Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001541796
Ethics application status
Approved
Date submitted
20/11/2022
Date registered
13/12/2022
Date last updated
13/12/2022
Date data sharing statement initially provided
13/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Is whole body cryotherapy beneficial for football players?
Scientific title
The influence of whole body cryotherapy as a form of biological regeneration in football players.
Secondary ID [1] 308451 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
biological regeneration in sport 328252 0
Condition category
Condition code
Physical Medicine / Rehabilitation 325297 325297 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will undergo 5 whole body cryotherapy sessions (cryosauna) scheduled for a fixed time of day, performed daily for 5 days. The time of a single session will be 2-3 minutes, at a temperature of - 150°C. After each therapeutic session in the cryosauna, the subject will undergo a 15-minute warm-up on cardio equipment: stationary bike 5 minutes, rowing machine 5 minutes, treadmill 5 minutes. Adherence to the intervention will be monitored by a member of the study team.
Intervention code [1] 324896 0
Rehabilitation
Comparator / control treatment
The comparison group will also undergo a cryosauna treatment, without cold stimuli (the cryosauna will not be activated). Placebo therapy will be performed every day for 5 days, time analogous to the experimental group 2-3 minutes, at ambient temperature. After each therapeutic session in the cryosauna, the subject will undergo a 15-minute warm-up on cardio equipment: stationary bike 5 minutes, rowing machine 5 minutes, treadmill 5 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 333159 0
level of inflammation markers in blood (total creatine kinase (CK), cortisol, testosterone, tumor necrosis factor (TNFa), interleukins IL-6, IL-10)
Timepoint [1] 333159 0
before intervention, after 3. and 5. session of cryosauna, after 3 days from the end of the 5 sessions of cryosauna.
Primary outcome [2] 333160 0
movement coordination (Witty SEM by Microgate)
Timepoint [2] 333160 0
before the intervention, after the end of 5 sessions of cryosauna treatments
Primary outcome [3] 333161 0
Maximum lower limb power (swing jump, jump without swing, tapping by OptoGait)
Timepoint [3] 333161 0
before the intervention, after the end of 5 sessions of cryosauna treatments
Secondary outcome [1] 416001 0
Single movement speed assessment
Timepoint [1] 416001 0
before the intervention, after the end of 5 sessions of cryosauna treatments
Secondary outcome [2] 416002 0
well-being (Profile of Mood State, POMS)
Timepoint [2] 416002 0
before intervention, after 3. and 5. session of cryosauna, after 3 days from the end of the 5 sessions of cryosauna.
Secondary outcome [3] 416003 0
physical and mental impact of training stress (Recovery-Stress Questionnaire for Athletes)
Timepoint [3] 416003 0
before intervention, after 3. and 5. session of cryosauna, after 3 days from the end of the 5 sessions of cryosauna.
Secondary outcome [4] 416004 0
pain (McGill Pain Questionnaire)
Timepoint [4] 416004 0
before intervention, after 3. and 5. session of cryosauna, after 3 days from the end of the 5 sessions of cryosauna.
Secondary outcome [5] 416005 0
body composition (BIA scan)
Timepoint [5] 416005 0
before intervention, after its completion
Secondary outcome [6] 416006 0
blood pressure (sphygmomanometer)
Timepoint [6] 416006 0
before and after each cryosauna treatment, after a 15-minute warm-up
Secondary outcome [7] 416007 0
oxygen saturation in blood (pulse oximeter)
Timepoint [7] 416007 0
before and after each cryosauna treatment, after a 15-minute warm-up

Eligibility
Key inclusion criteria
healthy volunteer
man
a football player
third league
Minimum age
17 Years
Maximum age
37 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
lack of current medical examinations performed by a sports doctor

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2023
Actual
Date of last participant enrolment
Anticipated
16/01/2023
Actual
Date of last data collection
Anticipated
24/01/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 25149 0
Poland
State/province [1] 25149 0
Gorzow Wielkopolski

Funding & Sponsors
Funding source category [1] 312695 0
Self funded/Unfunded
Name [1] 312695 0
Izabela Rozycka
Country [1] 312695 0
Poland
Primary sponsor type
University
Name
Poznan University of Physical Education
Address
ul. Krolowej Jadwigi 27/39
61-871 Poznan
Country
Poland
Secondary sponsor category [1] 314309 0
None
Name [1] 314309 0
Address [1] 314309 0
Country [1] 314309 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311995 0
Komisja Bioetyczna przy Uniwersytecie Medycznym im. Karola Marcinkowskiego w Poznaniu
Ethics committee address [1] 311995 0
Ethics committee country [1] 311995 0
Poland
Date submitted for ethics approval [1] 311995 0
Approval date [1] 311995 0
03/11/2022
Ethics approval number [1] 311995 0
845/22

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123106 0
Ms Izabela Rozycka
Address 123106 0
Poznan University of Physical Education
ul. Estkowskiego 13
66-400 Gorzow Wielkopolski
Country 123106 0
Poland
Phone 123106 0
+48602328768
Fax 123106 0
Email 123106 0
[email protected]
Contact person for public queries
Name 123107 0
Anita Kulik
Address 123107 0
Poznan University of Physical Education
ul. Estkowskiego 13
66-400 Gorzow Wielkopolski
Country 123107 0
Poland
Phone 123107 0
+48695577949
Fax 123107 0
Email 123107 0
[email protected]
Contact person for scientific queries
Name 123108 0
Anita Kulik
Address 123108 0
Poznan University of Physical Education
ul. Estkowskiego 13
66-400 Gorzow Wielkopolski
Country 123108 0
Poland
Phone 123108 0
+48695577949
Fax 123108 0
Email 123108 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17664Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.