A Randomized Controlled Trial to Study the Effect of Exercise Training Breathing Helium-Hyperoxia on The Exercise Tolerance and Quality of Life of Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Constant-load exercise tolerance after 6 weeks of exercise rehabilitation
研究概览
简要总结
The purpose of this study is to examine whether breathing helium-hyperoxia during exercise in a pulmonary rehabilitation program can improve the exercise tolerance and health related quality of life of patients with Chronic Obstructive Pulmonary Disease (COPD).
详细描述
It is well accepted that the exercise training as part of a comprehensive pulmonary rehabilitation program can improve exercise tolerance, functional status and quality of life in patients with COPD. It is feasible that if patients were able to perform a greater volume or intensity of exercise during rehabilitation then the outcomes of the program would be improved. Recent research has demonstrated that breathing a helium-hyperoxic gas mixture can significantly reduce dynamic hyperinflation and dyspnea during exercise in patients with COPD and can increase exercise tolerance to a greater extent than breathing room air or a nitrogen-based hyperoxic gas. If patients with COPD were to breathe a helium-hyperoxic gas during exercise they should be able to tolerate a greater intensity of exercise while maintaining similar levels of exertional symptoms to those observed at lower exercise intensities breathing room air. As a result patients randomized to the helium-hyperoxia condition should obtain greater improvements in exercise tolerance than those receiving usual care (i.e. breathing room air)
Comparisons: Standard pulmonary rehabilitation of patients with COPD receiving either usual care (air breathing) or helium-hyperoxia (40% O2, 60% Helium).
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
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1/FVC<70% predicted;
- •FEV1<70% predicted;
- •RV>140% predicted.
排除标准
- •Cardiovascular contraindications to exercise;
- •Musculoskeletal abnormalities that limit exercise tolerance;
- •SpO2<85% during a constant work rate test;
- •On supplemental oxygen.
- •Exacerbation within the last month
结局指标
主要结局
Constant-load exercise tolerance after 6 weeks of exercise rehabilitation
次要结局
- Maximum oxygen consumption after 6 weeks of exercise rehabilitation
- Quality of Life measured after 6 weeks of exercise rehabilitation
- Dyspnea at an isotime during constant-load exercise after 6 weeks of exercise rehabilitation
