Coronary Artery Disease (CAD)
Conditions
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.
Interventions
PROCEDUREhypoxic 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
Sponsors
Istituto Auxologico Italiano
University of Innsbruck
University of Giessen
Institute of Mountain Emergency Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resting oxygen saturation (%) at altitude | Through study completion, an average of 1.5 years | Resting oxygen saturation changes after the pre-conditioning and pre-adaptation program at 3000 m altitude |
| Oxygen saturation during exercise at altitude | Through study completion, an average of 1.5 years | Oxygen saturation during exercise changes after the pre-conditioning and pre-adaptation program at 3000 m altitude |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Through study completion, an average of 1.5 years | Markers of physiological stress may change due to the programs |
| Heart rate (bpm) responses during rest and during exercise at altitude | Through study completion, an average of 1.5 years | Heart rate response changes after the pre-conditioning and pre-adaptation program at rest and during exercise at 3000 m altitude. |
| Changes in baroreflex sensitivity (BRS) from before to after the pre-conditioning and pre-adaptation program | Through study completion, an average of 1.5 years | 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 | Through study completion, an average of 1.5 years | Markers of myocardial injury may change due to the programs |
| 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 | HRV may change due to the programs |
| Blood pressure (mmHg) responses during rest and during exercise at altitude | Through study completion, an average of 1.5 years | Blood pressure responses during rest and during exercise at altitude |
Countries
Italy
Outcome results
None listed