Efficacy of an Individual Rehabilitation Program in Polymyositis and Dermatomyositis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- HAQ score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of an active rehabilitation program on disability and quality of life of patients affected by dermatomyositis and polymyositis.
详细描述
Dermatomyositis (DM) and polymyositis (PM) are inflammatory disabling neuromuscular disorders. Despite partial benefit of pharmacological treatments, muscle strength, functional status and quality of life remain impaired. Although the use muscle exercises in (DM) and (PM) have been reported, its efficacy on disability and quality of life has not been proved.
Te aim of the study is to evaluate the benefit at mid term (12 months) of an active rehabilitation program administrated to patients affected by PM and DM.
Method: a 3 year prospective, multicentric, randomized controlled trial A program of 12 individual exercise sessions (3 per week during 4 weeks) is compared to conventional care. Patients are followed 12 month after the inclusion.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Dermatomyositis ore polymyositis according to the International Myositis Assessment and Clinical Studies Group
- •functional impairment (an HAQ score greater than 0.5)
- •stability of muscle impairment
- •medical insurance
排除标准
- •no recent inflammatory activity
- •other chronic disease
- •cognitive impairment
- •patients who participated to a rehabilitation program before inclusion
结局指标
主要结局
HAQ score
时间窗: 6 month and 1 year after rehabilitation
次要结局
- muscle strength (MRC manual muscle testing)(at 6 month and one year after rehabilitation)
- Quality of life (SF36 score)(6 month and 1 year after rehabilitation)
- MFM(motor function measure)(6 month and one year after rehabilitation)