Effect of Altitude on Exercise Performance of Patients With Chronic Obstructive Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in exercise performance from baseline measured at 490 m
研究概览
简要总结
The purpose of this study is to investigate the effect of a stay at moderate altitude on exercise performance of patients with chronic obstructive lung disease.
详细描述
Patients with moderate to severe COPD living below 800 m, will be recruited to participate in a randomized cross-over field trial evaluating the hypothesis that exercise capacity during a 4 day sojourn at moderate altitude is reduced in comparison to low altitude. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline), 2 days at Davos Clavadel (1650 m), and 2 days at Davos Jakobshorn (2590 m). The main outcome is the 6 minute walk distance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
- •residents at low altitude (<800 m)
排除标准
- •Unstable condition, COPD exacerbation
- •Mild (GOLD 1) or very severe COPD (GOLD 4)
- •requirement for oxygen therapy at low altitude residence
- •hypoventilation
- •pulmonary hypertension
- •more than mild or unstable cardiovascular disease
- •use of drugs that affect respiratory center drive
- •internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day), inability to perform 6 min walk test.
- •previous intolerance to moderate altitude (<2600m).
- •Exposure to altitudes >1500m for >2 days within the last 4 weeks before the study.
- •Pregnant or nursing patients
研究组 & 干预措施
D: high-intermediate-low altitude
Altitude exposure sequence D, 2590-1630-490 m
干预措施: altitude exposure (Other)
A: low-intermediate-high altitude
Altitude exposure sequence A, 490-1630-2590m
干预措施: altitude exposure (Other)
B: low-high-intermediate altitude
Altitude exposure sequence B, 490-2590-1630 m
干预措施: altitude exposure (Other)
C: intermediate-high-low altitude
Altitude exposure sequence C, 1630-2590-490 m
干预措施: altitude exposure (Other)
结局指标
主要结局
Change in exercise performance from baseline measured at 490 m
时间窗: Change in 6 min walk distance from 490 m baseline during 2 days at 2590 m
6 min walk distance
次要结局
- Change in perceived exertion from baseline measured at 490 m(Change in perceived exertion from 490 m baseline during 2 days at 1650 m)
- Change in exercise performance from baseline measured at 490 m(Change in 6 min walk distance from 490 m baseline during 2 days at 1650 m)
- Change in pulmonary function from baseline measured at 490 m(Change in pulmonary function from 490 m baseline during 2 days at 1650 m)
- Change in arterial blood gases from baseline measured at 490 m(Change in arterial blood gases from 490 m baseline during 2 days at 1650 m)
- Change in pulmonary function from baseline measured at 490 m(Change in pulmonary function from 490 m baseline during 2 days at 2590 m)
- Change in arterial blood gases from baseline measured at 490 m(Change in arterial blood gases from 490 m baseline during 2 days at 2590 m)
- Change in perceived exertion from baseline measured at 490 m(Change in perceived exertion from 490 m baseline during 2 days at 2590 m)