Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate altitude sojourn | Experimental | Sojourn at moderate altitude (2048 m) |
|
| Low altitude sojourn | Experimental | Sojourn at low altitude (490 m, baseline) |
|
| Oxygen | Active Comparator | Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m |
|
| Sham oxygen (room air) | Placebo Comparator | Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate altitude sojourn | Behavioral | Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 min walk distance | 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. | Day 2 at 2048 m |
| Measure | Description | Time Frame |
|---|---|---|
| 6 min walk distance | 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. | day 3 at 2048 m |
| Arterial blood gas analysis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Konrad E Bloch, MD | University Hospital, Zürich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Pulmonary Division | Zurich | CH-8091 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Low altitude sojourn | Behavioral | Low altitude baseline evaluations will be performed during a stay at Zurich (490) |
|
|
| Oxygen | Drug | Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m |
|
|
| Sham oxygen (room air) | Drug | Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 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.
| Day 2 at 2048 m |
| Spirometry | 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. | Day 2 at 2048 m |
| Perceived exertion | 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. | Day 2 at 2048 m |
| Perceived exertion | 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. | 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 sojourn at 2048 m (altitude) and 490 m (baseline); and during the oxygen and sham oxygen treatment periods at 2028 m. | Day 1 to 3 at 2048 m |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D006976 | Hypertension, Pulmonary |
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074584 | WW Domain-Containing Oxidoreductase |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
Not provided
Not provided