Patients With Chronic Obstructive Pulmonary Disease At Altitude

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Other: altitude exposure

• Registration Number: NCT01875133
• Lead Sponsor: University of Zurich

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
• residents at low altitude (<800 m)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
D: high-intermediate-low altitude	altitude exposure	Altitude exposure sequence D, 2590-1630-490 m
B: low-high-intermediate altitude	altitude exposure	Altitude exposure sequence B, 490-2590-1630 m
C: intermediate-high-low altitude	altitude exposure	Altitude exposure sequence C, 1630-2590-490 m
A: low-intermediate-high altitude	altitude exposure	Altitude exposure sequence A, 490-1630-2590m

Primary Outcome Measures

Name	Time	Method
Change in exercise performance from baseline measured at 490 m	Change in 6 min walk distance from 490 m baseline during 2 days at 2590 m	6 min walk distance

Secondary Outcome Measures

Name	Time	Method
Change in perceived exertion from baseline measured at 490 m	Change in perceived exertion from 490 m baseline during 2 days at 1650 m	Borg CR10 scale at end of 6 min walk
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	6 min walk distance
Change in pulmonary function from baseline measured at 490 m	Change in pulmonary function from 490 m baseline during 2 days at 1650 m	lung volumes by spirometry
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	Arterial blood gas analysis

Trial Locations

Locations (1)

University Hospital Zurich, Pulmonary Division; 🇨🇭 Zurich, Switzerland