Official Title
Assessment of Pulmonary Function and Physiological Adaptation of Lung Transplant Recipients at Extreme Altitude: The Mount Aconcagua (6971 m) Expedition
Brief Summary

This prospective observational study investigates the effects of intermittent hypoxicconditioning and real high-altitude exposure in lung transplant recipients compared withhealthy controls.The study includes an eight-week home-based preparatory phase during which participantsuse a normobaric hypoxic tent with reduced oxygen concentration. Prior to this phase, allparticipants receive standardized training on the safe use of the equipment. During thepreparatory period, daily vital parameters, including heart rate, oxygen saturation, andheart rate variability, are recorded using a sports watch and a pulse oximeter. Symptoms,adverse events, and subjective well-being are documented daily in an electronic diary.All data are transmitted to the study team via encrypted electronic systems, allowingcontinuous remote monitoring. At the end of the preparatory phase, participants undergo aclinical evaluation to confirm fitness for the expedition phase.The expedition phase consists of a monitored ascent of Aconcagua (6,971 meters). Beforedeparture, all participants are required to attend a comprehensive safety, protection,and first aid training conducted jointly by the study team and professional expeditionproviders. The expedition is planned and led by an experienced international expeditioncompany in cooperation with a local provider specializing in high-altitudemountaineering.The expedition includes arrival in Mendoza, preparatory procedures such as equipmentchecks and permits, followed by a staged ascent to base camp. Subsequent days involverest periods and acclimatization hikes with the establishment of progressively highercamps. A summit attempt is planned after sufficient acclimatization, followed by descentto high camp. A weather-dependent buffer period is included before the final descent tothe valley and return to Mendoza, where the expedition concludes.Total study participation is expected to last approximately 15 weeks, including abouteight weeks of home-based preparation and approximately three weeks at altitude. A finalfollow-up examination is conducted 2 to 4 weeks after completion of the expedition,marking the end of study participation.

Detailed Description

Not Provided

Active, not recruiting
Lung Transplantation
Hypoxia
Altitude
High-altitude Adaptation
Immunosuppression
Physical Fitness
Oxygen Saturation Measurement
Microbiota
Eligibility Criteria

Inclusion Criteria:

Lung transplant recipients:

- Age ≥ 18 years

- > 1 years after lung transplantation

- Stable lung function over 6 month prior to inclusion, FEV1 +/-10% from baseline

- VO2peak of more than 25 ml/min/kg

- Physical and mental fitness, defined as the ability to complete strenuous day trips
lasting 8 to 10 hours independently without suffering from a fear of heights, an
altitude exposure of at least 2500m must be confirmed.

- Negative pregnancy test for women of childbearing age

- Written informed consent

Healthy volunteers:

- Age ≥ 18 years

- VO2peak of more than 25 ml/min/kg

- Physical and mental fitness, defined as the ability to complete strenuous day trips
lasting 8 to 10 hours independently without suffering from a fear of heights

- Negative pregnancy test for women of childbearing age

- Written informed consent

Exclusion Criteria:

Lung transplant recipients:

- Age < 18 years

- Refusal to participate in the study

- Pregnancy

Healthy controls:

- Age < 18 years

- Refusal to participate in the study

- Pregnancy

- Chronic obstructive pulmonary disease (COPD)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Austria
Locations

Medical University of Vienna
Vienna, Vienna, Austria

Not Provided

Medical University of Vienna
NCT Number
MeSH Terms
Hypoxia