Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign Ave., Urbana, IL 61801, USA; 906 S. Goodwin Ave., Urbana, IL 61801, USA.
Contemp Clin Trials. 2016 Mar;47:32-9. doi: 10.1016/j.cct.2015.12.002. Epub 2015 Dec 4.
The Guidelines for Exercise in Multiple Sclerosis (GEMS) program is a randomized controlled trial (RCT) examining the feasibility and efficacy of a home-based exercise training program based on recent physical activity guidelines and principles of behavior change for improving symptoms and health-related quality of life (HRQOL) in adults with multiple sclerosis (MS). The primary aim is to assess program feasibility in the four domains of process (e.g., recruitment, retention, and adherence), resources (e.g., communication, staff requirements, and monetary costs), management (e.g., time and accuracy in data collection/entry, and reporting of adverse events) and scientific outcomes (e.g., safety, burden, participant feedback and efficacy/outcomes). The trial will recruit individuals with mild-to-moderate MS-related disability across the United States who will be randomized into intervention or waitlist control conditions. All participants will complete home-based assessments (including wearing an accelerometer for 7 days and completion of a questionnaire booklet) prior to and upon completion of the 4-month program. Participants in the intervention will receive a 4-month home-based exercise program emphasizing aerobic and resistance training. Participants will be provided with exercise equipment, a DVD, a manual and a log-book. The exercise program will be supplemented with periodic newsletters in the mail highlighting principles of behavior change, and video-chats with an exercise specialist to provide motivation and social accountability. This trial serves to inform development of Phase II and III RCTs which can determine the actual efficacy and effectiveness of home-based exercise based on the MS-specific physical activity guidelines for improving symptoms and HRQOL.
多发性硬化症运动指南（GEMS）项目是一项随机对照试验（RCT），旨在检验基于近期体力活动指南和行为改变原则的家庭运动训练方案在改善多发性硬化症患者症状和健康相关生活质量（HRQOL）方面的可行性和疗效。该方案的主要目的是评估方案在四个领域的可行性，包括过程（例如招募、保留和依从性）、资源（例如沟通、人员需求和货币成本）、管理（例如数据收集/录入的时间和准确性，以及不良事件的报告）和科学结果（例如安全性、负担、参与者反馈和疗效/结果）。该试验将在美国招募轻度至中度多发性硬化症相关残疾的个体，并将其随机分为干预组或候补对照组。所有参与者将在开始和完成 4 个月的方案之前和之后完成家庭评估（包括佩戴加速度计 7 天和完成问卷手册）。干预组参与者将接受为期 4 个月的家庭运动计划，强调有氧运动和阻力训练。参与者将获得运动设备、DVD、手册和日志本。该运动计划将通过定期邮寄的时事通讯补充，重点介绍行为改变原则，并通过视频聊天与运动专家进行交流，以提供动力和社会责任感。这项试验旨在为第二阶段和第三阶段 RCT 的开展提供信息，这些 RCT 可以根据多发性硬化症特定的体力活动指南，确定家庭运动在改善症状和 HRQOL 方面的实际疗效和有效性。
