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Trial registered on ANZCTR


Registration number
ACTRN12620001219976p
Ethics application status
Submitted, not yet approved
Date submitted
10/08/2020
Date registered
16/11/2020
Date last updated
25/11/2020
Date data sharing statement initially provided
16/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of a high intensity interval training program (Sport-HIIT) on health and well-being among adolescents’ participating in organised-sport.
Scientific title
Evaluating the efficacy of a high intensity interval training program (Sport-HIIT) on health and well-being among adolescents’ participating in organised-sport.
Secondary ID [1] 301977 0
‘Nil known'
Universal Trial Number (UTN)
‘Nil known'
Trial acronym
Sport-HIIT (Sport-high intensity interval training)
Linked study record
This record is a sub-study of ACTRN12617000178347 (Uni-HIIT).

Notably, Uni-HIIT included an adult population within a University setting, where as Sport-HIIT is intended for adolescents in a sport i.e., different setting whilst still incorporating HIIT.

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular health 318540 0
Mental health i.e.,well-being 318541 0
Condition category
Condition code
Cardiovascular 316547 316547 0 0
Normal development and function of the cardiovascular system
Mental Health 316548 316548 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This program will investigate the effects of the provision of ‘Sport-HIIT’ in the first 10 minutes of training of various sports. Consenting coaches (will be provided with resources/instructions) and their players will participate in a weekly HIIT session (10 minutes in total i.e., a 2 minute dynamic warm up and a 1 x 8 minute HIIT session), for 8 weeks, i.e., delivered their usual coach. A research member can instruct/demonstrate how to conduct a session with the coaches i.e., provide training to assist them in their delivery. (Notably, coaches will be provided any additional training necessary to conduct their own Sport-HIIT sessions for the remaining weeks of the program before normal training.) The type of HIIT sessions players participate in may vary but will consist of a combination of aerobic and resistance exercises in a 30 sec : 30 sec rest to work ratio. Resources i.e., HIIT cards and music will be supplied and provided by a research member.
All players can participate in the HIIT training sessions but only those players returning signed parental consent forms will complete assessments. Participants will be given a brief survey measuring their HIIT self-efficacy, future intentions for physical activity, affective state and enjoyment relating to the sessions. They will also participate in a series of fitness tests including the 20m SRT (beep test) measuring cardio respiratory fitness, the push-up test measuring muscular fitness (upper body) and the standing long jump test to assess muscular power (lower body). Measurements and surveys will be collected at baseline and post-test (approx. 8 weeks) by a member of the research team.
Sport-HIIT will be run during the playing seasons throughout 2021, and offered to the majority of organised sporting clubs in the Hunter Region, NSW, Australia. Sport-HIIT will be implemented and evaluated as a randomised controlled trial (RCT). All staff/players who choose to participate in the study will be randomised, by a computer generated algorithm, into either the intervention group (who complete the program straight away) or the wait-list control group (who will receive the program, just delayed). Each sport will involve 4 teams of which 2 will be randomised to intervention and 2 assigned to a wait-list control
The study will be completed in two (2) phases:
Phase 1: GPS tracking during game play & Phase 2: SPORT-HIIT Study
Phase 1: Participants will wear a GPS during game play. The use of the GPS devices will be explained to all players before the first game (i.e., what they are and what they do), and players will also have an opportunity to ask any questions before their use. The GPS devices will be distributed by a member of the research team accompanied by the coach. The GPS is a small device placed in the pocket of a chest vest that can be worn over players t-shirt. The GPS device can be fitted by the player themselves on the playing grounds/ovals. At the end of the game, either the coach and/or research member will collect the GPS devices. The GPS will not be labelled with players details and have no visual representation of the data it collects.
a) The Sport HIIT study will involve players completing assessments (psychological and physical) before and after the 8-week Sport HIIT program during their normal training sessions and at their normal training location (or immediately before training if more suitable for the coach and players). Coaches will supervise whilst a research member implements the measures with the exception of the GPS devices, which coaches may simply hand out to their players.
b) Following baseline assessments, coaches will implement tailored 8-min Sport-HIIT sessions (following a 2 min dynamic warm up) at the start of each normal training session (for 8-weeks).
All Sport-HIIT sessions with include a range of body weight and aerobic exercises and are designed to be enjoyable i.e., encouraging participants to work in pairs of their choice (with one participant undertaking the ‘work’ phase while their partner rests). As the intervention progresses, participants will also be provided with additional elements of choice including: music (playlists) and exercise choices during a workout for example. Importantly, graded exercises to suit all fitness/skill levels will be provided.
The intensity of exercises completed in the sessions will be assessed via HR monitors. The HR monitors will be worn on a chest strap, connected wirelessly to a receiver. The HR monitor will be worn during physical sessions i.e., during the Sport-HIIT sessions. A member of the research team accompanied by the coach will distribute HR monitors. Students will be instructed on how to put on the HR monitors themselves. HR monitors will be collected and cleaned at the end of each Sport-HIIT session.

