Effect of Training in Normobaric Hypoxia on Cardiac Markers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- To evaluate the effect of 3 weeks of endurance training in two methods of hypoxic training (LH-TL, and IHT) on myocardial contractility in response to a single exercise until volitional exhaustion in normoxia and hypoxia
研究概览
简要总结
The goal of this study is to determine changes in the concentration of cardiac biomarkers in blood in response to a single bout of exercise performed until volitional exhaustion under hypoxic conditions, and in response to endurance and resistance training in athletes in hypoxia. The investigators hypothesize that: (1) adverse changes in the myocardium may occur during exercise in acute normobaric hypoxia, but they are at least partially reversed by adaptive alterations induced by training in hypoxia; (2) this response is identical in athletes with eccentric cardiac hypertrophy and those with concentric cardiac hypertrophy.
The study consists of three stages. Stage 1 (completed) has examine changes in the blood levels of cardiac biomarkers in response to a single bout of exercise performed until volitional exhaustion in normoxia and during different levels of hypoxia (2000, 3000m). This stage has examined men aged 20-40 years involved in competitive cycling and triathlon, and untrained, healthy men.
Stage 2 of the study will examine changes in the blood levels of cardiac biomarkers in cyclists (aged 20-40) in response to a 3-week endurance training in hypoxia and to passive prolonged exposure (11 to 12 hours a day) to a simulated altitude of 3000m. Stage 3 will examine changes in blood levels of cardiac biomarkers in response to a 3-week resistance training in hypoxia (3000m). This stage of the study will involve men aged 20-40 training in strength sports.
The project will help clarify the effects of hypoxia on the physiological state of the heart in athletes with eccentric or concentric cardiac hypertrophy, as well as determine the differences between competitive athletes vs. untrained, healthy men in the response to hypoxia. The findings may be used in planning and controlling the training process in both strength and endurance disciplines. The research to be conducted in the project is basic research, but it may have a certain applicative aspect.
详细描述
The goal of this interventional trial is to determine changes in the concentration of cardiac biomarkers in blood in response to exercise performed until volitional exhaustion: (1) after a single exposure to normoxia and normobaric hypoxic conditions with varying levels of the hypoxic stimulus, in trained and untrained men; (2) after 3 weeks of endurance training in normobaric hypoxia in cyclists (eccentric hypertrophy); (3) after 3 weeks of resistance training in normobaric hypoxia in strength athletes (concentric hypertrophy).
The research project involves assessing the physiological state of the myocardium after acute and chronic exposure to normobaric hypoxia in athletes with eccentric and concentric cardiac hypertrophy by measuring selected cardiac biomarkers in blood serum: cardiac troponins I and T (cTnI and cTnT), myoglobin (Myo), and the creatine kinase-myocardial band fraction (CK-MB), B-type natriuretic peptide (NT-proBNP), N-terminal pro-hormone of BNP (H-FABP) and ischemia-modified albumin (IMA). In addition, the levels of the following markers will be observed: hypoxia-inducible factor-1 (HIF-1α), vascular endothelial growth factor A (VEGF-A), nitrites and nitrates (NO breakdown products).
The study consists of three stages. Stage 1 (has been completed). All participants have performed two consecutive ergocycle tests (the graded exercise test GXT and constant-workload exercise test CXT with 10 minutes of active recovery break in different environment (S1-normoxia, S2-2000 m a.s.l., S3- 3000 m a.s.l.). The fraction of inspired oxygen (FIO2) is as follows: S1 (normoxia) = 20.9%; S2 (2000 m a.s.l.) = 16,5%; S3 (3000 m a.s.l.) = 14.4%. The hypoxic environment was maintained using AirZone climate technology (AirSport).
In stage 2 of the study, changes in the blood levels of cardiac biomarkers in 36 male cyclists in response to 3 weeks of endurance training in hypoxia (3000m) will be examined. The participants will be randomly assigned to three groups: (1) LHTL "live high, train low"; (2) IHT "intermittent hypoxic training"; (3) the control group (C) - normoxic training.
The experiment will consist of two series of testing: S1 (baseline tests) and S2 (tests after three weeks of training and after 3 days of rest).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age 20-40 years
- •VO2max of not less than 60 ml/kg/min
- •training experience of at least 6 years (for stage 1) and 3 years (for stage 2 and 3)
- •at least a six-month wash-out period from any previous altitude training, - competitive cyclists in the pre-competition phase of training (for stage 2)
- •no chronic diseases
- •systolic blood pressure 100-140 mmHg and diastolic blood pressure 60-90 mmHg.
