Clinical trial NCT01875133: Patients With Chronic Obstructive Pulmonary Disease At Altitude
Official title: Effect of Altitude on Exercise Performance of Patients With Chronic Obstructive Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: airway disease
bronchitis
emphysema
lung
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in exercise performance from baseline measured at 490 m
timeFrame: Change in 6 min walk distance from 490 m baseline during 2 days at 2590 m
Secondary outcomes:
measure: Change in exercise performance from baseline measured at 490 m
timeFrame: Change in 6 min walk distance from 490 m baseline during 2 days at 1650 m
measure: Change in pulmonary function from baseline measured at 490 m
timeFrame: Change in pulmonary function from 490 m baseline during 2 days at 2590 m
measure: Change in pulmonary function from baseline measured at 490 m
timeFrame: Change in pulmonary function from 490 m baseline during 2 days at 1650 m
measure: Change in arterial blood gases from baseline measured at 490 m
timeFrame: Change in arterial blood gases from 490 m baseline during 2 days at 2590 m
measure: Change in arterial blood gases from baseline measured at 490 m
timeFrame: Change in arterial blood gases from 490 m baseline during 2 days at 1650 m
measure: Change in perceived exertion from baseline measured at 490 m
timeFrame: Change in perceived exertion from 490 m baseline during 2 days at 2590 m
measure: Change in perceived exertion from baseline measured at 490 m
timeFrame: Change in perceived exertion from 490 m baseline during 2 days at 1650 m
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
affiliation: University Hospital, Zürich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
affiliation: University Hospital, Zürich
name: Tsogyal D Latshang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwarz EI, Latshang TD, Furian M, Fluck D, Segitz S, Muller-Mottet S, Ulrich S, Bloch KE, Kohler M. Blood pressure response to exposure to moderate altitude in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2019 Mar 14;14:659-666. doi: 10.2147/COPD.S194426. eCollection 2019.
citation: Furian M, Flueck D, Latshang TD, Scheiwiller PM, Segitz SD, Mueller-Mottet S, Murer C, Steiner A, Ulrich S, Rothe T, Kohler M, Bloch KE. Exercise performance and symptoms in lowlanders with COPD ascending to moderate altitude: randomized trial. Int J Chron Obstruct Pulmon Dis. 2018 Oct 26;13:3529-3538. doi: 10.2147/COPD.S173039. eCollection 2018.