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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Kraków, Poland, 31-571
        • Recruiting
        • University School of Physical Education in Cracow
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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%);
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.
Experimental: hypoxia-thermoneutral
Training performed under normobaric hypoxia (3000 m above sea level) and thermoneutral conditions (21°C) and constant humidity (40%);
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.
Experimental: normoxia-heat
training performed under normoxia (200 m above sea level) and high ambient temperature (31°C) and constant humidity (40%);
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.
Experimental: hypoxia-heat
training performed under normobaric hypoxia (3,000 m above sea level) and high ambient temperature (31°C) and constant humidity (40%);
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.
Experimental: normoxia-cold
Training performed in normoxia (200 m above sea level) and low ambient temperature (-11°C) and constant humidity (40%).
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.
Experimental: hypoxia-cold
training performed under normobaric hypoxia (3,000 m above sea level) and low ambient temperature (-11°C) and constant humidity (40%);
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.
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%);
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University School of Physical Education, Krakow, Poland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings