Cardio-respiratory Responses During Hypoxic Exercise in Individuals Born Prematurely
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Cardio-respiratory control at rest in normoxia and hypoxia in preterm and full term individuals
研究概览
简要总结
This project will consist of two studies, each investigating resting and exercise cardio-respiratory responses during exposure to hypoxia in individuals born prematurely and individuals born at full term of two different age groups: Kids (10-14 yrs) and Adults (18-22 yrs).Additional study will be performed on a preterm adult cohort (15 participants) that will investigate potential differences between hypobaric and normobaric hypoxia as outlined in the following section.
详细描述
The study protocol in each age group will comprise two visits to the laboratory testing sessions in a randomized order. On one occasion the participants will perform a resting hypoxia test and a graded exercise test to voluntary exhaustion in normoxic condition ((NORM; fraction of inspired oxygen (FiO2)=0.209, placebo). On a second visit the participants will perform a hypoxia sensitivity test and a graded exercise test to voluntary exhaustion in hypoxic condition (HYPO; FiO2=0.120 corresponding to terrestrial altitude of approx. 4000 m). Indirect calorimetry, near infrared spectroscopy and ECG measurements will be performed throughout all tests. During both testing sessions the participants will also undergo anthropometry measurements and pulmonary function testing. The outline of the research visits is presented in the bellow figure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male individuals
- •PRETERM group; gestational age: ≤ 32 weeks; gestational weight ≤ 1500 g
- •CONTROL group: full term born individuals ≤ 38 weeks
排除标准
- •Medication required that may interfere with the interpretation of the results
- •Chronically illnesses
- •Hormonal therapy
- •Recent sub-standard nutritional status
- •Family history of respiratiory, cardio-vascular, renal or hematological disease History of: thyroid dysfunction, renal stones, diabetes, allergies, hypertension, hypocalcaemia, uric acidaemia, lipidaemia or hyperhomocystinaemia
- •History of mental illness
- •Smoker within six months prior to the start of the study
- •Abuse of drugs, medicine or alcohol
- •Participation in another study up to two months before study onset
- •No signed consent form before the onset of the experiment
- •Blood donors in the past three months before the onset of the experiment
- •Vegetarian and Vegans
- •History of vestibular disorders
- •Claustrophobia
结局指标
主要结局
Cardio-respiratory control at rest in normoxia and hypoxia in preterm and full term individuals
时间窗: One year
The resting test will be performed in supine position with participants breathing normoxic air (FiO2=0.21) for 30 min and hypoxic gas for the subsequent 30-min (FiO2=0.120). During the whole protocol duration the respiration, local blood flow, ECG and EEG will be measured non-invasively. The resting test will be performed in supine position with participants breathing normoxic air (FiO2=0.21) for 30 min and hypoxic gas for the subsequent 30-min (FiO2=0.120). During the whole protocol duration the respiration, local blood flow, ECG and EEG will be measured non-invasively.
Tolerance to hypoxia during rest and exercise in preterm and full term individuals
时间窗: Two year
All graded exercise tests will be performed on electromagnetically controlled cycle-ergometer Ergo Bike Premium.The participants will be required to maintain a cadence of 60·min-1 throughout the whole test. The test is terminated when the participant is unable to maintain the assigned cadence. The resting test will be performed in supine position with participants breathing normoxic air (FiO2=0.21) for 30 min and hypoxic gas for the subsequent 30-min (FiO2=0.120). During the whole protocol duration the respiration, local blood flow, ECG and EEG will be measured non-invasively. The resting test will be performed in supine position with participants breathing normoxic air (FiO2=0.21) for 30 min and hypoxic gas for the subsequent 30-min (FiO2=0.120). During the whole protocol duration the respiration, local blood flow, ECG and EEG will be measured non-invasively.
次要结局
- Sensitivity to hypoxia during rest and exercise - Richalet test(One year)
- Changes in intestinal metabolites as a result of hypoxic exposure(One year)
- Differences between normobaric and hypobaric hypoxia in preterm individuals(Two years)
- Oxidative stress responses to hypoxic exercise in preterm and full term(One year)