Depending on each of the participant(s) i.e., experience, fitness levels, any previous injuries etc. sessions will aim for an intensity of 70 to 90 percent max heart rate during the sessions, as measured by the HR monitors. Notably, this is dependent on the capability of each participant though representative of the overall aim to achieve ‘High Intensity’ as described by a plethora of research.


HIIT cards are being designed specifically for this study i.e., to ensure they are appealing/fun/engaging for the youth. All Sport-HIIT sessions with include a range of body weight and aerobic exercises with images on how to perform each skill correctly on the cards.
Specific examples of exercises completed in the HIIT sessions, may include e.g. skipping, push-ups, lunges, squats, shuttle runs etc.
To monitor adherence to the intervention a roll will be recorded by the coach each session.
Players aged 12-18 years will be invited and are eligible to participate in the study. Face to face delivery will be conducted by their normal coach (with varying levels experience, appropriate for community sport).
Intervention code [1] 318266 0
Prevention
Comparator / control treatment
Sport-HIIT will be implemented and evaluated as a randomised controlled trial (RCT). All staff/players who choose to participate in the study will be randomised, by a computer generated algorithm, into either the intervention group (who complete the program straight away) or the wait-list control group (who will receive the program, just delayed). Each sport will involve 4 teams of which 2 will be randomised to intervention and 2 assigned to a wait-list control. The control group will be offered the intervention after the 8 week intervention period and once all follow-up assessments are conducted.

The control group will partake in typical training methods i.e., as per usual practice to act as a comparator.

All measures will be taken at baseline and follow-up for both arms (int vs control)

Sport specific movement patterns
• GPS: distance travelled/tracking during gameplay

Physical Fitness (10-15min)
• Muscular fitness: 90° push-up test & the standing long jump assessment
• Cardio-respiratory fitness: 20 metre SRT (beep test)

Player Questionnaires (approximately 5-10 min):
• Physical Self Perception Profile: will be measured using a questionnaire
• HIIT self-efficacy and future intention: will be measured using a questionnaire.
• Feelings/Affective State questionnaire: will be administered before and after each exercise session for the duration of the intervention i.e., will be used to assess moods pre-and-post Sport-HIIT.
• Evaluation survey: completed by coaches & participants at the end of the program (approx. 3-5 min)
Control group
Active

Outcomes
Primary outcome [1] 324675 0
Cardio-respiratory fitness: 20 metre SRT (beep test)
Timepoint [1] 324675 0
Once at Baseline mid-Feb, 2021 and once at Follow-up late-April, 2021 (i.e., Immediately post intervention for the intervention arm i.e., after 8 weeks of delivery) or after 8 weeks of typical training sessions for control).
Primary outcome [2] 324676 0
GPS: distance travelled/tracking during gameplay. The GPS is a small device placed in the pocket of a chest vest that can be worn over players t-shirt.
Timepoint [2] 324676 0
From Baseline mid-Feb, 2021 to Follow-up late-April, 2021
Assessed at weekly games from enrollment until 8 weeks post-enrollment for both intervention and control arms.
Secondary outcome [1] 385380 0
Muscular fitness: Lower body strength i.e., standing long jump assessment
Timepoint [1] 385380 0
Once at Baseline mid-Feb, 2021 and once at Follow-up late-April, 2021 (i.e., Immediately post intervention for the intervention arm i.e., after 8 weeks of delivery) or after 8 weeks of typical training sessions for control).
Secondary outcome [2] 385381 0
Physical Self Perception Profile questionnaire: (i.e., PSPP by Harter, 1985) will be measured using a questionnaire. Athlete Competence subscale of the Self-perception Profile for Children specifically.
Timepoint [2] 385381 0
Once at Baseline mid-Feb, 2021 and once at Follow-up late-April, 2021 (i.e., Immediately post intervention for the intervention arm i.e., after 8 weeks of delivery) or after 8 weeks of typical training sessions for control).
Secondary outcome [3] 385382 0
HIIT Self-Efficacy Scale (HIIT-SES) via a questionnaire. (Development and Evaluation of the High Intensity Interval Training Self-efficacy Questionnaire (HIIT-SQ). This is currently under review/Manuscript submitted for publication.
Timepoint [3] 385382 0
Once at Baseline mid-Feb, 2021 and once at Follow-up late-April, 2021 (i.e., Immediately post intervention for the intervention arm i.e., after 8 weeks of delivery) or after 8 weeks of typical training sessions for control).
Secondary outcome [4] 385383 0
Feelings/Affective State questionnaire: will be administered before and after each exercise session for the duration of the intervention i.e., will be used to assess moods pre-and-post Sport-HIIT. This was designed specifically for this study and its linked trial (Uni-HIIT - ACTRN12617000178347). Full details available through full text "Efficacy and feasibility of HIIT training for university students: The Uni-HIIT RCT". (Eather et al., 2019).
Timepoint [4] 385383 0
From Baseline mid-Feb, 2021 to Follow-up late-April, 2021
Assessed at each session from enrollment until 8 weeks post-enrollment regardless of being in the intervention or control arm.
Secondary outcome [5] 385384 0
Evaluation survey: completed by coaches & participants at the end of the program. This was designed specifically for this study.
Timepoint [5] 385384 0
Once at follow-up late-April, 2021 (Immediately post intervention for intervention arm i.e., after 8 weeks of delivery) or after 16 weeks i.e., for the wait list control. has received the program.
Secondary outcome [6] 386604 0
Muscular fitness: Upper body strength i.e., 90° push-up test
Timepoint [6] 386604 0
Once at Baseline mid-Feb, 2021 and once at Follow-up late-April, 2021 (i.e., Immediately post intervention for the intervention arm i.e., after 8 weeks of delivery) or after 8 weeks of typical training sessions for control).
Secondary outcome [7] 386605 0
Intention to participate in high intensity interval training (HIIT) will be measured using a questionnaire. This questionnaire was designed specifically for this study.
Timepoint [7] 386605 0
Once at Baseline mid-Feb, 2021 and once at Follow-up late-April, 2021 (i.e., Immediately post intervention for the intervention arm i.e., after 8 weeks of delivery) or after 8 weeks of typical training sessions for control).
Secondary outcome [8] 386606 0
Motivation for sport questionnaire via "A modification to the behavioural regulation in exercise questionnaire to include an assessment of amotivation" (Markland & Tobin, 2004).
Timepoint [8] 386606 0
Once at Baseline mid-Feb, 2021 and once at Follow-up late-April, 2021 (i.e., Immediately post intervention for the intervention arm i.e., after 8 weeks of delivery) or after 8 weeks of typical training sessions for control).
Secondary outcome [9] 386607 0
Enjoyment of sport questionnaire via Physical Activity Enjoyment Scale Short Form (adapted for HIIT/Sport). Using Physical Activity Enjoyment Scale short form--does it fit for children? This has been adapted/repeated to include feeling of HIIT as well as sport.
Timepoint [9] 386607 0
Once at Baseline mid-Feb, 2021 and once at Follow-up late-April, 2021 (i.e., Immediately post intervention for the intervention arm i.e., after 8 weeks of delivery) or after 8 weeks of typical training sessions for control).

