Acute Exposure to Simulated Hypoxia on Exercise Capacity
Raktažodžiai
Santrauka
apibūdinimas
Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis.
Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device.
Towards the end of the exposure after approximately 1h, the participants will perform a constant loaded exercise test on an Ergometer with a calculated resistance of their 60% max. workload.
The patients will be encouraged to perform this test up to their physical exhaustion.
Datos
Paskutinį kartą patikrinta: | 07/31/2019 |
Pirmasis pateikimas: | 07/08/2018 |
Numatytas registravimas pateiktas: | 07/17/2018 |
Pirmas paskelbtas: | 07/18/2018 |
Paskutinis atnaujinimas pateiktas: | 08/14/2019 |
Paskutinis atnaujinimas paskelbtas: | 08/15/2019 |
Faktinė studijų pradžios data: | 07/31/2018 |
Numatoma pirminio užbaigimo data: | 03/31/2019 |
Numatoma studijų užbaigimo data: | 03/31/2019 |
Būklė ar liga
Intervencija / gydymas
Device: Simulated Altitude (FiO2: 15.1%)
Device: Shamed Hypoxia (FiO2: 20.9)
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Experimental: Order A The participants will be exposed to shamed hypoxia (FiO2: 20.9% equivalent to sea level and consecutively to simulated altitude (FiO2: 15.1% equivalent to 2500m above sea level) administered by an altitude Simulator ("Altitrainer", SMTEC), simulated altitude (FiO2: 15.1%), with a facemask. | |
Experimental: Order B The participant will be exposed to hypoxia (FiO2, 15.1% equivalent to 2500m above sea level), simulated altitude (FiO2: 15.1%), and consecutively to shamed hypoxia (FiO2, 20.9%) administered by an altitude simulator ("Altitrainer", SMTEC) with a facemask. |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - Informed consent - PH diagnosed according to internation Guidelines: mean pulmonary artery presssure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of initial diagnosis - PH class 1 (PAH) or 4 (CTEPH) - Stable condition, on the same medication for > 4 weeks - Patient live permanently at an altitude < 1000m asl. Exclusion Criteria: - Resting partial Oxygen pressure (PaO2) ≤7.3 kiloPascal (kPA) corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed) - Severe daytime hypercapnia (pCO2 > 6.5 kPa) - Susceptibility to high altitude related diseases (AMS, High Altitude Pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes. - Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation - Residence > 1000m above sea level - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability - Women who are pregnant or breast feeding |
Rezultatas
Pirminės rezultatų priemonės
1. Endurance time under hypoxia (FiO2: 15.1%) [Towards the end of a one hour exposure]