Clinical trial NCT04177563: Whole Body Cryotherapy and Morphological and Rheological Indicators
Official title: Impact of Systemic Cryotherapy on the Rheological, Morphological, and Biochemical Blood Indicators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: whole-body cryotherapy
healthy men
blood components
Lead sponsor: University School of Physical Education, Krakow, Poland
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the planned study was to evaluate the effect of repeated cryostimulation treatments on immunological, morphological, and biochemical indicators of the peripheral blood of healthy, young Men

Detailed description: A group of 18 healthy men aged 19-26 participated in the study. The group included a group of ten students with high physical activity and a group of eight students with moderate physical activity.

Whole-body cryotherapy was performed in a cryochamber located in the Malopolska Cryotherapy Centre in Krakow (Poland) in the spring of 2013 and in the winter and spring of 2014.

The temperature inside the vestibule during the procedure was about -60 ºC and in the actual chamber about -120 ºC. The concentration of oxygen in the air of the cryochamber was kept constant at 21-22% and continuously controlled by two independent oxygen probes.

The participants of the study were subjected to 24 whole-body cryotherapy treatments (one treatment three times a week for two months). Before the procedure, they were informed about how to move and breathe in the cryochamber. Each entrance to the cryochamber was preceded by a 30-second adaptation period in the vestibule at a temperature of -60 ºC. Then the subjects entered the cryochamber for three minutes. During the treatment, the men wore short trousers, woollen socks and gloves, hats or headbands to protect against freezing and clogs. Moreover, the mouths and noses of the participants were covered with surgical masks, secured with a strip of gauze. During the procedure, the subjects were in permanent eye contact with the doctor and the staff.

Eligibility criteria: Inclusion Criteria:

* informed consent for research;
* equal age and above 18 years of age;
* no contraindications to cryostimulation procedures;
* physically active

Exclusion Criteria:

* lack of informed consent for research
* children and adolescents under 18 years of age,
* patients with inflammatory diseases, infectious, autoimmune and cancer

Primary outcomes:
measure: blood collection in a group of participants with high and moderate physical activity
timeFrame: up to 3 months
Secondary outcomes:
measure: blood collection in both groups tested
timeFrame: for 3 months
Other outcomes:
measure: Research in both groups
timeFrame: through study completion, an average of 1 month
Locations:
Study officials:
affiliation: University of Physical Education in Krakow, Poland
name: Magdalena Kepinska-Szyszkowska, PhD
role: PRINCIPAL_INVESTIGATOR
References: