CTRI/2019/11/021869已完成3 期
Efficacy and safety of exercise in mild to moderate myasthenia gravis: an openlabeled controlled trial.
Prinicipal Investigator1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- MGQOL-15 score
研究概览
简要总结
Myasthenia gravis (MG) is a rare autoimmune disease of neuromuscular junction. MG manifests with fatigability and fluctuating weakness of ocular, facial bulbar respiratory, axial and limb muscles.Exercise training is safe nonpharmacological intervention and may have physical and psychological advantages in MG. There is no randomised controlled trial on the efficacy and safety of exercise in MG .The present study is aimed at evaluating the efficacy and safety of exercise or rest in mild to moderate MG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •MG patients attending the neurology Outdoor or indoor services of SGPGIMS.
- •MGFA score of stage II to III.
- •Able to undergo 6minute walk test.
排除标准
- •Enrolled in another trial.
- •Contraindications to exercise like coronary artery disease and stroke and pulmonary disease, osteoarthritis, pregnancy or medical condition reducing survival to less than 2 years.
- •Hospitalization in past 8 weeks.
- •MGFA score of stage I, IV or V.
- •MGQOL score > 45.
结局指标
主要结局
MGQOL-15 score
时间窗: 1,2 and 3 months
次要结局
- 1. Increase in the dose of AchEIs drugs or additional immunosuppression or use of PE,IVIG.(2. Myasthenic muscle score: at 1,2 and 3 month.)
研究者
研究点 (1)
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