A Reeducation Program to Effort to Improve the Walking of Multiple Sclerosis Patients

NCT02874677 | Terminated

• 2 other identifiers: RC-P00482016-A00745-46
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief Summary

Multiple sclerosis (MS) is a disease affecting the white matter of the central nervous system. In France, it concerns approximately 80 000 patients and represents one of the most frequent neurological affections in young adults. Effort deconditioning of people affected by MS is already proven, but it is not just linked to the disease itself. The decrease of capacities to produce an effort is aggravated by neurovegetative and cardiovascular disorders. The limitation or the complete stop of physical activity is often linked to the fear of a handicap aggravation. Causes of stop are multiple, including fatigue and balance disorders, even if the handicap level is low (average EDSS = 2). Walking disorders generated by MS are frequent, represent the first symptom of the disease (10 to 20 % of cases) and alter significantly the quality of life. Some reeducation programs were proposed in hospitalization with some efficiency on functional capacities. It is now admitted that physical exercise is not noxious, and allows the implementation of effort reeducation for MS. Randomized controlled studies have shown in MS patients an improvement of physical abilities, of O2max (aerobic capacity), of quality of life and a decrease of fatigue. For MS, only a few studies estimate the effect of effort reeducation on treadmill. Unfortunately, the efficiency of these programs on walking endurance are controversial. During the maximal cardiorespiratory effort test, the ventilatory threshold 1 (VT1) corresponds to a greater increasing of CO2 compared to O2. The identification of VT1 allows the precise determination of the limit from which the body is incapable of producing the necessary energy to realize an effort using the aerobic metabolism. The VT1 is situated at a level of load with enough intensity for the subject to support the test without dyspnea. A VT1 lower than 40 % of the theoretical VO2 max is considered as a marker of maladjustment to effort due to dyspnea and excessive muscular fatigue. This indication is very informative about the quality of life of patients. The goal of this study is to apply a personalized reeducation concerning the working load pre-hyperventilation to deconditioned subjects, easily worried by effort induced breathlessness and fatigue in order to get the optimization of the aerobic function. The hypothesis is that reeducation at this level improves the distance of walking and the quality of life of patients affected by MS.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Ventilatory threshold; Effort Reeducation

Outcome Measures

Primary Outcomes (1)

• Distance estimated by the 6 minutes Walk Test

  Distance covered during 6 minutes estimated by the 6 minutes Walk Test (6MWT) performed at the inclusion visit then at 6 weeks and at 3 months after the effort reeducation program (experimental group) or not (control group).

  Change in baseline at 6 weeks and at 3 months

Secondary Outcomes (7)

• Walking speed measured by the timed 25-ft walk test (T25FWT)

  Change in baseline at 6 weeks and at 3 months

• Heart rate estimation at the end of the 6 minutes walk test

  Change in baseline at 6 weeks and at 3 months

• Walking perception measured by the Twelve Item MS Walking Scale (MSWS-12) scale

  Change in baseline at 6 weeks and at 3 months

• Effort test for the estimation of the maximal consumption of oxygen (O2max)

  Change in baseline at 6 weeks and at 3 months

• Multiple sclerosis-59 French scale for the estimation of the quality of life

  Change in baseline at 6 weeks and at 3 months

Study Arms (2)

Control

NO INTERVENTION

Routine activities

Experimental

EXPERIMENTAL

Effort reeducation program : 3 sessions of 20 minutes per week during 6 weeks

Other: Effort reeducation program

Interventions

Effort reeducation program OTHER

personalized reeducation program at a load level preceding hyperventilation

Experimental

Eligibility Criteria

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

You may qualify if:

• People with remittent or progressive multiple sclerosis defined by the criteria of Mc Donald revised in 2005
• Expended Disability Status Scale (EDSS) between 4 and 6
• Age between 18 and 65 years old
• No defined relapse of MS for at least 6 weeks
• At least more than 4 weeks since the last corticoids bolus
• Coverage of the social insurance

You may not qualify if:

• Understanding disorders
• Medical history of orthopaedic or and rheumatologic invalidating
• Contraindications to test effort, after a cardiological consultation and ECG
• Cardiovascular and respiratory diseases not stabilized
• Osteo-articular diseases not stabilized
• Pregnant or breast-feeding woman

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (4)

Centre Hospitalier Universitaire d'Amiens

Amiens, Hauts-de-France, 80000, France

Location

Centre Jacques Calvé

Berck, Hauts-de-France, 62600, France

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, Hauts-de-France, 59000, France

Location

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, Hauts-de-France, 59000, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Caroline Massot, MD

  Groupement des Hôpitaux de l'Institut Catholique de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 22, 2016
• Study Start: December 7, 2017
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)