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

• 批准号: 10922555
• 负责人: Stephanie Silveira Gee
• 金额: $ 10.87万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-10-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10922555
• 关键词: Feasibility; Initial; Efficacy; Wheelchair; Exercise

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.

项目摘要 据估计，美国目前有100万成年人患有多发性硬化症（MS）。 基于MS的独特性和渐进性，多达三分之一的MS人群需要完全或部分- 使用轮椅的时间运动训练被认为是一种安全、有效的辅助MS的二线治疗方法 症状管理，然而，大多数研究都排除了患有MS的轮椅使用者 调查MS中运动的功效和促进。MS轮椅使用者是独特的， 患有诸如脊髓损伤和脑瘫等其他慢性残疾状况的轮椅使用者（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 适合特定疾病的需求和偏好。轮椅使用者的新型运动训练计划， MS可能会通过改善症状，身体成分和治疗来降低长期医疗费用。 整体健康（即，减少的共病状况）。拟议研究的总体目标是获得 可行性和初步疗效数据，以提供一个知情的，基于家庭的，远程支持， MS轮椅使用者的监督运动训练计划。 我们的研究团队启动了一个三步社区参与的研究议程， 为拟议的研究奠定基础。首先，对患有MS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- 基础训练。接下来，我们招募了一个社区咨询委员会， 创建一个轮椅运动训练项目。随后，焦点小组参与者提供了反馈意见 关于拟议的运动训练计划材料和交付的适当性，以指导最终 适应这一过程产生了一个新的运动训练计划，轮椅使用与MS， 在拟议的研究中测试了可行性和初步疗效。24名患有多发性硬化症的轮椅使用者将被 在达拉斯-沃斯堡大都会区招募，随机分为运动训练组和注意力/接触控制组 在16周内提供健康状况。该研究将评估可行性（具体目标1： 招募、保留和安全性）、可接受性（具体目标2：参与者满意度和感知），以及 感兴趣的科学结果（具体目标3：代谢健康、MS症状和运动行为 改变）。如果成功，拟议的研究将为指导更大规模的疗效试验提供关键数据， 实质上移动针在康复研究和实践的轮椅使用者与MS给予那里 对于这部分MS人群，没有基于证据的体力活动指南。拟议 研究直接与NIH预防途径研讨会：体育活动可以改善 轮椅使用者的健康？和国家医疗康复研究中心的使命 提高身体残疾人的健康、生产力、独立性和生活质量。