Self-Management Program Based on Physical Exercises in People With Multiple Sclerosis

NCT02607020 | Unknown

• 1 other identifier: AUTOMOVEMS01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Fatigue

  Modified Fatigue Impact Scale (MFIS)

  28 days

• 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

Secondary Outcomes (15)

• Safety (Number of patients with adverse events related to treatment).

  Through study completion, an average of 9 months

• Change in MS-specific health related quality of life

  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

• Change in MS-specific health related quality of life

  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

• Change in walking capacity

  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

• Change in plasmatic cytokines: IFNg

  Baseline and immediately after the intervention

Study Arms (2)

Physical exercise

EXPERIMENTAL

Other: Physical exercises in an self-management setting

Relaxation

ACTIVE COMPARATOR

Other: Relaxation

Interventions

Physical exercises in an self-management setting OTHER

Workout sessions will be based on the principle of self-management, without direct supervision of a therapist. Sessions will include: 1\. Twenty minutes of aerobic exercises 1.2. Five to ten minutes of stretching exercises. 2.3. Fifteen to twenty minutes of resistance exercises to improve muscle strength of lower limbs. The targeted muscles will be the hip flexors, the knee extensors and flexors, and the foot extensors and plantar flexors. These exercises will comply with the recommendations of the American College of Sports Medicine (ACSM, 2011). Patients will be asked to perform muscle contractions against the gravity (about 15 repeats). There will be on average 5 to 6 series per session. Several muscle groups of the lower limbs will be trained during the same session.

Physical exercise

Relaxation OTHER

The relaxation sessions of the control group will be carried out with the help of soothing music. Patients will receive a Compact Disc (CD) of soothing music at the inclusion. Patients will also have an electronic training logbook that will be reviewed each week by a therapist. They will have a phone contact with the therapist every two weeks, to discuss about the treatment and adapt it if necessary. They will also have a reminder session every four weeks.

Relaxation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• An affection of one or both lower limbs limiting their ability to walk;
• Another illness contraindicating the practice of exercises (ACSM criteria, 2011);
• Pregnancy
• Participation in a regular exercise program at least 3 times a week for at least 30 minutes for more than 6 months.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• Hôpital Raymond Poincaré: collaborator
• CHU de Reims: collaborator

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (31)

• 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. Epub 2014 Feb 6.

  PMID: 24503204 BACKGROUND

• 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. Epub 2012 Mar 8.

  PMID: 22521927 BACKGROUND

• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

  PMID: 3809245 BACKGROUND

• 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. eCollection 2014.

  PMID: 24718087 BACKGROUND

• Cakt BD, Nacir B, Genc H, Saracoglu M, Karagoz A, Erdem HR, Ergun 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.

  PMID: 20216060 BACKGROUND

• 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. Epub 2014 Jan 13.

  PMID: 24421303 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.

  PMID: 16754576 BACKGROUND

• 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. doi: 10.1177/1352458507079445. Epub 2007 Sep 19.

  PMID: 17881393 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.

  PMID: 19884575 BACKGROUND

• 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. doi: 10.1093/clinids/18.supplement_1.s79.

  PMID: 8148458 BACKGROUND

• Giovannoni G. Multiple sclerosis related fatigue. J Neurol Neurosurg Psychiatry. 2006 Jan;77(1):2-3. doi: 10.1136/jnnp.2005.074948.

  PMID: 16361582 BACKGROUND

• 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. doi: 10.1177/1352458507082607. Epub 2007 Oct 17.

  PMID: 17942508 BACKGROUND

• 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. Epub 2014 Jul 5.

  PMID: 25000308 BACKGROUND

• 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. doi: 10.1212/wnl.60.1.31.

  PMID: 12525714 BACKGROUND

• 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. Epub 2012 Aug 27.

  PMID: 22935407 BACKGROUND

• 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. doi: 10.1191/135248506ms1373ed. No abstract available.

  PMID: 16900749 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.

  PMID: 6685237 BACKGROUND

• 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. Epub 2013 May 10.

  PMID: 23669008 BACKGROUND

• 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. doi: 10.1016/j.jbiomech.2004.07.002.

  PMID: 15863120 BACKGROUND

• 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. doi: 10.1002/pri.358.

  PMID: 17536648 BACKGROUND

• 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;2015(9):CD009956. doi: 10.1002/14651858.CD009956.pub2.

  PMID: 26358158 BACKGROUND

• 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.

  PMID: 21402370 BACKGROUND

• 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.

  PMID: 21387374 BACKGROUND

• 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. doi: 10.1682/jrrd.2010.08.0159.

  PMID: 22234713 BACKGROUND

• 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. doi: 10.1053/apmr.2001.9396.

  PMID: 11239279 BACKGROUND

• 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. Epub 2013 Aug 2.

  PMID: 24314679 BACKGROUND

• 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. doi: 10.1177/1352458507080733. Epub 2007 Oct 17.

  PMID: 17942521 BACKGROUND

• 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.

  PMID: 10740096 BACKGROUND

• Wade DT. Measurement in neurological rehabilitation. Curr Opin Neurol Neurosurg. 1992 Oct;5(5):682-6.

  PMID: 1392142 BACKGROUND

• 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. Epub 2013 May 4.

  PMID: 23651867 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maxime VALET, MD

  UCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Lejeune, PhD

CONTACT

+32 2 764 16 48; thierry.lejeune@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professeur

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 17, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2020
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

BE (1)