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Published in: Systematic Reviews 1/2021

01-12-2021 | Multiple Sclerosis | Protocol

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

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

Published in: Systematic Reviews | Issue 1/2021

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Abstract

Background

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.

Objectives

To 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.

Methods

Eight 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.

Discussion

The 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 registration

PROSPERO 2020 CRD42020190544
Appendix
Available only for authorised users
Literature
1.
2.
go back to reference GMS Collaborators. Global, regional, and national burden of multiple sclerosis 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016 - The Lancet Neurology. Lancet Neurol. 2019;18(3):269–85.CrossRef GMS Collaborators. Global, regional, and national burden of multiple sclerosis 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016 - The Lancet Neurology. Lancet Neurol. 2019;18(3):269–85.CrossRef
3.
go back to reference King R. Atlas of MS 3rd edition. PART 1: mapping multiple sclerosis around the world key epidemiology findings. London: Multiple Sclerosis International Federation; 2020. King R. Atlas of MS 3rd edition. PART 1: mapping multiple sclerosis around the world key epidemiology findings. London: Multiple Sclerosis International Federation; 2020.
6.
go back to reference Benito-Leon J, Martinez-Martin P. Health-related quality of life in multiple sclerosis. Neurologia. 2003;18(4):210–7.PubMed Benito-Leon J, Martinez-Martin P. Health-related quality of life in multiple sclerosis. Neurologia. 2003;18(4):210–7.PubMed
8.
go back to reference Kalb R, Brown TR, Coote S, Costello K, Dalgas U, Garmon E, et al. Exercise and lifestyle physical activity recommendations for people with multiple sclerosis throughout the disease course. Multiple Sclerosis Journal. 2020;Early online DOI 10.1177/1352458520915629. Kalb R, Brown TR, Coote S, Costello K, Dalgas U, Garmon E, et al. Exercise and lifestyle physical activity recommendations for people with multiple sclerosis throughout the disease course. Multiple Sclerosis Journal. 2020;Early online DOI 10.1177/1352458520915629.
9.
go back to reference Dalgas U, Hvid LG, Kwakkel G, Motl RW, de Groot V, Feys P, et al. Moving exercise research in multiple sclerosis forward (the MoXFo initiative): developing consensus statements for research. Multiple Sclerosis Journal. 2020;Early online, DOI 10.1177/1352458520910360. Dalgas U, Hvid LG, Kwakkel G, Motl RW, de Groot V, Feys P, et al. Moving exercise research in multiple sclerosis forward (the MoXFo initiative): developing consensus statements for research. Multiple Sclerosis Journal. 2020;Early online, DOI 10.1177/1352458520910360.
11.
go back to reference McCabe M. A needs analysis of Australians with MS: Multiple Sclerosis Research Australia; 2012. McCabe M. A needs analysis of Australians with MS: Multiple Sclerosis Research Australia; 2012.
12.
go back to reference National Institute for Health and Clinical Excellence. 2018 surveillance of multiple sclerosis in adults: management (NICE guideline G186). 2018. National Institute for Health and Clinical Excellence. 2018 surveillance of multiple sclerosis in adults: management (NICE guideline G186). 2018.
13.
go back to reference Richardson EV, Fifolt M, Barstow E, Silveira SL, Sikes EM, Motl RW. The priorities of neurologists for exercise promotion in comprehensive multiple sclerosis care - ScienceDirect. Multiple Sclerosis and Related Disorders. 2020;38:e101482.CrossRef Richardson EV, Fifolt M, Barstow E, Silveira SL, Sikes EM, Motl RW. The priorities of neurologists for exercise promotion in comprehensive multiple sclerosis care - ScienceDirect. Multiple Sclerosis and Related Disorders. 2020;38:e101482.CrossRef
19.
go back to reference Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta A, Mackibbon KA, et al. The effects of exercise training on fitness, mobility, fatigue, and health related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013;94(9):1800–28. https://doi.org/10.1016/j.apmr.2013.04.020.PubMedCrossRef Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta A, Mackibbon KA, et al. The effects of exercise training on fitness, mobility, fatigue, and health related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013;94(9):1800–28. https://​doi.​org/​10.​1016/​j.​apmr.​2013.​04.​020.PubMedCrossRef
26.
go back to reference Sadeghi Bahmani D, Kesselring J, Papadimitriou M, Bansi J, Pühse U, Gerber M, et al. In patients with multiple sclerosis, both objective and subjective sleep, depression, fatigue, and paresthesia improved after 3 weeks of regular exercise. Front Psychiatry. 2019;3(10):265.CrossRef Sadeghi Bahmani D, Kesselring J, Papadimitriou M, Bansi J, Pühse U, Gerber M, et al. In patients with multiple sclerosis, both objective and subjective sleep, depression, fatigue, and paresthesia improved after 3 weeks of regular exercise. Front Psychiatry. 2019;3(10):265.CrossRef
