Safety of exercise training in multiple sclerosis: a protocol for an updated systematic review and meta-analysis

L. A. Pilutti,A. P. Metse,Y. C. Learmonth,R. W. Motl,B. Chan,M. P. Herring

doi:10.1186/s13643-021-01751-0

Abstract

BackgroundThere has been an exponential growth in the number of clinical research studies regarding exercise training in multiple sclerosis, and literature reviews and meta-analyses have documented the many benefits of exercise training. This research further requires careful review for documenting the safety of exercise training in multiple sclerosis, as clarity on safety represents a major hurdle in the clinical prescription of exercise behaviour.ObjectivesTo enhance understanding of the feasibility of exercise in multiple sclerosis, we (1) provide a protocol of a systematic review and meta-analysis that summarises rates and risks of clinical relapse, adverse events (i.e., an unfavourable outcome that occurs during the intervention delivery time period), and serious adverse events (i.e., an untoward occurrence that results in death or is life threatening, requires hospitalisation, or results in disability during the intervention delivery time period), as well as retention, adherence, and compliance, from randomised controlled trials of exercise training in persons with multiple sclerosis; and (2) identify moderators of relapse, adverse events, and serious adverse event rates.MethodsEight field-relevant databases will be searched electronically. Studies that involve a randomised controlled trial of exercise training (with non-exercise, non-pharmacological, comparator), report on safety outcomes, and include adults with multiple sclerosis will be included. Rates and relative risks of the three primary outcomes (relapse, adverse event, and serious adverse event) will be calculated and reported each with standard error and 95% confidence interval. Random-effects meta-analysis will estimate mean population relative risk for outcomes. Potential sources of variability, including participant characteristics, features of the exercise stimulus, and comparison condition, will be examined with random-effects meta-regression with maximum likelihood estimation.DiscussionThe results from this systematic review and meta-analysis will inform and guide healthcare practitioners, researchers, and policymakers on the safety of exercise training in persons with multiple sclerosis. Where possible, we will identify the impact of exercise type, exercise delivery style, participant disability level, and the prescription of exercise guidelines, on the safety of exercise training. The result will identify critical information on the safety of exercise in persons with multiple sclerosis, while also identifying gaps in research and setting priorities for future enquiries.Systematic review registrationPROSPERO 2020 CRD42020190544

Highlights

There has been an exponential growth in the number of clinical research studies regarding exercise training in multiple sclerosis, and literature reviews and meta-analyses have documented the many benefits of exercise training
That study reported that people with Multiple sclerosis (MS) receiving a form of exercise intervention had lower rates of relapse equating to approximately 27% lower relapse rate for exercise training versus non-exercise control conditions
In terms of adverse events (AE), 22 of the 26 randomised controlled trial (RCT) recorded dropout rate, and this is important as another indicator of intervention feasibility; the mean dropout rate across studies was 15.2% for control group participants and 15.5% for exercise training participants

Summary

Introduction

There has been an exponential growth in the number of clinical research studies regarding exercise training in multiple sclerosis, and literature reviews and meta-analyses have documented the many benefits of exercise training. This research further requires careful review for documenting the safety of exercise training in multiple sclerosis, as clarity on safety represents a major hurdle in the clinical prescription of exercise behaviour. MS is the most common nontraumatic disabling disease among young adults and is more common in females [5]. The underlying cause of the disease is unknown, and the disease follows a relapsing-remitting clinical trajectory in the majority of cases. The health burden is high such that the 2016 Global Burden of Disease study reported that over 1.1 million disability-adjusted life-years were attributable to MS [2]

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