ANZCTR - Registration

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]

‘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

Mental health i.e.,well-being

Condition category

Condition code

Cardiovascular

Normal development and function of the cardiovascular system

Mental Health

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]

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]

Cardio-respiratory fitness: 20 metre SRT (beep test)

Timepoint [1]

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]

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]

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]

Muscular fitness: Lower body strength i.e., standing long jump assessment

Timepoint [1]

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]

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]

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]

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]

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]

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]

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]

Evaluation survey: completed by coaches & participants at the end of the program. This was designed specifically for this study.

Timepoint [5]

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]

Muscular fitness: Upper body strength i.e., 90° push-up test

Timepoint [6]

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]

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]

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]

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]

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]

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]

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

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]

2300 - Newcastle

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Unfunded

Country [1]

Primary sponsor type

University

Name

University of Newcastle

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee.

Ethics committee address [1]

The University of Newcastle Human Research Ethics Committee.
The University of Newcastle, University Drive, Callaghan NSW 2308, Australia,

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/03/2020

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The program Sport-HIIT will include a range of body weight and aerobic exercises that 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. 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. Consenting coaches (after receiving instructions and resources) assists their players with 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. We hypothesise that students may receive various benefits to a variety of health outcomes i.e., resulting from participation.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Narelle Eather

Address

The University of Newcastle University Dr, Callaghan NSW 2308

Country

Australia

Phone

+61 2 4971 6232

Email

[email protected]

Contact person for public queries

Name

Dr Narelle Eather

Address

The University of Newcastle University Dr, Callaghan NSW 2308

Country

Australia

Phone

+61 2 4971 6232

Email

[email protected]

Contact person for scientific queries

Name

Dr Narelle Eather

Address

The University of Newcastle University Dr, Callaghan NSW 2308

Country

Australia

Phone

+61 2 4971 6232

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically