E-based physical exercise in patients with multiple sclerosis and comorbidity (COMPACT): feasibility study and protocol for a randomized controlled trial

Background: Comorbidity is prevalent among people with multiple sclerosis (pwMS) and may contribute to disease progression. Physical exercise (PE) reduces symptoms in pwMS and also benefits comorbidities. Digital (e)-based PE has been proposed as a tool to support the integration of PE. Aims: To describe a protocol for a randomized controlled trial (RCT) based on a structured approach and the results from a controlled feasibility study of an e-based PE intervention in pwMS with and without comorbidities. Method: In a RCT following a feasibility study (n=50), patients will be randomly assigned in a 1:1 ratio to receive either usual care (n=150) or usual care plus an e-based PE program at home (n=150). The exercise program consists of resistance training with resistance bands targeting the lower extremities. The sessions will enable participants to engage in group exercises from their homes, supervised online by physiotherapists, two 60-minute sessions per week for 6 months (24 weeks and 48 sessions). The primary endpoint is change of walking capacity using the 6-minutes' walk test. Secondary endpoints include "no evidence of disease activity" (NEDA)-3 scale, measures of quality of life and fatigue as well as levels of neurofilament light chain in blood and cerebrospinal fluid.Results of the feasibility study: Fifty individuals were eligible and randomized to an intervention group (n = 23) or to a usual care control group (n = 27). A total of 24 sessions were conducted for three months in groups of 6, supervised by the physiotherapist. In the intervention group, two pwMS did not begin the PE program due to occupational constraints with a resulting recruitment rate of 91.3% (21/23). Of the remaining 21 individuals, 16 (76.2%) completed the follow-up assessments with a mean attendance of 15.2 (range 6-22) sessions per participant, corresponding to a 63% adherence rate. No intervention-related adverse events were reported. Conclusion: This protocol describes a prospective RCT study and the supporting feasibility data of an e-based PE performed at home. The effects of e-based PE performed at home will be evaluated, offering a significant contribution to the field of digital healthcare solutions and MS. Clinical Trial Registration: https://clinicaltrials.gov/, identifier NCT06298201.