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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease (CAD)
• Intervention / Treatment: Procedure: hypoxic exposure

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannes Gatterer, PhD; Phone Number: +39 0471 055 578; Email: hannes.gatterer@eurac.edu

Study Locations

• Italy
  • BZ
    • Bolzano, BZ, Italy, 39100
      • Recruiting
      • EURAC Research
      • Contact: Hannes Gatterer; Phone Number: +39 0471 055 578; Email: hannes.gatterer@eurac.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent hypoxia (IH) pre-conditioning; 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; 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
Experimental: Hypoxia pre-adaptation; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate (bpm) responses during rest and during exercise at altitude	Heart rate response changes after the pre-conditioning and pre-adaptation program at rest and during exercise at 3000 m altitude.	Through study completion, an average of 1.5 years
Blood pressure (mmHg) responses during rest and during exercise at altitude	Blood pressure 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	Inflammatory markers may change due to the programs	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	Markers of physiological stress may change due to the programs	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	HRV may change due to the programs	Through study completion, an average of 1.5 years
Changes in baroreflex sensitivity (BRS) from before to after the pre-conditioning and pre-adaptation program	BRS may change due to the programs	Through study completion, an average of 1.5 years
Changes of markers of myocardial injury (e.g., highly sensitive cardiac troponin T) from before to after the pre-conditioning and pre-adaptation program	Markers of myocardial injury may change due to the programs	Through study completion, an average of 1.5 years

Collaborators and Investigators

• Sponsor: Institute of Mountain Emergency Medicine
• Collaborators: University of Giessen; Istituto Auxologico Italiano; University of Innsbruck
• Investigators: Principal Investigator: Hannes Gatterer, PhD, Institute of Mountain Emergency Medicine, Eurac Research

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Signs and Symptoms, Respiratory; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypoxia
• Other Study ID Numbers: HYP-P-SP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data underlying scientific publications will be stored in open repositories (accessible).
• IPD Sharing Time Frame: After publications
• IPD Sharing Access Criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No