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Danish researchers are embarking on a new study to find out just how effective exercise in MS is for those in the early stages of the disease. Much needed! Here's a touch from the full proposal, which you can read in full at the link below.
Neurology
Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES)
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.
http://creativecommons.org/licenses/by-nc/4.0/
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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http://dx.doi.org/10.1136/bmjopen-2020-043699
Exercise therapy appears to be one of the most potent supplementary (non-pharmacological) treatment strategies. Indeed, research evidence from the past 20 years has shown that exercise (1) is safe, tolerable and poses a limited risk of adverse events for patients with MS,14 (2) has numerous beneficial effects on general physical capacity and several MS-related symptoms,15 (3) likely holds a neuroprotective and disease-modifying potential16 17 and (4) may reduce the risk and/or postpone MS diagnosis.18 However, in a recent paper from our group, we pointed out that, despite the disease-modifying potential of exercise in MS, exercise is predominately viewed and used as symptomatic treatment.11 Consequently, exercise has generally been initiated rather late in the disease course (≥5 years since diagnosis) based on existing research studies.11 This leaves an uninvestigated ‘window of opportunity’ for exercise therapy in the early phase treatment of MS, with the interesting potential to preserve the neurological and functional reserve at a higher level than medical treatment alone.
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 Riemenschneider1,
- Lars G Hvid1,
- Steffen Ringgaard2,
- Mikkel K E Nygaard3,
- Simon F Eskildsen3,
- Thor Petersen4,
- Egon Stenager5,6,
- Ulrik Dalgas1
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.
http://creativecommons.org/licenses/by-nc/4.0/
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
View Full Text
http://dx.doi.org/10.1136/bmjopen-2020-043699