NCT06896773

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for not_applicable healthy

Timeline
7mo left

Started Jun 2024

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Jun 2024Dec 2026

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

March 26, 2025

Status Verified

November 1, 2024

Enrollment Period

2.6 years

First QC Date

January 9, 2025

Last Update Submit

March 19, 2025

Conditions

Keywords

normobaric hypoxiacardiac markersendurance trainingresistance training

Outcome Measures

Primary Outcomes (55)

  • 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.

    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) \[million/mm3\]

    Up to 1 year

  • 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.

    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 \[%oxygen\].

    Up to 1 year

  • 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.

    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 VEGF-A \[pg/ml\].

    Up to 1 year

  • 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.

    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 cTnI \[ng/L\] and cTnT \[ng/L\].

    Up to 1 year

  • 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.

    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 Myo \[mcg/L\].

    Up to 1 year

  • 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.

    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 CK-MB \[IU/L\].

    Up to 1 year

  • 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.

    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 H-FABP \[ng/mL\].

    Up to 1 year

  • 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.

    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 IMA \[U/L\].

    Up to 1 year

  • 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.

    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 NT-proBNP \[pg/mL\].

    Up to 1 year

  • 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.

    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 nitrites and nitrates \[mg/l\].

    Up to 1 year

  • The effect of single exercise until volitional exhaustion in normoxia and normobaric hypoxic conditions, on myocardial contractility in trained and untrained men.

    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.

    Up to 1 year

  • 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.

    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 VO2max \[ml oxygen/kg of body weight/minute\].

    Up to 1 year

  • 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.

    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) \[million/mm3\].

    Up to 1 year

  • 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.

    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 HIF-1α \[%oxygen\].

    Up to 1 year

  • 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.

    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 VEGF-A \[pg/ml\]..

    Up to 1 year

  • 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.

    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 cTnI \[ng/L\] 5 and cTnT \[ng/L\].

    Up to 1 year

  • 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.

    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 Myo \[mcg/L\].

    Up to 1 year

  • 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.

    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 H-FABP \[ng/mL\].

    Up to 1 year

  • 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.

    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 IMA \[U/L\].

    Up to 1 year

  • 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.

    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 NT-proBNP \[pg/mL\].

    Up to 1 year

  • 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.

    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 nitrites and nitrates \[mg/l\].

    Up to 1 year

  • 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.

    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 VO2max \[ml oxygen/kg of body weight/minute\].

    Up to 1 year

  • 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.

    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 acid-base balance \[-\].

    Up to 1 year

  • 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.

    Echocardiography at rest and immediately after the graded exercise test (GXT) and constant-workload exercise test (CXT), after 2, 6, will undergo.

    Up to 1 year

  • To evaluate the muscle strength in normoxia

    Muscle strength \[1RM\] test in normoxia environment. The tests will be conducted in two exercises: a barbell bench press and a barbell squat.

    Up to 2 years

  • 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

    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.

    Up to 2 years

  • 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

    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) \[million/mm3\].

    Up to 2 years

  • 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

    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 \[%oxygen\].

    Up to 2 years

  • 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

    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 VEGF-A \[pg/ml\].

    Up to 2 years

  • 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

    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 cTnI \[ng/L\] and cTnT \[ng/L\].

    Up to 2 years

  • 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

    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 Myo \[mcg/L\].

    Up to 2 years

  • 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

    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 CK-MB \[IU/L\].

    Up to 2 years

  • 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

    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 H-FABP \[ng/mL\].

    Up to 2 years

  • 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

    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 IMA \[U/L\].

    Up to 2 years

  • 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

    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 NT-proBNP \[pg/mL\].

    Up to 2 years

  • 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

    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 nitrites and nitrates \[mg/l\].

    Up to 2 years

  • 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

    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 VO2max \[ml oxygen/kg of body weight/minute\].

    Up to 2 years

  • 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

    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 LA concentration \[mmol/L\].

    Up to 2 years

  • 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

    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 acid-base balance \[-\].

    Up to 2 years

  • 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)

    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) \[million/mm3\].

    Up to 2 years

  • 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)

    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 \[%oxygen\].

    Up to 2 year

  • 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)

    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 VEGF-A \[pg/ml\].

    Up to 2 year

  • 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)

    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 cTnI \[ng/L\] and cTnT \[ng/L\].

    Up to 2 year

  • 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)

    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 Myo \[mcg/L\].

    Up to 2 year

  • 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)

    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 CK-MB \[IU/L\].

    Up to 2 year

  • 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)

    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 H-FABP \[ng/mL\].

    Up to 2 year

  • 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)

    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 IMA \[U/L\].

    Up to 2 year

  • 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)

    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 NT-proBNP \[pg/mL\].

    Up to 2 year

  • 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)

    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 nitrites and nitrates \[mg/l\].

    Up to 2 year

  • 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)

    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 VO2max \[ml oxygen/kg of body weight/minute\]

    Up to 2 year

  • 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)

    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 LA concentration \[mmol/L\]

    Up to 2 year

  • 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)

    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 acid-base balance \[-\].

    Up to 2 year

  • 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)

    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.

    Up to 2 years

  • 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.

    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 CK-MB \[IU/L\].

    Up to 1 year

  • 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.

    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 acid-base balance \[-\].

    Up to 1 year

Study Arms (7)

Trained group - cyclists and triathletes

EXPERIMENTAL

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.

