A Reeducation Program to Effort to Improve the Walking of Multiple Sclerosis Patients (AEROSEP)
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|ClinicalTrials.gov Identifier: NCT02874677|
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : August 22, 2018
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|
|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|
|Actual Study Start Date :||December 7, 2017|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||May 2020|
No Intervention: Control
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
- 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).
- Walking speed measured by the timed 25-ft walk test (T25FWT) [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
- Heart rate estimation at the end of the 6 minutes walk test [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
- 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.
- Effort test for the estimation of the maximal consumption of oxygen (O2max) [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
- 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 ]
- Fatigue Impact Scale (EMIF-SEP) [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
- Effort test for the estimation of the ventilatory threshold (VT1) [ Time Frame: Change in baseline at 6 weeks and at 3 months ]
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
|Contact: Amélie Lansiaux, PhD, MD||+33 3 20 22 57 firstname.lastname@example.org|
|Contact: Jean-Jacques Vitagliano, PhD||+33 3 20 22 57 51||Vitagliano.Jean-Jacques@ghicl.net|
|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, 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||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|
|Principal Investigator:||Caroline Massot, MD||Groupement des Hôpitaux de l'Institut Catholique de Lille|