Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Exercise Performance
- Conditions
- Interstitial Lung DiseasePrecapillary Pulmonary Hypertension
- Interventions
- Behavioral: Moderate altitude sojournBehavioral: Low altitude sojournDrug: Sham oxygen (room air)
- Registration Number
- NCT02143687
- Lead Sponsor
- University of Zurich
- Brief Summary
The purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with pulmonary hypertension or with interstitial lung disease.
- Detailed Description
Patients with pulmonary hypertension or with interstitial lung disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypotheses that: a), exercise capacity during a 2 day sojourn at moderate altitude is reduced in comparison to low altitude; b), exercise capacity during a 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy compared to room air (sham oxygen) administered during nights at altitude. Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 days each spent at moderate altitude (St. Moritz Salastrains, 2048 m), separated by a wash-out period of at least 2 weeks spent at low altitude (\<800 m). The order of stays at the different altitudes and of the treatments will be randomized.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Precapillary pulmonary hypertension, or interstitial lung disease.
- New York Heart Association class 2-3.
- Residence at low altitude (<800m).
- Unstable or exacerbated condition
- Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4
- Requirement for oxygen therapy at low altitude residence
- Hypoventilation
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Moderate altitude sojourn Moderate altitude sojourn Sojourn at moderate altitude (2048 m) Moderate altitude sojourn Sham oxygen (room air) Sojourn at moderate altitude (2048 m) Oxygen Moderate altitude sojourn Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m Oxygen Sham oxygen (room air) Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m Low altitude sojourn Sham oxygen (room air) Sojourn at low altitude (490 m, baseline) Oxygen Oxygen Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m Low altitude sojourn Moderate altitude sojourn Sojourn at low altitude (490 m, baseline) Sham oxygen (room air) Moderate altitude sojourn Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights Moderate altitude sojourn Low altitude sojourn Sojourn at moderate altitude (2048 m) Low altitude sojourn Low altitude sojourn Sojourn at low altitude (490 m, baseline) Oxygen Low altitude sojourn Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m Sham oxygen (room air) Low altitude sojourn Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights Sham oxygen (room air) Sham oxygen (room air) Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights Moderate altitude sojourn Oxygen Sojourn at moderate altitude (2048 m) Low altitude sojourn Oxygen Sojourn at low altitude (490 m, baseline) Sham oxygen (room air) Oxygen Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
- Primary Outcome Measures
Name Time Method 6 min walk distance Day 2 at 2048 m Difference in the distance walked in 6 min between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
- Secondary Outcome Measures
Name Time Method 6 min walk distance day 3 at 2048 m Difference in the distance walked in 6 min between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Spirometry Day 2 at 2048 m Difference in spirometry between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Arterial blood gas analysis Day 2 at 2048 m Change in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Perceived exertion Day 3 at 2048 m Difference in the perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.
Severe hypoxemia Day 1 to 3 at 2048 m Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the sojourn at 2048 m (altitude) and 490 m (baseline); and during the oxygen and sham oxygen treatment periods at 2028 m.
Trial Locations
- Locations (1)
University Hospital Zurich, Pulmonary Division
🇨ðŸ‡Zurich, Switzerland