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

Abstract

IntroductionSubjective 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 analysisA 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 disseminationEthical 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 numberDRKS00023943.

Experiences of fatigued persons with multiple sclerosis with multimodal agility-based exercise training and the ReFEx study protocol: a qualitative extension of a feasibility study

“…Future group-based exercise studies should include participants with similar levels of motor performance and include additional self-ratings of exercise demands, postsession. The present results, supplemented by our quantitative results, 22 further show that future studies conducted in an inpatient rehabilitation setting can involve fatigued pwMS in high-frequency exercise schedules if this includes adequate rest breaks. Furthermore, new forms of exercise interventions should be well described in the study information sheet to minimise participants favouring traditional exercise approaches.…”

“…The MAT group exercised 5 x/week for 30 min in the gym and 3 x/week for 30 min in the pool, both in a group setting of maximum eight participants. The group followed a MAT-manual (see protocol), 21 based on the three components of MAT 16 : (1) standing balance exercises, (2) dynamic balance exercises including functional leg strength and (3) agility-like exercises (eg, change of direction, change of velocity); each with defined sensory modifications and cognitive challenges. For load management in the gym-setting, three sessions with higher physical demands (ie, agility-like components and functional leg strength) were interspersed with two sessions on standing balance or exercises with a cognitive focus.…”

“…In the SET, individuals performed moderate intensity (ie, ‘light’ to ‘somewhat hard’ on the 6–20 Rated Perceived Exertion (RPE) scale) endurance training, 5 x/week for 22 min on a cycle ergometer, and strength training, 3 x/week for 30 min on machines (predetermined lower extremity exercises with progression). 21 Cycle ergometer sessions were running all day in the clinic. Thus, the SET participants had flexible schedules and trained together with around five other patients from the NRC, who did not participate in the study.…”

“…The qualitative study focused on semistructured face-toface interviews, conducted prior to discharge from the Neurological Rehabilitation Centre 'Godeshoehe' (NRC, Bonn, Germany) and was an extension of a randomised controlled feasibility study with 22 pwMS, described in detail in the protocol, 21 and the quantitative results paper. 22 In brief, eligible pwMS were informed about the study, and after consent, were randomised to perform either MAT or SET during their inpatient stay (4-6 weeks, individually determined by the treating physician based on medical indications). Participants were assessed for perceived fatigue, fatigability and further secondary outcomes at admission and discharge (ie, preintervention and postintervention).…”

“…The possibility of high-frequency exercise in this fatigued MS-collective is complemented by acquired quantitative data, showing an average adherence of 90% for both groups (596 sessions analysed). 22 Still, participants' statements indicated the importance of installing rest breaks for 30 min to 60 min, especially after the gym-sessions, as study-unrelated appointments might influence participants' ability to recover. Indeed, rest period allowing for fatigue was a common exercise facilitator in the studies reviewed by Motl and Learmonth.…”