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

N/ACompletedNCT02066519

Assistance Publique - Hôpitaux de Paris45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myasthenia Gravis

Interventions

Physical exercise programme using a rowing machineBEHAVIORAL

3 sessions per week of individualized physical training using a rowing machine during 3 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

ICU and medical surgery department, Raymond Poincaré Hospital

Garches, Hauts-de-Seine, France

Outcomes

Primary Outcomes

Change in the quality of life between M3 and M6 by MGQOL score

Time frame: M3 and M6

Secondary Outcomes

Muscular strength

Muscular strength (before exercise period, after exercise period and 3 months after)

Time frame: M3, M6 and M9

Frequency of MG exacerbations

Time frame: 6 MONTHS

Frequency and severity of cardiovascular side-effects

Time frame: 6 MONTHS

Cumulative dose of steroids within the 3 months of the exercise programme

Time frame: 6 MONTHS

Doses of anticholinesterasic and steroids at 3, 6 and 9 months

Time frame: M3, M6 and M9

Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months

Time frame: M3, M6 and M9

Plasma levels of pro- and anti-inflammatory cytokines at 9 months

Time frame: M9

Muscular fatigability

fatigability (before exercise period, after exercise period and 3 months after)

Time frame: M3, M6 and M9

Muscular endurance

muscular endurance (before exercise period, after exercise period and 3 months after)

Time frame: M3, M6 and M9

Data from ClinicalTrials.gov

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