Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000330145
Ethics application status
Approved
Date submitted
19/02/2019
Date registered
4/03/2019
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Date results provided
4/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of partial-body cryostimulation after training on sleep quality in professional soccer players
Scientific title
Effect of partial-body cryostimulation after training on sleep quality in professional soccer players
Secondary ID [1] 297444 0
Nil khnown
Universal Trial Number (UTN)
U1111-1228-8516
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
-Hypertension 311796 0
-arterial disease 311797 0
-Myocardial infarction less than 6 months 311798 0
-Respiratory condition (asthma, bronchopneumopathy) 311799 0
-Circulatory insufficiency (Raynaud's syndrome) 311800 0
-Angina pectoris 311801 0

-Pace maker or subcutaneous device 311802 0
-Deep vein thrombosis / phlebitis 311803 0
-Nephritic colic, hepatic colic 311804 0
-Hyperuricemia (gout attack) 311805 0
-Cold allergy 311806 0
-Cutaneous infection (acute bacterial or viral) 311807 0

-Acute infection 311808 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310255 310255 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
each player experienced different exposure durations at -180°C in a partial-body chamber (Cryotechno®, Castelnau le Lez, France) in a random order (no cryostimulation, 180-s exposure, twice 90-s exposure separated by a 5-min rest at room temperature, and 90-s exposure). These exposures are separated by a Week. A partial-body chamber consists of an open tank in which the subject is exposed to cold, excluding the head and neck. The cold temperature is obtained by spraying nitrogen (expanded nitrogen) inside the tank. Such devices have already been described. In the cabin, the subjects wore bathing suits, a pair of gloves, socks, and slippers. The subjects were instructed to turn around continuously in the cabin during the exposure period. The cryostimulation sessions were undertaken under medical supervision. The exercise physiologist administrated the intervention and the mode of administration was one-on-one.
Intervention code [1] 313702 0
Treatment: Other
Comparator / control treatment
The control group did not receive treatment (they are not exposed to cryotherapy)
Control group
Active

Outcomes
Primary outcome [1] 319141 0
The number of movements during the night was used by a dimensional accelerometer
Timepoint [1] 319141 0
the whole night Following the cryotherapy exposure
Primary outcome [2] 319231 0
Subjective sleep quality was evaluated by the Spiegel questionnare
Timepoint [2] 319231 0
the next day at Morning
Secondary outcome [1] 367075 0
Heart rate variability was assessed by a heart rate monitor


Timepoint [1] 367075 0
before and immediately after cryotherapy
Secondary outcome [2] 367389 0
Skin temperature was assessed by an infrared thermometer
Timepoint [2] 367389 0
Before and immediately after cryotherapy exposure

Eligibility
Key inclusion criteria
Healthy ( has no chronic diseases and no diseases among those presented as a contraindication to cryotherapy) and physically active volunteers (practice more than three hours of physical activity per week).
- Professional soccer players.
Minimum age
20 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindications to cryotherapy:
Hypertension, arterial disease
Myocardial infarction less than 6 months stroke pulmonary embolism
Respiratory condition (asthma, bronchopneumopathy)
Circulatory insufficiency (Raynaud's syndrome)
Angina pectoris
Pace maker or subcutaneous device
Deep vein thrombosis / phlebitis
Nephritic colic, hepatic colic
Hyperuricemia (gout attack)
Cold allergy
Cutaneous infection (acute bacterial or viral)
Acute infection
Recent intake of alcohol or drugs

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)
randomised by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The required sample size was calculated from our control data concerning the number movements (counts/min) during the sleeping time using G*Power version 3.1, according to Beck ( Beck T. The importance of a priori sample size estimation in strength and conditioning research. J Strength Cond Res. 2013;27:2323-37) Using an a priori repeated-measures design with a desired power (1-beta) set at 0.80, and an alpha risk of 0.05, six subjects represent a sufficient number of subjects to detect a significant difference.The results are expressed as mean and standard deviation (SD) values or standard error when specified. The Gaussian distribution was tested for each variable using the Shapiro–Wilk test. Changes in the different variables were evaluated using repeated-measures ANOVA followed by Tukey post hoc test when appropriate. The effect size of the changes was assessed by the Hedges’ g (g) as presented by Dupuy et al (Dupuy O, Lussier M, Fraser S, Bherer L, Audiffren M, Bosquet L. Effect of overreaching on cognitive performance and related cardiac autonomic control. Scand J Med Sci Sports. 2014;24:234) and was considered to be either small (g less than 0.2 or equal to 0.5), moderate (g less than 0.5 or equal to 0.8), or large (g greater than 0.8) according to the Cohen scale (Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ ed.: Erlbaum; 1988.). A p<0.05 was considered to be statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/03/2018
Date of last participant enrolment
Anticipated
Actual
5/04/2018
Date of last data collection
Anticipated
Actual
27/04/2018
Sample size
Target
10
Accrual to date
Final
9
Recruitment outside Australia
Country [1] 21289 0
France
State/province [1] 21289 0
Poitiers

Funding & Sponsors
Funding source category [1] 302016 0
Self funded/Unfunded
Name [1] 302016 0
Country [1] 302016 0
Primary sponsor type
University
Name
University of Poitiers, faculty of sport sciences
Address
8 ALL Jean Monnet, 86000 Poitiers
Country
France
Secondary sponsor category [1] 301803 0
None
Name [1] 301803 0
None
Address [1] 301803 0
none
Country [1] 301803 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302693 0
Ethics Committee for Research in Science and Technology of Physical and Sports Activities (CERSTAPS)
Ethics committee address [1] 302693 0
Ethics committee country [1] 302693 0
France
Date submitted for ethics approval [1] 302693 0
01/01/2018
Approval date [1] 302693 0
15/02/2018
Ethics approval number [1] 302693 0
2018-12-07-25

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

Contacts
Principal investigator
Name 91078 0
Dr Douzi Wafa
Address 91078 0
Faculté sciences du sport
Bâtiment C6
8, allée Jean Monnet TSA 31113
86073 Poitiers cedex 9
Country 91078 0
France
Phone 91078 0
+33667291556
Fax 91078 0
Email 91078 0
[email protected]
Contact person for public queries
Name 91079 0
Douzi Wafa
Address 91079 0
Faculté sciences du sport
Bâtiment C6
8, allée Jean Monnet TSA 31113
86073 Poitiers cedex 9
Country 91079 0
France
Phone 91079 0
+33667291556
Fax 91079 0
Email 91079 0
[email protected]
Contact person for scientific queries
Name 91080 0
Douzi Wafa
Address 91080 0
Faculté sciences du sport
Bâtiment C6
8, allée Jean Monnet TSA 31113
86073 Poitiers cedex 9
Country 91080 0
France
Phone 91080 0
+33667291556
Fax 91080 0
Email 91080 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?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePartial-body cryostimulation after training improves sleep quality in professional soccer players.2019https://dx.doi.org/10.1186/s13104-019-4172-9
N.B. These documents automatically identified may not have been verified by the study sponsor.