Hypoxia Pre-conditioning and Mountain Sport

Coronary Artery Disease (CAD) Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725539
• Other study ID #: HYP-P-SP
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Institute of Mountain Emergency Medicine
• Contact: Hannes Gatterer, PhD
• Phone: +39 0471 055 578
• Email: hannes.gatterer[@]eurac.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Hypoxia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Italy	Eurac Research	Bolzano	BZ

Sponsors (4)

Lead Sponsor	Collaborator
Institute of Mountain Emergency Medicine	Istituto Auxologico Italiano, University of Giessen, University of Innsbruck

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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