Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in the quality of life between M3 and M6 by MGQOL score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Patient ≥ 18 and ≤ 70 years old
- •Patient having an health insurance
- •Informed written consent
排除标准
- •Patients under particular protection
- •Enrolment in another biomedical research in the last 3 months;
- •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 %
- •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%)
- •MGFA grade I, grade IV or V
- •Severe cognitive impairment
- •MGQOL-15 below 15/60
研究组 & 干预措施
Physical exercise arm
Arm with physical exercise on rowing machine between M3 and M6
干预措施: Physical exercise programme using a rowing machine (Behavioral)
Control arm
Arm with standard medical care without additional physical exercise
结局指标
主要结局
Change in the quality of life between M3 and M6 by MGQOL score
时间窗: M3 and M6
次要结局
- Frequency and severity of cardiovascular side-effects(6 MONTHS)
- Cumulative dose of steroids within the 3 months of the exercise programme(6 MONTHS)
- Plasma levels of pro- and anti-inflammatory cytokines at 9 months(M9)
- Muscular strength(M3, M6 and M9)
- Frequency of MG exacerbations(6 MONTHS)
- Muscular endurance(M3, M6 and M9)
- Severity of MG exacerbations(6 MONTHS)
- Psychological status (STAI, BECK, MINI et SEI scales) at 3, 6 and 9 months(M3, M6 and M9)
- Muscular fatigability(M3, M6 and M9)
- Frequency and severity of respiratory side-effects(6 MONTHS)
- Doses of anticholinesterasic and steroids at 3, 6 and 9 months(M3, M6 and M9)