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临床试验/NCT04725539
NCT04725539已完成不适用

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

Institute of Mountain Emergency Medicine1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
1
主要终点
Oxygen saturation during exercise at altitude

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: hypoxic exposure (Procedure)

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.

干预措施: hypoxic exposure (Procedure)

结局指标

主要结局

Oxygen saturation during exercise at altitude

时间窗: 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

Resting oxygen saturation (%) at altitude

时间窗: 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

次要结局

  • 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)
  • Blood pressure (mmHg) responses during rest and during exercise at altitude(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)
  • Heart rate (bpm) responses during rest and during exercise at altitude(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)
  • 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 in baroreflex sensitivity (BRS) from before to after the pre-conditioning and pre-adaptation program(Through study completion, an average of 1.5 years)

研究者

发起方
Institute of Mountain Emergency Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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