Pragmatic exercise intervention in people with mild to moderate multiple sclerosis: A randomised controlled feasibility study

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Abstract

Background

People with Multiple Sclerosis (PwMS) are less physically active than the general population and pragmatic approaches designed to equip them with the skills and confidence to participate in long-term physical activity are required.

Objective

The objective of this study was to determine the feasibility of a pragmatic exercise intervention in PwMS.

Methods

A voluntary sample of 30 PwMS (male n = 4, female n = 26; mean age = 40 years; range = 24–49 years), with mild to moderate disability (EDSS  5.5), were recruited from eligible participants attending outpatient clinics. A total of 28 participants were randomised to a 10 week pragmatic exercise intervention (2 × supervised and 1 × home-based session per week) or usual care. Clinical, functional and quality of life (MSQoL-54) outcomes were assessed at baseline, immediately and 3 months after the intervention.

Results

Attrition was low (2 participants lost to immediate follow-up and 4 participants lost to 3 month follow-up), with high compliance rates (> 75% of all sessions). The intervention group achieved progression of exercise volume (24.3 ± 7.0 to 30.9 ± 5.5 min per session), intensity (60.4 ± 8.8 to 67.7 ± 6.9% HR max) and training impulse (min × average HR = training impulse/load [arbitrary units; AU]) (2600 ± 1105 to 3210 ± 1269 AU) during the intervention, whilst significantly increasing(P = 0.050) their physical composite score (MSQOL-54) at 10 weeks and readiness to exercise (P = 0.003) at 3 months compared with usual care.

Conclusion

This pragmatic intervention was feasible for PwMS, but further research is needed to assess its long-term impact on physical activity behaviour.

Introduction

Evidence suggests that People with Multiple Sclerosis (PwMS) are less physically active than the general population [1], but exercise self-efficacy has consistently been reported to influence participation [2], [3]. Current research supports the health benefits of supervised, one to one facility based exercise interventions for people with mild to moderate disability from Multiple Sclerosis (MS). These include, increased muscle strength and aerobic capacity, improved mood state and enhanced quality of life (QoL), with no evidence of patient harm [4], [5]. In the long-term, this approach may prove difficult for PwMS and is unlikely to be cost effective. More high quality randomised control trials (RCTs) to assess the efficacy of pragmatic interventions for equipping PwMS with the skills and confidence needed to exercise independently long-term are required [6]. This is important as despite the benefits of exercise, PwMS appear to find long-term exercise behaviour change difficult and interventions based on behaviour change theories are likely to optimise the chances of long term behaviour change. One approach to this is the Transtheoretical Model [7] of behaviour change, which outlines a series of stages that people move through in the behaviour change process and suggests strategies or processes that can be used to facilitate movement through the stages. This model has been used to promote physical activity behaviour change in other populations but not in PwMS [8].

The primary aim of this study was to investigate the feasibility of a ‘pragmatic’ exercise intervention, that included cognitive–behavioural strategies within the framework of the Transtheoretical Model, to facilitate long term physical activity behaviour change in PwMS. In this study ‘pragmatic’ is defined as a practical, achievable and flexible programme that allows for individual choice and utilises behaviour change tools to enhance self-efficacy and promote long-term behaviour change. Feasibility was measured in terms of recruitment, acceptability of the intervention, compliance and attrition, safety and suitability of exercise dose and appropriateness of outcome measures. The secondary aim was to obtain preliminary data on the impact of the intervention on key health outcomes by comparison with PwMS randomised to a usual care control group. We hypothesized that PwMS will find a pragmatic approach to exercise feasible, with results indicating improvements in physical function and quality of life.

Section snippets

Participant inclusion/exclusion criteria

A total of 30 participants were recruited from MS clinics at Sheffield Teaching Hospitals NHS Foundation Trust (UK). All participants were aged 18–65 years, fulfilled the modified McDonald diagnostic criteria for MS [9], had an Expanded Disability Status Score (EDSS; [10]) ≤ 5.5 and were stable on disease modifying treatment for ≥ 3 months prior to recruitment. Participants who experienced relapses within the preceding 3 months, had other illnesses substantially affecting their ability to exercise

Recruitment, retention and compliance

Thirty PwMS were recruited at a rate of 1.4 participants per month, of these 28 were randomised to pragmatic exercise (n = 15) or usual care control (n = 13). Two participants withdrew prior to randomization (increased commitments, opted to participate in drugs trial). Table 1 shows the baseline characteristics of participants.

From the usual care group, one participant withdrew in week 10 (MS relapse), whilst in the intervention group, one participant withdrew in week 5 due to increased work and

Discussion

This study evaluated the feasibility of a mixed (supervised and home-based) pragmatic exercise intervention, designed to promote confidence and motivation for self-directed exercise in people with mild to moderate disability due to MS. Our findings suggest that this type of intervention is feasible, with excellent retention (10 weeks, 87%; 3 months, 80%) and high compliance (> 75% of all sessions) rates, and with this pragmatic approach leading to progression in exercise duration and intensity

Conclusions

Our findings suggest that this type of pragmatic exercise intervention is feasible for people with mild to moderate MS, with good compliance reported for both aspects of the programme. No other studies to date have investigated the feasibility of this type of pragmatic exercise programme, combining individually tailored aerobic (supervised and home-based) exercise, with flexibility, balance and core work, and behavioural strategies to encourage PwMS to be more physically active. In addition, a

Acknowledgements

This project was funded by Sheffield Teaching Hospitals NHS Foundation Trust and a larger scale randomised controlled trial has been funded by the UK Multiple Sclerosis Society.

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