NCT06159374

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

November 28, 2023

Last Update Submit

December 6, 2023

Conditions

Keywords

trainingexercisehuman performanceaerobic capacityanaerobic capacitymaximal oxygen uptakemuscle power

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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

Study Arms (8)

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%);

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%);

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%);

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%);

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%).

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%);

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%);

Other: exercise and environmental conditions

Interventions

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.

hypoxia-coldhypoxia-heathypoxia-heat-humidityhypoxia-thermoneutralnormoxia-coldnormoxia-heatnormoxia-thermoneutral

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • any training (including hypoxia training or exposure) performed in the 6 months prior to the beginning of the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University School of Physical Education in Cracow

Krakow, 31-571, Poland

RECRUITING

MeSH Terms

Conditions

Altitude SicknessMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marcin Maciejczyk, Prof. dr

    Departament of Physiology and Biochemistry

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 6, 2023

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations