NCT00882817已完成4 期
Effects of Pulmonary Rehabilitation in Interstitial Lung Diseases: a Prospective Randomized Controlled Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- changes in six minute walking distance after 6 months
研究概览
简要总结
Treatment in interstitial lung diseases (ILD) is frequently ineffective. Pulmonary rehabilitation (PR) is an excellent therapeutic option in another chronic lung diseases such as chronic obstructive pulmonary disease (COPD). This prospective randomized controlled study aims to evaluate the short and long-term effects of PR in patients with ILD. For this purpose, 60 ILD patients will be randomly assigned to a PR or a control group.
The investigators hypothesize that PR will improve exercise capacity, increase muscle force, reduce dyspnea and improve quality of life and daily life activities in ILD patients.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of interstitial lung disease according to internationally established criteria
- •Dyspnea on exertion
- •Stable medical therapy
- •Stable clinical condition at inclusion, with no infection or exacerbation in the previous 4 weeks
排除标准
- •Co-morbidities that do not allow exercise training (unstable angina, recent myocardial infarction or cerebrovascular accident, active cancer, severe orthopedic disorders).
- •Life expectancy below 3 months
结局指标
主要结局
changes in six minute walking distance after 6 months
时间窗: 6 months
primary outcome of rehabilitation programm
次要结局
- Changes in dyspnea and quality of life scores (MMRC, CRDQ, SGRQ),(3-6-12 months)
- Change in peripheral and respiratory muscle force(3-6-12 months)
- Change in maximal exercise capacity(3-6-12 months)
- Change in daily physical activity measured by Sensewear armband(3-6-12 months)
- Changes in pulmonary function and blood gases at rest(3-6-12 months)
- Change number of disease-related hospitalizations and survival(3-6-12 months)
- Change in functional exercise capacity measured by the 6 minute walking distance(12 months)
- To evaluate feasibility and safety of pulmonary rehabilitation in interstitial lung disease(6 months)
- Changes in six minute walking distance(at 3, 12 months)
研究者
研究点 (2)
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