NCT04177563

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable quality-of-life

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2015

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2014

Enrollment Period

2.6 years

First QC Date

November 13, 2019

Last Update Submit

November 26, 2019

Conditions

Keywords

whole-body cryotherapyhealthy menblood components

Outcome Measures

Primary Outcomes (1)

  • blood collection in a group of participants with high and moderate physical activity

    Determination of blood components

    up to 3 months

Secondary Outcomes (1)

  • blood collection in both groups tested

    for 3 months

Other Outcomes (1)

  • Research in both groups

    through study completion, an average of 1 month

Study Arms (2)

a group of ten students with high physical activity

EXPERIMENTAL

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

a group of eight students with moderate physical activity

EXPERIMENTAL

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

Interventions

Whole-body cryotherapy

a group of eight students with moderate physical activitya group of ten students with high physical activity

Eligibility Criteria

Age18 Years - 27 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Magdalena Kepinska-Szyszkowska, PhD

    University of Physical Education in Krakow, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 26, 2019

Study Start

June 1, 2013

Primary Completion

December 20, 2015

Study Completion

December 20, 2015

Last Updated

November 29, 2019

Record last verified: 2014-11

Data Sharing

IPD Sharing
Will not share