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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06223087
Other study ID # 296/BS/INP/2021
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source University School of Physical Education, Krakow, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 60 Years
Eligibility Inclusion Criteria: - Good health, practitioners of winter swimming - control group: never did winter swimming and had a sedentary lifestyle. Exclusion Criteria: - medical contraindications to winter bathing

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Poland University of Physical Education Kraków

Sponsors (1)

Lead Sponsor Collaborator
University School of Physical Education, Krakow, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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