Effects of a Personalized Standardized Rehabilitation Program on the Quality of Life of Patients With Systemic Sclerosis Patients : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- HAQ DI:Health Assessment questionnaire disability index
研究概览
简要总结
Systemic sclerosis (SSc) is a connective-tissue disease characterized by excessive collagen deposition, vascular hyper-reactivity and obliterative microvascular phenomena leading to disability, handicap, and worsening of quality of life. Pharmacological treatments are mainly used for vascular involvement. To date, no pharmacological treatment have been shown to be effective for the fibrosis leading to skin, tendon, and joint disability. Our hypothesis is that rehabilitation could be an interesting non pharmacological treatment in order to decrease the handicap of SSc patients. Our objective is to evaluate the effect of a personalized standardized rehabilitation program on the quality of life of SSc patients in a multicentric randomized controlled trial. This trial will compare a personalized standardized rehabilitation program to the usual non pharmacological treatment. The primary outcome measure will be the HAQ DI (Health Assessment Questionnaire Disability Index). A Zelen design will be used for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged from 18 years or more, with diagnostic of SSc considering the ACR and/or Leroy and Medsger's criteria.
- •HAQ greater than or equal to 0.5
- •A perception of limitation of mouth opening and/or at least one limitation in range of motion due to illness
- •Good understanding of the French language
排除标准
- •Associated chronic handicap diseases (stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, amputated ....)
- •Any underlying disease that may be incompatible with the management, discovery at the inclusion visit
- •Cognitive problems making it impossible to assess the primary outcome measure
- •Patients with a standardized rehabilitation program within 6 months prior to inclusion
- •Impairment of comprehension or expression of the French language
- •Patients participating in another clinical trial or participated in another clinical trial in the previous 3 months.
研究组 & 干预措施
Control group
Habitual care
Intervention group
The patients in this group will do a personalized standardized rehabilitation program on the quality of life.
干预措施: standardized reeducation and readaptation program (Procedure)
结局指标
主要结局
HAQ DI:Health Assessment questionnaire disability index
时间窗: at 12 months
Health Assessment questionnaire disability index
次要结局
- Forced expiratory volume (FEV)(at 12 months)
- Satisfaction of clinical condition(at 12 months)
- Mac Tar (Mc Master Toronto Arthritis questionnaire)(at 12 months)
- S-HAQ ( scleroderma-modified health assessment questionnaire)(at 12 months)
- SF 36(at 12 months)
- Kapandji modified index(at 12 months)
- Rodnan score(at 12 months)
- Hand Cochin Function Scale(at 12 months)
- Pain(at 12 months)
- Mouth opening(at 12 months)