Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES)

Morten Riemenschneider; Lars G Hvid; Steffen Ringgaard; Mikkel K E Nygaard; Simon F Eskildsen; Thor Petersen; Egon Stenager; Ulrik Dalgas

doi:10.1136/bmjopen-2020-043699

Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES)

BMJ Open. 2021 Jan 12;11(1):e043699. doi: 10.1136/bmjopen-2020-043699.

Authors

Morten Riemenschneider¹, Lars G Hvid², Steffen Ringgaard³, Mikkel K E Nygaard⁴, Simon F Eskildsen⁴, Thor Petersen⁵, Egon Stenager^{6

7}, Ulrik Dalgas²

Affiliations

¹ Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark mori@ph.au.dk.
² Exercise Biology, Department of Public Health, Aarhus University, Aarhus, Denmark.
³ The MR Research Centre, Aarhus University Hospital, Aarhus N, Denmark.
⁴ Center of Functionnally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
⁵ The Multiple Sclerosis Clinic, Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.
⁶ Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark.
⁷ Department of Neurology, MS-Clinic of Southern Jutland (Sønderborg, Esbjerg, Kolding), Sønderborg, Denmark.

Abstract

Introduction: In the relapsing remitting type of multiple sclerosis (MS) reducing relapses and neurodegeneration is crucial in halting the long-term impact of the disease. Medical disease-modifying treatments have proven effective, especially when introduced early in the disease course. However, patients still experience disease activity and disability progression, and therefore, supplemental early treatment strategies are warranted. Exercise appear to be one of the most promising supplemental treatment strategies, but a somewhat overlooked 'window of opportunity' exist early in the disease course. The objective of this study is to investigate exercise as a supplementary treatment strategy early in the disease course of MS.

Methods and analysis: The presented Early Multiple Sclerosis Exercise Study is a 48-week (plus 1-year follow-up) national multicentre single-blinded parallel group randomised controlled trial comparing two groups receiving usual care plus supervised high-intense exercise or plus health education (active control). Additionally, data will be compared with a population-based control group receiving usual care only obtained from the Danish MS Registry. The primary outcomes are annual relapse rate and MRI derived global brain atrophy. The secondary outcomes are disability progression, physical and cognitive function, MS-related symptoms, and exploratory MRI outcomes. All analyses will be performed as intention to treat.

Ethics and dissemination: The study is approved by The Central Denmark Region Committees on Health Research Ethics (1-10-72-388-17) and registered at the Danish Data Protection Agency (2016-051-000001 (706)). All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.

Trial registration number: NCT03322761.

Keywords: multiple sclerosis; rehabilitation medicine; sports medicine.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Exercise
Exercise Therapy*
Humans
Magnetic Resonance Imaging
Multicenter Studies as Topic
Multiple Sclerosis* / therapy
Randomized Controlled Trials as Topic

Associated data

ClinicalTrials.gov/NCT03322761