Capitalising on the Opinions of Persons with MS to Inform the Main Trial. Participant Opinions from Participation in a Feasibility Study

Background: Patient and public involvement and engagement (PPIE) is endorsed by the National Institute of Health and other entities internationally for identifying and prioritising patient-driven research agendas. PPIE is an important step in translating research from feasibility trials to larger Phase II and phase III studies. Guidelines for exercise in multiple sclerosis (MS) have been established and these have important translational utility for MS research. However participation in exercise research studies is low amongst persons with MS. To date there has been minimal engagement with persons with MS in research design involving exercise. It is important to understand participant experiences in exercise research participation, and this will improve the translation of preliminary research into a larger phase II efficacy study that encourages exercise behaviours amongst persons with MS.

Objectives: To understand experiences of persons with MS related to participation in a feasibility study of a home-based exercise intervention supplemented with behavioural change modules and based on current physical activity guidelines for MS – Project GEMS.

Methods: Eighteen participants with mild to moderate disability as a result of MS, and who lived across the United States engaged in telephone interviews and providing written feedback for this study. All participants were the original Project GEMS intervention participants and they were asked to comment on the following topics; initial participation in the research process, experiences participating in the study (i.e., home-based assessment and intervention), and suggestions for study improvement. Coding and thematic analysis was performed on the qualitative data.

Results:  Analysis identified three main themes for improving the research for a future phase II efficacy study. Themes were 1) informing persons with MS about research (e.g., clinical sites, email mail outs and advertisements on MS organisation websites), 2) overcoming problems of research participation (e.g., completing assessments, and complying with intervention protocol), and 3) suggestions for improving the design and delivery of the research (e.g., variety of exercise and advanced progression of exercises).  

Conclusions: Exercise participation is important for persons living with MS, and engaging persons with MS in program evaluation will provide vital information that improves the design and delivery of future exercise studies. To that end, we primarily report important data which will help engage persons with MS in research opportunities, and incorporate patient experiences and which should be included in future Phase II exercise intervention studies.