Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001341819
Ethics application status
Approved
Date submitted
13/09/2021
Date registered
7/10/2021
Date last updated
7/10/2021
Date data sharing statement initially provided
7/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of cognitively demanding resistance training breaks in high school students’.
Scientific title
Effects of cognitively demanding resistance training breaks on high school students’ executive functions, on task behaviour and muscular fitness.
Secondary ID [1] 305297 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Executive functions 323612 0
Muscular fitness 323613 0
Condition category
Condition code
Public Health 321148 321148 0 0
Health promotion/education
Musculoskeletal 321149 321149 0 0
Normal musculoskeletal and cartilage development and function
Neurological 321150 321150 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Investigating the impact of cognitively demanding resistance training breaks.
Why: To gain further understanding on the topic of physical activity breaks combined with varying levels of associated cognitive demand to a) executive function b) on-task behaviour and c) muscular fitness.
What: This is a four arm randomised control trial and there are 3 different intervention groups which will be provided with 3 different intervention videos each lasting 6-8 minutes and set to a Tabata format of 20sec on/ 10sec off x 8 sets; a total workout time of 4 minutes:
a) The High activity/High cognitive demand group (HAHC) respond to the stimulus by performing the correlating resistance training exercise (e.g. 1 session totals 32 x 5 seconds of resistance training activities). Examples of body weight exercises included in the intervention are: table push ups, squats to a chair, tricep dips on a chair. An example of a video that will be used in the intervention can be seen here - https://drive.google.com/file/d/16zkKk1dK3TfZ4n933E07dOlhl9vbmsK3/view?usp=sharing
b) The High activity/Low cognitive demand group (HALC) complete the same resistance training exercises but require no cognitive demand, rather simply copy the performer on the video. An example of a video that will be used in the intervention can be seen here - https://drive.google.com/file/d/1-P9Q1GAEpqpOHOBUE7Opi7G8UezWazlM/view?usp=sharing
c) The Low physical activity/High cognitive demand (LAHC) respond to the stimulus by selecting an image on the response wheel on their desk in front of them. An example of a video that will be used in the intervention can be seen here - https://drive.google.com/file/d/1wlvWQU7Nl0vFzQqHj_CTqUlJY-i4wT5d/view?usp=sharing
Who provided: The video was produced by working with experts from the fitness industry, specifically strength trainers with expertise in delivering resistance training activities to adolescents. At the point of delivery, it will be classroom teachers who play the video to the class and supervise the safety of their students. A 3 hour training session is delivered to all teachers involved in the study where key elements of safety, motivation and technique are explained. The procedure for delivery is for students to enter the classroom and place their bag safely out of the way (this is clearly indicated on a safety video at the beginning of the study). The teacher will then ask the class if any students are unwell or suffering from an injury. At this point, the teacher makes a decision based on outlined scenarios discussed in training to either modify the student's workload or exempt them from that session. The video is then played and students participate in the workout. The Tabata style has students exercise for 20 seconds and resting for 10 seconds repeated 8 times. The total video time is 6 minutes. At the completion of the video, students return to their seat and begin class work.
How: The intervention is provided to the class of Year 10 students as a group at the beginning of each mathematics lesson for 4 weeks (A total of 12 sessions).
Where: The intervention will occur in a standard Highschool mathematics classroom. No movement to furniture is required and students perform all exercises using only the desk and chair.
When and how much: Each video lasts for 6-8 minutes with a total workout time of 4 minutes. The video is delivered at the beginning of each mathematics lesson (3 times per week) for a total of 4 weeks.
Tailoring: Tailoring can occur for students who are injured. Eg a student with a broken arm can modify exercises to complete another exercise that does not utilise the use of their arm e.g. lunges. All modifications are discussed in the teacher training session.
Modifications: No modifications are intended.
How well - planned: Planned fidelity checks are to occur weekly by myself - the lead investigator. A structured set of questions outline a fidelity check ensuring continuity to the delivery of the videos across schools.
Intervention code [1] 321708 0
Behaviour
Intervention code [2] 321709 0
Lifestyle
Comparator / control treatment
The comparator/control arm for this study will be used. Students in the same level mathematics class will continue with their normal classroom practice (no treatment given) as a control measure. They will enter the classroom, have the roll marked and proceed with normal learning activities. The only formal requirements for this group is that they
a) Do not perform any physical activity in the first 6 minutes of the lesson
b) do not complete any academic work in the first 6 minutes.
Control group
Active

Outcomes
Primary outcome [1] 328939 0
Executive function - Working memory

Assessed using the NIH Toolbox for 7-17 year olds. The test of episodic memory adapted for use with early adolescents was used.
Timepoint [1] 328939 0
Assessments at baseline and baseline+4 weeks
Primary outcome [2] 328940 0
Executive function - Inhibition

Assessed using the NIH Toolbox for 7-17 year olds. Flanker test assessing attention and inhibitory control was used.
Timepoint [2] 328940 0
Assessments at baseline and baseline+4 weeks
Primary outcome [3] 328941 0
Executive function - Cognitive flexibility

Assessed using the NIH Toolbox for 7-17 year olds. The Dimensional Change Card Sort test was used.
Timepoint [3] 328941 0
Assessments at baseline and baseline+4 weeks
Secondary outcome [1] 400899 0
Time spent on-task during mathematics lessons will be observed using momentary time sampling, reported as a percentage of time.

