Exercise-based Therapy for Multiple Sclerosis Patients
The Inflammatory Synaptopathy as a Target of Exercise Therapy in the Fight Against Multiple Sclerosis
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Exercise
What it measured
Main measures
Changes in clinical disability (EDSS)
Changes from baseline (time 0, t0), 4 weeks after the end of exercise protocol (time 1, t1) and 8 weeks after the end of exercise protocol (time 2, t2)
Disability progressionChanges in clinical disability: Multiple Sclerosis Functional Composite (MSFC)
Changes from baseline (time 0, t0), 4 weeks after the end of exercise protocol (time 1, t1) and 8 weeks after the end of exercise protocol (time 2, t2)
Disability progressionThinking and memoryWalking and mobilityChanges in clinical disability (VA)
Changes from baseline (time 0, t0), 4 weeks after the end of exercise protocol (time 1, t1) and 8 weeks after the end of exercise protocol (time 2, t2)
Vision
Other measures (5)
Changes in Mood-depressive trait
Changes from baseline (time 0, t0) to the end of the 4-week exercise protocol (time 1, t1) and 8 weeks after the end of exercise protocol (time 2, t2)
Mood and sleepChanges in Mood-anxiety trait
Changes from baseline (time 0, t0) to the end of the 4-week exercise protocol (time 1, t1) and 8 weeks after the end of exercise protocol (time 2, t2)
Mood and sleepNeurophysiological assessment
Changes from baseline (time 0, t0) to the end of the 4-week exercise protocol (time 1, t1)
Myelin repairNerve conduction testsChanges in autonomic function
Changes from baseline (time 0, t0) to the end of the 4-week exercise protocol (time 1, t1)
Walking and mobilityChanges in peripheral cytokine levels
Changes from baseline (time 0, t0) to the end of 4 week-exercise protocol (time 1, t1) and 8 weeks after the end of exercise protocol (time 2, t2)
Immune response
Who could take part
MS (type not specified) · 18 to 65 · EDSS 5 to 6
Show the full criteria
Inclusion criteria
* Ability to provide written informed consent to the study; * Diagnosis of MS definite according to 2010 revised McDonald's criteria (Polman et al., 2011); * Age range 18-65 (included); * EDSS range between 4,5 and 6,5 (included); * Ability to participate to the study protocol.
Exclusion criteria
* Inability to provide written informed consent to the study; * Altered blood count; * Female with positive pregnancy test at baseline or having active pregnancy plans in the following months after the beginning of the protocol; * Contraindications to gadolinium (MRI); * Contraindications to TMS; * Patients with comorbidities for neurological disease other than MS, included other neurodegenerative chronic diseases or chronic infections (i.e tubercolosis, infectious hepatitis, HIV/AIDS); * Unstable medical condition or infections; * Use of medications with increased risk of seizures (i.e. Fampridine, 4-Aminopyridine); * Concomitant use of drugs that may alter synaptic transmission and plasticity (cannabinoids, L-dopa, antiepiletics, nicotine, baclofen, SSRI, botulinum toxin).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Exercise is reported to have significant beneficial effects in Multiple Sclerosis (MS) patients, particularly with respect to cardiovascular function, aerobic capacity, muscular strength and ambulatory performance. Inflammation-mediated synaptic alterations have been measured by means of transcranial magnetic stimulation (TMS) and found to correlate with disability level in MS. Due to their plastic nature, synapses represent a good therapeutic target that is sensitive to environmental stimulation, such as physical exercise. The aim of this study is to evaluate the effect of exercise in reducing peripheral inflammation that drives the synaptic pathology and neurodegeneration occurring in the brain of MS patients. Recruited patients will be given a therapeutic exercise program, consisting of 3 hours of treatment per day, 6 days/week for 4 weeks. The program will be applied on hospitalised patients to ensure adherence to the program and reducing the risk of abandonment. The rehabilitation program will be planned by a physician specialised in physical and rehabilitation medicine and will consist of both passive and active therapeutic exercises specifically aimed at restoring or maintaining muscular flexibility, range of motion, balance, coordination of movements, postural passages and transfers, and ambulation. The day of recruitment (t0) patients will undergo radiological and neurological examination. The effect of exercise will be evaluated with respect to neurologic function, mood and neurophysiological parameters, autonomic system function, and peripheral marker levels assessed at t0 and after 4 weeks (t1). A second time point will be included (t2, 8 weeks after the end of the treatment) to address long-term effects, with analysis limited to neurologic and mood measurements and peripheral marker levels.
