Abstract
We undertook a randomized controlled trial (RCT) that examined the effects of a remotely-delivered, culturally-tailored exercise training (ET) program on immediate and sustained improvements in patient-reported outcome measures (PROMs) of walking dysfunction, symptoms, and health-related quality of life (HRQOL) among African-Americans with multiple sclerosis (MS).
The study involved a Phase-II, parallel-group, RCT design, and enrolled 123 participants who were randomly assigned into remotely-delivered, culturally-tailored ET (Intervention; n = 63) or stretching and flexibility (Control; n = 60) conditions. The conditions were administered over 4-months by a behavioral coach uninvolved in screening, recruitment, random assignment, or outcome collection. We collected PROMs every 4 months over an 8-month period (baseline, immediate follow-up, 4-month follow-up). The primary PROM was walking dysfunction measured by the 12-item Multiple Sclerosis Walking Scale (MSWS-12).
The linear mixed model did not identify a statistically significant interaction between condition and time on MSWS-12 (p = .40). There was a statistically significant time effect on MSWS-12 (p < .005). This coincided with immediate and sustained reductions in MSWS-12 scores compared with baseline for both the Intervention and Control conditions that exceeded the established MCID of 8 points.
Our results provide preliminary evidence for the efficacy of two ET approaches for improving walking dysfunction in African-Americans with MS.