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Patients With Chronic Obstructive Pulmonary Disease At Altitude

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01875133
First Posted: June 11, 2013
Last Update Posted: May 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose
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.

Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD) Other: altitude exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Effect of Altitude on Exercise Performance of Patients With Chronic Obstructive Lung Disease

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Change in exercise performance from baseline measured at 490 m [ Time Frame: Change in 6 min walk distance from 490 m baseline during 2 days at 2590 m ]
    6 min walk distance


Secondary Outcome Measures:
  • Change in exercise performance from baseline measured at 490 m [ Time Frame: 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 [ Time Frame: Change in pulmonary function from 490 m baseline during 2 days at 2590 m ]
    lung volumes by spirometry

  • Change in pulmonary function from baseline measured at 490 m [ Time Frame: 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 [ Time Frame: Change in arterial blood gases from 490 m baseline during 2 days at 2590 m ]
    Arterial blood gas analysis

  • Change in arterial blood gases from baseline measured at 490 m [ Time Frame: Change in arterial blood gases from 490 m baseline during 2 days at 1650 m ]
    Arterial blood gas analysis

  • Change in perceived exertion from baseline measured at 490 m [ Time Frame: Change in perceived exertion from 490 m baseline during 2 days at 2590 m ]
    Borg CR10 scale at end of 6 min walk

  • Change in perceived exertion from baseline measured at 490 m [ Time Frame: Change in perceived exertion from 490 m baseline during 2 days at 1650 m ]
    Borg CR10 scale at end of 6 min walk


Estimated Enrollment: 50
Study Start Date: May 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: low-intermediate-high altitude
Altitude exposure sequence A, 490-1630-2590m
Other: altitude exposure
stay at different altitudes: 490, 1630, 2590 m
B: low-high-intermediate altitude
Altitude exposure sequence B, 490-2590-1630 m
Other: altitude exposure
stay at different altitudes: 490, 1630, 2590 m
C: intermediate-high-low altitude
Altitude exposure sequence C, 1630-2590-490 m
Other: altitude exposure
stay at different altitudes: 490, 1630, 2590 m
D: high-intermediate-low altitude
Altitude exposure sequence D, 2590-1630-490 m
Other: altitude exposure
stay at different altitudes: 490, 1630, 2590 m

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875133


Locations
Switzerland
University Hospital Zurich, Pulmonary Division
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
University of Zurich
Investigators
Study Chair: Konrad E Bloch, MD University Hospital, Zürich
Principal Investigator: Tsogyal D Latshang, MD University Hospital, Zürich
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01875133     History of Changes
Other Study ID Numbers: 2013-0088
First Submitted: May 29, 2013
First Posted: June 11, 2013
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by University of Zurich:
airway disease
bronchitis
emphysema
lung

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases


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