HealthyNCT07664072
Single Effort in Air Temperature of Minus 10°C
A study testing cold and neutral in people with Healthy, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 23 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cold and neutral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 11 May 2024to 11 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 23 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men
Who cannot join
- women
Trial locations and contacts
1 site in 1 country.
Poland1 site
University of Physical Culture
Krakow, Lesser Poland Voivodeship, 31-571
About this study
Official title: Single Effort in Air Temperature of Minus 10°C Changes the Erythrocyte Aggregation Indicators in Young Healthy Men
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.
Read the detailed description
2.1 Study group characteristics The study involved 30 healthy males, students of the University of Physical Culture in Krakow, Poland, faculty of physiotherapy. Their mean body height was 178.9 ± 6.5 cm, mean body mass equaled 76.8 ± 11.3 kg. After the subjects were assigned to each group, the average body height in the experimental group (177.9 ± 5.9 cm) and in the control/neutral group (179.9 ± 7.2 cm) was calculated. The average body mass in the experimental group (73.1 ± 6.6 kg) was lower than that in the control group (81.2 ± 14.1 kg).
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 turn, performed the same physical effort but in the open air, in thermoneutral conditions (the air temperature was 18.1°C on the day of the study).
The experiment comprised 3 stages: (1) Before the exercise, blood samples were taken from the participants. This was performed in the morning hours on 11 May 2024 at the Blood Physiology Laboratory of the Central Research and Development Laboratory, University of Physical Culture in Krakow. (2) Both groups undertook an exertion test. (3) Blood samples were collected from all participants again after the exercise.
The study followed the tenets of the Declaration of Helsinki and was approved by the Ethics Committee of the Regional Medical Chamber in Krakow, Poland 2.2 Research method A two-factor experimental design with repeated measures was employed in the study. Ambient temperature (low vs. thermoneutral) constituted the between-subject factor; time of measurement (pre- and post-exercise) was the within-subject factor. The study followed the design of an exploratory investigation. In the group allocation of the participants, the principle of double randomization was employed. In experimental research, where a phenomenon is induced by the researcher on purpose, its course is observed in a planned and controlled way. Therefore, the influence of particular factors on the studied parameters can be assessed. Conclusions are drawn on the basis of the discovered relationships; the accuracy of the conclusions is evaluated with a specific probability. In the present study, a significance level of α = 0.05 was assumed, corresponding to a 95% confidence level.
2.3 Parallel group technique The participants were randomly allocated to the experimental group and the control group; the double randomization principle was followed. The first measurement preceded introducing the experimental factor.
The two groups were observed but only the experimental group received the additional stimulus, namely low temperature, i.e. the experimental factor. A second measurement was then performed, allowing to evaluate the changes imposed by the intervention. Owing to the application of a control group, it was possible to state if the reported changes in erythrocyte deformability resulted from the experimental factor - and not from other variables, which were uncontrolled. Although confounding variables are not regarded as essential in the main analysis, they can impact on the research results, leading to effect misinterpretation. Here, exposure to low ambient temperature constituted the experimental factor. The testing environments were different in the two groups (controlled thermal climate chamber in the experimental group and natural outdoor conditions in the control group), which was taken into consideration when interpreting the results.
2.4 Shuttle run test In the current study, cardiorespiratory capacity was determined with the use of an endurance shuttle run test. This is a standardized, incremental protocol commonly applied to provoke progressively increasing cardiorespiratory load. Direct physiological intensity indicators were not recorded but the same protocol was used in both groups in order to obtain comparable external workload progression.
The test started with a steady pace, which equaled 8 km/h. Subsequently, the running speed increased by 0.5 km/h per minute. The subjects ran a 20-m distance back and forth and then touched the finish line with one foot. The running pace was indicated by a beep. The participant finalized the test if they failed to reach the line at a distance of at least 3 m before the beep sound for two successive running sections. The number of completed sections was considered the test result.
2.5 Methods of blood analysis A qualified nurse collected fasting blood samples in 10-ml Vacuette tubes in the morning hours. The staff at the Blood Physiology Laboratory of the Central Research and Development Laboratory, University of Physical Culture in Krakow supervised the procedure, following the applicable standards. Serum indicators were determined in the laboratory of Diagnostyka S.A. in Krakow.
2.6 Morphological assessments The morphological analyses of blood included red blood cell count (RBC) [106/mm3] and hemoglobin (HGB) [g/dl] and were performed with the use of an ABX Micros 60 analyzer (Horiba ABX SAS, Montpellier, France).
