Hypoxia, AltitudeNCT06159374
Effects of Physical Training in Altered Environmental Conditions on Exercise Performance
A study testing exercise and environmental conditions in people with Hypoxia, Altitude and Cold Exposure, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
Trial summary
The main objective of the study is to evaluate the physiological-biochemical effects of physical training under artificially altered climatic conditions (using a hypoxic thermoclimatic chamber) in particular to determine the effect of such training on exercise capacity and physiological response, including the effect… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Altitude, Cold Exposure, Heat Exposure
- What is being tested?
- exercise and environmental conditions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- absence of medical contraindications to high-intensity physical exertion. The medical examination is required (included an exercise ECG, blood tests to exclude anemia or low hemoglobin and iron concentration)
Who cannot join
- any training (including hypoxia training or exposure) performed in the 6 months prior to the beginning of the intervention
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University School of Physical Education in Cracow
Krakow, 31-571
Anna Radon, 48 12 6831142, anna.radon@awf.krakow.pl
About this study
Official title: Effects of Physical Training in Altered Environmental Conditions (in a Hypoxic Thermoclimatic Chamber) on Exercise Capacity and Selected Physiological Responses of the Human Body
The main objective of the study is to evaluate the physiological-biochemical effects of physical training under artificially altered climatic conditions (using a hypoxic thermoclimatic chamber) in particular to determine the effect of such training on exercise capacity and physiological response, including the effect of training in high-performance athletes. The study will evaluate the effects of physical training and the simultaneous application of hypoxia and heat/cold on aerobic and anaerobic capacity and the physiological response of the human body. The aim of the study is to find the most favourable environmental conditions for physical training in order to maximise physical performance.
- Conditions
- Hypoxia, Altitude, Cold Exposure, Heat Exposure
- Being tested
- exercise and environmental conditions
- Keywords
- training, exercise, human performance, aerobic capacity, anaerobic capacity, maximal oxygen uptake, muscle power
- Medical subject headings
- Altitude Sickness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and environmental conditionsOther
Participants will perform interval training for 4 weeks in a variety of environmental conditions. There will be a measurement of aerobic and anaerobic capacity before and after the training. Before and after the first and last workout, blood will be drawn for biochemical analysis.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group |
| normoxia-thermoneutral | Experimental | Training performed under normoxia (200 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%); Receives: Other: exercise and environmental conditions |
| hypoxia-thermoneutral | Experimental | Training performed under normobaric hypoxia (3000 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%); Receives: Other: exercise and environmental conditions |
| normoxia-heat | Experimental | training performed under normoxia (200 m above sea level) and high ambient temperature (31°C) and constant humidity (40%); Receives: Other: exercise and environmental conditions |
| hypoxia-heat | Experimental | training performed under normobaric hypoxia (3,000 m above sea level) and high ambient temperature (31°C) and constant humidity (40%); Receives: Other: exercise and environmental conditions |
| normoxia-cold | Experimental | Training performed in normoxia (200 m above sea level) and low ambient temperature (-11°C) and constant humidity (40%). Receives: Other: exercise and environmental conditions |
| hypoxia-cold | Experimental | training performed under normobaric hypoxia (3,000 m above sea level) and low ambient temperature (-11°C) and constant humidity (40%); Receives: Other: exercise and environmental conditions |
| hypoxia-heat-humidity | Experimental | training performed under normobaric hypoxia (3,000 m above sea level) and high ambient temperature (31°C) and high humidity (70%); Receives: Other: exercise and environmental conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of aerobic capacity (endurance)
Measurement of maximal oxygen uptake and determination of ventilatory thresholds (ergospirometry)
Measured: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
Measurement of anaerobic capacity
Measurement of maximal anaerobic power (Wingate Anaerobic Test)
Measured: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
Blood analysis
indicators of muscle damage, inflammatory markers (interleukins), oxidative stress, lactate concentration, tissue oxygenation, selected hormones (including erythropoietin) and enzymes, HIF (hypoxia inducible factor), selected vitamins, morphology (including reticulocytes), rheology and blood biochemistry
