Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001711202
Ethics application status
Approved
Date submitted
7/10/2018
Date registered
17/10/2018
Date last updated
21/11/2018
Date data sharing statement initially provided
21/11/2018
Date results information initially provided
21/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Whole-body cryostimulation in sportsmen a study of the effect of cryogenic temperatures on oxidative stress and inflammation after the exercise
Scientific title
The effect of submaximal exercise preceded by single whole-body cryotherapy on the markers of oxidative stress and inflammation in blood of sportsmen
Secondary ID [1] 296261 0
None
Secondary ID [2] 296339 0
None
Universal Trial Number (UTN)
U1111-1221-8919
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oxidative stress 309930 0
inflammation 309931 0
Condition category
Condition code
Inflammatory and Immune System 308704 308704 0 0
Normal development and function of the immune system
Musculoskeletal 308705 308705 0 0
Normal musculoskeletal and cartilage development and function
Injuries and Accidents 308706 308706 0 0
Other injuries and accidents
Musculoskeletal 308813 308813 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SUBJECTS
The study group consisted of 56 sportsmen: volleyball players (n = 18), basketball players (n = 16), football players (n = 22) and 32 amateur athletes. The subjects will be underwent
2-3 min WBC procedure (temp. -130 degrees Celsius) and next 40 min aerobic physical effort. After two weeks control examination will be performed, aerobic physical effort without any stimulation in the cryogenic chamber. The study will be performed during the sportsmen resting time after a trainings and sports competitions, while amateurs finished their exercises two weeks before the start of the study. Blood samples will be taken with ulnar vein four times: before the start of the experiment (before the WBC), just after the WBC procedure, after exercise accompanied by cryostimulation and after exercise without wholly exposed to extremely low temperatures.
TEST CONDITIONS
The study will be performed during the sportsmen resting time after a trainings and sports competitions, while amateurs finished their exercises two weeks before the start of the study.
The first physical effort (combined with cryostimulation) as a part of the experiment will be conducted two weeks after the end of the training session (and/or sports competitions). The second exercise (control, without cryostimulation) will be performed two weeks after the first one. During the first stage of the study, prior to the exercise the athletes will be subjected to a single whole-body cryotherapy (WBC) procedure. Then the sportsmen will start 40-min submaximal physical effort using a cycle ergometer Monark 828 E (Monark Exercise AB, Sweden). At the second stage of the study the subjects will start the same exercise, but no cryostimulation (control exercise). The frequency of heart contraction should be the physiological criterion of the burdening of the organism. During both stages of the study it should be equal to ~85% HRmax and it should be keep the same during the whole physical effort by all the athletes. The heart rate is monitored by means of a Polar H7 Heart Rate Sensor (Polar Electro Oy, Finland) connected to the PC.
THE COURSE OF THE WHOLE BODY CRYOSTIMULATION (WBC) PROCEDURE
The whole body cryotherapy will be conducted by means of a single entry into the Arctica cryochamber with the effect of cold retention (Metrum CryoFlex, Poland). The cryogenic chamber is cooled using synthetic vapors, liquid air, which is a homogenous mixture of nitrogen and oxygen (with 22% ± 2% of oxygen). This increases the safety of the procedure. In order to make use of the cold retention phenomenon the cryogenic chamber is placed about 2.5 m under the floor level. Each study participant entered the actual therapy chamber by means of stairs which constituted a mild adaptive area. An open vestibule, in which the temperature is kept at -60ºC during all of the procedures, is located at the base of the stairs. The vestibule and the main chamber are separated by double swing-doors. During the procedure the temperature was maintained at -130ºC. Before entering the cryochamber the subjects put on a special safety suit to protect certain parts of the body against frostbite. Dust masks were used to protect the air passages. Every subject will be informed about the rules of conduct during the procedure: the need for slow, shallow breathing (short nasal inhalation, longer oral exhalation) and the way to move about (slow walking in circles). The total time a subject stayed in the cryochamber will be not longer than 2 minutes. Every entry into the main chamber will be preceded by 10-20 seconds of adaptation in the open vestibule (temp. -60ºC). In cryogenic chamber can stay at the same time 5 subjects.
The subjects will be qualified for the WBC on the basis of a positive assessment of their health during a medical checkup. The research will be supervised by a physician (doctor) and physiotherapist with 5 years of professional experience.
The experiment will be carried out in the center of sport and recreation.
Intervention code [1] 312592 0
Prevention
Comparator / control treatment
The subjects will be underwent WBC procedure (temp. -130 degrees Celsius) and next 40 min aerobic physical effort. After two weeks control examination will be performed, aerobic physical effort without any stimulation in the cryogenic chamber.
Control group
Active