排除标准
- •participants who use drugs
- •drink alcohol or smoke,
- •hypertension
- •prematurely stopped the exercise test.
研究组 & 干预措施
Trained group - cyclists and triathletes
The participants in training group will meet the following criteria: male, aged 20-40, VO2max of not less than 60 ml/kg/min, training experience of at least 6 years and at least a six-month wash-out period from any previous altitude training. Additionally, inclusion criteria in both groups will be: no chronic diseases; (3) systolic blood pressure 100-140 mmHg and diastolic blood pressure 60-90 mmHg. The study will exclude participants who use drugs, drink alcohol or smoke, have hypertension, prematurely stopped the exercise test.
干预措施: Impact of Normobaric Hypoxia on Cardiac Biomarkers in trained men (Other)
Untrained group - healthy men
Inclusion criteria will be: male, aged 20-40 years, no chronic diseases, systolic blood pressure 100-140 mmHg and diastolic blood pressure 60-90 mmHg. The study will exclude participants who use drugs, drink alcohol or smoke, have hypertension, prematurely stopped the exercise test.
LHTL group (live high, train low)
The LHTL group: male, aged 20-40, competitive cyclists in the pre-competition phase of training, with a wash-out period of at least six months after previous altitude training, VO2max of not less than 60 ml/kg/min, training experience of at least 6 years, no chronic diseases, systolic blood pressure 100-140 mmHg and diastolic blood pressure 60-90 mmHg. The LHTL group will be exposed to normobaric hypoxia (FIO2 = 14.4%, corresponding to an altitude of 3000 m a.s.l.) in a hotel room for 11 to 12 hours a day (evenings and nights) and train under normoxic conditions.The study will exclude participants who use drugs, drink alcohol or smoke, have hypertension, prematurely stopped the exercise test.
IHT group- intermittent hypoxic training
Participants in the IHT group: male, aged 20-40, competitive cyclists in the pre-competition phase of training, with a wash-out period of at least six months after previous altitude training, VO2max of not less than 60 ml/kg/min, training experience of at least 6 years, no chronic diseases, systolic blood pressure 100-140 mmHg and diastolic blood pressure 60-90 mmHg. Participants in the IHT group will live in normoxic conditions, but part of their training will be performed in normobaric hypoxia (FIO2 = 14.4%, 3000 m a.s.l.) in a hypoxic chamber. The study will exclude participants who use drugs, drink alcohol or smoke, have hypertension, prematurely stopped the exercise test.
干预措施: Effects of Hypoxic Endurance Training on Cardiac Biomarkers in the IHT group (Other)
Control group - C
The C group: male, aged 20-40, competitive cyclists, in the pre-competition phase of training, with a wash-out period of at least six months after previous altitude training, VO2max of not less than 60 ml/kg/min, training experience of at least 6 years, no chronic diseases; systolic blood pressure 100-140 mmHg and diastolic blood pressure 60-90 mmHg. The participants will live and perform endurance training in normoxic conditions. The study will exclude participants who use drugs, drink alcohol or smoke, have hypertension, prematurely stopped the exercise test.
干预措施: Effects of Hypoxic Endurance Training on Cardiac Biomarkers in the Control group (Other)
HRT group - hypoxic resistance training
The participants in the HRT group: male, aged 20-40, at least three years of systematic strength training, wash-out period of at least six months after previous altitude/hypoxic training, no chronic diseases, systolic blood pressure 100-140 mmHg and diastolic blood pressure 60-90 mmHg. Participants will perform resistance training in normobaric hypoxia (FIO2 = 14.4%, 3000 m a.s.l.). The study will be excluded participants who use drugs, drink alcohol or smoke, have hypertension, prematurely stopped the exercise test.
干预措施: Effects of Hypoxic Strength Training on Cardiac Biomarkers in the HRT group (Other)
NRT group - normoxia resistance training
The participants in the NRT group: male, aged 20-40, at least three years of systematic strength training, wash-out period of at least six months after previous altitude/hypoxic training, no chronic diseases, systolic blood pressure 100-140 mmHg and diastolic blood pressure 60-90 mmHg. Participants will perform resistance training in normoxia. The study will be excluded participants who use drugs, drink alcohol or smoke, have hypertension, prematurely stopped the exercise test.
