NCT07664072

Brief Summary

Exercise in the cold is an attractive option for many athletes. Erythrocyte aggregation, as one of the main rheological parameters, constitutes an important indicator of microcirculation and oxygen transport capacity in the human body; therefore, its changes in response to exercise and cold are of clinical and physiological relevance. The purpose of the study was to determine the effects of a single physical effort at low temperature (-10°C) in a thermal climate chamber on the red blood cell system, erythrocyte aggregation, lactate, cortisol, and testosterone in healthy males. Methods: The study was experimental in nature and assumed a comparison of the body response to exercise performed at reduced (-10°C) and neutral (18°C) temperatures. It involved 30 healthy males, students of physiotherapy at the University of Physical Culture in Krakow, Poland. The enrolled individuals were divided into 2 groups: group 1 (n = 15) ran in a thermal climate chamber at an air temperature of -10°C, group 2 (n = 15) ran in the fresh air at a neutral air temperature of 18°C.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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

May 11, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

Same day

First QC Date

June 2, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

Cold airBeep testAggregation indexerythrocyte aggregationlactatecortisoltestosterone

Outcome Measures

Primary Outcomes (5)

  • blood sampling: AI

    aggregation index

    twice: before starting the exercise and immediately after finishing it

  • blood sampling:AMP

    amplitude of aggregation

    twice: before starting the exercise and immediately after finishing it

  • blood sampling: T1/2

    half-time kinetics of total aggregation

    twice: before starting the exercise and immediately after finishing it

  • blood sampling: RBC

    red blood cells

    twice: before starting the exercise and immediately after finishing it

  • blood sampling: Hb

    hemoglobin

    twice: before starting the exercise and immediately after finishing it

Study Arms (2)

Single effort in air temperature of -10°C

EXPERIMENTAL

The body response to exercise performed at reduced (-10°C) temperature

Other: cold

Single effort in neutral (18°C) condition

EXPERIMENTAL

The body response to exercise performed at neutral (18°C) temperature

Other: neutral

Interventions

coldOTHER

the exercise, blood samples

Single effort in air temperature of -10°C
neutralOTHER

the exercise, blood samples

Single effort in neutral (18°C) condition

Eligibility Criteria

Age22 Years - 23 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Healthy men

You may not qualify if:

  • women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Physical Culture

Krakow, Lesser Poland Voivodeship, 31-571, Poland

Location

MeSH Terms

Interventions

Cold Temperature

Intervention Hierarchy (Ancestors)

TemperatureThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Aneta Teległow, Professor

    University of Physcial Eduction, Kraków, Poland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
The workout was undertaken in a thermal climate chamber in the Laboratory for Climate Technology Research and Heavy Duty Machines, Cracow University of Technology in Krakow. The thermal climate chamber meets the requirements of the PN-EN ISO/IEC 17025:2005 standard and possesses an accreditation certificate No. AB 1678, issued by the Polish Centre for Accreditation. The Laboratory for Climate Technology Research and Heavy Duty Machines is a research center accredited in the field of defense and security by the Minister of National Defense (accreditation No.: 55/MON/2018).
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Simple randomization with a 1:1 allocation ratio served to randomly assign the participants to the experimental or control group. This was done before the first blood sampling, with the randomization sequence generated prior to the study. No stratification factors were used. The participants in the experimental group performed physical exertion under the conditions of low temperature (-10°C). The workout was undertaken in a thermal climate chamber in the Laboratory for Climate Technology Research and Heavy Duty Machines, Cracow University of Technology in Krakow. The thermal climate chamber meets the requirements of the PN-EN ISO/IEC 17025:2005 standard and possesses an accreditation certificate No. AB 1678, issued by the Polish Centre for Accreditation. The Laboratory for Climate Technology Research and Heavy Duty Machines is a research center accredited in the field of defense and security by the Minister of National Defense (accreditation No.: 55/MON/2018). The control group, in t
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor University

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 23, 2026

Study Start

May 11, 2024

Primary Completion

May 11, 2024

Study Completion

May 11, 2024

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

laboratory measurement results, age, gender

Shared Documents
STUDY PROTOCOL
Time Frame
1 day
Access Criteria
ACCESS TO DATA BY CONTACTING my email:aneta.teleglow@awf.krakow.pl

Locations