Randomised controlled pilot and feasibility study of multimodal agility-based exercise training (MAT) versus strength and endurance training (SET) to improve multiple sclerosis-related fatigue and fatigability during inpatient rehabilitation (ReFEx): study protocol

INTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: DRKS00023943.