Abstract：
BACKGROUND: Older adults with multiple sclerosis (MS) present with low physical activity participation, cognitive and ambulatory dysfunctions, and compromised quality of life (QOL).
OBJECTIVE: We propose a NIH Stage-I, randomized controlled trial (RCT) that examines the feasibility and efficacy of a 16-week theory-based, remotely-delivered, exercise training program for improving cognitive and physical functions in older adults with MS who have moderate mobility disability without severe cognitive impairment.
METHODS: This Stage-I study utilizes a parallel-group RCT design. Participants (N = 50; age ≥ 50 years) will be randomly assigned into exercise training (combined aerobic and resistance exercise) or active control (flexibility and stretching) conditions. The conditions will be undertaken within a participant\'s home/community over a 16-week period, and monitored remotely and supported by Zoom-based chats guided by social cognitive theory (SCT) via a behavioral coach. Participants will receive training manuals and equipment, one-on-one behavioral coaching, action-planning calendars, self-monitoring logs, and SCT-based newsletters. The primary outcomes include feasibility (e.g., recruitment and retention rates), exercise behavior and physical activity; other outcomes include physical function (lower-extremity function, mobility, walking), cognition (processing speed, learning and memory, executive function), MS symptoms, QOL, and vascular function. We will collect outcome data at baseline (Week 0), post-intervention (Week 16), and follow-up (Week-32). Data analysis will follow intent-to-treat principles using linear mixed-effects models.
CONCLUSIONS: This Stage-I trial adopts an innovative approach for exercise training via telerehabilitation and is convenient and accessible for older adults with MS. If successful, the study will provide foundations for future research using remotely-delivered exercise intervention for managing the consequences of aging with MS.
BACKGROUND: NCT05930821.
OBJECTIVE: We propose a NIH Stage-I, randomized controlled trial (RCT) that examines the feasibility and efficacy of a 16-week theory-based, remotely-delivered, exercise training program for improving cognitive and physical functions in older adults with MS who have moderate mobility disability without severe cognitive impairment.
METHODS: This Stage-I study utilizes a parallel-group RCT design. Participants (N = 50; age ≥ 50 years) will be randomly assigned into exercise training (combined aerobic and resistance exercise) or active control (flexibility and stretching) conditions. The conditions will be undertaken within a participant\'s home/community over a 16-week period, and monitored remotely and supported by Zoom-based chats guided by social cognitive theory (SCT) via a behavioral coach. Participants will receive training manuals and equipment, one-on-one behavioral coaching, action-planning calendars, self-monitoring logs, and SCT-based newsletters. The primary outcomes include feasibility (e.g., recruitment and retention rates), exercise behavior and physical activity; other outcomes include physical function (lower-extremity function, mobility, walking), cognition (processing speed, learning and memory, executive function), MS symptoms, QOL, and vascular function. We will collect outcome data at baseline (Week 0), post-intervention (Week 16), and follow-up (Week-32). Data analysis will follow intent-to-treat principles using linear mixed-effects models.
CONCLUSIONS: This Stage-I trial adopts an innovative approach for exercise training via telerehabilitation and is convenient and accessible for older adults with MS. If successful, the study will provide foundations for future research using remotely-delivered exercise intervention for managing the consequences of aging with MS.
BACKGROUND: NCT05930821.
摘要：
背景：患有多发性硬化症（MS）的老年人体力活动参与率较低，认知和步行功能障碍，生活质量（QOL）受损。
目的：我们提出NIH第一阶段，随机对照试验（RCT），检查了基于16周理论的可行性和有效性，远程交付，运动训练计划，用于改善患有中度活动障碍且无严重认知障碍的MS老年人的认知和身体功能。
方法：本I期研究采用平行组RCT设计。参与者（N=50;年龄≥50岁）将被随机分配到运动训练（有氧和阻力运动相结合）或主动控制（柔韧性和伸展）条件。这些条件将在16周内在参与者的家中/社区内进行，并远程监控，并通过行为教练由社会认知理论（SCT）指导的基于缩放的聊天支持。参加者将获得培训手册和设备，一对一的行为辅导,行动计划日历，自我监控日志，和基于SCT的新闻通讯。主要结果包括可行性(例如，招聘和保留率)，锻炼行为和身体活动；其他结果包括身体功能(下肢功能，移动性,步行)，认知(处理速度，学习和记忆，执行功能)，MS症状,QOL,和血管功能。我们将在基线（第0周）收集结果数据，干预后（第16周），和随访（第32周）。数据分析将遵循使用线性混合效应模型的意向治疗原则。
结论：此阶段-I试验采用了一种通过远程康复进行运动训练的创新方法，对于患有MS的老年人来说很方便。如果成功,该研究将为未来的研究提供基础，使用远程提供的运动干预来管理MS衰老的后果。
背景：NCT05930821。
目的：我们提出NIH第一阶段，随机对照试验（RCT），检查了基于16周理论的可行性和有效性，远程交付，运动训练计划，用于改善患有中度活动障碍且无严重认知障碍的MS老年人的认知和身体功能。
方法：本I期研究采用平行组RCT设计。参与者（N=50;年龄≥50岁）将被随机分配到运动训练（有氧和阻力运动相结合）或主动控制（柔韧性和伸展）条件。这些条件将在16周内在参与者的家中/社区内进行，并远程监控，并通过行为教练由社会认知理论（SCT）指导的基于缩放的聊天支持。参加者将获得培训手册和设备，一对一的行为辅导,行动计划日历，自我监控日志，和基于SCT的新闻通讯。主要结果包括可行性(例如，招聘和保留率)，锻炼行为和身体活动；其他结果包括身体功能(下肢功能，移动性,步行)，认知(处理速度，学习和记忆，执行功能)，MS症状,QOL,和血管功能。我们将在基线（第0周）收集结果数据，干预后（第16周），和随访（第32周）。数据分析将遵循使用线性混合效应模型的意向治疗原则。
结论：此阶段-I试验采用了一种通过远程康复进行运动训练的创新方法，对于患有MS的老年人来说很方便。如果成功,该研究将为未来的研究提供基础，使用远程提供的运动干预来管理MS衰老的后果。
背景：NCT05930821。
