- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04177563
Whole Body Cryotherapy and Morphological and Rheological Indicators
Impact of Systemic Cryotherapy on the Rheological, Morphological, and Biochemical Blood Indicators
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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. |
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. |
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
Time Frame: up to 3 months
|
Determination of blood components
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
blood collection in both groups tested
Time Frame: for 3 months
|
Determination of blood rheology
|
for 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Research in both groups
Time Frame: through study completion, an average of 1 month
|
determination of blood biochemical components
|
through study completion, an average of 1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Magdalena Kepinska-Szyszkowska, PhD, University of Physical Education in Krakow, Poland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- USPKrakow
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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