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Completed

NCT Number: NCT04725539

Hypoxia Pre-conditioning and Mountain Sport

Mountain sport activities as for example hiking or skiing may involve the risk of adverse health events especially in older people not accustomed to the specific mountain sport at altitude or people with pre-existing health issues. Increased activation of the sympathetic nervous system and abrupt changes in heart rate and blood pressure are thought to trigger these adverse effects. Preventive measures include regular physical activity (i.e. training) and adequate medical treatment. Hypoxia pre-adaptation (e.g., pre-adapt one night at moderate altitude) and pre-conditioning (e.g., intermittent hypoxia (IH) training), which was shown to lead to some favorable sympathetic nervous system, ventilatory and metabolic adaptations and additionally exerts anti-inflammatory action, could be hypothesized of being a further preventive measure. The aim of this research project is to investigate whether intermittent hypoxia pre-conditioning or sleeping one night at altitude (i.e., current recommendation before practicing mountain leisure sports in the elderly) is able to increase oxygen saturation during passive hypoxia exposure and during simulated hiking and skiing at altitude. Additionally, it is aimed to investigate whether such procedure reduces the physiological responses (i.e., heart rate, its variability and blood pressure (including baroreflex sensitivity) responses as well as metabolic, ventilatory, inflammatory and redox responses) during these activities.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurac Research

Bolzano, BZ, 39100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants will include normally physically active males and females (age 50-70 years; New York Heart Association (NYHA) class I and II) with or without prior myocardial infarction, living <600 m.

Exclusion criteria

  • Persons with CAD will be excluded if they will not be able to perform light to moderate exercise, or had recent myocardial infarction and/or revascularisation (< 8 weeks prior to inclusion in the study), episode of unstable angina, de-compensated heart failure, life-threatening arrhythmia, ejection fraction < 50%, known symptomatic aortic outflow obstruction, severe hypertension (>180/100 mm Hg), pulmonary hypertension or any other severe systemic non-cardiac disease. Exclusion criteria will additionally include regular smoking of more than five cigarettes per day, regular drug intake, habitual residence > 600 m and one or more overnight stay at > 1000 m during the previous 4 weeks.

Treatment and study plan

hypoxic exposure

Procedure

Administration of different hypoxic doses.

Intermittent hypoxia:

days 1-5 duration of breathing periods 5*3min (FiO2 14-21%) days 8-12 duration of breathing periods 4*4min (FiO2 = 12%) and 3*3 min (FiO2 = 21%) days 15-19 duration of breathing periods 5*5min (FiO2 = 10%) and 4*3 min (FiO2 = 21%)

one night at 1900m

Primary outcomes

  1. Resting oxygen saturation (%) at altitude

    Time frame: Through study completion, an average of 1.5 years

    Resting oxygen saturation changes after the pre-conditioning and pre-adaptation program at 3000 m altitude

  2. Oxygen saturation during exercise at altitude

    Time frame: Through study completion, an average of 1.5 years

    Oxygen saturation during exercise changes after the pre-conditioning and pre-adaptation program at 3000 m altitude

Secondary outcomes

  1. Heart rate (bpm) responses during rest and during exercise at altitude

    Time frame: Through study completion, an average of 1.5 years

    Heart rate response changes after the pre-conditioning and pre-adaptation program at rest and during exercise at 3000 m altitude.

  2. Blood pressure (mmHg) responses during rest and during exercise at altitude

    Time frame: Through study completion, an average of 1.5 years

    Blood pressure responses during rest and during exercise at altitude

  3. Changes of inflammatory markers (i.e., hsCRP) from before to after the pre-conditioning and pre-adaptation program

    Time frame: Through study completion, an average of 1.5 years

    Inflammatory markers may change due to the programs

  4. Changes of physiological stress markers (i.e., catecholamine) from before to after the pre-conditioning and pre-adaptation program

    Time frame: Through study completion, an average of 1.5 years

    Markers of physiological stress may change due to the programs

  5. Changes in heart rate variability (HRV) from before to after the pre-conditioning and pre-adaptation program

    Time frame: Through study completion, an average of 1.5 years

    HRV may change due to the programs

  6. Changes in baroreflex sensitivity (BRS) from before to after the pre-conditioning and pre-adaptation program

    Time frame: Through study completion, an average of 1.5 years

    BRS may change due to the programs

  7. Changes of markers of myocardial injury (e.g., highly sensitive cardiac troponin T) from before to after the pre-conditioning and pre-adaptation program

    Time frame: Through study completion, an average of 1.5 years

    Markers of myocardial injury may change due to the programs

Sponsors and collaborators

Lead sponsor

Institute of Mountain Emergency Medicine

Other

Collaborators

  • Istituto Auxologico Italiano
  • University of Giessen
  • University of Innsbruck, Austria

Registry information

Official study title

Effects of Hypoxia Pre-conditioning on Physiological Responses During Mountain Sport Activities in Persons With a History of Coronary Artery Disease

Acronym: Hyx-PRE-Spo

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2021
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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