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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06159374
Other study ID # MEIN 2021/DPI/229
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2025

Study information

Verified date December 2023
Source University School of Physical Education, Krakow, Poland
Contact Anna Radon, MSc
Phone +45126831142
Email anna.radon@awf.krakow.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 128
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: 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) Exclusion Criteria: any training (including hypoxia training or exposure) performed in the 6 months prior to the beginning of the intervention

Study Design


Intervention

Other:
exercise and environmental conditions
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.

Locations

Country Name City State
Poland University School of Physical Education in Cracow Kraków

Sponsors (1)

Lead Sponsor Collaborator
University School of Physical Education, Krakow, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of aerobic capacity (endurance) Measurement of maximal oxygen uptake and determination of ventilatory thresholds (ergospirometry) 7 days before training and 7-10 days after the training. Training will last 4 weeks.
Primary Measurement of anaerobic capacity Measurement of maximal anaerobic power (Wingate Anaerobic Test) 7 days before training and 7-10 days after the training. Training will last 4 weeks.
Primary 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 Before (10 min) and after (3 min) the first and last training. The training will last 4 weeks and will consist of 12 workouts
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