Hypoxia Pre-conditioning and Mountain Sport

NCT04725539 | Completed

• 1 other identifier: HYP-P-SP
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease (CAD)

Outcome Measures

Primary Outcomes (2)

• Resting oxygen saturation (%) at altitude

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

  Through study completion, an average of 1.5 years

• Oxygen saturation during exercise at altitude

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

  Through study completion, an average of 1.5 years

Secondary Outcomes (7)

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

  Through study completion, an average of 1.5 years

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

  Through study completion, an average of 1.5 years

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

  Through study completion, an average of 1.5 years

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

  Through study completion, an average of 1.5 years

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

  Through study completion, an average of 1.5 years

Study Arms (2)

Intermittent hypoxia (IH) pre-conditioning

EXPERIMENTAL

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.

Procedure: hypoxic exposure

Hypoxia pre-adaptation

EXPERIMENTAL

The hypoxia pre-adaptation program consists of sleeping 1 night at 1900m. The control setting includes sleeping 1 night close to sea level.

Procedure: hypoxic exposure

Interventions

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

Hypoxia pre-adaptation; Intermittent hypoxia (IH) pre-conditioning

Eligibility Criteria

• Age: 50 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Institute of Mountain Emergency Medicine: lead
• Istituto Auxologico Italiano: collaborator
• University of Innsbruck: collaborator
• University of Giessen: collaborator

Study Sites (1)

Eurac Research

Bolzano, BZ, 39100, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hannes Gatterer, PhD

  Institute of Mountain Emergency Medicine, EURAC Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 26, 2021
• Study Start: January 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publications
• Access Criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Locations

IT (1)