NCT06549933

Brief Summary

The aim of the study was to determine the effect of a 5-day PBC on reducing inflammation and improving motor skills in soccer players during the initial phase of the training period. The five-day cryostimulation applied did not significantly affect the profile of inflammatory markers in soccer players. However, a reduction in visuo-motor reaction time (RT) was registered in PBC-treated soccer players, suggesting the potential benefits of this method in improving motor skills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

November 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
Last Updated

January 16, 2025

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 24, 2024

Last Update Submit

January 15, 2025

Conditions

Keywords

cryostimulationregenerationfootball playersinflammationmotor functions

Outcome Measures

Primary Outcomes (6)

  • IL-6 (Interleukin-6)

    Immunoenzymatic assay method using a diagnostic ELISA Kit

    Before, after 3 days and 5 days of cryostimulation

  • TNF-alpha (Tumor necrosis factor-alpha)

    Immunoenzymatic assay method using a diagnostic ELISA Kit

    Before, after 3 days and 5 days of cryostimulation

  • IL-10 (Interleukin-10)

    Immunoenzymatic assay method using a diagnostic ELISA Kit

    Before, after 3, and 5 days of cryostimulation

  • CK (creatine kinase)

    Immunoenzymatic assay method using a diagnostic ELISA Kit

    Before, after 3, and 5 days of cryostimulation

  • Cortisol

    Immunoenzymatic assay method using a diagnostic ELISA Kit

    Before, after 3, and 5 days of cryostimulation

  • Testosterone

    Immunoenzymatic assay method using a diagnostic ELISA Kit

    Before, after 3, and 5 days of cryostimulation

Secondary Outcomes (1)

  • Anthropometric measurments

    Before, after 3, and 5 days of cryostimulation

Study Arms (1)

Cryostimulation

EXPERIMENTAL

Cryostimulation performed in a cryosauna for five consecutive days.

Other: Criostymulation

Interventions

Method: Cryosauna. Temperature: -160°C. Duration: 5 days. Session Timing: 9:00 a.m. Session Length: 3 minutes per day

Cryostimulation

Eligibility Criteria

Age18 Years - 36 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • athletes
  • no previous experience with systemic cryotherapy
  • any other forms of recovery or cosmetic treatments

You may not qualify if:

  • alcohol or any other stimulants
  • anti-inflammation drugs
  • injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznań University of Physical Education

Poznan, 61-871, Poland

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Izabela Różycka

    Poznan University of Physical Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Athletes undergoing regular training were divided into two groups. One of them was subjected to cryotherapy treatments, the other was a control group, not subjected to any treatments at that time.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2024

First Posted

August 12, 2024

Study Start

November 25, 2023

Primary Completion

February 24, 2024

Study Completion

April 15, 2024

Last Updated

January 16, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations