Patients With Chronic Obstructive Pulmonary Disease At Altitude

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Altitude on Exercise Performance of Patients With Chronic Obstructive Lung Disease

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Other: altitude exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic obstructive pulmonary disease (COPD), GOLD grade 2-3 residents at low altitude (<800 m) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A: low-intermediate-high altitude<br>Altitude exposure sequence A, 490-1630-2590m | Other: altitude exposure<br>* stay at different altitudes: 490, 1630, 2590 m<br>|
| Other: B: low-high-intermediate altitude<br>Altitude exposure sequence B, 490-2590-1630 m | Other: altitude exposure<br>* stay at different altitudes: 490, 1630, 2590 m<br>|
| Other: C: intermediate-high-low altitude<br>Altitude exposure sequence C, 1630-2590-490 m | Other: altitude exposure<br>* stay at different altitudes: 490, 1630, 2590 m<br>|
| Other: D: high-intermediate-low altitude<br>Altitude exposure sequence D, 2590-1630-490 m | Other: altitude exposure<br>* stay at different altitudes: 490, 1630, 2590 m<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise performance from baseline measured at 490 m | 6 min walk distance | Change in 6 min walk distance from 490 m baseline during 2 days at 2590 m | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise performance from baseline measured at 490 m | 6 min walk distance | 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 | lung volumes by spirometry | Change in pulmonary function from 490 m baseline during 2 days at 2590 m | 
| Change in pulmonary function from baseline measured at 490 m | lung volumes by spirometry | 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 | Arterial blood gas analysis | Change in arterial blood gases from 490 m baseline during 2 days at 2590 m | 
| Change in arterial blood gases from baseline measured at 490 m | Arterial blood gas analysis | Change in arterial blood gases from 490 m baseline during 2 days at 1650 m | 
| Change in perceived exertion from baseline measured at 490 m | Borg CR10 scale at end of 6 min walk | Change in perceived exertion from 490 m baseline during 2 days at 2590 m | 
| Change in perceived exertion from baseline measured at 490 m | Borg CR10 scale at end of 6 min walk | Change in perceived exertion from 490 m baseline during 2 days at 1650 m | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway disease, bronchitis, emphysema, lung