- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06159374
Effects of Physical Training in Altered Environmental Conditions on Exercise Performance
December 6, 2023 updated by: University School of Physical Education, Krakow, Poland
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anna Radoń, MSc
- Phone Number: +45126831142
- Email: anna.radon@awf.krakow.pl
Study Locations
-
-
-
Kraków, Poland, 31-571
- Recruiting
- University School of Physical Education in Cracow
-
Contact:
- Anna Radon
- Phone Number: 48 12 6831142
- Email: anna.radon@awf.krakow.pl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Control group
|
|
|
Experimental: normoxia-thermoneutral
Training performed under normoxia (200 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%);
|
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.
|
|
Experimental: hypoxia-thermoneutral
Training performed under normobaric hypoxia (3000 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%);
|
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.
|
|
Experimental: normoxia-heat
training performed under normoxia (200 m above sea level) and high ambient temperature (31°C) and constant humidity (40%);
|
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.
|
|
Experimental: hypoxia-heat
training performed under normobaric hypoxia (3,000 m above sea level) and high ambient temperature (31°C) and constant humidity (40%);
|
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.
|
|
Experimental: normoxia-cold
Training performed in normoxia (200 m above sea level) and low ambient temperature (-11°C) and constant humidity (40%).
|
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.
|
|
Experimental: hypoxia-cold
training performed under normobaric hypoxia (3,000 m above sea level) and low ambient temperature (-11°C) and constant humidity (40%);
|
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.
|
|
Experimental: hypoxia-heat-humidity
training performed under normobaric hypoxia (3,000 m above sea level) and high ambient temperature (31°C) and high humidity (70%);
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
7 days before training and 7-10 days after the training. Training will last 4 weeks.
|
|
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)
|
7 days before training and 7-10 days after the training. Training will last 4 weeks.
|
|
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
|
Before (10 min) and after (3 min) the first and last training. The training will last 4 weeks and will consist of 12 workouts
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Marcin Maciejczyk, Prof. dr, Departament of Physiology and Biochemistry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
November 28, 2023
First Submitted That Met QC Criteria
November 28, 2023
First Posted (Actual)
December 6, 2023
Study Record Updates
Last Update Posted (Estimated)
December 13, 2023
Last Update Submitted That Met QC Criteria
December 6, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEIN 2021/DPI/229
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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