Clinical trial · Interventional
Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis
NCT02066519CI-TRIAL-00034306MGEXcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical exercise programme using a rowing machine | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Physical exercise arm
- description
- Arm with physical exercise on rowing machine between M3 and M6
- interventionNames
- Behavioral: Physical exercise programme using a rowing machine
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Arm with standard medical care without additional physical exercise
Primary outcomes (1)
- measure
- Change in the quality of life between M3 and M6 by MGQOL score
- timeFrame
- M3 and M6
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDBirnbaum 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. PMID 34304969
- DERIVEDBirnbaum 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. PMID 29347991