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
Centrum Stomatologii
ul. Bukowska 70, pok A204
60-812 Poznan
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
Whole-body cryotherapy is a treatment in which the human body is affected by low temperature. The treatment consists in a 2-3-minute stay in a cryosauna, in which liquid nitrogen vapor is blown in, with a temperature of about -150 ° C and lower. Low temperature has many effects on the human body. The aim of the study is to assess blood markers of inflammation, psychophysical properties with selected coordination abilities, speed of execution of a single movement, maximum power of lower limbs in football players after the end of the league season. Subjects will undergo 5 therapeutic sessions 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. The comparison group will also undergo a cryosauna treatment, without cold stimuli (the cryosauna will not be activated). Plecebo 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. Measurement of blood pressure and saturation will be carried out before and after each treatment in the cryosauna, after a 15-minute warm-up.
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
i.rozycka@awf-gorzow.edu.pl
Contact person for public queries
Name 123107 0
Dr 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
a.kulik@awf-gorzow.edu.pl
Contact person for scientific queries
Name 123108 0
Dr 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
a.kulik@awf-gorzow.edu.pl

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  a.kulik@awf-gorzow.edu.pl



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.