RestNCT06549933
The Effect of Cryostimulation on Inflammation and Motor Functions. The Study Was Conducted to Determine the Effect of Five Days of Whole-body Cryostimulation (PBC) on Reducing Inflammation and Improving Motor Skills in Soccer Players
A study testing Criostymulation in people with Rest and Training, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 36 years, men onlyHealthy volunteers can take part
- What is being tested?
- Criostymulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 sitePoland
- Study dates
- 25 Nov 2023to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- athletes
- no previous experience with systemic cryotherapy
- any other forms of recovery or cosmetic treatments
Who cannot join
- alcohol or any other stimulants
- anti-inflammation drugs
- injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Cryostimulation on Reducing Inflammation and Improving Motor Skills in Football Player
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.
Read the detailed description
Cryostimulation is one of the methods of post-exercise recovery, involving short-term (3 min) exposure of the body to extremely low temperatures, oscillating between -100°C and -190°C. The purpose of this therapy is to reduce inflammation, reduce physical and mental fatigue and use it as a passive form of preparing the body for further exercise as part of the training process.
The study was conducted to determine the effect of five days of whole-body cryostimulation (PBC) on reducing inflammation and improving motor skills in soccer players. A group of 24 football players was randomly divided into a test group (PBC; -140°C ± 20°C, 3 min, 5 days) and a control group (CON). Before the cryostimulation session, both groups were subjected to visual-motor ability tests, which were repeated on the last day of the study. Blood samples were collected at four time points (P0-1 day, P1-3 day, P2-5 day, P3-2 days after the test). Levels of creatine kinase (CK), tumor necrosis factor (TNFα), interleukins (IL-6, IL-10), testosterone (T) and cortisol (C) were determined in the samples.
- Being tested
- Criostymulation
- Keywords
- cryostimulation, regeneration, football players, inflammation, motor functions
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CriostymulationOther
Method: Cryosauna. Temperature: -160°C. Duration: 5 days. Session Timing: 9:00 a.m.
Session Length: 3 minutes per day
| Study group | Role | What they receive |
|---|---|---|
| Cryostimulation | Experimental | Cryostimulation performed in a cryosauna for five consecutive days. Receives: Other: Criostymulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 (Interleukin-6)
Immunoenzymatic assay method using a diagnostic ELISA Kit
Measured: Before, after 3 days and 5 days of cryostimulation
TNF-alpha (Tumor necrosis factor-alpha)
Immunoenzymatic assay method using a diagnostic ELISA Kit
Measured: Before, after 3 days and 5 days of cryostimulation
IL-10 (Interleukin-10)
Immunoenzymatic assay method using a diagnostic ELISA Kit
Measured: Before, after 3, and 5 days of cryostimulation
CK (creatine kinase)
Immunoenzymatic assay method using a diagnostic ELISA Kit
Measured: Before, after 3, and 5 days of cryostimulation
Cortisol
Immunoenzymatic assay method using a diagnostic ELISA Kit
Measured: Before, after 3, and 5 days of cryostimulation
Testosterone
Immunoenzymatic assay method using a diagnostic ELISA Kit
Measured: Before, after 3, and 5 days of cryostimulation
Secondary outcomes (1)
Anthropometric measurments
Analysis of body composition, Tanita BC-418
Measured: Before, after 3, and 5 days of cryostimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start25 Nov 2023
- Primary completion24 Feb 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Izabela Różycka, Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549933
- Sponsor's protocol ID
- Kriokomora 845/22
- Other IDs
- 12622001541796
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Cryostimulation on Reducing Inflammation and Improving Motor Skills in Football Player
- ClinicalTrials.gov ID
- NCT06549933
- Acronym / sponsor ID
- Kriokomora 845/22
- Keywords
- cryostimulation, regeneration, football players, inflammation, motor functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 24 Feb 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cryostimulation is one of the methods of post-exercise recovery, involving short-term (3 min) exposure of the body to extremely low temperatures, oscillating between -100°C and -190°C. The purpose of this therapy is to reduce inflammation, reduce physical and mental fatigue and use it as a passive form of preparing the body for further exercise as part of the training process.
The study was conducted to determine the effect of five days of whole-body cryostimulation (PBC) on reducing inflammation and improving motor skills in soccer players. A group of 24 football players was randomly divided into a test group (PBC; -140°C ± 20°C, 3 min, 5 days) and a control group (CON). Before the cryostimulation session, both groups were subjected to visual-motor ability tests, which were repeated on the last day of the study. Blood samples were collected at four time points (P0-1 day, P1-3 day, P2-5 day, P3-2 days after the test). Levels of creatine kinase (CK), tumor necrosis factor (TNFα), interleukins (IL-6, IL-10), testosterone (T) and cortisol (C) were determined in the samples.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cryostimulation | Experimental | Other: CriostymulationCryostimulation performed in a cryosauna for five consecutive days. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- athletes
- no previous experience with systemic cryotherapy
- any other forms of recovery or cosmetic treatments
Key exclusion criteria (3 listed)
- alcohol or any other stimulants
- anti-inflammation drugs
- injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CriostymulationMethod: Cryosauna. Temperature: -160°C. Duration: 5 days. Session Timing: 9:00 a.m. Session Length: 3 minutes per day | Other | Cryostimulation |
Primary outcome
IL-6 (Interleukin-6)
Time frame: Before, after 3 days and 5 days of cryostimulation
Immunoenzymatic assay method using a diagnostic ELISA Kit
TNF-alpha (Tumor necrosis factor-alpha)
Time frame: Before, after 3 days and 5 days of cryostimulation
Immunoenzymatic assay method using a diagnostic ELISA Kit
IL-10 (Interleukin-10)
Time frame: Before, after 3, and 5 days of cryostimulation
Immunoenzymatic assay method using a diagnostic ELISA Kit
CK (creatine kinase)
Time frame: Before, after 3, and 5 days of cryostimulation
Immunoenzymatic assay method using a diagnostic ELISA Kit
Cortisol
Time frame: Before, after 3, and 5 days of cryostimulation
Immunoenzymatic assay method using a diagnostic ELISA Kit
Testosterone
Time frame: Before, after 3, and 5 days of cryostimulation
Immunoenzymatic assay method using a diagnostic ELISA Kit
1 secondary outcome
Anthropometric measurments
Time frame: Before, after 3, and 5 days of cryostimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Izabela Różycka principal investigator
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Criostymulation in people with Rest and Training, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 (Interleukin-6) (time frame: Before, after 3 days and 5 days of cryostimulation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.