Effects of a 6-week Hypoxia-hyperoxia Exposure Protocol on Sedentary Older Adults on Heart Rate Variability, Blood Pressure, Respiratory Muscle Strength, Pulmonary Function, Inflammatory Biomarkers and Arterial Oxygen Saturation, a Randomized Double-blind Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 主要终点
- Heart rate variability
研究概览
简要总结
The supply of oxygen is essential for energy production, recovery from efforts, and human life. Intermittent Hypoxia-Hyperoxia Exposure (IHHE) is a novel technique in which the subject is exposed to a respiratory environment with reduced oxygen fraction, controlled through a specific software, using a facial mask and a hypoxic generation device. The objective of this study is to determine if there is a relationship between intermittent hypoxia-hyperoxia exposure and cardiorespiratory condition, blood pressure, and arterial oxygen saturation.
According to our hypothesis, acute IHHE in elderly adults may influence cardiorespiratory condition, inflammatory biomarkers, blood pressure, and arterial oxygen saturation.
The study will be conducted as a randomized clinical trial. The subjects will be divided into two groups: the experimental group will undergo an IHHE session, breathing air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, with 1-3 minutes of rest in hyperoxia (FiO2 30-40%) for a total of 4-8 cycles, based on their acute response to hypoxia. The sham group will undergo a 5-cycle protocol with an FiO2 of 21%.
Both groups will follow a 6-week protocol with three weekly sessions (Monday, Wednesday, and Friday).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being over 65 years old.
- •Having no previous experience in hypoxic training.
- •Engaging in less than 150 minutes of physical activity per week.
排除标准
- •Having any pathology that prevents the subject from being independent in terms of walking and functionality.
- •Subjects with impaired cognitive abilities.
- •Subjects with pulmonary hypertension, decompensated heart or respiratory disease.
- •To have or have had cancer
结局指标
主要结局
Heart rate variability
时间窗: 24 hours before intervention and 24 hours after 6 week intervention
The analysis of Heart Rate Variability will be conducted using a heart rate monitor. Cardiac electrical signals will be monitored with a band placed on the chest for 5 minutes with the subject in supine position on a stretcher, in a quiet environment, soft light, and a comfortable temperature. Subjects are instructed not to speak or make voluntary movements during this analysis.
次要结局
- Blood pressure(24 hours before intervention and 24 hours after 6 week intervention)
- Arterial oxygen saturation(24 hours before intervention and 24 hours after 6 week intervention)
- Respiratory muscle strength(24 hours before intervention and 24 hours after 6 week intervention)
- Pulmonary function(24 hours before intervention and 24 hours after 6 week intervention)
- Inflammatory biomarkers(24 hours before intervention and 24 hours after 6 week intervention)