Multiple Sclerosis Clinical Trial
— AUTOMOVEMSOfficial title:
Self-Management Program Based on Physical Exercises for People With Multiple Sclerosis With Mild Neurological Impairment: A Randomized Controlled Trial
Fatigue is the most chronic and disabling symptom in multiple sclerosis patients. Self-management physical exercise programs seem promising to allow patients to improve their fatigue and their deconditioning. However, the effectiveness of such programs has been poorly assessed until now. The objectives of the present study are to evaluate the relationships between fatigue and physical capacity among slightly affected MS patients, and to carry on a large trial to assess the effectiveness of a self-management exercise program in the same patients. Sixty-four patients will be included and will be asked, after an educational period, to perform at least three exercise sessions of more than 30 minutes each week, over a period of three months. Patients will be splitted in two groups : one group will perform endurance and resistance physical exercises, and the other one will perform relaxation exercises with the help of soothing music. A regular coaching will adapt the exercises and motivate the patients to continue the treatment. Assessors won't be informed of patients' treatment. Four evaluations will be done, and will notably assess muscle strength, endurance, fatigue and social participation.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | January 2020 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - A diagnosis of MS performed by a specialized neurologist (revised McDonald criteria, 2010), regardless of the form of the disease (relapsing-remitting, primary progressive, secondary progressive); - An EDSS score less than or equal to 3.5, with a functional score less than or equal to 2 for the pyramidal and cerebellar functions; - An age between 18 and 65 years. Exclusion Criteria: - An affection of one or both lower limbs limiting their ability to walk; - Another illness contraindicating the practice of exercises (ACSM criteria, 2011); - An episode of relapse within the 4 weeks prior to inclusion; - Participation in a study targeting rehabilitation, within the 3 months prior to inclusion; - Modification of drug treatment of MS (disease-modifying treatment and symptomatic treatment) in the 3 months prior to inclusion; - Change in the physiotherapy prescription within the 3 months prior to inclusion. - Pregnancy - Participation in a regular exercise program at least 3 times a week for at least 30 minutes for more than 6 months. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques universitaires Saint-Luc | Bruxelles |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain | CHU de Reims, Hôpital Raymond Poincaré |
Belgium,
Baert I, Freeman J, Smedal T, Dalgas U, Romberg A, Kalron A, Conyers H, Elorriaga I, Gebara B, Gumse J, Heric A, Jensen E, Jones K, Knuts K, Maertens de Noordhout B, Martic A, Normann B, Eijnde BO, Rasova K, Santoyo Medina C, Truyens V, Wens I, Feys P. Responsiveness and clinically meaningful improvement, according to disability level, of five walking measures after rehabilitation in multiple sclerosis: a European multicenter study. Neurorehabil Neural Repair. 2014 Sep;28(7):621-31. doi: 10.1177/1545968314521010. — View Citation
Batcho CS, Thonnard JL, Nielens H. PWC 75%/kg, a fitness index not linked to resting heart rate: testing procedure and reference values. Arch Phys Med Rehabil. 2012 Jul;93(7):1196-200. doi: 10.1016/j.apmr.2012.02.021. — View Citation
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. — View Citation
Boudarham J, Roche N, Pradon D, Delouf E, Bensmail D, Zory R. Effects of quadriceps muscle fatigue on stiff-knee gait in patients with hemiparesis. PLoS One. 2014 Apr 9;9(4):e94138. doi: 10.1371/journal.pone.0094138. — View Citation
Cakt BD, Nacir B, Genç H, Saraçoglu M, Karagöz A, Erdem HR, Ergün U. Cycling progressive resistance training for people with multiple sclerosis: a randomized controlled study. Am J Phys Med Rehabil. 2010 Jun;89(6):446-57. doi: 10.1097/PHM.0b013e3181d3e71f. — View Citation
Carter A, Daley A, Humphreys L, Snowdon N, Woodroofe N, Petty J, Roalfe A, Tosh J, Sharrack B, Saxton JM. Pragmatic intervention for increasing self-directed exercise behaviour and improving important health outcomes in people with multiple sclerosis: a randomised controlled trial. Mult Scler. 2014 Jul;20(8):1112-22. doi: 10.1177/1352458513519354. — View Citation
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. — View Citation
Dalgas U, Stenager E, Ingemann-Hansen T. Multiple sclerosis and physical exercise: recommendations for the application of resistance-, endurance- and combined training. Mult Scler. 2008 Jan;14(1):35-53. Review. — View Citation
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. — View Citation
Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. — View Citation
Giovannoni G. Multiple sclerosis related fatigue. J Neurol Neurosurg Psychiatry. 2006 Jan;77(1):2-3. — View Citation
Goldman MD, Marrie RA, Cohen JA. Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Mult Scler. 2008 Apr;14(3):383-90. — View Citation
Guerra E, di Cagno A, Mancini P, Sperandii F, Quaranta F, Ciminelli E, Fagnani F, Giombini A, Pigozzi F. Physical fitness assessment in multiple sclerosis patients: a controlled study. Res Dev Disabil. 2014 Oct;35(10):2527-33. doi: 10.1016/j.ridd.2014.06.013. — View Citation
Heine M, van de Port I, Rietberg MB, van Wegen EE, Kwakkel G. Exercise therapy for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2015 Sep 11;(9):CD009956. doi: 10.1002/14651858.CD009956.pub2. Review. — View Citation
Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. — View Citation
Induruwa I, Constantinescu CS, Gran B. Fatigue in multiple sclerosis - a brief review. J Neurol Sci. 2012 Dec 15;323(1-2):9-15. doi: 10.1016/j.jns.2012.08.007. Review. — View Citation
Krupp L. Fatigue is intrinsic to multiple sclerosis (MS) and is the most commonly reported symptom of the disease. Mult Scler. 2006 Aug;12(4):367-8. — View Citation
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. — View Citation
Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Review. — View Citation
Lauer RT, Stackhouse C, Shewokis PA, Smith BT, Orlin M, McCarthy JJ. Assessment of wavelet analysis of gait in children with typical development and cerebral palsy. J Biomech. 2005 Jun;38(6):1351-7. — View Citation
Nilsagard Y, Lundholm C, Gunnarsson LG, Dcnison E. Clinical relevance using timed walk tests and 'timed up and go' testing in persons with multiple sclerosis. Physiother Res Int. 2007 Jun;12(2):105-14. — View Citation
Plow MA, Finlayson M, Rezac M. A scoping review of self-management interventions for adults with multiple sclerosis. PM R. 2011 Mar;3(3):251-62. doi: 10.1016/j.pmrj.2010.11.011. Review. — View Citation
Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366. — View Citation
Rae-Grant AD, Turner AP, Sloan A, Miller D, Hunziker J, Haselkorn JK. Self-management in neurological disorders: systematic review of the literature and potential interventions in multiple sclerosis care. J Rehabil Res Dev. 2011;48(9):1087-100. Review. — View Citation
Rossier P, Wade DT. Validity and reliability comparison of 4 mobility measures in patients presenting with neurologic impairment. Arch Phys Med Rehabil. 2001 Jan;82(1):9-13. — View Citation
Sandoval AE. Exercise in multiple sclerosis. Phys Med Rehabil Clin N Am. 2013 Nov;24(4):605-18. doi: 10.1016/j.pmr.2013.06.010. Review. — View Citation
Simeoni M, Auquier P, Fernandez O, Flachenecker P, Stecchi S, Constantinescu C, Idiman E, Boyko A, Beiske A, Vollmer T, Triantafyllou N, O'Connor P, Barak Y, Biermann L, Cristiano E, Atweh S, Patrick D, Robitail S, Ammoury N, Beresniak A, Pelletier J; MusiQol study group.. Validation of the Multiple Sclerosis International Quality of Life questionnaire. Mult Scler. 2008 Mar;14(2):219-30. — View Citation
Vernay D, Gerbaud L, Biolay S, Coste J, Debourse J, Aufauvre D, Beneton C, Colamarino R, Glanddier PY, Dordain G, Clavelou P. [Quality of life and multiple sclerosis: validation of the french version of the self-questionnaire (SEP-59)]. Rev Neurol (Paris). 2000 Mar;156(3):247-63. French. — View Citation
Wade DT. Measurement in neurological rehabilitation. Curr Opin Neurol Neurosurg. 1992 Oct;5(5):682-6. Review. — View Citation
Yusuf A, Koski L. A qualitative review of the neurophysiological underpinnings of fatigue in multiple sclerosis. J Neurol Sci. 2013 Jul 15;330(1-2):4-9. doi: 10.1016/j.jns.2013.04.012. Review. — View Citation
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation
* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue | Modified Fatigue Impact Scale (MFIS) | 28 days | No |
Primary | Change in fatigue | MFIS | Evaluation at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention | No |
Secondary | Safety (Number of patients with adverse events related to treatment). | Number of patients with adverse events related to treatment | Through study completion, an average of 9 months | Yes |
Secondary | Change in MS-specific health related quality of life | Multiple Sclerosis Impact Scale (MSIS-29) | 2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention | No |
Secondary | Change in MS-specific health related quality of life | Multiple Sclerosis International Quality of Life (MusiQol) | 2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention | No |
Secondary | Change in walking capacity | using a questionnaire (MSWS-12) | 2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention | No |
Secondary | Change in plasmatic cytokines: IFNg | plasmatic titration of IFNg (pg/mL) | Baseline and immediately after the intervention | No |
Secondary | Change in plasmatic cytokines: TNFa | plasmatic titration of TNFa (pg/mL) | Baseline and immediately after the intervention | No |
Secondary | Adherence | Percentage of sessions completed | Weekly through the intervention (during 3 months) | No |
Secondary | Adherence | duration of exercising | Weekly through the intervention (during 3 months) | No |
Secondary | Amount of physical activity performed | Using a self-reported questionnaire | From the first day after the completion of the treatment, every 3 months up to 6 months. | No |
Secondary | Change in Cardiorespiratory fitness | physical working capacity at 75% of the predicted maximal heart rate per kilogram of body weight (PWC75%) | 2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention | No |
Secondary | Change in Cardiorespiratory fitness | Oxygen Uptake Efficiency Slope (OUES) | 2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention | No |
Secondary | Change in Lower limbs spasticity | Ashworth scale | 2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention | No |
Secondary | Change in objective walking endurance | 2 Minute Walking Test | 2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention | No |
Secondary | Change in static and dynamic balance | Timed up-and-go test | 2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention | No |
Secondary | Change in Neurological Disability | Expanded Disability Status Scale | 2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention | No |
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