The effects of a pragmatic exercise intervention in people with multiple sclerosis.

?Background: People with multiple sclerosis (PwMS) are less physically active than the general population. Moderate intensity exercise is likely to be safe and may provide an effective intervention for improving health outcomes for people with mild-to-moderate disability from MS. A robustly designed trial, using a pragmatic approach constructed to be cost-effective and elicit long-lasting behaviour change is required to influence health care practice.Objectives:To determine the feasibility of a pragmatic exercise intervention for PwMS and to determine if this type of intervention can provide a cost effective solution to improving health outcomes and increasing exercise and physical activity at up to nine months follow-up in PwMS compared with usual care alone.Methods: We initially conducted a feasibility randomised controlled trial, recruiting a voluntary sample of 30 PwMS (male n = 4, female n = 26; mean age 40 years; range 24 to 49 years; Expanded Disability Status Scale (EDSS) 0.0 to 5.5). Results from which informed the design of a large-scale randomised controlled trial (RCT). A total of 120 PwMS (male n = 34, female n = 86; mean age 46 years; range 19 to 65 years; EDSS 1.0 to 6.5) were then recruited to a three month exercise intervention (two supervised and one home-based session for first six weeks; one supervised and two home-based session for the final six weeks) plus usual care or usual care alone. Cognitive behavioural strategies were used to promote long-term behaviour change. The primary outcome was self-reported exercise behaviour change (Godin Leisure Time Exercise Questionnaire (GLTEQ)). Secondary outcomes included clinical, functional and quality-of- life (MSQol-54) measures.Results: The feasibility trial demonstrated that attrition was low (6.7% at immediate follow-up and 20% at three months follow-up) and compliance was high (> 75% of all sessions). The main trial reported significant improvements in self-reported exercise behaviour (p = 0.01), fatigue (p < 0.0001) and many MSQol-54 domains (p < 0.03). Only the significant improvements in overall quality of life (p = 0.001), and the sub-domains of emotional wellbeing (p = 0.01) and social function (p = 0.004) were maintained at the nine months follow-up. The probability of the intervention being cost-effective was 0.75 at the threshold of &pound;20,000 per quality adjusted life year (QALY).Conclusion: This pragmatic intervention was not only feasible, but outcomes from the main trial suggest that it is highly likely to be cost effective, leading to improved self-reported exercise behaviour, fatigue and a sustained enhancement of health-related quality of life. This provides a strong evidence base to influence the prescription of exercise into the treatment pathway for PwMS within the NHS.