-01 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10570319
关键词：
Adult Adverse event Aerobic Exercise Attention Behavior Behavioral Body Composition Central Nervous System Cerebral Palsy Cholesterol Chronic Clinical Trials Communities Data Disease Disease Management Disparity Educational Intervention Educational workshop Equipment Exclusion Exercise Fatigue Feedback Fellowship Focus Groups Foundations Functional disorder Future Glucose Glycosylated hemoglobin A Goals Guidelines Health Health Benefit Health Promotion Home Immune Immune System Diseases Insurance Intervention Interview Mediating Medical Care Costs Medical center Mental Depression Metabolic Mission Multiple Sclerosis Nature Needles Neurodegenerative Disorders Occupational Therapy Outcome Pain Participant Pathway interactions Perception Personal Satisfaction Persons Pharmacological Treatment Physical activity Physical therapy Population Prevention Process Productivity Protocols documentation Quality of life Randomized Randomized, Controlled Trials Recommendation Rehabilitation therapy Reporting Research Safety Sample Size Sampling Spinal cord injury Structure Surveys Symptoms Testing Training Programs Transportation Triglycerides United States United States National Institutes of Health Update Wellness Program Wheelchairs White Matter Disease behavior change community engaged research comorbidity cost disability efficacy trial evidence base evidence based guidelines exercise intervention exercise prescription exercise program exercise training experience feasibility testing formative assessment gray matter improved insight interest meetings member multiple sclerosis patient novel physically handicapped preference programs recruit rehabilitation management rehabilitation research satisfaction strength training symptom management symptomatic improvement time use

项目摘要

Project Summary There are an estimated 1 million adults currently living with multiple sclerosis (MS) in the United States. Based on the unique and progressive nature of MS, up to one third of the MS population requires full or part- time use of a wheelchair. Exercise training is identified as a safe, effective second-line therapy for aiding in MS symptom management, however wheelchair users with MS have been excluded from the majority of research investigating the efficacy and promotion of exercise in MS. Wheelchair users with MS are unique from wheelchair users with other chronic disabling conditions such as spinal cord injury and cerebral palsy (e.g., immune system dysfunction and variable disease course), and warrant focal applications of exercise training that suit disease-specific needs and preferences. Novel exercise training programs for wheelchair users with MS would potentially reduce long-term medical costs through improved symptoms, body composition, and overall health (i.e., reduced comorbid conditions). The overarching goal of the proposed research is to obtain feasibility and initial efficacy data for delivering a stakeholder-informed, home-based, remotely-supported and supervised exercise training program among wheelchair users with MS. Our research team initiated a three-step community-engaged research agenda that provided a foundation for the proposed research. First, semi-structured interviews with wheelchair users with MS regarding preferences for exercise training provided a foundation indicating the need for structured, home- based exercise training. Next, we recruited a community advisory board to advise the research team in creating a wheelchair exercise training program. Subsequently, focus group participants provided feedback regarding the appropriateness of the proposed exercise training program materials and delivery to guide final adaptations. This process yielded a novel exercise training program for wheelchair used with MS that will be tested for feasibility and initial efficacy in the proposed study. Twenty-four wheelchair users with MS will be recruited in the Dallas-Fort Worth Metroplex and randomized into exercise training or attention/contact control wellness condition delivered over a 16-week period. The study will assess the feasibility (Specific Aim 1: recruitment, retention, and safety), acceptability (Specific Aim 2: participant satisfaction and perceptions), and scientific outcomes of interest (Specific Aim 3: metabolic health, MS symptoms, and exercise behavior change). If successful, the proposed research will provide critical data for guiding a larger efficacy trial that may substantially move the needle in rehabilitation research and practice for wheelchair users with MS given there are no evidence-based physical activity guidelines for this segment of the MS population. The proposed research is directly aligned with NIH Pathways to Prevention Workshop: Can Physical Activity Improve the Health of Wheelchair Users? and the National Center for Medical Rehabilitation Research Center’s mission of enhancing the health, productivity, independence, and quality of life of people with physical disabilities.

项目概要据估计，美国目前有 100 万成年人患有多发性硬化症 (MS)。基于多发性硬化症的独特性和进展性，多达三分之一的多发性硬化症人群需要完全或部分治疗运动训练被认为是治疗多发性硬化症的安全、有效的二线疗法。症状管理，但是患有多发性硬化症的轮椅使用者已被排除在大多数研究之外研究多发性硬化症轮椅使用者的锻炼效果和促进作用是独一无二的。患有其他慢性致残疾病（如脊髓损伤和脑瘫）的轮椅使用者（例如，免疫系统功能障碍和可变的疾病过程），并保证运动训练的重点应用适合轮椅使用者的特定疾病需求和偏好的新颖运动训练计划。多发性硬化症可能会通过改善症状、身体成分和治疗来降低长期医疗成本。整体健康（即减少合并症）。拟议研究的总体目标是获得提供利益相关者知情、基于家庭、远程支持和对患有多发性硬化症的轮椅使用者进行监督运动训练计划。我们的研究团队启动了一项由社区参与的三步研究议程，该议程提供了首先，对患有多发性硬化症的轮椅使用者进行半结构化访谈。关于运动训练的偏好提供了一个基础，表明需要结构化的、家庭训练接下来，我们招募了一个社区咨询委员会来为研究团队提供建议。随后，焦点小组参与者提供了反馈。关于拟议的演习训练计划材料和交付指南的适当性这一过程产生了一种针对多发性硬化症使用的轮椅的新颖运动训练计划。将在拟议的研究中测试 24 名患有多发性硬化症的轮椅使用者的可行性和初步疗效。在达拉斯-沃斯堡大都会招募并随机接受运动训练或注意力/接触控制该研究将评估 16 周内的健康状况（具体目标 1：招募、保留和安全）、可接受性（具体目标 2：参与者满意度和看法）以及感兴趣的科学成果（具体目标 3：代谢健康、多发性硬化症症状和运动行为如果成功，拟议的研究将为指导可能的更大规模的疗效试验提供关键数据。极大地推动了患有 MS 的轮椅使用者的康复研究和实践目前还没有针对这部分 MS 人群的循证体育活动指南。研究与 NIH 预防途径研讨会直接相关：身体活动能否改善轮椅使用者的健康？国家医疗康复研究中心的使命提高身体残疾者的健康、生产力、独立性和生活质量。