Papers
Background
Charron S, McKay KA, Tremlett H. Physical activity and disability outcomes in multiple sclerosis: A systematic review (2011-2016). Mult Scler Relat Disord. 2018 Feb;20:169-177. doi: 10.1016/j.msard.2018.01.021. Epub 2018 Feb 2.Background
Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.Background
Dalgas U, Stenager E, Jakobsen J, Petersen T, Hansen HJ, Knudsen C, Overgaard K, Ingemann-Hansen T. Resistance training improves muscle strength and functional capacity in multiple sclerosis. Neurology. 2009 Nov 3;73(18):1478-84. doi: 10.1212/WNL.0b013e3181bf98b4.Background
Deckx N, Wens I, Nuyts AH, Hens N, De Winter BY, Koppen G, Goossens H, Van Damme P, Berneman ZN, Eijnde BO, Cools N. 12 Weeks of Combined Endurance and Resistance Training Reduces Innate Markers of Inflammation in a Randomized Controlled Clinical Trial in Patients with Multiple Sclerosis. Mediators Inflamm. 2016;2016:6789276. doi: 10.1155/2016/6789276. Epub 2016 Jan 20.Background
Edwards T, Pilutti LA. The effect of exercise training in adults with multiple sclerosis with severe mobility disability: A systematic review and future research directions. Mult Scler Relat Disord. 2017 Aug;16:31-39. doi: 10.1016/j.msard.2017.06.003. Epub 2017 Jun 12.Background
Feinstein A, DeLuca J, Baune BT, Filippi M, Lassman H. Cognitive and neuropsychiatric disease manifestations in MS. Mult Scler Relat Disord. 2013 Jan;2(1):4-12. doi: 10.1016/j.msard.2012.08.001. Epub 2012 Sep 25.Background
Feys P, Giovannoni G, Dijsselbloem N, Centonze D, Eelen P, Lykke Andersen S. The importance of a multi-disciplinary perspective and patient activation programmes in MS management. Mult Scler. 2016 Aug;22(2 Suppl):34-46. doi: 10.1177/1352458516650741.Background
Golzari Z, Shabkhiz F, Soudi S, Kordi MR, Hashemi SM. Combined exercise training reduces IFN-gamma and IL-17 levels in the plasma and the supernatant of peripheral blood mononuclear cells in women with multiple sclerosis. Int Immunopharmacol. 2010 Nov;10(11):1415-9. doi: 10.1016/j.intimp.2010.08.008. Epub 2010 Aug 24.Background
Motl RW, Sandroff BM, Kwakkel G, Dalgas U, Feinstein A, Heesen C, Feys P, Thompson AJ. Exercise in patients with multiple sclerosis. Lancet Neurol. 2017 Oct;16(10):848-856. doi: 10.1016/S1474-4422(17)30281-8. Epub 2017 Sep 12.Background
Rampello A, Franceschini M, Piepoli M, Antenucci R, Lenti G, Olivieri D, Chetta A. Effect of aerobic training on walking capacity and maximal exercise tolerance in patients with multiple sclerosis: a randomized crossover controlled study. Phys Ther. 2007 May;87(5):545-55. doi: 10.2522/ptj.20060085. Epub 2007 Apr 3.
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History
Started
May 2019
Main results due
Nov 2020
Finished
May 2021