Clinician-led, single-blind, randomised controlled trial evaluating the efficacy of a high-intensity resistance and impact training intervention for improving health-related quality of life in people with multiple sclerosis: protocol for STRONG-MS.

Abstract

Introduction: People with multiple sclerosis (MS) engage in less physical activity and experience higher rates of osteoporosis, falls and fractures than the general population, contributing to reduced health-related quality of life (HRQoL) and increased healthcare costs. High-intensity resistance and impact training (HiRIT) has beneficial effects on bone, muscle and physical function in other populations, but its effectiveness in people with MS is unclear.

Methods and analysis: STRONG-MS is a codesigned, clinician-led, single-blind, randomised controlled trial evaluating the effect of a HiRIT programme, ONERO, on HRQoL for people with MS. Secondary aims include assessing changes in bone mineral density, body composition, physical function, fatigue, mood as well as intervention safety, feasibility, acceptability, sustainability and cost-effectiveness. One hundred and eighty participants will be randomised (2:1) to ONERO or usual care for 12 months. The intervention comprises two times weekly, supervised, small-group sessions delivered by accredited allied health professionals. Outcomes will be assessed at 12 and 24 months using intention-to-treat analyses. Sustainability will be evaluated during a second 12-month period, during which participants fund ongoing participation privately or through support schemes.

Ethics and dissemination: The study has approval from a Health Human Research Ethics Committee. All participants will provide written informed consent. Findings will be disseminated through peer-reviewed publications, conference presentations and summaries for participants, consumer representatives and community organisations. This study will provide novel evidence on the ability of the ONERO to improve HRQoL and musculoskeletal health in people with MS as well as its feasibility, acceptability and sustainability, to inform poststudy implementation.