2.7 Red blood cell aggregation index A Laser-Assisted Optical Rotational Red Cell Analyzer (Lorrca) (MaxSis Lorrca®, RR Mechatronics, Zwaag, The Netherlands) was applied. The aggregation parameters of aggregation index (AI), amplitude of aggregation (AMP), and half-time kinetics of total aggregation (T½) were evaluated with the Lorrca MaxSis Osmoscan (MaxSis Lorrca®, RR Mechatronics, Zwaag, The Netherlands).
2.8 Biochemical parameters Testosterone concentration [nmol/l] was evaluated with an Alinity I, Abbott immunochemical analyzer. The level of cortisol (μg/dl) was established with chemiluminescence (Abbott, Abbott Park, IL, USA). To determine lactate concentration, the enzymatic method (ARCHITECT c System, Abbott, USA) was used.
- Conditions
- Healthy
- Being tested
- cold, neutral
- Keywords
- Cold air, Beep test, Aggregation index, erythrocyte aggregation, lactate, cortisol, testosterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coldOther
the exercise, blood samples
neutralOther
the exercise, blood samples
| Study group | Role | What they receive |
|---|---|---|
| Single effort in air temperature of -10°C | Experimental | The body response to exercise performed at reduced (-10°C) temperature Receives: Other: cold |
| Single effort in neutral (18°C) condition | Experimental | The body response to exercise performed at neutral (18°C) temperature Receives: Other: neutral |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sampling: AI
aggregation index
Measured: twice: before starting the exercise and immediately after finishing it
blood sampling:AMP
amplitude of aggregation
Measured: twice: before starting the exercise and immediately after finishing it
blood sampling: T1/2
half-time kinetics of total aggregation
Measured: twice: before starting the exercise and immediately after finishing it
blood sampling: RBC
red blood cells
Measured: twice: before starting the exercise and immediately after finishing it
blood sampling: Hb
hemoglobin
Measured: twice: before starting the exercise and immediately after finishing it
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start11 May 2024
- Primary completion11 May 2024
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aneta Teleglow, University School of Physical Education, Krakow, Poland
- Investigators
- Aneta Teległow, Professor, Study director, University of Physcial Eduction, Kraków, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664072
- Sponsor's protocol ID
- 429/BS/INP/2026
- Other IDs
- 429/BS/INP/2026
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: laboratory measurement results, age, gender
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Effort in Air Temperature of Minus 10°C Changes the Erythrocyte Aggregation Indicators in Young Healthy Men
- ClinicalTrials.gov ID
- NCT07664072
- Acronym / sponsor ID
- 429/BS/INP/2026
- Conditions
- Healthy
- Keywords
- Cold air, Beep test, Aggregation index, erythrocyte aggregation, lactate, cortisol, testosterone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Study start
- 11 May 2024 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
2.1 Study group characteristics The study involved 30 healthy males, students of the University of Physical Culture in Krakow, Poland, faculty of physiotherapy. Their mean body height was 178.9 ± 6.5 cm, mean body mass equaled 76.8 ± 11.3 kg. After the subjects were assigned to each group, the average body height in the experimental group (177.9 ± 5.9 cm) and in the control/neutral group (179.9 ± 7.2 cm) was calculated. The average body mass in the experimental group (73.1 ± 6.6 kg) was lower than that in the control group (81.2 ± 14.1 kg).
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 turn, performed the same physical effort but in the open air, in thermoneutral conditions (the air temperature was 18.1°C on the day of the study).
The experiment comprised 3 stages: (1) Before the exercise, blood samples were taken from the participants. This was performed in the morning hours on 11 May 2024 at the Blood Physiology Laboratory of the Central Research and Development Laboratory, University of Physical Culture in Krakow. (2) Both groups undertook an exertion test. (3) Blood samples were collected from all participants again after the exercise.
The study followed the tenets of the Declaration of Helsinki and was approved by the Ethics Committee of the Regional Medical Chamber in Krakow, Poland 2.2 Research method A two-factor experimental design with repeated measures was employed in the study. Ambient temperature (low vs. thermoneutral) constituted the between-subject factor; time of measurement (pre- and post-exercise) was the within-subject factor. The study followed the design of an exploratory investigation. In the group allocation of the participants, the principle of double randomization was employed. In experimental research, where a phenomenon is induced by the researcher on purpose, its course is observed in a planned and controlled way. Therefore, the influence of particular factors on the studied parameters can be assessed. Conclusions are drawn on the basis of the discovered relationships; the accuracy of the conclusions is evaluated with a specific probability. In the present study, a significance level of α = 0.05 was assumed, corresponding to a 95% confidence level.
2.3 Parallel group technique The participants were randomly allocated to the experimental group and the control group; the double randomization principle was followed. The first measurement preceded introducing the experimental factor.
The two groups were observed but only the experimental group received the additional stimulus, namely low temperature, i.e. the experimental factor. A second measurement was then performed, allowing to evaluate the changes imposed by the intervention. Owing to the application of a control group, it was possible to state if the reported changes in erythrocyte deformability resulted from the experimental factor - and not from other variables, which were uncontrolled. Although confounding variables are not regarded as essential in the main analysis, they can impact on the research results, leading to effect misinterpretation. Here, exposure to low ambient temperature constituted the experimental factor. The testing environments were different in the two groups (controlled thermal climate chamber in the experimental group and natural outdoor conditions in the control group), which was taken into consideration when interpreting the results.
2.4 Shuttle run test In the current study, cardiorespiratory capacity was determined with the use of an endurance shuttle run test. This is a standardized, incremental protocol commonly applied to provoke progressively increasing cardiorespiratory load. Direct physiological intensity indicators were not recorded but the same protocol was used in both groups in order to obtain comparable external workload progression.
The test started with a steady pace, which equaled 8 km/h. Subsequently, the running speed increased by 0.5 km/h per minute. The subjects ran a 20-m distance back and forth and then touched the finish line with one foot. The running pace was indicated by a beep. The participant finalized the test if they failed to reach the line at a distance of at least 3 m before the beep sound for two successive running sections. The number of completed sections was considered the test result.
2.5 Methods of blood analysis A qualified nurse collected fasting blood samples in 10-ml Vacuette tubes in the morning hours. The staff at the Blood Physiology Laboratory of the Central Research and Development Laboratory, University of Physical Culture in Krakow supervised the procedure, following the applicable standards. Serum indicators were determined in the laboratory of Diagnostyka S.A. in Krakow.
2.6 Morphological assessments The morphological analyses of blood included red blood cell count (RBC) [106/mm3] and hemoglobin (HGB) [g/dl] and were performed with the use of an ABX Micros 60 analyzer (Horiba ABX SAS, Montpellier, France).
2.7 Red blood cell aggregation index A Laser-Assisted Optical Rotational Red Cell Analyzer (Lorrca) (MaxSis Lorrca®, RR Mechatronics, Zwaag, The Netherlands) was applied. The aggregation parameters of aggregation index (AI), amplitude of aggregation (AMP), and half-time kinetics of total aggregation (T½) were evaluated with the Lorrca MaxSis Osmoscan (MaxSis Lorrca®, RR Mechatronics, Zwaag, The Netherlands).
2.8 Biochemical parameters Testosterone concentration [nmol/l] was evaluated with an Alinity I, Abbott immunochemical analyzer. The level of cortisol (μg/dl) was established with chemiluminescence (Abbott, Abbott Park, IL, USA). To determine lactate concentration, the enzymatic method (ARCHITECT c System, Abbott, USA) was used.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Single effort in air temperature of -10°C | Experimental | Other: coldThe body response to exercise performed at reduced (-10°C) temperature |
| Single effort in neutral (18°C) condition | Experimental | Other: neutralThe body response to exercise performed at neutral (18°C) temperature |
Who may qualify
- Ages
- 22 to 23 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men
Key exclusion criteria (1 listed)
- women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coldthe exercise, blood samples | Other | Single effort in air temperature of -10°C |
| neutralthe exercise, blood samples | Other | Single effort in neutral (18°C) condition |
Primary outcome
blood sampling: AI
Time frame: twice: before starting the exercise and immediately after finishing it
aggregation index
blood sampling:AMP
Time frame: twice: before starting the exercise and immediately after finishing it
amplitude of aggregation
blood sampling: T1/2
Time frame: twice: before starting the exercise and immediately after finishing it
half-time kinetics of total aggregation
blood sampling: RBC
Time frame: twice: before starting the exercise and immediately after finishing it
red blood cells
blood sampling: Hb
Time frame: twice: before starting the exercise and immediately after finishing it
hemoglobin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. laboratory measurement results, age, gender
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aneta Teległow, Professor study director
University of Physcial Eduction, Kraków, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold and neutral in people with Healthy, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood sampling: AI (time frame: twice: before starting the exercise and immediately after finishing it). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.