Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000209796
Ethics application status
Approved
Date submitted
17/11/2021
Date registered
7/02/2022
Date last updated
15/09/2022
Date data sharing statement initially provided
7/02/2022
Date results information initially provided
15/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
High intensity interval training intervention within physical education class on health-related fitness in children aged 10 to 15
Scientific title
High intensity interval training intervention within physical education class on health-related fitness based on Eurofit test battery in children aged 10 to 15 who attend primary school
Secondary ID [1] 305832 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low fitness level 324366 0
Overweight 324931 0
Obesity 324936 0
Condition category
Condition code
Public Health 321848 321848 0 0
Health promotion/education
Diet and Nutrition 322364 322364 0 0
Obesity
Musculoskeletal 322365 322365 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention will be introduced to one primary school in the city of Zagreb, Croatia during the second semester of a school year 2021/2022. The intervention will provide two high intensity interval training sessions per week embedded in Physical Education classes to children aged 10 to 15. High intensity interval training will last 10 minutes per Physical Education session. Petra Juric, mag. cin. will implement the intervention and will be fully involved in the implementation process. Associates (blinded from group allocation) from the Faculty of Kinesiology will carry out initial and final measurements. The measurements before the beginning of the intervention, and at the end of the intervention, after 12 weeks. Regarding the transfer of instruments, they will be calibrated before each new cycle of use, while the transfer itself will be performed with precautions to minimize the possibility of damage. Intention to treat principle will be implemented meaning that no students will be excluded from the study unless they actively withdraw from the study after consenting. As part of the informed consent process, a health status report is submitted by the parent and is determined by the family doctor. The main information on the child's health status will be collected simultaneously with parental consent regarding research participation. The main target objective of the high intensity interval training within the Physical Education lessons will be the improvement of physical fitness scores based on EUROFT measures and reduced adiposity. The intervention will last three months, during the second semester of the school year 2021/2022. Approximately 100 students will be included in the intervention. There are approximately 25 students in each Physical Education class in most primary schools so that means we will have four intervention classes. Students in the intervention group who will participate at a minimum of 80% of Physical Education classes will be included in the data analysis. The intervention group will be introduced high intensity interval training program at the beginning of each Physical Education lesson. High intensity interval training will be conducted progressively over 12 weeks, with an increase in intensity according to the abilities of children and adolescents. One stimulus will consist of the following: preparation phase lasting 2 minutes, passive rest lasting 30 seconds, first working phase lasting 2 minutes, second passive rest lasting 30 seconds, second working phase lasting 2 minutes, and active rest lasting 2 minutes. Several variations of stimuli will be applied cyclically, to keep children and adolescents interested and motivated. During passive rest, the heart rate will be estimated in a standing position for 6 seconds, which will be subsequently multiplied by 10. Based on this, the load level will be monitored, where children and adolescents will have one introduction session before the start of the intervention to learn how to self-assess heart rate and get acquainted with the settings of the intervention that will be carried out. Since there are many holidays during the second semester of the school year 2021/2022, children will not do high intensity interval training sessions during this period. They will continue with the intervention after returning to school, with a total of 24 stimuli during 12 weeks while being present at the school. Eurofit Fitness test battery will be used for evaluating effects of an intervention.

Exercises will be:

Example 1
Prep phase: Jumping Jacks x 10; Running in Place x 10; Rhythmic Jumping x 10; Repeat until time is up
Passive recovery 1: Standing still take pulse (6 seconds x 10)
Working phase 1: Push-ups x 10; 5m Shuttle Sprint x 10; Squats x 10; 5m Shuttle Sprint x 10; Repeat until time is up
Passive recovery 2: Standing still take pulse (6 seconds x 10)
Working phase 2: Twisting Push-ups x 10; 5m Shuttle Sprint x 10; Plank Leg Raises x 10
5m Shuttle Sprint x 10; Repeat until time is up
Active recovery: Dynamic/static stretching w
Teacher returns to the normal teaching program for the remaining lesson time

Example 2
Prep phase: Diamond Jumps x 10; High Knee Runs x 10; Speed Skaters x 10; Repeat until time is up
Passive recovery 1: Standing still take pulse (6 seconds x 10)
Working phase 1: Chair Triceps Dips x 10; 5m Shuttle Sprint x 10; Reverse Lunge x 10; 5m Shuttle Sprint x 10; Repeat until time is up
Passive recovery 2: Standing still take pulse (6 seconds x 10)
Working phase 2: Plank to Push-ups x 10; 5m Shuttle Sprint x 10; V-Sit x 10; 5m Shuttle Sprint x 10; Repeat until time is up
Active recovery: Dynamic/static stretching
Teacher returns to the normal teaching program for the remaining lesson time

Example 3
Prep phase: Power Jumping x 10; Mountain Climbers x 10; Tuck Jumps x 10; Repeat until time is up
Passive recovery 1: Standing still take pulse (6 seconds x 10)
Working phase 1: Twisting Push-ups x 10; 5m Shuttle Sprint x 10; Plank Leg Raises x 10; 5m Shuttle Sprint x 10; Repeat until time is up
Passive recovery 2: Standing still take pulse (6 seconds x 10)
Working phase 2: Push-ups x 10; 5m Shuttle Sprint x 10; Squats x 10; 5m Shuttle Sprint x 10; Repeat until time is up
Active recovery: Dynamic/static stretching
Teacher returns to the normal teaching program for the remaining lesson time

Example 4
Prep phase: Squat Jumps x 10; Burpees x 10; Plank Jacks x 10; Repeat until time is up
Passive recovery 1: Standing still take pulse (6 seconds x 10)
Working phase 1: Plank to Push-ups x 10; 5m Shuttle Sprint x 10; V-Sit x 10; 5m Shuttle Sprint x 10; Repeat until time is up
Passive recovery 2: Standing still take pulse (6 seconds x 10)
Working phase 2: Chair Triceps Dips x 10; 5m Shuttle Sprint x 10; Reverse Lunge x 10; 5m Shuttle Sprint x 10; Repeat until time is up
Active recovery: Dynamic/static stretching
Teacher returns to the normal teaching program for the remaining lesson time

Participants will not be asked to aim for a pre-specified level of intensity during the intervention sessions. If a student is able to increase the frequency of a specific exercise performance, he or she will do it. If a student feels he or she cannot increase the frequency, he or she will remain doing an exercise at a slower rate.

