Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance

University of Zurich32 enrolled

Overview

The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with chronic obstructive lung disease.

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 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy via a nasal cannula. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline), and during 2 days at St. Moritz Salastrains (2048 m).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

oxygenDRUG

Nocturnal nasal oxygen during stay at 2048 m

sham oxygen (room air)DRUG

Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Zurich, Pulmonary Division

Zurich, Switzerland

Outcomes

Primary Outcomes

6 min walk distance

Difference in the distance walked in 6 min between the oxygen and sham oxygen period

Time frame: Day 2 at 2048 m

Secondary Outcomes

6 min walk distance

Difference in the distance walked in 6 min between the oxygen and sham oxygen period

Time frame: day 3 at 2048 m

Arterial blood gas analysis

Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH

Time frame: Day 2 at 2048 m

Spirometry

Difference in spirometric variables between the oxygen and sham oxygen period

Time frame: Day 2 at 2048 m

Perceived exertion

Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk

Time frame: Day 2 at 2048 m

Perceived exertion

Difference in perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk

Time frame: Day 3 at 2048 m

Severe hypoxemia

Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the oxygen and sham oxygen treatment periods at 2028 m.

Time frame: Day 1 to 3 at 2048 m

Data from ClinicalTrials.gov

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