Carter A, Daley A, Humphreys L, Snowdon N, Woodroofe N, Petty J, Roalfe A, Tosh J, Sharrack B, Saxton J. Pragmatic intervention for increasing self-directed exercise behaviour and improving important health outcomes in people with multiple sclerosis: a randomised controlled trial. Mult Scler. 2014 Jan 13. [Epub ahead of print]
BACKGROUND: Exercise programmes that can demonstrate evidence of long-lasting clinical effectiveness are needed for people with multiple sclerosis (PwMS).
OBJECTIVE: The objective of this study was to assess the effects of a practically implemented exercise programme on self-directed exercise behaviour and important health outcomes in PwMS to nine months of follow-up.
METHODS: We conducted a parallel-arm, randomised controlled trial: 120 PwMS (Expanded Disability Status Scale (EDSS) 1.0-6.5) randomised to a three-month exercise intervention plus usual care, or usual care only. Two supervised plus one home-exercise session (weeks 1-6) were followed by one supervised and two home-exercise sessions (weeks 7-12). Cognitive-behavioural techniques promoted long-term exercise behaviour change. Outcomes were blindly assessed at baseline and at three and nine months after randomisation. The primary outcome was self-reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ)). Secondary outcomes included fatigue and health-related quality of life (HRQoL).
RESULTS: The intervention increased self-reported exercise (9.6 points; 95% CI: 2.0 to 17.3 points; p = 0.01) and improved fatigue (p < 0.0001) and many HRQoL domains (p ≤ 0.03) at three months. The improvements in emotional well-being (p = 0.01), social function (p = 0.004) and overall quality of life (p = 0.001) were sustained for nine months.
CONCLUSION: This pragmatic approach to implementing exercise increases self-reported exercise behaviour, improves fatigue and leads to a sustained enhancement of HRQoL domains in PwMS.
So following from yesterdays post of another fatigue trial there is some movement in this area at last. ProfG talked about deconditioning and the thought that if you are unfit then things make you tired. Get fitter and have more energy. This study shows that if you can exercise and keep at it then there can be improvements. But is it worth it?…..Is it a load of Tosh?
Will Dr Dre approve of this?
The only Tosh is the author
Tosh J, Dixon S, Carter A, Daley A, Petty J, Roalfe A, Sharrack B, Saxton JM. Cost effectiveness of a pragmatic exercise intervention (EXIMS) for people with multiple sclerosis: economic evaluation of a randomised controlled trial. Mult Scler. 2014 Jan 13.
Background: Exercise is a safe, non-pharmacological adjunctive treatment for people with multiple sclerosis but cost effective
approaches to implementing exercise within health care settings are needed.
Objective: The objective of this paper is to assess the cost effectiveness of a pragmatic exercise intervention in conjunction with usual care compared to usual care only in people with mild to moderate multiple sclerosis.
Methods: A cost-utility analysis of a pragmatic randomised controlled trial over nine months of follow-up was conducted. A total of 120 people with multiple sclerosis were randomised (1:1) to the intervention or usual care. Exercising participants received 18 supervised and 18 home exercise sessions over 12 weeks. The primary outcome for the cost utility analysis was the incremental cost per quality-adjusted life year (QALY) gained, calculated using utilities measured by the EQ-5D questionnaire.
Results: The incremental cost per QALY of the intervention was £10,137 per QALY gained compared to usual care. The probability of being cost effective at a £20,000 per QALY threshold was 0.75, rising to 0.78 at a £30,000 per QALY threshold.
Conclusion: The pragmatic exercise intervention is highly likely to be cost effective at current established thresholds,
and there is scope for it to be tailored to particular sub-groups of patients or services to reduce its cost impact.
Well every trial needs to assess whether there is cost effectiveness from the treatment, this study ticks that box. What and where next?