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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Effort reeducation program
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Ventilatory threshold, Effort Reeducation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire d'Amiens
  • Centre Jacques Calvé
  • Centre Hospitalier Régional Universitaire de Lille
  • Groupement des Hôpitaux de l'Institut Catholique de LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Experimental

Arm Description

Routine activities

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Walking speed measured by the timed 25-ft walk test (T25FWT)
Heart rate estimation at the end of the 6 minutes walk test
Walking perception measured by the Twelve Item MS Walking Scale (MSWS-12) scale
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)
Multiple sclerosis-59 French scale for the estimation of the quality of life
Fatigue Impact Scale (EMIF-SEP)
Effort test for the estimation of the ventilatory threshold (VT1)

Full Information

First Posted
August 17, 2016
Last Updated
August 26, 2019
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT02874677
Brief Title
A Reeducation Program to Effort to Improve the Walking of Multiple Sclerosis Patients
Acronym
AEROSEP
Official Title
Effects of an Endurance Training Program at Ventilatory Threshold on the Walking Distance of Ambulatory Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Multiple sclerosis 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. There are several symptoms, including pyramidal syndrome, sensory syndrome, visual disorders, fatigue, bladder-sphincter disorders, etc. It is an unpredictable chronic disease. Most of the time, it evolves by relapse at the beginning, then, after a few years, the disease becomes secondarily progressive. In some cases, the evolution is directly progressive. Efforts oriented to the deconditioning of people affected by multiple sclerosis are already proven, but they are not only linked to the disease itself. The decrease of capacities to produce an effort is aggravated by neurovegetative and cardiovascular disorders. The limitation, even the complete stop, of physical activity is often linked to the fear of a handicap aggravation. Causes of stop are multiple, including fatigue (general and muscular) and balance disorders, even if the handicap level is low (average EDSS = 2). Walking disorders generated by this pathology are frequent and represent the first symptom of the disease (10 to 20 % of cases). These walking disorders quickly appear and alter significantly the quality of life. After several years of evolution, functional effects are more and more pronounced. The walking perimeter is estimated at 500 meters without help after 7 years of evolution on average, and no more than 100 meters after 15 years of evolution. At this stage, 50 % of patients need a technical help to move. 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 this pathology. Randomized controlled studies have shown in multiple sclerosis patients an improvement of physical abilities, of O2max (aerobic capacity), a decrease of fatigue and an improvement of quality of life. Actually, the cyclo-ergometer is the most common device used for the effort reeducation. Another approach is the use of a treadmill, based on the improvement of the walking reflex modeling and the enhancement of the specific walking work, thanks to a high frequency of repetitions. This device seems more adapted for the improvement of walking disorders than the cyclo-ergometer. For this pathology, only a few studies estimated the effect of effort reeducation on treadmill. Unfortunately, the efficiency of these programs on walking endurance is not well known and results are controversial. Indeed, only two randomized, controlled trials showed improvements of the walking speed and the energy cost of walking. However, the impact on the 2-Minute Walk Test (2MWT) was contradictory, probably due to the population studied (different EDSS and age) and the training duration (4 weeks Vs 8 weeks). Moreover, in these studies, the effort intensity is most of time determined from an arbitrary percentage of the theoretical maximal heart rate (HR) or the VO2max. The heart rate corresponding to the level of load of the ventilatory threshold (VT) described by Wasserman and al (1973) could be more efficient to measure the intensity of reeducation, compared to a heart rate (HR) determined from an arbitrary percentage. Four reasons are highlighted: The ventilatory threshold represents a well defined metabolic level (individualized measure) According to the subjects, ventilator threshold is not a constant percentage of "O2max", and suggests that it is also an individualized measure. During the maximal cardiorespiratory effort test, the ventilatory threshold 1 (VT1) corresponds to a greater increasing of CO2 compared to O2. The identification of this threshold 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Ventilatory threshold, Effort Reeducation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine activities
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Effort reeducation program : 3 sessions of 20 minutes per week during 6 weeks
Intervention Type
Other
Intervention Name(s)
Effort reeducation program
Intervention Description
personalized reeducation program at a load level preceding hyperventilation
Primary Outcome Measure Information:
Title
Distance estimated by the 6 minutes Walk Test
Description
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).
Time Frame
Change in baseline at 6 weeks and at 3 months
Secondary Outcome Measure Information:
Title
Walking speed measured by the timed 25-ft walk test (T25FWT)
Time Frame
Change in baseline at 6 weeks and at 3 months
Title
Heart rate estimation at the end of the 6 minutes walk test
Time Frame
Change in baseline at 6 weeks and at 3 months
Title
Walking perception measured by the Twelve Item MS Walking Scale (MSWS-12) scale
Description
It is an auto-questionnaire which estimates the impact of the disease on the walk capacity.
Time Frame
Change in baseline at 6 weeks and at 3 months
Title
Effort test for the estimation of the maximal consumption of oxygen (O2max)
Time Frame
Change in baseline at 6 weeks and at 3 months
Title
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
Title
Fatigue Impact Scale (EMIF-SEP)
Time Frame
Change in baseline at 6 weeks and at 3 months
Title
Effort test for the estimation of the ventilatory threshold (VT1)
Time Frame
Change in baseline at 6 weeks and at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Lansiaux, PhD, MD
Phone
+33 3 20 22 57 41
Email
lansiaux.amelie@ghicl.net
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Jacques Vitagliano, PhD
Phone
+33 3 20 22 57 51
Email
Vitagliano.Jean-Jacques@ghicl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Massot, MD
Organizational Affiliation
Groupement des Hôpitaux de l'Institut Catholique de Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Amiens
City
Amiens
State/Province
Nord Pas-de-Calais
ZIP/Postal Code
80000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aude Page, MD
First Name & Middle Initial & Last Name & Degree
Abdullatif Alkhedr, MD
Facility Name
Centre Jacques Calvé
City
Berck
State/Province
Nord Pas-de-Calais
ZIP/Postal Code
62600
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Rigaux, MD
Facility Name
Centre Hospitalier Régional Universitaire de Lille
City
Lille
State/Province
Nord Pas-de-Calais
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Blanchard, MD
First Name & Middle Initial & Last Name & Degree
Patrick Vermersch, MD, PhD
Facility Name
Groupement des Hôpitaux de l'Institut Catholique de Lille
City
Lille
State/Province
Nord Pas-de-Calais
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Massot, MD
First Name & Middle Initial & Last Name & Degree
Cécile Donzé, MD
First Name & Middle Initial & Last Name & Degree
Hichem Khenioui, MD
First Name & Middle Initial & Last Name & Degree
Hautecoeur Patrick, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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