Other: Impact of Normobaric Hypoxia on Cardiac Biomarkers in trained men

Untrained group - healthy men

EXPERIMENTAL

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)

EXPERIMENTAL

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

EXPERIMENTAL

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.

Other: Effects of Hypoxic Endurance Training on Cardiac Biomarkers in the IHT group

Control group - C

EXPERIMENTAL

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.

Other: Effects of Hypoxic Endurance Training on Cardiac Biomarkers in the Control group

HRT group - hypoxic resistance training

EXPERIMENTAL

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.

Other: Effects of Hypoxic Strength Training on Cardiac Biomarkers in the HRT group

NRT group - normoxia resistance training

EXPERIMENTAL

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.

Other: Effects of Hypoxic Strength Training on Cardiac Biomarkers in the NRT group

Interventions

The intervention will consist of three series differing in terms of simulated altitude: S1 (normoxia), S2 (2000 m a.s.l.), and S3 (3000 m a.s.l.). Each research series will consist of one day of the measurements. All participants will perform two ergocycle tests (the graded exercise test GXT and constant-workload exercise test CXT at the individual lactate threshold workload (WRLT) until volitional exhaustion) with 10 minutes of active recovery break in different environment (S1, S2, S3- 3000). The order of the series will be randomized across all participants. The fraction of inspired oxygen (FIO2) will depend on the series and will be 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 will be maintained using AirZone climate technology (AirSport). Between the series, there will be a one-week active rest break excluding exposure to hypoxia and performance of high-intensity exercise.

Trained group - cyclists and triathletes

The participants in IHT group will live in normoxic conditions, but part of their training will be performed in normobaric hypoxia in a hypoxic chamber. The experiment will consist of two series of testing: S1 (baseline) and S2 (after 3 weeks of training and 3 days of rest). All participants will perform the same testing protocol as in stage 1-albeit in a normoxic environment and after 72h of rest, all testing procedures will be repeated in a hypoxic environment.

IHT group- intermittent hypoxic training

The participants in the NRT group will perform resistance training in normoxia. The experiment will consist of two series of testing (S1 and S2), performed in a laboratory. S1 will involve baseline testing, while S2 will be performed after three weeks of training after 3 days of rest. Each research series will consist of three measurement days. The testing protocol and blood sampling will be the same as in the first and second stages of the research. After next 72h of rest, all participants will have their muscle strength assessed using the one-repetition maximum (1RM) test in normoxia environment. The tests will be conducted in two exercises: a barbell bench press and a barbell squat.

NRT group - normoxia resistance training

The intervention will consist of three series differing in terms of simulated altitude: S1 (normoxia), S2 (2000 m a.s.l.), and S3 (3000 m a.s.l.). Each research series will consist of one day of the measurements. All participants will perform two ergocycle tests (the graded exercise test GXT and constant-workload exercise test CXT at the individual lactate threshold workload (WRLT) until volitional exhaustion) with 10 minutes of active recovery break in different environment (S1, S2, S3- 3000). The order of the series will be randomized across all participants. The fraction of inspired oxygen (FIO2) will depend on the series and will be 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 will be maintained using AirZone climate technology (AirSport). Between the series, there will be a one-week active rest break excluding exposure to hypoxia and performance of high-intensity exercise.

The participants from 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). Participants in this group will perform interval training under normoxic conditions. The experiment will consist of two series of testing: S1 (baseline) and S2 (after 3 weeks of training and 3 days of rest). All participants will perform the same testing protocol as in stage 1-albeit in a normoxic environment and after 72h of rest, all testing procedures will be repeated in a hypoxic environment.

The participants in the C group will live and train in normoxic conditions. The experiment will consist of two series of testing: S1 (baseline) and S2 (after 3 weeks of training and 3 days of rest). All participants will perform the same testing protocol as in stage 1-albeit in a normoxic environment and after 72h of rest, all testing procedures will be repeated in a hypoxic environment.

Control group - C

The participants in the HRT group will perform resistance training in normobaric hypoxia (FIO2 = 14.4%, 3000 m a.s.l.). The experiment will consist of two series of testing (S1 and S2), performed in a laboratory. S1 will involve baseline testing, while S2 will be performed after three weeks of training after 3 days of rest. Each research series will consist of three measurement days. The testing protocol and blood sampling will be the same as in the first and second stages of the research. After next 72h of rest, all participants will have their muscle strength assessed using the one-repetition maximum (1RM) test in normoxia environment. The tests will be conducted in two exercises: a barbell bench press and a barbell squat.

HRT group - hypoxic resistance training

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • males
  • 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.

You may not qualify if:

  • participants who use drugs
  • drink alcohol or smoke,
  • hypertension
  • prematurely stopped the exercise test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Józef Piłsudski University of Physical Education in Warsaw, Poland

Warsaw, Masovian Voivodeship, 00-968, Poland

Location

Related Publications (1)

  • Robert G, Milosz C, Kamila P, Ewa K, Adam N, Michal S, Natalia GZ, Katarzyna K, Jozef L. The Impact of High-Intensity Exercise in Normobaric Hypoxia on Right Ventricular Function in Trained and Untrained Men-An Echocardiographic Study. Compr Physiol. 2026 Feb;16(1):e70090. doi: 10.1002/cph4.70090.

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Miłosz Czuba, Prof.

    Józef Piłsudski University of Physical Education in Warsaw, Poland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

March 26, 2025

Study Start

June 1, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 26, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Starting 6 months after publication
Access Criteria
Additional supporting information will be available upon request.

Locations