Effect of Multimodal Exercise Training in Patients With Multiple Scler
Effect of Multimodal Exercise Training on Disease Activity and Functional Status in Patients With Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- Multimodal Exercise Training
- Control Group
What it measured
Main measures
Multiple Sclerosis Functional Composite Test (The change between the initial value and the value after 3 months will be evaluated).
Baseline and end of weeks 12
Disability progressionThinking and memoryWalking and mobilityArm and hand functionFunctional Magnetic Resonance Imaging (fMRI) (The change between the initial value and the value after 3 months will be evaluated).
Baseline and end of weeks 12
MRI lesionsNerve conduction testsBrain-derived neurotrophic factor (BDNF) assessment (The change between the initial value and the value after 3 months will be evaluated).
Baseline and end of weeks 12
Physical function
Other measures (7)
The Expanded Disability Status Scale (EDSS) (The change between the initial value and the value after 3 months will be evaluated).
Baseline and end of weeks 12
Disability progressionVisionThinking and memoryBladder, bowel and sexual function6 Minute Walk Test (6MWT) (The change between the initial value and the value after 3 months will be evaluated).
Baseline and end of weeks 12
FatigueWalking and mobilityActiGraph wGT3X-BT (The change between the initial value and the value after 3 months will be evaluated).
Baseline and end of weeks 12
Physical functionThe Godin Leisure-Time Exercise Questionnaire (The change between the initial value and the value after 3 months will be evaluated).
Baseline and end of weeks 12
Physical functionBalance Assessment (The change between the initial value and the value after 3 months will be evaluated).
Baseline and end of weeks 12
Walking and mobilityFatigue Severity Scale (The change between the initial value and the value after 3 months will be evaluated).
Baseline and end of weeks 12
FatigueMultiple Sclerosis International Quality of Life Questionnaire (MusiQoL) (The change between the initial value and the value after 3 months will be evaluated).
Baseline and end of weeks 12
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 20 to 65 · EDSS 3.0 to 5.5
Show the full criteria
Inclusion criteria
* Being diagnosed with multiple sclerosis by a neurologist * Volunteering to participate in the study * Being ambulatory * EDSS between 3.0-5.5 * Being literate * Having internet access * Not having participated in a standardized physiotherapy and rehabilitation program in the last 3 months
Exclusion criteria
* Having an orthopedic problem affecting its mobility * Having psychiatric problems, severe cognitive impairment, or epilepsy in addition to the MS diagnosis * Blurred vision or visual impairment * Pregnancy * Having had an attack or received corticosteroid treatment 3 months before participating in the study * Having a disease affecting immunological parameters (infection, cancer, etc.)
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
The study aims to examine the effects of multimodal exercise training including aerobic, strengthening and balance exercises via face-to-face and asynchronous video-based telerehabilitation on disease activity, disability level, aerobic capacity, physical activity level, balance, fatigue level and quality of life in individuals with multiple sclerosis. Therefore, this study consists of two hypotheses. Hypotheses: H0: Multimodal exercise training has no effect on disease activity and functional status in patients with multiple sclerosis H1: Multimodal exercise training has effects on disease activity and functional status in patients with multiple sclerosis
Papers
Background
Rocca MA, Romano F, Tedone N, Filippi M. Advanced neuroimaging techniques to explore the effects of motor and cognitive rehabilitation in multiple sclerosis. J Neurol. 2024 Jul;271(7):3806-3848. doi: 10.1007/s00415-024-12395-0. Epub 2024 May 1.Background
Shobeiri P, Karimi A, Momtazmanesh S, Teixeira AL, Teunissen CE, van Wegen EEH, Hirsch MA, Yekaninejad MS, Rezaei N. Exercise-induced increase in blood-based brain-derived neurotrophic factor (BDNF) in people with multiple sclerosis: A systematic review and meta-analysis of exercise intervention trials. PLoS One. 2022 Mar 3;17(3):e0264557. doi: 10.1371/journal.pone.0264557. eCollection 2022.Background
Briken S, Rosenkranz SC, Keminer O, Patra S, Ketels G, Heesen C, Hellweg R, Pless O, Schulz KH, Gold SM. Effects of exercise on Irisin, BDNF and IL-6 serum levels in patients with progressive multiple sclerosis. J Neuroimmunol. 2016 Oct 15;299:53-58. doi: 10.1016/j.jneuroim.2016.08.007. Epub 2016 Aug 5.Background
Cutter GR, Baier ML, Rudick RA, Cookfair DL, Fischer JS, Petkau J, Syndulko K, Weinshenker BG, Antel JP, Confavreux C, Ellison GW, Lublin F, Miller AE, Rao SM, Reingold S, Thompson A, Willoughby E. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain. 1999 May;122 ( Pt 5):871-82. doi: 10.1093/brain/122.5.871.Background
Bosma LV, Kragt JJ, Brieva L, Khaleeli Z, Montalban X, Polman CH, Thompson AJ, Tintore M, Uitdehaag BM. Progression on the Multiple Sclerosis Functional Composite in multiple sclerosis: what is the optimal cut-off for the three components? Mult Scler. 2010 Jul;16(7):862-7. doi: 10.1177/1352458510370464. Epub 2010 May 20.Background
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.Background
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.Background
Polhemus A, Haag C, Sieber C, Sylvester R, Kool J, Gonzenbach R, von Wyl V. Methodological heterogeneity biases physical activity metrics derived from the Actigraph GT3X in multiple sclerosis: A rapid review and comparative study. Front Rehabil Sci. 2022 Nov 28;3:989658. doi: 10.3389/fresc.2022.989658. eCollection 2022.Background
Weikert M, Motl RW, Suh Y, McAuley E, Wynn D. Accelerometry in persons with multiple sclerosis: measurement of physical activity or walking mobility? J Neurol Sci. 2010 Mar 15;290(1-2):6-11. doi: 10.1016/j.jns.2009.12.021. Epub 2010 Jan 8.Background
Cattaneo D, Regola A, Meotti M. Validity of six balance disorders scales in persons with multiple sclerosis. Disabil Rehabil. 2006 Jun 30;28(12):789-95. doi: 10.1080/09638280500404289.
Loading reviews and guidelines…
History
Started
Feb 2025
Main results due
May 2027
Finished
May 2028