Eligibility
Key inclusion criteria
Players aged 12-18 years will be invited and are eligible to participate in the study. Only players who provide written informed consent will complete the evaluation of the program including all questionnaires and physiological tests. Must be registered players in the club of that sport.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Must not be over 18 years of age or 11 years old at time of measurements.

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)
All staff/players who choose to participate in the study will be randomized, by a computer generated algorithm, into either the intervention group or control.

Allocation was concealed by sealed envelopes to all those involved.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All staff/players who choose to participate in the study will be randomized, by a computer generated algorithm, into either the intervention group or control.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All staff/players who choose to participate in the study will be randomised, by a computer generated algorithm, into either the intervention group (who complete the program straight away) or the wait-list control group (who will receive the program, just delayed). Each sport will involve 4 teams of which 2 will be randomised to intervention and 2 assigned to a wait-list control.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All analyses will be conducted using the statistical software package IBM SPSS 21 (SPSS Inc. Chicago, IL) and alpha levels were set at p < 0.05. Independent samples t-tests will be performed on continuous variables (e.g. age) and chi-square tests performed on dichotomous variables (e.g. sex) for identifying differences between groups at baseline in key demographic and outcome variables. A descriptive analysis was conducted to assess retention, recruitment, adherence and satisfaction among participants. Linear mixed models will be fitted with an unstructured covariance structure to compare intervention and control groups for all outcomes (for the impact of group (intervention or control), time (treated as categorical with levels baseline and immediate post-intervention) and the group-by-time interaction.) Linear mixed models are consistent with the intention-to-treat principle (Mallinckrodt, Watkin, Molenberghs, Carroll, & Lilly, 2004). Cohen’s d effect size will be calculated (d= mean difference in change scores / pooled variance) and interpreted as: .20 = small, .50 = moderate and .80 = large effect.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/01/2021
Actual
Date of last participant enrolment
Anticipated
12/02/2021
Actual
Date of last data collection
Anticipated
31/05/2021
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 30921 0
2300 - Newcastle

Funding & Sponsors
Funding source category [1] 306403 0
Self funded/Unfunded
Name [1] 306403 0
Unfunded
Country [1] 306403 0
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 306909 0
None
Name [1] 306909 0
Address [1] 306909 0
Country [1] 306909 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306602 0
The University of Newcastle Human Research Ethics Committee.
Ethics committee address [1] 306602 0
Ethics committee country [1] 306602 0
Australia
Date submitted for ethics approval [1] 306602 0
11/03/2020
Approval date [1] 306602 0
Ethics approval number [1] 306602 0

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

Contacts
Principal investigator
Name 104426 0
Dr Narelle Eather
Address 104426 0
The University of Newcastle University Dr, Callaghan NSW 2308
Country 104426 0
Australia
Phone 104426 0
+61 2 4971 6232
Fax 104426 0
N/A
Email 104426 0
Narelle.Eather@newcastle.edu.au
Contact person for public queries
Name 104427 0
Narelle Eather
Address 104427 0
The University of Newcastle University Dr, Callaghan NSW 2308
Country 104427 0
Australia
Phone 104427 0
+61 2 4971 6232
Fax 104427 0
N/A
Email 104427 0
Narelle.Eather@newcastle.edu.au
Contact person for scientific queries
Name 104428 0
Narelle Eather
Address 104428 0
The University of Newcastle University Dr, Callaghan NSW 2308
Country 104428 0
Australia
Phone 104428 0
+61 2 4971 6232
Fax 104428 0
N/A
Email 104428 0
Narelle.Eather@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No sharing of IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8736Ethical approval  Narelle.eather@newcastle.edu.au



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.