Feasibility, acceptability, and initial efficacy of a wheelchair exercise training program in persons with multiple sclerosis: study protocol for a parallel group randomized controlled trial.

Abstract

Purpose: This study is a randomized controlled trial (RCT) that examines the feasibility, acceptability, and initial efficacy of a home-based, remotely supported and supervised exercise training program that was developed using a three-step community engaged research process for persons with multiple sclerosis (MS) who are wheelchair users.

Materials and methods: The study design is a parallel group RCT (NCT05888727). We aim to enroll 24 wheelchair users with MS who will be randomly assigned using REDCap randomization module into exercise training or attention/contact wellness control conditions. The conditions will be delivered remotely over 16 weeks and supported using online, one-onone behavioral coaching. The feasibility outcomes of interest include recruitment and retention rates, and safety outcomes collected throughout the study period. The acceptability outcomes include participant satisfaction and perceptions measured using formative surveys and interviews following the 16-week period. Efficacy outcomes include metabolic health, MS symptoms, and exercise behavior measured before and after the 16-week period. The data analysis will follow intent-to-treat principles using 2 group by 2 time mixed factor ANOVA with estimation of Cohen's d values as effect sizes.

Conclusions: The results will guide future research targeting health outcomes using exercise training among wheelchair users with MS who have largely been absent from health promotion research.