Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis

Conditions
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Myasthenia Gravis

Intervention / Treatment
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* Behavioral: Physical exercise programme using a rowing machine


Participation Criteria
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Eligibility Criteria
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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 positive dosage of ant-RACh or MuSK auto-antibodies; If absent, myasthenic symptoms decrement> 10% in EMNG and test the positive prostigmine 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 : Unstable coronary Syndrome or myocardial infarction within the past 3 months Heart failure with systolic ejection fraction < 50 % Respiratory failure defined by a vital capacity (CV) < 70 % Stroke Other neuromuscular pathology Disabling Rheumatologic disease (> 80 % disability according to the Barthel scale) Chronic Pain or disabling orthopaedic conditions Hospitalization in the last 3 months for a serious medical or surgical condition Anemia (hematocrit < 30%) MGFA grade I, grade IV or V Severe cognitive impairment MGQOL-15 below 15/60

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical exercise arm<br>Arm with physical exercise on rowing machine between M3 and M6 | Behavioral: Physical exercise programme using a rowing machine<br>* 3 sessions per week of individualized physical training using a rowing machine during 3 months.<br>|
| No Intervention: Control arm<br>Arm with standard medical care without additional physical exercise | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the quality of life between M3 and M6 by MGQOL score |  | M3 and M6 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myasthenia gravis, physical exercise, quality of life, muscular performance, fatigability