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: 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
• 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

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 估计有100万成年人目前在美国居住多发性硬化症（MS）。 根据MS的独特和进步性质，多达三分之一的MS人口需要充分或部分 时间使用轮椅。运动训练被确定为一种安全有效的二线治疗，以帮助MS 症状管理，但是拥有MS的轮椅使用者已被排除在大多数研究之外 研究MS中运动的效率和促进。带有MS的轮椅使用者是独一无二的 轮椅使用者患有其他慢性残疾条件，例如脊髓损伤和脑瘫（例如， 免疫系统功能障碍和可变疾病病程）以及锻炼训练的焦点应用 适合特定疾病的需求和偏好。适用于轮椅使用者的新颖锻炼培训计划 MS有可能通过改善症状，身体成分和 总体健康（即降低合并症）。拟议研究的总体目标是获得 可行性和初始效率数据，用于传递利益相关者信息，以家庭为基础的，远程支持和 MS轮椅使用者的监督运动训练计划。 我们的研究团队发起了一个三步社区参与的研究议程，提供了一个 拟议研究的基础。首先，与MS的轮椅用户进行半结构化访谈 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 - 基于运动训练。接下来，我们招募了一个社区顾问委员会，以建议研究团队 创建轮椅运动训练计划。随后，焦点小组参与者提供了反馈 关于拟议的运动培训计划材料和交付以指导最终的适当性 改编。这个过程产生了一项针对MS的轮椅的新型运动训练计划，这将是 在拟议的研究中测试了可行性和初始效率。 MS的二十四个轮椅使用者将是 在达拉斯 - 沃思沃思沃思大都会 健康状况在16周期间提供。该研究将评估可行性（特定目的1： 招聘，保留和安全性），可接受性（特定目的2：参与者的满意和看法），以及 感兴趣的科学结果（特定目标3：代谢健康，MS症状和运动行为 改变）。如果成功，拟议的研究将提供关键数据，以指导更大的效率试验 在那里给了MS的轮椅使用者的康复研究和练习中的针头 不是基于证据的体育活动指南，涉及MS人群的这一部分。提议 研究直接与NIH预防研讨会的途径保持一致：体育活动可以改善 轮椅使用者的健康？以及国家医疗康复研究中心的任务 增强身体障碍患者的健康，生产力，独立性和生活质量。