Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000432314
Ethics application status
Approved
Date submitted
9/02/2017
Date registered
24/03/2017
Date last updated
24/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
High intensity interval training in soccer players: the chronotype effect
Scientific title
Acute effects of High Intensity Interval Training on autonomic control, sleep quality and cortisol concentration performed at different times of the day in healthy subjects
Secondary ID [1] 291137 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autonomic Control 301977 0
Sleep Quality 301978 0
Mood States 301979 0
Condition category
Condition code
Cardiovascular 301622 301622 0 0
Normal development and function of the cardiovascular system
Metabolic and Endocrine 301624 301624 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The single session of high-intensity endurance interval training protocol will consist of 4 bouts of 4 minutes (4X4) at 90-95% HRmax with 3 min of active recovery at 50-60% HRmax. The training intervention will start with a standardized 10-min warm-up and will end with a 3-min cool-down period at a self-selected intensity. The acute training sessions will be conducted outdoor by an exercise physiologist, on an athletic track in dry, windless weather conditions with a temperature about 15-20 degrees. Subjects will be trained in groups. After a baseline assessment subjects will be randomly assigned morning training that started performing the high intensity interval training protocol at 8.00 am or evening training that started performing the high intensity interval training protocol at 8.00 pm. Both groups will be blinded about the aim of the study. Adherence will be monitored registering the attendance of players during each training session
Intervention code [1] 297117 0
Treatment: Other
Comparator / control treatment
Comparation between exercise at 8:00am and 8:00pm
Control group
Active

Outcomes
Primary outcome [1] 301041 0
Autonomic control, assessed by heart rate variability (via beat-to-beat heart rate monitor).
Timepoint [1] 301041 0
Heart rate variability measurements will be performed at rest, before, after 12 and 24 hours the high-intensity endurance interval training protocol.
Primary outcome [2] 301042 0
Sleep quality, assessed using actigraphy (worn for one full night's sleep at each timepoint).
Timepoint [2] 301042 0
The sleep data will be recorded the night before and the two nights after the high-intensity endurance interval training protocol.
Primary outcome [3] 301044 0
Salivary Cortisol Concentration
Timepoint [3] 301044 0
Measurement of salivary cortisol secretion will be performed before, at the end of the training session and after 15 min, 30 min, 45 min, 60 min the completion of the high-intensity endurance interval training protocol.
Secondary outcome [1] 331569 0
The profile of mood states will be assessed using a 32 items questionnaire which reflects an individual’s mood on five primary dimensions (depression, fatigue, vigour, tension and anger). Subjects will complete the POMS data will be analysed for each specific dimension and an “energy index” will be calculated as “vigour-fatigue” and used to monitor changes in energy balance.
Timepoint [1] 331569 0
Subjects have to complete the questionnaire before and after 12 and 24 hours the completion of the high-intensity endurance interval training protocol.

Eligibility
Key inclusion criteria
More than 18 years old; male; being soccer players of at least 5-10 years; 6 hours of training a week; with a morning or evening chronotype scores
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
smoking, use of medications and any other medical condition contraindicating physical exercise

Study design
Purpose of the study
Educational / counselling / training
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/10/2015
Date of last participant enrolment
Anticipated
Actual
29/10/2015
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 8651 0
Italy
State/province [1] 8651 0
Milano

Funding & Sponsors
Funding source category [1] 295589 0
University
Name [1] 295589 0
Universita degli Studi di Milano
Country [1] 295589 0
Italy
Primary sponsor type
University
Name
Universita degli Studi di Milano
Address
Via Giuseppe Colombo 71, 20133 Milano, Italy
Country
Italy
Secondary sponsor category [1] 294421 0
None
Name [1] 294421 0
Address [1] 294421 0
Country [1] 294421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296911 0
Institutional Ethics Review Committee of the Universita degli Studi di Milano
Ethics committee address [1] 296911 0
Ethics committee country [1] 296911 0
Italy
Date submitted for ethics approval [1] 296911 0
01/10/2015
Approval date [1] 296911 0
12/10/2015
Ethics approval number [1] 296911 0
N. 52/15

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

Contacts
Principal investigator
Name 70506 0
Prof Antonio La Torre
Address 70506 0
Department of Biomedical Sciences for Health, Universita degli Studi di Milano, Via Giuseppe Colombo 71, 20133 Milano, Italy
Country 70506 0
Italy
Phone 70506 0
+390250314617
Fax 70506 0
Email 70506 0
antonio.latorre@unimi.it
Contact person for public queries
Name 70507 0
Matteo Bonato
Address 70507 0
Department of Biomedical Sciences for Health, Universita degli Studi di Milano, Via Giuseppe Colombo 71, 20133 Milano, Italy
Country 70507 0
Italy
Phone 70507 0
+390250314617
Fax 70507 0
Email 70507 0
matteo.bonato@unimi.it
Contact person for scientific queries
Name 70508 0
Matteo Bonato
Address 70508 0
Department of Biomedical Sciences for Health, Universita degli Studi di Milano, Via Giuseppe Colombo 71, 20133 Milano, Italy
Country 70508 0
Italy
Phone 70508 0
+390250314617
Fax 70508 0
Email 70508 0
matteo.bonato@unimi.it

No information has been provided regarding IPD availability


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
No additional documents have been identified.