The Benefits of Individualized Follow-up With a Sport-Health Professional in the Care of Patients With Chronic Respiratory Diseases, to Maintain Long-term Benefits After a Respiratory Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 352
- 试验地点
- 4
- 主要终点
- Difference in average number of daily steps
研究概览
简要总结
Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term.
The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits.
This study concerns patients with a diagnosis of one or more chronic respiratory diseases.
It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms:
- a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group)
- a control group receiving only usual care
详细描述
Pulmonary rehabilitation is an integral part of care for patients with chronic respiratory diseases. It improves patients' physical capacities, quality of life and symptoms, at least in the short term.
The hypothesis that patients receiving personalized support from a professional following pulmonary rehabilitation will maintain long-term benefits.
This study concerns patients with a diagnosis of one or more chronic respiratory diseases.
It is a multicenter, blinded, randomized controlled superiority trial in 2 parallel arms:
- a group comparing follow-up and personalized support after a pulmonary rehabilitation program (experimental group)
- a control group receiving only usual care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of one or more chronic respiratory diseases (asthma, chronic obstructive pulmonary disease, diffuse interstitial lung disease, bronchiectasis, obstructive sleep apnea syndrome, etc.).
- •Participation in a respiratory pulmonary program
- •Have given consent
- •Patient of legal age
- •Patient affiliated to Social Security
排除标准
- •Any medical contraindication to the practice of adapted physical activity in rehabilitation
- •Patients under guardianship or curatorship
- •Patients deprived of their liberty
- •Patients over 80 years of age at the time of inclusion.
研究组 & 干预措施
Control arm
Patient in the control arm will beneficiate from commun practice
Experimental arm
Patient in the control arm will beneficiate from a personalized follow-up and support after a pulmonary rehabilitation program
干预措施: Personalized follow-up and support (Other)
结局指标
主要结局
Difference in average number of daily steps
时间窗: At inclusion (V1) and at 24 Months (V5)
The difference in average daily steps measured by accelerometry (over 7 days) at the end of the pulmonary rehabilitation course (V1) and after 24 months of personalized follow-up (V5).
次要结局
- Cost-utility comparison between the two groups(At 24 Months (V5))
- Comparison of changes in physical activity levels between the two groups(At 24 Months (V5))
- Comparison of changes in physical capacities between the two groups(A 24 Months (V5))
- Comparison of changes in symptoms between the two groups(At 24 Months (V5))
- Comparison of changes in psychological dimensions between the two groups(At 24 Months (V5))
- Comparison of changes in health indicator between the two groups(At 24 Months (V5))
- Comparison of changes in quality of life indicator between the two groups(At 24 Months (V5))
- Comparison of changes in parameters (barriers and levers to physical activity) between the two groups(At 24 Months (V5))
- Comparison of changes in physical capacities between the two groups(At 24 Months (V5))
- Cost-utility comparison between the two groups(At 24 Months (V5))
- Comparison of changes in physical activity levels between the two groups(At 24 Months (V5))
- Comparison of changes in symptoms between the two groups(At 24 Months (V5))
- Comparison of changes in quality of life indicator between the two groups(At 24 Months (V5))
- Comparison of changes in parameters (barriers and levers to physical activity) between the two groups(At 24 Months (V5))
- Comparison of changes in psychological dimensions between the two groups(At 24 Months (V5))
- Comparison of changes in health indicator between the two groups(At 24 Months (V5))