Neurological Rehabilitation Centre Godeshoehe, Bonn, Germany
Department of Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany.
BMJ Open. 2022 Sep 6;12(9):e062160. doi: 10.1136/bmjopen-2022-062160.
Subjective fatigue and objectively assessed fatigability are common symptoms in persons with multiple sclerosis (pwMS). Recent work has suggested a positive effect of balance and motor control training (BMCT) in reducing fatigue. It is unclear whether this effect can also be attained during inpatient rehabilitation. Multimodal agility-based exercise training (MAT) has been developed as a framework that incorporates BMCT with added agility components but has not been applied to pwMS. Therefore, this study will evaluate the feasibility of a randomised controlled trial comparing MAT against strength and endurance training (SET) for the improvement of MS-related fatigue and fatigability in a German neurological rehabilitation centre.
A total of 24 pwMS (Expanded Disability Status Scale ≤5.0, Fatigue Scale for Motor and Cognitive Functions ≥53) will be randomly assigned to either SET or land and water-based MAT for 4-6 weeks during inpatient rehabilitation. Assessments of subjective fatigue, motor and cognitive fatigability, cognitive and cardiorespiratory performance, and balance confidence will be performed at admission and discharge. Subjective fatigue will also be assessed at 1, 4 and 12 weeks after discharge. Feasibility outcomes will include patients' acceptance of study procedures and interventions, recruitment rate, retention rate, time needed to complete baseline assessments, intervention adherence and fidelity. All quantitative outcomes will be reported descriptively. A total of 12 pwMS (6 per group) will be interviewed to gain insights into participants' experiences during study participation.
Ethical approval has been obtained from the Ethics Committee of the University of Bonn (reference number: 543/20). Dissemination of findings is planned via peer-reviewed journals, conferences and media releases.
DRKS00023943.
主观疲劳和客观评估的疲劳易感性是多发性硬化症（pwMS）患者常见的症状。最近的研究表明，平衡和运动控制训练（BMCT）对减轻疲劳有积极作用。但在住院康复期间，这种效果是否能够实现尚不清楚。基于多模态敏捷性的运动训练（MAT）已经作为一种框架被开发出来，它将 BMCT 与附加的敏捷性成分相结合，但尚未应用于 pwMS。因此，本研究将评估在德国神经康复中心，比较 MAT 与力量和耐力训练（SET）对改善 MS 相关疲劳和疲劳易感性的随机对照试验的可行性。
共有 24 名 pwMS（扩展残疾状况量表≤5.0，运动和认知功能疲劳量表≥53）将在住院康复期间随机分配到 SET 或陆地和水上 MAT 组，进行 4-6 周的治疗。在入院和出院时进行主观疲劳、运动和认知疲劳易感性、认知和心肺功能以及平衡信心的评估。出院后 1、4 和 12 周还将评估主观疲劳。可行性结果将包括患者对研究程序和干预措施的接受程度、招募率、保留率、完成基线评估所需的时间、干预依从性和保真度。所有定量结果将进行描述性报告。总共将对 12 名 pwMS（每组 6 名）进行访谈，以了解参与者在研究参与期间的体验。
波恩大学伦理委员会已批准该研究（参考编号：543/20）。计划通过同行评议的期刊、会议和媒体发布来传播研究结果。
DRKS00023943。