Outcomes
Primary outcome [1] 307680 0
Measurement of thiobarbituric acid reactive substances (TBARS) level in erythrocytes.
Timepoint [1] 307680 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Primary outcome [2] 307682 0
Measurement of superoxide dismutase (SOD) activity in erythrocytes
Timepoint [2] 307682 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Primary outcome [3] 307683 0
Measurement total concentration of lipid peroxides (LOOH) concentration in serum
Timepoint [3] 307683 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation
Secondary outcome [1] 352560 0
Measurement of A vitamin concentration in plasma (the outcome is primary)
Timepoint [1] 352560 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Secondary outcome [2] 352561 0
Measurement of kinase creatine (CK) activity in plasma (the outcome is primary)
Timepoint [2] 352561 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Secondary outcome [3] 352894 0
Measurement of conjugated dienes (CD) level in erythrocytes and in plasma.
Timepoint [3] 352894 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Secondary outcome [4] 352895 0
Measurement of glutathione peroxidase (GPx) activity in erythrocytes (the outcome is primary)
Timepoint [4] 352895 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Secondary outcome [5] 352896 0
Measurement of catalase (CAT) activity in erythrocytes (the outcome is primary)
Timepoint [5] 352896 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Secondary outcome [6] 352899 0
Measurement cytokine - interleukin 1, beta (IL-1ß) concentration in serum (the outcome is primary)
Timepoint [6] 352899 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Secondary outcome [7] 352900 0
Measurement cytokine - interleukin 6 (IL-6) concentration in serum (the outcome is primary)
Timepoint [7] 352900 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Secondary outcome [8] 352901 0
Measurement cytokine - Tumor Necrosis Factor alpha (TNF-a) concentration in serum (the outcome is primary).
Timepoint [8] 352901 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Secondary outcome [9] 352902 0
Measurement cytokine - Transforming Growth Factor beta 1 (TGF-ß1) concentration in serum (the outcome is primary).
Timepoint [9] 352902 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Secondary outcome [10] 352904 0
Measurement of E vitamin concentration in plasma (the outcome is primary)
Timepoint [10] 352904 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.
Secondary outcome [11] 352959 0
Measurement of thiobarbituric acid reactive substances (TBARS) level in plasma (the outcome is primary)
Timepoint [11] 352959 0
At the first stage of the study the blood samples were obtained three times: before the start of the study (before entering the cryochamber), right after the cryotherapy (before the exercise) and immediately after submaximal exercise on the cycloergometer. During the control stage the blood samples were taken once - after the control exercise which took place 2 weeks after the cryochamber stimulation.

Eligibility
Key inclusion criteria
Practising sport professionally or amateurishly.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Occurrence of any diseases.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
23/12/2009
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
64
Accrual to date
Final
64
Recruitment outside Australia
Country [1] 20899 0
Poland
State/province [1] 20899 0

Funding & Sponsors
Funding source category [1] 300855 0
University
Name [1] 300855 0
Nicolaus Copernicus University, Collegium Medicum
Country [1] 300855 0
Poland
Primary sponsor type
University
Name
Nicolaus Copernicus University
Address
Jurija Gagarina 11 Str,, 87-100 Torun
Country
Poland
Secondary sponsor category [1] 300408 0
None
Name [1] 300408 0
Address [1] 300408 0
Country [1] 300408 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301630 0
Bioethical Committee at the Collegium Medicum of Nicolaus Copernicus University (Bydgoszcz, Poland)
Ethics committee address [1] 301630 0
M. Curie Sklodowskiej 9 Str., Bydgoszcz, Poland
Ethics committee country [1] 301630 0
Poland
Date submitted for ethics approval [1] 301630 0
20/02/2009
Approval date [1] 301630 0
25/03/2009
Ethics approval number [1] 301630 0
KB 24/2009

Summary
Brief summary
To evaluate the effect of whole-body cryostimulation (WBC) preceding submaximal exercise on the inflammatory process and oxidative stress biomarkers in the blood of sportsmen. The subjects were exposed to low temperatures (-130 degrees Celsius) and then a 40-minute exercise (80% HRmax). Blood samples were taken: before the start of the experiment, just after the WBC session, after the exercise accompanied by cryostimulation and after the exercise without WBC. The activity of antioxidant enzymes, the concentration of thiobarbituric acid-reactive substances, the level of conjugated dienes and A and E vitamins, as well as creatine kinase, cytokines (IL-1ß, IL-6, TNF-a, TGF-ß1) and total lipid peroxides concentration were determined in the blood.
Trial website
Trial related presentations / publications
C. Mila-Kierzenkowska, A. Jurecka, A. Wozniak, The effect of submaximal exercise preceded by single whole-body cryotherapy on the markers of oxidative stress and inflammation in blood of volleyball players, Oxid. Med. Cell. Longev. ID:409567 (2013).
Public notes

Contacts
Principal investigator
Name 87594 0
Dr Alicja Jurecka
Address 87594 0
Jagiellonian University Medical College, 21 Nicolaus Copernicus Street, 31-501 Krakow, Poland
Country 87594 0
Poland
Phone 87594 0
+48 12 424 82 04
Fax 87594 0
+48 12 421 34 56
Email 87594 0
[email protected]
Contact person for public queries
Name 87595 0
Dr Alicja Jurecka
Address 87595 0
Department of Orthopaedics and Physiotherapy, Faculty of Health Care, Jagiellonian University Medical College, 21 Nicolaus Copernicus Street, 31-501 Krakow, Poland
Country 87595 0
Poland
Phone 87595 0
+48 12 424 82 04
Fax 87595 0
+48 12 421 34 56
Email 87595 0
[email protected]
Contact person for scientific queries
Name 87596 0
Dr Alicja Jurecka
Address 87596 0
Department of Orthopaedics and Physiotherapy, Faculty of Health Care, Jagiellonian University Medical College, 21 Nicolaus Copernicus Street, 31-501 Krakow, Poland
Country 87596 0
Poland
Phone 87596 0
+48 12 424 82 04
Fax 87596 0
+48 12 421 34 56
Email 87596 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
No consent of the study participants (professional athletes).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
230Ethical approval    376134-(Uploaded-14-11-2018-05-35-41)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes http://dx.doi.org/10.1155/2013/409567 The date of... [More Details] 376134-(Uploaded-14-11-2018-05-45-58)-Journal results publication.pdf

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
43Study results articleYes http://dx.doi.org/10.1155/2013/409567 The date of... [More Details] 376134-(Uploaded-14-11-2018-05-45-58)-Journal results publication.pdf
2949Plain language summaryNo The subjects (n=87) were exposed to low temperatur... [More Details]

Documents added automatically
No additional documents have been identified.