Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES)
| العنوان: | Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES) |
|---|---|
| المؤلفون: | Mikkel Nygaard, Ulrik Dalgas, Thor Petersen, Simon Fristed Eskildsen, Egon Stenager, Morten Riemenschneider, Steffen Ringgaard, Lars G. Hvid |
| المصدر: | Riemenschneider, M, Hvid, L N, Ringgaard, S, Torstensen, M K E N, Eskildsen, S F, Petersen, T, Stenager, E & Dalgas, U 2021, ' 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, vol. 11, no. 1, 043699 . https://doi.org/10.1136/bmjopen-2020-043699 BMJ Open, Vol 11, Iss 1 (2021) Riemenschneider, M, Hvid, L G, Ringgaard, S, Nygaard, M K E, Eskildsen, S F, Petersen, T, Stenager, E & Dalgas, U 2021, ' 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, vol. 11, no. 1, e043699 . https://doi.org/10.1136/bmjopen-2020-043699 BMJ Open |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | medicine.medical_specialty, Multiple Sclerosis, Sports medicine, Population, lcsh:Medicine, Disease, multiple sclerosis, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Humans, Multicenter Studies as Topic, Medicine, 030212 general & internal medicine, education, Exercise, Randomized Controlled Trials as Topic, education.field_of_study, Window of opportunity, Intention-to-treat analysis, sports medicine, business.industry, Multiple sclerosis, lcsh:R, rehabilitation medicine, General Medicine, medicine.disease, Magnetic Resonance Imaging, Exercise Therapy, Neurology, Physical therapy, Health education, business, 030217 neurology & neurosurgery |
| الوصف: | IntroductionIn 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 analysisThe 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 disseminationThe 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 numberNCT03322761. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::865df39ce40062ca7c4920d44f17a4be https://pure.au.dk/portal/da/publications/study-protocol-randomised-controlled-trial-evaluating-exercise-therapy-as-a-supplemental-treatment-strategy-in-early-multiple-sclerosis-the-early-multiple-sclerosis-exercise-study-emses(7e1a46b5-339d-4a3f-9635-4321eb09cd6a).html |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....865df39ce40062ca7c4920d44f17a4be |
| قاعدة البيانات: | OpenAIRE |
| الوصف غير متاح. |