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

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ClinicalTrials.gov Identifier: NCT02874677
Recruitment Status : Not yet recruiting
First Posted : August 22, 2016
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Effort reeducation program Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of an Endurance Training Program at Ventilatory Threshold on the Walking Distance of Ambulatory Patients With Multiple Sclerosis
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Routine activities
Experimental: Experimental
Effort reeducation program : 3 sessions of 20 minutes per week during 6 weeks
Other: Effort reeducation program
personalized reeducation program at a load level preceding hyperventilation




Primary Outcome Measures :
  1. Distance estimated by the 6 minutes Walk Test [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
    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).


Secondary Outcome Measures :
  1. Walking speed measured by the timed 25-ft walk test (T25FWT) [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
  2. Heart rate estimation at the end of the 6 minutes walk test [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
  3. Walking perception measured by the Twelve Item MS Walking Scale (MSWS-12) scale [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
    It is an auto-questionnaire which estimates the impact of the disease on the walk capacity.

  4. Effort test for the estimation of the maximal consumption of oxygen (O2max) [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
  5. Multiple sclerosis-59 French scale for the estimation of the quality of life [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
  6. Fatigue Impact Scale (EMIF-SEP) [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
  7. Effort test for the estimation of the ventilatory threshold (VT1) [ Time Frame: Change in baseline at 6 weeks and at 3 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874677


Contacts
Contact: Amélie Lansiaux, PhD, MD +33 3 20 22 57 41 lansiaux.amelie@ghicl.net
Contact: Jean-Jacques Vitagliano, PhD +33 3 20 22 57 51 Vitagliano.Jean-Jacques@ghicl.net

Locations
France
Centre Hospitalier Universitaire d'Amiens Not yet recruiting
Amiens, Nord Pas-de-Calais, France, 80000
Principal Investigator: Aude Page, MD         
Principal Investigator: Abdullatif Alkhedr, MD         
Centre Jacques Calvé Not yet recruiting
Berck sur Mer, Nord Pas-de-Calais, France, 62600
Principal Investigator: Pascal Rigaux, MD         
Centre Hospitalier Régional Universitaire de Lille Not yet recruiting
Lille, Nord Pas-de-Calais, France, 59000
Principal Investigator: Anne Blanchard, MD         
Sub-Investigator: Patrick Vermersch, MD, PhD         
Groupement des Hôpitaux de l'Institut Catholique de Lille Not yet recruiting
Lille, Nord Pas-de-Calais, France, 59000
Principal Investigator: Caroline Massot, MD         
Sub-Investigator: Cécile Donzé, MD         
Sub-Investigator: Hichem Khenioui, MD         
Sub-Investigator: Hautecoeur Patrick, MD, PhD         
Sponsors and Collaborators
Lille Catholic University
Investigators
Principal Investigator: Caroline Massot, MD Groupement des Hôpitaux de l'Institut Catholique de Lille

Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02874677     History of Changes
Other Study ID Numbers: RC-P0048
2016-A00745-46 ( Other Identifier: ANSM )
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lille Catholic University:
Multiple sclerosis
Ventilatory threshold
Effort Reeducation

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases