Hypoxia Pre-conditioning and Mountain Sport (Hyx-PRE-Spo)
Primary Purpose
Coronary Artery Disease (CAD)
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
hypoxic exposure
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease (CAD)
Eligibility Criteria
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.
Sites / Locations
- Eurac ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intermittent hypoxia (IH) pre-conditioning
Hypoxia pre-adaptation
Arm 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.
The hypoxia pre-adaptation program consists of sleeping 1 night at 1900m. The control setting includes sleeping 1 night close to sea level.
Outcomes
Primary Outcome Measures
Resting oxygen saturation (%) at altitude
Resting oxygen saturation changes after the pre-conditioning and pre-adaptation program at 3000 m altitude
Oxygen saturation during exercise at altitude
Oxygen saturation during exercise changes after the pre-conditioning and pre-adaptation program at 3000 m altitude
Secondary Outcome Measures
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.
Blood pressure (mmHg) responses during rest and during exercise at altitude
Blood pressure responses during rest and during exercise at altitude
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
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
Changes in heart rate variability (HRV) from before to after the pre-conditioning and pre-adaptation program
HRV may change due to the programs
Changes in baroreflex sensitivity (BRS) from before to after the pre-conditioning and pre-adaptation program
BRS may change due to the programs
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
Full Information
NCT ID
NCT04725539
First Posted
January 8, 2021
Last Updated
March 24, 2022
Sponsor
Institute of Mountain Emergency Medicine
Collaborators
Istituto Auxologico Italiano, University of Innsbruck, University of Giessen
1. Study Identification
Unique Protocol Identification Number
NCT04725539
Brief Title
Hypoxia Pre-conditioning and Mountain Sport
Acronym
Hyx-PRE-Spo
Official Title
Effects of Hypoxia Pre-conditioning on Physiological Responses During Mountain Sport Activities in Persons With a History of Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Mountain Emergency Medicine
Collaborators
Istituto Auxologico Italiano, University of Innsbruck, University of Giessen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intermittent hypoxia (IH) pre-conditioning
Arm Type
Experimental
Arm 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.
Arm Title
Hypoxia pre-adaptation
Arm Type
Experimental
Arm Description
The hypoxia pre-adaptation program consists of sleeping 1 night at 1900m. The control setting includes sleeping 1 night close to sea level.
Intervention Type
Procedure
Intervention Name(s)
hypoxic exposure
Intervention Description
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 Outcome Measure Information:
Title
Resting oxygen saturation (%) at altitude
Description
Resting oxygen saturation changes after the pre-conditioning and pre-adaptation program at 3000 m altitude
Time Frame
Through study completion, an average of 1.5 years
Title
Oxygen saturation during exercise at altitude
Description
Oxygen saturation during exercise changes after the pre-conditioning and pre-adaptation program at 3000 m altitude
Time Frame
Through study completion, an average of 1.5 years
Secondary Outcome Measure Information:
Title
Heart rate (bpm) responses during rest and during exercise at altitude
Description
Heart rate response changes after the pre-conditioning and pre-adaptation program at rest and during exercise at 3000 m altitude.
Time Frame
Through study completion, an average of 1.5 years
Title
Blood pressure (mmHg) responses during rest and during exercise at altitude
Description
Blood pressure responses during rest and during exercise at altitude
Time Frame
Through study completion, an average of 1.5 years
Title
Changes of inflammatory markers (i.e., hsCRP) from before to after the pre-conditioning and pre-adaptation program
Description
Inflammatory markers may change due to the programs
Time Frame
Through study completion, an average of 1.5 years
Title
Changes of physiological stress markers (i.e., catecholamine) from before to after the pre-conditioning and pre-adaptation program
Description
Markers of physiological stress may change due to the programs
Time Frame
Through study completion, an average of 1.5 years
Title
Changes in heart rate variability (HRV) from before to after the pre-conditioning and pre-adaptation program
Description
HRV may change due to the programs
Time Frame
Through study completion, an average of 1.5 years
Title
Changes in baroreflex sensitivity (BRS) from before to after the pre-conditioning and pre-adaptation program
Description
BRS may change due to the programs
Time Frame
Through study completion, an average of 1.5 years
Title
Changes of markers of myocardial injury (e.g., highly sensitive cardiac troponin T) from before to after the pre-conditioning and pre-adaptation program
Description
Markers of myocardial injury may change due to the programs
Time Frame
Through study completion, an average of 1.5 years
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannes Gatterer, PhD
Phone
+39 0471 055 578
Email
hannes.gatterer@eurac.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannes Gatterer, PhD
Organizational Affiliation
Institute of Mountain Emergency Medicine, EURAC Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurac Research
City
Bolzano
State/Province
BZ
ZIP/Postal Code
39100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannes Gatterer
Phone
+39 0471 055 578
Email
hannes.gatterer@eurac.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Hypoxia Pre-conditioning and Mountain Sport
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