Whole Body Cryotherapy and Morphological and Rheological Indicators

Impact of Systemic Cryotherapy on the Rheological, Morphological, and Biochemical Blood Indicators

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

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Other: whole body cryostimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 27 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: a group of ten students with high physical activity; 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. Blood was collected from each participant (with an empty stomach) at a laboratory located at the Academy of Physical Education in Krakow, where after a ten-minute rest in a sitting position at room temperature (about 19 °C), blood was collected from the vein in the crook of the elbow by a laboratory diagnostician in accordance with applicable standards. Blood was collected 13 times.	Other: whole body cryostimulation; Whole-body cryotherapy
Experimental: a group of eight students with moderate physical activity; 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. Blood was collected from each participant (with an empty stomach) at a laboratory located at the Academy of Physical Education in Krakow, where after a ten-minute rest in a sitting position at room temperature (about 19 °C), blood was collected from the vein in the crook of the elbow by a laboratory diagnostician in accordance with applicable standards. Blood was collected 13 times.	Other: whole body cryostimulation; Whole-body cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood collection in a group of participants with high and moderate physical activity	Determination of blood components	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood collection in both groups tested	Determination of blood rheology	for 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Research in both groups	determination of blood biochemical components	through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: University School of Physical Education, Krakow, Poland
• Investigators: Principal Investigator: Magdalena Kepinska-Szyszkowska, PhD, University of Physical Education in Krakow, Poland

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): December 20, 2015
• Study Completion (Actual): December 20, 2015

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 23, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: whole-body cryotherapy; healthy men; blood components
• Other Study ID Numbers: USPKrakow

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No