干预措施: Effects of Hypoxic Strength Training on Cardiac Biomarkers in the NRT group (Other)
结局指标
主要结局
To evaluate the effect of 3 weeks of endurance training in two methods of hypoxic training (LH-TL, and IHT) on myocardial contractility in response to a single exercise until volitional exhaustion in normoxia and hypoxia
时间窗: Up to 2 years
For each participant, echocardiography at rest and immediately after the graded exercise test (GXT) and constant-workload exercise test (CXT), after 2, 6, and 24 hours will undergo.
The effect of single exercise until volitional exhaustion in normoxia and normobaric hypoxic conditions, on cardiac biomarker concentrations in blood in trained and untrained men.
时间窗: Up to 1 year
For each participant, blood samples will be taken at five time points during each series of the study: before and immediately after the graded exercise test (GXT) and constant-workload exercise test (CXT), after 2, 6, and 24 hours. The blood samples will be used to determine blood profile based on complete blood count (CBC) \[million/mm3\]
To determine the relationship between the fitness level (trained vs. untrained) and changes in cardiac biomarker concentrations in blood in response to a single exercise until volitional exhaustion in normoxia and hypoxia.
时间窗: Up to 1 year
Changes in the concentration of cardiac biomarkers in blood in response to two consecutive ergocycle tests during exposure normoxia and different levels of hypoxia in trained and untrained man during each series of the study: before and immediately after the graded exercise test (GXT) and constant-workload exercise test (CXT), after 2, 6, and 24 hours will be measured. The blood samples will be used to determine complete blood count (CBC) \[million/mm3\].
To evaluate the effect of 3 weeks of endurance training in two methods of hypoxic training (LH-TL, and IHT) on cardiac biomarkers in response to a single exercise until volitional exhaustion in normoxia and hypoxia
时间窗: Up to 2 years
For each participant, blood samples will be taken at five time points during each series of the study: before and immediately after the graded exercise test (GXT) and constant-workload exercise test (CXT), after 2, 6, and 24 hours. The blood samples will be used to determine complete blood count (CBC) \[million/mm3\].
To evaluate the effect of 3 weeks of resistance training in hypoxia on cardiac biomarkers concentration in blood in response to a single exercise until volitional exhaustion in normoxia and hypoxia (3000 m. a.s.l)
时间窗: Up to 2 year
For each participant, blood samples will be taken at five time points during each series of the study: before and immediately after the graded exercise test (GXT) and constant-workload exercise test (CXT), after 2, 6, and 24 hours. The blood samples will be used to determine HIF-1α \[%oxygen\].
The effect of single exercise until volitional exhaustion in normoxia and normobaric hypoxic conditions, on myocardial contractility in trained and untrained men.
时间窗: Up to 1 year
For each participant, before and immediately after the graded exercise test (GXT) and constant-workload exercise test (CXT), after 2, 6, and 24 hours echocardiography will undergo.
To determine the relationship between the fitness level (trained vs. untrained) and changes in myocardial contractility in response to a single exercise until volitional exhaustion in normoxia and hypoxia.
时间窗: Up to 1 year
Echocardiography at rest and immediately after the graded exercise test (GXT) and constant-workload exercise test (CXT), after 2, 6, will undergo.
To evaluate the muscle strength in normoxia
时间窗: Up to 2 years
Muscle strength \[1RM\] test in normoxia environment. The tests will be conducted in two exercises: a barbell bench press and a barbell squat.
To evaluate the effect of 3 weeks of resistance training in hypoxia on myocardial contractility in response to a single exercise until volitional exhaustion in normoxia and hypoxia (3000 m. a.s.l)
时间窗: Up to 2 years
For each participant, blood samples will be taken at five time points during each series of the study: before and immediately after the graded exercise test (GXT) and constant-workload exercise test (CXT) tests, after 2, 6, and 24 hours. Echocardiography at rest and immediately the tests will undergo.
To evaluate the effect of 3 weeks of resistance training in hypoxia on cardiac biomarkers concentration in blood in response to a single exercise until volitional exhaustion in normoxia and hypoxia (3000 m. a.s.l)
时间窗: Up to 2 years
For each participant, blood samples will be taken at five time points during each series of the study: before and immediately after the graded exercise test (GXT) and constant-workload exercise test (CXT) tests, after 2, 6, and 24 hours. The blood samples will be used to determine complete blood count (CBC) \[million/mm3\].
次要结局
未报告次要终点