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

项目摘要 据估计，目前美国有100万成年人患有多发性硬化症(MS)。 根据多发性硬化症的独特和进步性质，多达三分之一的多发性硬化症患者需要全部或部分- 轮椅的使用时间。运动训练被认为是治疗多发性硬化症的安全、有效的二线治疗方法 症状处理，然而患有多发性硬化症的轮椅使用者被排除在大多数研究之外 研究MS的锻炼效果和促进作用轮椅使用者患有MS是独特的 具有其他慢性残疾情况的轮椅使用者，例如脊髓损伤和脑瘫(例如， 免疫系统功能障碍和不同的病程)，并保证重点应用运动训练 适合特定疾病的需求和偏好。为轮椅使用者提供新颖的运动训练计划 多发性硬化症可能会通过改善症状、身体成分和 总体健康(即减少并存疾病)。拟议研究的首要目标是获得 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的运动训练计划。 我们的研究团队启动了一个三步社区参与的研究议程，提供了一个 为拟议的研究奠定了基础。首先，对患有多发性硬化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，表明需要有组织的、家庭- 以锻炼为基础的训练。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 创建轮椅运动训练计划。随后，焦点小组参与者提供了反馈 关于建议的运动训练计划材料和交付的适当性，以指导最终 改编。这一过程产生了一种新的轮椅运动训练计划，该计划将与MS一起使用 在拟议的研究中对可行性和初步效果进行了测试。24名患有多发性硬化症的轮椅使用者将 在达拉斯-沃斯堡大都会医院招募，并随机进入运动训练或注意力/接触控制 健康状况在16周内交付。研究将评估可行性(具体目标1： 招聘、留住和安全)、可接受性(具体目标2：参与者满意度和看法)； 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 更改)。如果成功，拟议的研究将为指导一项更大规模的疗效试验提供关键数据，该试验可能 多发性硬化症轮椅使用者康复研究与实践大动干戈 对于这部分多发性硬化症人群，没有基于证据的体力活动指南。建议数 研究直接与NIH预防之路研讨会相一致：体力活动能改善 轮椅使用者的健康？和国家医疗康复中心康复研究中心的使命 提高肢体残疾人的健康、生产力、独立性和生活质量。

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.