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The purpose of this study is to demonstrate that a 3 months physical exercise programme improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized since at least 6 months under prednisone and/or azathioprine.
Three centers randomized simple blind clinical trial whose objective is to assess the efficacy on QoL improvement, and the tolerance of physical exercise over a period of 3 months in patients with generalized MG who have been stabilized since at least 6 months.
During the 3 months pre-inclusion phase, the characteristics of MG will be collected. Physical activity and performance will be assessed monthly.
MGQOL15 will be assessed at inclusion.
Patients will be randomized in either intervention arm or control arm.
The intervention arm will consist of three sessions exercise per week during three months. The daily exercise will be performed on a rowing machine that will be adapted to the patient's own physical ability.
Physical activity will be measured with the help of an actimeter.
Once a month, MG evolution and tolerance to exercise will be assessed and MG treatment dose will be collected.
Exercise will be interrupted in case of MG exacerbation.
Quality of life and psychological status will be assessed at 3, 6 and 9 months.
Plasma levels of pro and anti-inflammatory cytokines will be measured at 3, 6 and 9 months in order to assess the effects of exercise on immune response.
Patients enrolled in the control arm will benefit from the same follow-up but will not have exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical exercise arm | Experimental | Arm with physical exercise on rowing machine between M3 and M6 |
|
| Control arm | No Intervention | Arm with standard medical care without additional physical exercise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise programme using a rowing machine | Behavioral | 3 sessions per week of individualized physical training using a rowing machine during 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the quality of life between M3 and M6 by MGQOL score | M3 and M6 |
| Measure | Description | Time Frame |
|---|---|---|
| Muscular strength | Muscular strength (before exercise period, after exercise period and 3 months after) | M3, M6 and M9 |
| Frequency of MG exacerbations | 6 MONTHS |
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Inclusion Criteria:
Patient with generalized MG of stage II or III according to the MGFA classification, stabilized for at least 6 months. Criteria for MG are either
Patient ≥ 18 and ≤ 70 years old
Patient having an health insurance
Informed written consent
Exclusion Criteria:
Patients under particular protection
Enrolment in another biomedical research in the last 3 months;
Patients for whom physical practice is contra-indicated because of :
MGFA grade I, grade IV or V
Severe cognitive impairment
MGQOL-15 below 15/60
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| Name | Affiliation | Role |
|---|---|---|
| Tarek SHARSHAR, MD, PhD | ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU and medical surgery department, Raymond Poincaré Hospital | Garches | Hauts-de-Seine | 92380 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34304969 | Derived | Birnbaum S, Porcher R, Portero P, Clair B, Demeret S, Eymard B, Gargiulo M, Louet E, Berrih-Aknin S, Le Panse R, Aegerter P, Hogrel JY, Sharshar T; MGEX Study Group. Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial. Neuromuscul Disord. 2021 Aug;31(8):726-735. doi: 10.1016/j.nmd.2021.05.002. Epub 2021 May 27. | |
| 29347991 |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Frequency and severity of cardiovascular side-effects | 6 MONTHS |
| Cumulative dose of steroids within the 3 months of the exercise programme | 6 MONTHS |
| Doses of anticholinesterasic and steroids at 3, 6 and 9 months | M3, M6 and M9 |
| Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months | M3, M6 and M9 |
| Plasma levels of pro- and anti-inflammatory cytokines at 9 months | M9 |
| Muscular fatigability | fatigability (before exercise period, after exercise period and 3 months after) | M3, M6 and M9 |
| Muscular endurance | muscular endurance (before exercise period, after exercise period and 3 months after) | M3, M6 and M9 |
| Severity of MG exacerbations | 6 MONTHS |
| Frequency and severity of respiratory side-effects | 6 MONTHS |
| Birnbaum S, Hogrel JY, Porcher R, Portero P, Clair B, Eymard B, Demeret S, Bassez G, Gargiulo M, Louet E, Berrih-Aknin S, Jobic A, Aegerter P, Thoumie P, Sharshar T; MGEX Study Group. The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial. Trials. 2018 Jan 18;19(1):49. doi: 10.1186/s13063-017-2433-2. |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |