NCT06223087

Brief Summary

Exposure of the human body to cold water triggers numerous beneficial physiological changes. The study aimed to assess the impact of regular winter swimming on blood morphological, rheological, and biochemical indicators and activity of antioxidant enzymes in males. The study includes winter swimmers and a control group. Blood samples were taken twice - before the start (November) of the winter swimming season and after its end (March). The average duration of ice water baths was 3-5 minutes, with a minimum frequency of once a week. The water temperature during the swimming did not exceed 10°C, approaching 0°C during the winter period.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

December 30, 2023

Last Update Submit

January 15, 2024

Conditions

Keywords

bloodrheologycoldblood morphologybiochemistryexercise

Outcome Measures

Primary Outcomes (15)

  • blood sampling: platelets and leukocytes

    Measurements of: Platelets \[thousands/μl\], Leukocytes \[thousands/μl\], Neutrophils \[thousands/μl\], Eosinophils \[thousands/μl\], Basophils \[thousands/μl\], Lymphocytes \[thousands/μl\], Monocytes \[thousands/μl\].

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling: erythrocytes

    Measurement of: Erythrocytes \[mln/μl\],

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling: haemoglobin

    Determination of: Haemoglobin \[g/dl\], mean corpuscular haemoglobin concentration (MCHC) \[g/dl\],

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling: haematocrit

    Determination of: haematocrit \[%\], red blood cell distribution width coefficient of variation (RDW-CV) \[%\],

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling: haemoglobin mass

    Determination of: mean corpuscular haemoglobin (MCH) \[pg\],

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling: Erythrocytes

    Determination of mean corpuscular volume (MCV) \[fl\], red blood cell distribution width standard deviation (RDW-SD) \[fl\],

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling: rheology part 1

    Determination of red cell elongation index (EI) \[arbitrary unit: AU\], erythrocyte aggregation amplitude (AMP) \[AU\],

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling: rheology part 2

    Determination of: aggregation index (AI) \[%\],

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling:rheology part 3

    Determination of: half-time of total aggregation (t1/2) \[s\].

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling: oxidative stress

    Measurement of catalase (CAT) \[nmol/min/ml\], and glutathione peroxidase (GPx) \[nmol/min/ml\].

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling: oxidative stress - superoxide dismutase

    Measurement of superoxide dismutase (SOD) \[U/ml\],

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood biochemistry: Urea

    Measurement of: Urea \[mmol/l\].

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling: Testosterone

    Determination of Testosterone concentration \[ng/dl\],

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood sampling: Cortisol

    Determination of Cortisol concentration \[µg/dl\],

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

  • blood biochemistry: Creatine

    Determination of Creatinine concentration \[µmol/l\],

    twice: before the start of cold swimming in November and 5 months later (March), after the end of winter swimming

Study Arms (2)

control

group not practicing winter swimming

winter swimmers

group practicing winter swimming

Other: winter swimming

Interventions

Intervention involves bathing/swimming in cold water during the winter months in open waters

winter swimmers

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Experienced in winter swimming, regularly swimming in cold water (open water) at least once a week in the period November - March

You may qualify if:

  • Good health, practitioners of winter swimming
  • control group: never did winter swimming and had a sedentary lifestyle.

You may not qualify if:

  • medical contraindications to winter bathing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Physical Education

Krakow, 31571, Poland

Location

Related Publications (1)

  • Teleglow A, Konieczny K, Dobija I, Kusmierczyk J, Tota L, Rembiasz K, Maciejczyk M. Effect of regular winter swimming on blood morphological, rheological, and biochemical indicators and activity of antioxidant enzymes in males. BMC Sports Sci Med Rehabil. 2024 Jun 21;16(1):138. doi: 10.1186/s13102-024-00932-3.

MeSH Terms

Conditions

Common ColdMotor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Aneta Teleglow

    University of Physical Education, Kraków, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Blood Physiology Laboratory

Study Record Dates

First Submitted

December 30, 2023

First Posted

January 25, 2024

Study Start

January 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations