Patients With Chronic Obstructive Pulmonary Disease At Altitude

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Other: altitude exposure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, CH-8091
    • University Hospital Zurich, Pulmonary Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Tsogyal D Latshang, MD, University Hospital, Zürich

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Estimate): May 19, 2015
• Last Update Submitted That Met QC Criteria: May 18, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: lung; emphysema; airway disease; bronchitis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2013-0088