NCT01384981终止不适用
Effects of Non-invasive Ventilation on Exercise Capacity and Quality of Life in COPD-patients GOLD III/IV
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- change in 6 minute walking distance
研究概览
简要总结
The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary rehabilitation increases exercise capacity and quality of life more than pulmonary rehabilitation alone.
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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of COPD in stages GOLD III/ IV
- •receiving optimized medical treatment and long term oxygen therapy if needed
- •patients consent to participate in this trial
- •no treatment with NIV in the last 4 weeks
- •treatment with NIV in the last 4 weeks due to an acute exacerbation
排除标准
- •treatment with NIV in the last 4 weeks (except due to an acute exacerbation)
- •Intolerance to perform NIV
- •Acute exacerbation at baseline or during PR
- •Hypercapnia > pCO2 55mmHg
- •Inability to perform a 6 minute walking test
研究组 & 干预措施
pulmonary rehabilitation with NIV
Active Comparator
Patients receiving nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.
干预措施: pulmonary rehabilitation (Procedure)
pulmonary rehabilitation without NIV
Sham Comparator
Patients receiving no nocturnal non-invasiv Ventilation during a 3-week pulmonary Rehabilitation program.
干预措施: pulmonary rehabilitation (Procedure)
结局指标
主要结局
change in 6 minute walking distance
时间窗: day 1 and 25
change in 6 minute walking distance from baseline to day 25
次要结局
- change in quality of life (chronic respiratory questionnaire, CRQ)(day 1 and 25)
- change quality of life (Saint George´s Respiratory Questionnaire, SGRQ)(day 1 and 25)
研究者
Klaus Kenn
Dr. med Klaus Kenn, Head physician
Schön Klinik Berchtesgadener Land
研究点 (1)
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