Feasibility study design and methods for Project GEMS: Guidelines for Exercise in Multiple Sclerosis
Feasibility study design and methods for Project GEMS: Guidelines for Exercise in Multiple Sclerosis
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DOI：
10.1016/j.cct.2015.12.002
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发表时间：
2016-03-01
影响因子：
2.2
通讯作者：
Motl, Robert W.
中科院分区：
文献类型：
--
作者：
Adamson, Brynn C.;Learmonth, Yvonne C.;Motl, Robert W.
多发性硬化症锻炼指南(GEM)计划是一项随机对照试验(RCT)，旨在检验基于最新体力活动指南和行为改变原则的家庭锻炼计划的可行性和有效性，以改善多发性硬化症(MS)成年人的症状和健康相关生活质量(HRQOL)。主要目的是评估项目在流程(例如招聘、保留和遵守)、资源(例如沟通、员工需求和金钱成本)、管理(例如数据收集/录入和不良事件报告的时间和准确性)和科学结果(例如安全性、负担、参与者反馈和疗效/结果)四个领域的可行性。这项试验将在全美招募患有轻度到中度多发性硬化症相关残疾的个人，他们将被随机分为干预或等待名单控制条件。在完成为期4个月的计划之前和之后，所有参与者都将完成以家庭为基础的评估(包括佩戴加速度计7天并填写问卷手册)。干预的参与者将接受为期4个月的家庭锻炼计划，重点是有氧和阻力训练。参加者将获发运动器材、数码影碟、手册及航海日志。锻炼计划将通过邮件定期发布时事通讯，强调行为改变的原则，并与锻炼专家进行视频聊天，以提供动力和社会责任感。这项试验用于为第二阶段和第三阶段随机对照试验的发展提供信息，该试验可以根据改善症状和HRQOL的MS特定体力活动指南来确定家庭锻炼的实际效果和有效性。(C)2015 Elsevier Inc.保留所有权利。
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. (C) 2015 Elsevier Inc. All rights reserved.