NCT00886639已完成不适用
Effect Of Oxygen-Supply On The 6-Minute-Walking-Distance in Patients With Chronic Obstructive Pulmonary Disease (COPD) GOLD Stage III/IV Before And After A Multimodal Rehabilitation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Oxygen Response
研究概览
简要总结
The aim of this study is to investigate the six-minute-walking-distance of COPD-patients with breathing oxygen in comparison to breathing normal air. Patients, who increase their walking-distance about more than 15% or 35m only because of breathing oxygen, are so-called "Oxygen Responders." The study is aimed to find attributes of Oxygen Responder and to investigate, if a patient can change the "respond" with higher performance and endurance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Single (Participant)
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
- •Chronic obstructive pulmonary disease III/IV
排除标准
- •Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
- •Severe exacerbation during rehabilitation
- •Cardiac insufficiency
结局指标
主要结局
Oxygen Response
时间窗: day 1 and day 2; day 21 and day 22
Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks
次要结局
- Oxygen Partial Pressure (paO2)(day 2: minute "0" and "6")
- Diffusion Capacity(day 1 and 21)
- Lung Function(day 1 and 21)
- BORG-Score(day 21: minute 0 and minute 6)
- Oxygen Saturation(day 22: minute 0 and 6)
研究者
Klaus Kenn
Head physician (department of pneumology)
Schön Klinik Berchtesgadener Land
研究点 (2)
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