Pulmonary Rehabilitation in Fibrotic Pulmonary Sarcoidosis (Stage IV): Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 22
- 主要终点
- Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET)
研究概览
简要总结
The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program.
The secondary objectives are the following:
- assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program
- assess the improvement of exercise capacity by tests used in medical practice
- assess the correlation between daily activity and exercise capacity
- assess the improvement of dyspnea
- assess the improvement of quality of life and psychological state
详细描述
The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program
The secondary objectives are the following :
- assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program
- assess the improvement of exercise capacity by tests used in medical practice
- assess the correlation between daily activity and exercise capacity
- assess the improvement of dyspnea
- assess the improvement of quality of life and psychological state
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Stage IV Sarcoidosis
- •No hospitalization for respiratory distress in the 3 months preceding the inclusion
- •Dyspnea on exertion
- •Age over 18 years
排除标准
- •Physical disability does not allow the creation of a rehabilitation program
- •Inability to give written consent to the study
- •Refusal of contraception in women of childbearing age
- •Inability to participate in the entire study
- •No cover by the social security system
- •Inability to perform self-questionnaires etude
- •The trial does not include special populations include:
- •Pregnant women
- •Breastfeeding women
- •People in emergencies
- •Persons unable to consent
- •Persons deprived of liberty
研究组 & 干预措施
Pulmonary rehabilitation
Sarcoidosis patients will realize a pulmonary rehabilitation program
干预措施: Pulmonary rehabilitation program (Other)
Controls
Sarcoidosis patients who do not achieve a respiratory rehabilitation program but will have physical activity counseling.
结局指标
主要结局
Daily activity assessed by time (in minutes) spent in moderate activity (superior to 2,5 MET)
时间窗: 12 months
In everyday life, it corresponds to a walking in 5 km/h or in domestic chores. This measure will be realized by using Armband's accelerometer, in ambulatory. The measure will be realized over a period of 4 full days including the weekend.
次要结局
- Questionnaire to evaluate quality of life and/or psychological state : MRF 28(2, 6 and 12 months)
- Questionnaire to evaluate quality of life and/or psychological state : VSRQ(2, 6 and 12 months)
- Questionnaire to evaluate quality of life and/or psychological state : FAS(2, 6 and 12 months)
- Questionnaire to evaluate quality of life and/or psychological state : DIRECT(2, 6 and 12 months)
- exercise capacity assessed by symptom-limited cardiopulmonary exercise test, 6 minutes walk test, endurance test on bicycle, St Etienne questionnaire, 6 minutes stepper test(2, 6 and 12 months)
- MRC scale for dyspnea(2, 6 and 12 months)
- Daily activity assessed by time spent in moderate activity (superior to 2,5 MET)(2 and 6 months)
- Questionnaire to evaluate quality of life and/or psychological state : HAD(2, 6 and 12 months)