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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06204731
Other study ID # SKN/SP/570048/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date December 2026

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

- Cognitive assessment of the influence of a 4-week proprietary training program under normobaric hypoxia conditions on the levels of inflammatory markers, disturbances in prooxidant-antioxidant balance, degree of intestinal damage, and mitochondrial energy production rate in young sedentary males. - Applied objective: Development of practical training guidelines utilizing training in normobaric hypoxia conditions to enhance mechanisms related to oxygen transport, adaptive changes within the immune system, body's antioxidant capacity, gut permeability, substrate utilization efficiency, and mitochondrial function for coaches and athletes.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 29 Years
Eligibility Inclusion Criteria: - no known metabolic diseases, no contraindications to physical exercise and no history of high altitude sickness stated in interview. A medical examination (including ECG, blood and urine tests) is required. Exclusion Criteria: - changes in diet during the experiment, smoking and abuse of alcohol and/or other stimulants.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise and environmental conditions
Participants will engage in interval training and will reside and sleep at different altitudes for a period of 4 weeks. Aerobic and anaerobic capacity tests and an eccentric exercise test will be performed before and after the training intervention. Before and after the training program, somatic measurements will also be taken. 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 Krakow

Sponsors (2)

Lead Sponsor Collaborator
University School of Physical Education, Krakow, Poland Ministry of Education and Science,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 prooxidant-antioxidant imbalance, markers of inflammatory status, markers of muscle damage, markers of intestinal damage, HIF (hypoxia-inducible factor), EPO (erythropoietin), markers of mitochondrial metabolism, morphology (including reticulocytes). 7 days before training and 7- 10 days after the training. The training will last 4 weeks and will consist of 12 workouts.
Primary Somatic indices Body composition analysis ( body height [m], body mass [kg], Quetelet II Index [kg/m^2], lean body mass [kg], fat mass [kg], fat percentage [%] and total water content [kg] 7 days before training and 7-10 days after the training. Training will last 4 weeks.
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