Clinical trial NCT02066519: Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis
Official title: Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myasthenia Gravis
Keywords: Myasthenia gravis
physical exercise
quality of life
muscular performance
fatigability
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the quality of life between M3 and M6 by MGQOL score
timeFrame: M3 and M6
Secondary outcomes:
measure: Muscular strength
timeFrame: M3, M6 and M9
measure: Frequency of MG exacerbations
timeFrame: 6 MONTHS
measure: Frequency and severity of cardiovascular side-effects
timeFrame: 6 MONTHS
measure: Cumulative dose of steroids within the 3 months of the exercise programme
timeFrame: 6 MONTHS
measure: Doses of anticholinesterasic and steroids at 3, 6 and 9 months
timeFrame: M3, M6 and M9
measure: Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months
timeFrame: M3, M6 and M9
measure: Plasma levels of pro- and anti-inflammatory cytokines at 9 months
timeFrame: M9
measure: Muscular fatigability
timeFrame: M3, M6 and M9
measure: Muscular endurance
timeFrame: M3, M6 and M9
measure: Severity of MG exacerbations
timeFrame: 6 MONTHS
measure: Frequency and severity of respiratory side-effects
timeFrame: 6 MONTHS
Other outcomes:
Locations:
city: Garches
country: France
facility: ICU and medical surgery department, Raymond Poincaré Hospital
state: Hauts-de-Seine
Study officials:
affiliation: ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France
name: Tarek SHARSHAR, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.