Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 6 min walk distance
研究概览
简要总结
The purpose of this study is to investigate the effect of nocturnal oxygen therapy during 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 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy via a nasal cannula. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline), and during 2 days at St. Moritz Salastrains (2048 m).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
Oxygen
oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
干预措施: oxygen (Drug)
Oxygen
oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
干预措施: sham oxygen (room air) (Drug)
Sham oxygen
sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
干预措施: oxygen (Drug)
Sham oxygen
sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
干预措施: sham oxygen (room air) (Drug)
结局指标
主要结局
6 min walk distance
时间窗: Day 2 at 2048 m
Difference in the distance walked in 6 min between the oxygen and sham oxygen period
次要结局
- Perceived exertion(Day 3 at 2048 m)
- Arterial blood gas analysis(Day 2 at 2048 m)
- Spirometry(Day 2 at 2048 m)
- 6 min walk distance(day 3 at 2048 m)
- Severe hypoxemia(Day 1 to 3 at 2048 m)