A strategy which will be used to monitor adherence to the intervention will be class attendance rolls.
Intervention code [1] 322232 0
Lifestyle
Intervention code [2] 322233 0
Behaviour
Comparator / control treatment
Control groups will have usual physical education classes according to the curriculum without high intensity interval training intervention.
Control group
Active

Outcomes
Primary outcome [1] 329608 0
Fitness level based on Eurofit test battery
Timepoint [1] 329608 0
Baseline (pre-intervention) measurement: after the allocation of an ACTRN (registration number), 21 February 2022.
Final (post-intervention) measurement: 14 weeks after the start of the intervention, including 12 weeks of the intervention and two weeks of holidays embedded in this period.
During two weeks between February and June, there will be winter and spring holidays.
Secondary outcome [1] 403158 0
Body fat percentage estimated using skinfold calipers.
Timepoint [1] 403158 0
Baseline (pre-intervention) measurement: 21 February 2022
12 weeks post-intervention measurement: 30 May - 3 June 2022
During two weeks between February and June, there will be winter and spring holidays.

Eligibility
Key inclusion criteria
Primary school children and adolescents aged 10 to 15.
Minimum age
10 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children and adolescents who participate at regular Physical Education classes.

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)
Sealed opaque envelopes will be used to allocate classes in the intervention or in the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations were conducted to determine sample size. The target sample size that was determined using power calculations is 80 students in each arm of the study (intervention and control group).
Chi-square test will be used to check to baseline differences in number of boys and girls in intervention and control group and independent sample t-test to check the baseline difference in age, height, weight, body mass index z-score, percent over body mass index (BMI50), skinfolds, body fat percentage and waist circumference. Analysis of covariance (ANCOVA) will be used to compare changes in both groups adjusted for baseline age, baseline value of evaluated traits and for group-by-gender interactions. p value of<0.05will be regarded as a statistically significant difference.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/02/2022
Actual
14/02/2022
Date of last participant enrolment
Anticipated
21/02/2022
Actual
14/02/2022
Date of last data collection
Anticipated
3/06/2022
Actual
27/05/2022
Sample size
Target
160
Accrual to date
Final
207
Recruitment outside Australia
Country [1] 24339 0
Croatia
State/province [1] 24339 0
ZAGREB

Funding & Sponsors
Funding source category [1] 310185 0
Charities/Societies/Foundations
Name [1] 310185 0
Croatian Science Foundation
Country [1] 310185 0
Croatia
Primary sponsor type
Charities/Societies/Foundations
Name
Croatian Science Foundation
Address
Croatian Science Foundation
Horvacanski zavoj 15, 10000 Zagreb
Country
Croatia
Secondary sponsor category [1] 311271 0
Individual
Name [1] 311271 0
Dean Alan Dudley
Address [1] 311271 0
Macquarie University, Balaclava Rd, Macquarie Park NSW 2109
Country [1] 311271 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309868 0
Faculty of Kinesiology Ethics Committee, University of Zagreb
Ethics committee address [1] 309868 0
Horvacanski zavoj 15, 10000 Zagreb, Croatia
Ethics committee country [1] 309868 0
Croatia
Date submitted for ethics approval [1] 309868 0
01/11/2021
Approval date [1] 309868 0
13/12/2021
Ethics approval number [1] 309868 0
38./2021.

Summary
Brief summary
The aim of this study is to analyze the efficacy of a high intensity interval training intervention embedded in Physical Education class on health-related fitness of 10-to 15-year old students, including adiposity. The respective hypothesis is: high intensity interval training intervention embedded in a Physical Education class shows greater effects on health-related fitness, including adiposity in children aged 10 to 15 compared to a regular Physical Education curriculum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115670 0
Dr Associate professor dr. Dean Alan Dudley
Address 115670 0
Macquarie University, School of Education
Balaclava Rd, Macquarie Park NSW 2109, Australia
Country 115670 0
Australia
Phone 115670 0
+61 2 9850 4864
Fax 115670 0
Email 115670 0
dean.dudley@mq.edu.au
Contact person for public queries
Name 115671 0
Ms Petra Juric
Address 115671 0
Faculty of Kinesiology, University of Zagreb (program of the Croatian Science Foundation)
Horvacanski zavoj 15, 10000 Zagreb
Country 115671 0
Croatia
Phone 115671 0
+385917313588
Fax 115671 0
Email 115671 0
petra.juric@kif.unizg.hr
Contact person for scientific queries
Name 115672 0
Ms Petra Juric
Address 115672 0
Faculty of Kinesiology, University of Zagreb (program of the Croatian Science Foundation)
Horvacanski zavoj 15, 10000 Zagreb
Country 115672 0
Croatia
Phone 115672 0
+385917313588
Fax 115672 0
Email 115672 0
petra.juric@kif.unizg.hr

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
EmbaseDoes incorporating high intensity interval training in physical education classes improve fitness outcomes of students? A cluster randomized controlled trial.2023https://dx.doi.org/10.1016/j.pmedr.2023.102127
N.B. These documents automatically identified may not have been verified by the study sponsor.