Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 44
Inclusion Criteria
- positive dosage of ant-RACh or MuSK auto-antibodies;
- Informed written consent
- If absent, myasthenic symptoms decrement> 10% in EMNG and test the positive prostigmine
- ...
- positive dosage of ant-RACh or MuSK auto-antibodies;
- Informed written consent
- If absent, myasthenic symptoms decrement> 10% in EMNG and test the positive prostigmine
- Patient ≥ 18 and ≤ 70 years old
- Patient having an health insurance
Exclusion Criteria
- Chronic Pain or disabling orthopaedic conditions
- Heart failure with systolic ejection fraction < 50 %
- Other neuromuscular pathology
- ...
- Chronic Pain or disabling orthopaedic conditions
- Heart failure with systolic ejection fraction < 50 %
- Other neuromuscular pathology
- Disabling Rheumatologic disease (> 80 % disability according to the Barthel scale)
- Respiratory failure defined by a vital capacity (CV) < 70 %
- Hospitalization in the last 3 months for a serious medical or surgical condition
- Severe cognitive impairment
- Enrolment in another biomedical research in the last 3 months;
- Stroke
- MGQOL-15 below 15/60
- Unstable coronary Syndrome or myocardial infarction within the past 3 months
- Patients under particular protection
- Anemia (hematocrit < 30%)
- MGFA grade I, grade IV or V
Summary
- Conditions
- Myasthenia Gravis
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 phas...
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.
Inclusion Criteria
- positive dosage of ant-RACh or MuSK auto-antibodies;
- Informed written consent
- If absent, myasthenic symptoms decrement> 10% in EMNG and test the positive prostigmine
- ...
- positive dosage of ant-RACh or MuSK auto-antibodies;
- Informed written consent
- If absent, myasthenic symptoms decrement> 10% in EMNG and test the positive prostigmine
- Patient ≥ 18 and ≤ 70 years old
- Patient having an health insurance
Exclusion Criteria
- Chronic Pain or disabling orthopaedic conditions
- Heart failure with systolic ejection fraction < 50 %
- Other neuromuscular pathology
- ...
- Chronic Pain or disabling orthopaedic conditions
- Heart failure with systolic ejection fraction < 50 %
- Other neuromuscular pathology
- Disabling Rheumatologic disease (> 80 % disability according to the Barthel scale)
- Respiratory failure defined by a vital capacity (CV) < 70 %
- Hospitalization in the last 3 months for a serious medical or surgical condition
- Severe cognitive impairment
- Enrolment in another biomedical research in the last 3 months;
- Stroke
- MGQOL-15 below 15/60
- Unstable coronary Syndrome or myocardial infarction within the past 3 months
- Patients under particular protection
- Anemia (hematocrit < 30%)
- MGFA grade I, grade IV or V
Tracking Information
- NCT #
- NCT02066519
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Tarek SHARSHAR, MD, PhD ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France
- Tarek SHARSHAR, MD, PhD ICU and medical surgery Service, Raymond Poincaré Hospital, 92380 Garches, France