Multiple SclerosisAEROSEPNCT02874677
A Reeducation Program to Effort to Improve the Walking of Multiple Sclerosis Patients
A study testing Effort reeducation program in people with Multiple Sclerosis, run by Lille Catholic University at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Effort reeducation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesFrance
- Study dates
- 7 Dec 2017to 14 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier Universitaire d'Amiens
Amiens, Hauts-de-France, 80000
Centre Jacques Calvé
Berck, Hauts-de-France, 62600
Centre Hospitalier Régional Universitaire de Lille
Lille, Hauts-de-France, 59000
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, Hauts-de-France, 59000
About this study
Official title: Effects of an Endurance Training Program at Ventilatory Threshold on the Walking Distance of Ambulatory Patients With Multiple Sclerosis
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.
Read more
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Effort reeducation program
- Keywords
- Multiple sclerosis, Ventilatory threshold, Effort Reeducation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effort reeducation programOther
personalized reeducation program at a load level preceding hyperventilation
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Routine activities |
| Experimental | Experimental | Effort reeducation program : 3 sessions of 20 minutes per week during 6 weeks Receives: Other: Effort reeducation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change in baseline at 6 weeks and at 3 months
Secondary outcomes (7)
Walking speed measured by the timed 25-ft walk test (T25FWT)
Measured: Change in baseline at 6 weeks and at 3 months
Heart rate estimation at the end of the 6 minutes walk test
Measured: Change in baseline at 6 weeks and at 3 months
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.
Measured: Change in baseline at 6 weeks and at 3 months
Effort test for the estimation of the maximal consumption of oxygen (O2max)
Measured: Change in baseline at 6 weeks and at 3 months
Multiple sclerosis-59 French scale for the estimation of the quality of life
Measured: Change in baseline at 6 weeks and at 3 months
Fatigue Impact Scale (EMIF-SEP)
Measured: Change in baseline at 6 weeks and at 3 months
Effort test for the estimation of the ventilatory threshold (VT1)
Measured: Change in baseline at 6 weeks and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start7 Dec 2017
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Why it stopped: material issues in study centres
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Massot, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874677
- Sponsor's protocol ID
- RC-P0048
- Other IDs
- 2016-A00745-46
- Acronym
- AEROSEP
- Status last verified
- Mar 2024
- First submitted
- 17 Aug 2016
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Endurance Training Program at Ventilatory Threshold on the Walking Distance of Ambulatory Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02874677
- Acronym / sponsor ID
- AEROSEP / RC-P0048
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Ventilatory threshold, Effort Reeducation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: material issues in study centres
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Routine activities |
| Experimental | Experimental | Other: Effort reeducation programEffort reeducation program : 3 sessions of 20 minutes per week during 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effort reeducation programpersonalized reeducation program at a load level preceding hyperventilation | Other | Experimental |
Primary outcome
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).
7 secondary outcomes
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
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
Results and safety
The study was stopped early (reason given: material issues in study centres). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
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Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
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RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Massot, MD principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effort reeducation program in people with Multiple Sclerosis, run by Lille Catholic University at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: material issues in study centres). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance estimated by the 6 minutes Walk Test (time frame: Change in baseline at 6 weeks and at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.