JMIR Publications

ABSTRACT

Background:

Multiple sclerosis (MS) is a chronic neurological disease of the central nervous system primarily affecting young adults. Common challenges in MS include fatigue, physical and cognitive impairments, associated with low levels of physical activity, unemployment, impaired health-related quality of life (HRQoL), substantial personal and societal costs.

Objective:

The purpose of this study is to investigate effects of a comprehensive intervention, CoreDISTparticipation on barriers for work, physical activity, physical functions, fatigue, and HRQoL for employed pwMS and to perform a health-economic evaluation.

Methods:

The prospective, single blinded randomized controlled trial will include 114 pwMS (Expanded Disability Status Scale (0-4)) randomly allocated to the CoreDISTparticipation intervention-group or usual care. CoreDISTparticipation is a multidisciplinary intervention delivered across healthcare levels (hospitals and municipalities) and sectors (health and employment/welfare) including 1) Information videos; hospital outpatient physiotherapist assessment; meeting with employment consultant. 2) Municipality; group-based physiotherapy for 60 minutes, 6 weeks; one indoor CoreDIST-balance session and one outdoor CoreDIST-balance and high-intensity interval session. Tailored work follow-up. 3) 6 weeks of digitally supported independent training x 2 weekly. Assessments at baseline, weeks 9, and 16. Primary outcomes: Multiple Sclerosis Work Difficulties Questionnaire-23 and ActiGraph wGT3x-BT monitors. Secondary outcomes: Trunk Impairment Scale-modified Norwegian Version, Mini-Balance Evaluation Systems Test, AccuGait Optimized force platform, Six-minute walk-test, Multiple Sclerosis Walking Scale‐12, Multiple sclerosis Impact Scale-29 Norwegian version, European Quality of Life 5-Dimension (EQ-5D-5L) and Fatigue Severity Scale.

Results:

The study will identify short- and long-term effects of CoreDISTparticipation versus usual care on work barriers, physical activity, balance, walking, fatigue and quality of life in individuals with minor to moderate MS disability. The project will provide information on health economic factors including the utility of CoreDISTparticipation versus usual care, expressed in quality-adjusted life years, long-term employment status and work-related costs. The statistical analyses will include descriptive statistics and repeated measures mixed models performed in IBM SPSS Version29.

Conclusions:

CoreDISTparticipation is an innovative approach proactively addressing physical function, physical activity, and work participation. If effective, it offers a low-cost approach that potentially may enhance quality of life, workforce sustainability and reduce societal costs. Clinical Trial: ClinicalTrials.gov identifier: NCT06110468