Measured: Before (10 min) and after (3 min) the first and last training. The training will last 4 weeks and will consist of 12 workouts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia, AltitudeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcin Maciejczyk, Prof. dr, Study director, Departament of Physiology and Biochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159374
- Sponsor's protocol ID
- MEIN 2021/DPI/229
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Training in Altered Environmental Conditions (in a Hypoxic Thermoclimatic Chamber) on Exercise Capacity and Selected Physiological Responses of the Human Body
- ClinicalTrials.gov ID
- NCT06159374
- Acronym / sponsor ID
- MEIN 2021/DPI/229
- Conditions
- Hypoxia, Altitude, Cold Exposure, Heat Exposure
- Keywords
- training, exercise, human performance, aerobic capacity, anaerobic capacity, maximal oxygen uptake, muscle power
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to evaluate the physiological-biochemical effects of physical training under artificially altered climatic conditions (using a hypoxic thermoclimatic chamber) in particular to determine the effect of such training on exercise capacity and physiological response, including the effect of training in high-performance athletes. The study will evaluate the effects of physical training and the simultaneous application of hypoxia and heat/cold on aerobic and anaerobic capacity and the physiological response of the human body. The aim of the study is to find the most favourable environmental conditions for physical training in order to maximise physical performance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group |
| normoxia-thermoneutral | Experimental | Other: exercise and environmental conditionsTraining performed under normoxia (200 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%); |
| hypoxia-thermoneutral | Experimental | Other: exercise and environmental conditionsTraining performed under normobaric hypoxia (3000 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%); |
| normoxia-heat | Experimental | Other: exercise and environmental conditionstraining performed under normoxia (200 m above sea level) and high ambient temperature (31°C) and constant humidity (40%); |
| hypoxia-heat | Experimental | Other: exercise and environmental conditionstraining performed under normobaric hypoxia (3,000 m above sea level) and high ambient temperature (31°C) and constant humidity (40%); |
| normoxia-cold | Experimental | Other: exercise and environmental conditionsTraining performed in normoxia (200 m above sea level) and low ambient temperature (-11°C) and constant humidity (40%). |
| hypoxia-cold | Experimental | Other: exercise and environmental conditionstraining performed under normobaric hypoxia (3,000 m above sea level) and low ambient temperature (-11°C) and constant humidity (40%); |
| hypoxia-heat-humidity | Experimental | Other: exercise and environmental conditionstraining performed under normobaric hypoxia (3,000 m above sea level) and high ambient temperature (31°C) and high humidity (70%); |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- absence of medical contraindications to high-intensity physical exertion. The medical examination is required (included an exercise ECG, blood tests to exclude anemia or low hemoglobin and iron concentration)
Key exclusion criteria (1 listed)
- any training (including hypoxia training or exposure) performed in the 6 months prior to the beginning of the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise and environmental conditionsParticipants will perform interval training for 4 weeks in a variety of environmental conditions. There will be a measurement of aerobic and anaerobic capacity before and after the training. Before and after the first and last workout, blood will be drawn for biochemical analysis. | Other | hypoxia-cold, hypoxia-heat, hypoxia-heat-humidity, hypoxia-thermoneutral, normoxia-cold, normoxia-heat, normoxia-thermoneutral |
Primary outcome
Measurement of aerobic capacity (endurance)
Time frame: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
Measurement of maximal oxygen uptake and determination of ventilatory thresholds (ergospirometry)
Measurement of anaerobic capacity
Time frame: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
Measurement of maximal anaerobic power (Wingate Anaerobic Test)
Blood analysis
Time frame: Before (10 min) and after (3 min) the first and last training. The training will last 4 weeks and will consist of 12 workouts
indicators of muscle damage, inflammatory markers (interleukins), oxidative stress, lactate concentration, tissue oxygenation, selected hormones (including erythropoietin) and enzymes, HIF (hypoxia inducible factor), selected vitamins, morphology (including reticulocytes), rheology and blood biochemistry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin Maciejczyk, Prof. dr study director
Departament of Physiology and Biochemistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and environmental conditions in people with Hypoxia, Altitude and Cold Exposure, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Radoń, MSc (+45126831142, anna.radon@awf.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of aerobic capacity (endurance) (time frame: 7 days before training and 7-10 days after the training. Training will last 4 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.