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Completed

NCT Number: NCT01875133

Patients With Chronic Obstructive Pulmonary Disease At Altitude

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Bronchial Diseases Bronchitis Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Pulmonary Division

Zurich, CH-8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Altitude exposure

Other

stay at different altitudes: 490, 1630, 2590 m

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2013
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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