28.
go back to reference Wens I, Eijnde B, Hansen D. Muscular, cardiac, ventilatory and metabolic dysfunction in patients with multiple sclerosis: implications for screening, clinical care and endurance and resistance exercise therapy, a scoping review - ScienceDirect. J Neurol Sci. 367:107–21. Wens I, Eijnde B, Hansen D. Muscular, cardiac, ventilatory and metabolic dysfunction in patients with multiple sclerosis: implications for screening, clinical care and endurance and resistance exercise therapy, a scoping review - ScienceDirect. J Neurol Sci. 367:107–21.
31.
go back to reference Zarghami A, Taylor B, Marck CH, van der Mei I. Marie Pangan Lo L, Black L, et al. Multiple Sclerosis Research Australia: Modifiable lifestyle factors and MS. A guide for health professionals; 2020. Zarghami A, Taylor B, Marck CH, van der Mei I. Marie Pangan Lo L, Black L, et al. Multiple Sclerosis Research Australia: Modifiable lifestyle factors and MS. A guide for health professionals; 2020.
32.
go back to reference Motl RW, Learmonth YC, Pilutti LA, Gappmaier E, Coote S. Top 10 research questions related to physical activity and multiple sclerosis. Res Q Exerc Sport. 2015;16(2):117–29.CrossRef Motl RW, Learmonth YC, Pilutti LA, Gappmaier E, Coote S. Top 10 research questions related to physical activity and multiple sclerosis. Res Q Exerc Sport. 2015;16(2):117–29.CrossRef
33.
go back to reference Zorzela L, Loke YK, Ioannidis JP, Golder S, Santaguida P, Altman DG, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. Br Med J. 2016;352:i157.CrossRef Zorzela L, Loke YK, Ioannidis JP, Golder S, Santaguida P, Altman DG, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. Br Med J. 2016;352:i157.CrossRef
38.
go back to reference Niemeijer A, Lund H, Stafne SN, Ipsen T, Goldschmidt CL, Jørgensen CT, et al. Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. Br J Sports Med. 2019;early online. Niemeijer A, Lund H, Stafne SN, Ipsen T, Goldschmidt CL, Jørgensen CT, et al. Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. Br J Sports Med. 2019;early online.
41.
go back to reference Dennett R, Madsen L, Connolly L, Hosking J, Dalgas U, Freeman J. Adherence and drop-out in randomized controlled trials of exercise interventions in people with multiple sclerosis: a systematic review and meta-analyses - ScienceDirect. 2020;43:early online. Dennett R, Madsen L, Connolly L, Hosking J, Dalgas U, Freeman J. Adherence and drop-out in randomized controlled trials of exercise interventions in people with multiple sclerosis: a systematic review and meta-analyses - ScienceDirect. 2020;43:early online.
43.
go back to reference Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021 Mar 29;372:n71.PubMedPubMedCentralCrossRef Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021 Mar 29;372:n71.PubMedPubMedCentralCrossRef
48.
go back to reference Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Apr;100(2):126–31.PubMedPubMedCentral Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Apr;100(2):126–31.PubMedPubMedCentral
51.
go back to reference Landis JR, Koch GG. The measurement of observer agreement for categorical data. biometrics. 1977;159–74. Landis JR, Koch GG. The measurement of observer agreement for categorical data. biometrics. 1977;159–74.
53.
go back to reference Altman DG. Practical statistics for medical research. London: Chapman and Hall; 2001. Altman DG. Practical statistics for medical research. London: Chapman and Hall; 2001.
54.
go back to reference Pagano M, Gaureau K. Principles of biostatistics. 2nd ed. Brooks/Cole: Belmont, CA; 2000. Pagano M, Gaureau K. Principles of biostatistics. 2nd ed. Brooks/Cole: Belmont, CA; 2000.
56.
go back to reference Lipsey M, Wilson D. Practical meta-analysis, vol. 49. Thousand Oaks, CA: SAGE Publications Ltd; 2001. Lipsey M, Wilson D. Practical meta-analysis, vol. 49. Thousand Oaks, CA: SAGE Publications Ltd; 2001.
58.
go back to reference Hedges L, Olkin I. Statistical methods for meta-analysis. San Diego, CA: Academic Press; 1985. Hedges L, Olkin I. Statistical methods for meta-analysis. San Diego, CA: Academic Press; 1985.
61.
go back to reference Riebe D, Ehrman JK, Liguori G, Magal M. ACSM’s guidelines for exercise testing and prescription. 10th ed. Sydney: Wolters Kluwer/Lippincott Williams & Wilkins; 2018. Riebe D, Ehrman JK, Liguori G, Magal M. ACSM’s guidelines for exercise testing and prescription. 10th ed. Sydney: Wolters Kluwer/Lippincott Williams & Wilkins; 2018.
63.
Metadata
Title
Safety of exercise training in multiple sclerosis: a protocol for an updated systematic review and meta-analysis
Authors
Y. C. Learmonth
L. A. Pilutti
M. P. Herring
R. W. Motl
B. Chan
A. P. Metse
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Systematic Reviews / Issue 1/2021
Electronic ISSN: 2046-4053
DOI
https://doi.org/10.1186/s13643-021-01751-0

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