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Hypoxia Pre-conditioning and Mountain Sport (Hyx-PRE-Spo)

I

Institute of Mountain Emergency Medicine

Status

Completed

Conditions

Coronary Artery Disease (CAD)

Treatments

Procedure: hypoxic exposure

Study type

Interventional

Funder types

Other

Identifiers

NCT04725539
HYP-P-SP

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

17 participants in 2 patient groups

Intermittent hypoxia (IH) pre-conditioning
Experimental group
Description:
The IH pre-conditioning program will be performed in a sitting position by inhaling a gas mixture with reduced O2 content via face masks.The program will include five sessions per week for 3 weeks. Each session consists of three to five hypoxic (14-10% inspired fraction of oxygen) periods, each lasting 3-5 min with 3-min normoxic intervals. The control setting includes breathing room air via face mask.
Treatment:
Procedure: hypoxic exposure
Hypoxia pre-adaptation
Experimental group
Description:
The hypoxia pre-adaptation program consists of sleeping 1 night at 1900m. The control setting includes sleeping 1 night close to sea level.
Treatment:
Procedure: hypoxic exposure

Trial contacts and locations

1

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Central trial contact

Hannes Gatterer, PhD

Data sourced from clinicaltrials.gov

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