This observational tool has been adapted from the “Behaviour Observation of students in schools and the Applied Behaviour Analysis for Teachers”. All students will be observed in 15-sec intervals on a rotational basis over a 30-min period in the allocated mathematics time slot. Two observations per group at each time point will be included.
Timepoint [1] 400899 0
Assessments at baseline and baseline+4 weeks
Secondary outcome [2] 400900 0
Muscular fitness - Upper body

To assess this outcome the 90-degree push-up test on metronome till fatigue will be used.
Timepoint [2] 400900 0
Assessments at baseline and baseline+4 weeks
Secondary outcome [3] 400901 0
Muscular fitness - Core strength

Plank hold test till fatigue.
Timepoint [3] 400901 0
Assessments at baseline+4 weeks
Secondary outcome [4] 400902 0
Muscular fitness - lower leg

30-second squat test for maximum repetitions
Timepoint [4] 400902 0
Assessments at baseline+4 weeks
Secondary outcome [5] 400903 0
Teacher perception of the experience.

At the completion of the study, teachers will participate in a short interview, seeking their perception of the experience of delivering the study. The interview will last 30 minutes, be recorded, and is delivered one on one. The questions used have been designed specifically for this study and will provide qualitative data to determine feasibility, specifically:
Acceptability - The extent to which the program is considered suitable, satisfying, or attractive to program participants.
Practicality - The extent to which the program can be delivered using existing resources.
Timepoint [5] 400903 0
Occurring at a suitable time within 2 weeks of the completion of the study.
Secondary outcome [6] 400904 0
Student perception of the experience.

At the completion of the study, students will participate in a short focus group session, seeking their perception of the experience of delivering the study. The discussion will last 30 minutes, be recorded, and is delivered in a focus group setting with a minimum of 5 randomly selected students. The questions have been designed specifically for this study and will provide qualitative data to determine feasibility, specifically:
Acceptability - The extent to which the program is considered suitable, satisfying, or attractive to program participants.
Practicality - The extent to which the program can be delivered using existing resources.
Timepoint [6] 400904 0
Occurring at a suitable time within 2 weeks of the completion of the study.
Secondary outcome [7] 400905 0
Rate of perceived exertion

Students report their perceived physical exertion, using the Borg RPE scale.
Timepoint [7] 400905 0
At the completion of each intervention video
Secondary outcome [8] 400906 0
Mood was assessed using a modified version of the Profile of Mood States. Participants were asked: How are you feeling right now?
Timepoint [8] 400906 0
Before and after each intervention video.

Eligibility
Key inclusion criteria
Students participating in the study must be in year 10 at an NSW high school.
Minimum age
14 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Any acute or chronic condition that would limit the ability of the patient to participate in the study
• Parents have refused to give consent

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 envelopes
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
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
Outcomes will be analysed using linear mixed models in IBM SPSS Statistics, version 23.0 (SPSS Inc., IBM Company Armonk, NY, USA). This statistical approach is consistent with the intention-to-treat principle because missing data, assumed to be missing at random, are modelled using a likelihood-based analysis (Mallinckrodt et al., 2004;White et al., 2012). Mixed models will be used to assess the impact of the group-by-time interaction, using random intercepts to account for the clustered nature of the data (i.e. students located in classes). Alpha levels are set at p < 0.05 and Cohen’s d to be calculated to provide a further measure of effect size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/07/2020
Date of last participant enrolment
Anticipated
Actual
17/07/2020
Date of last data collection
Anticipated
Actual
24/09/2020
Sample size
Target
120
Accrual to date
Final
97
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 35291 0
2320 - Maitland

Funding & Sponsors
Funding source category [1] 309670 0
Charities/Societies/Foundations
Name [1] 309670 0
Hunter Medical Research Institute
Country [1] 309670 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 310688 0
University
Name [1] 310688 0
University of Newcastle, Priority research centre for physical activity and nutrition
Address [1] 310688 0
ATC Building, University Dr, Callaghan NSW 2308
Country [1] 310688 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309438 0
HUMAN RESEARCH ETHICS COMMITTEE - University of Newcastle
Ethics committee address [1] 309438 0
Ethics committee country [1] 309438 0
Australia
Date submitted for ethics approval [1] 309438 0
24/11/2019
Approval date [1] 309438 0
06/05/2020
Ethics approval number [1] 309438 0
H-2019-0415

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

Contacts
Principal investigator
Name 114158 0
Mrs Katie Robinson
Address 114158 0
HPE Building
University of Newcastle
Callaghan Dr, Callaghan NSW 2308
Country 114158 0
Australia
Phone 114158 0
+61 412578572
Fax 114158 0
Email 114158 0
[email protected]
Contact person for public queries
Name 114159 0
Katie Robinson
Address 114159 0
HPE Building
University of Newcastle
Callaghan Dr, Callaghan NSW 2308
Country 114159 0
Australia
Phone 114159 0
+61 412578572
Fax 114159 0
Email 114159 0
[email protected]
Contact person for scientific queries
Name 114160 0
Katie Robinson
Address 114160 0
HPE Building
University of Newcastle
Callaghan Dr, Callaghan NSW 2308
Country 114160 0
Australia
Phone 114160 0
+61 412578572
Fax 114160 0
Email 114160 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
Participants are under the age of 18 and although all information is de-identified, ethical approval was received on the basis that no raw data would be made public. Sufficient data analysis will be provided in future publications.


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.