Myasthenia Gravis
Conditions
Keywords
Myasthenia gravis, physical exercise, quality of life, muscular performance, fatigability
Brief summary
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
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.
Interventions
BEHAVIORALPhysical exercise programme using a rowing machine
3 sessions per week of individualized physical training using a rowing machine during 3 months.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Patient ≥ 18 and ≤ 70 years old 3. Patient having an health insurance 4. Informed written consent
Exclusion criteria
1. Patients under particular protection 2. Enrolment in another biomedical research in the last 3 months; 3. 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%) 4. MGFA grade I, grade IV or V 5. Severe cognitive impairment 6. MGQOL-15 below 15/60
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the quality of life between M3 and M6 by MGQOL score | M3 and M6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Muscular strength | M3, M6 and M9 | Muscular strength (before exercise period, after exercise period and 3 months after) |
| Muscular fatigability | M3, M6 and M9 | fatigability (before exercise period, after exercise period and 3 months after) |
| Muscular endurance | M3, M6 and M9 | muscular endurance (before exercise period, after exercise period and 3 months after) |
| Severity of MG exacerbations | 6 MONTHS | — |
| Frequency and severity of respiratory side-effects | 6 MONTHS | — |
| Plasma levels of pro- and anti-inflammatory cytokines at 9 months | M9 | — |
Countries
France
Outcome results
None listed