HealthyNCT06374732
The Benefits of a High-intensity Interval Training Intervention Delivered in a School Setting Among Adolescents
A study testing High-intensity interval training in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
A 12-week school-based high-intensity interval training intervention, with 8 classes of year 7 students randomly allocated to either intervention or control group. The interval training sessions will last for 6 to 10 minutes and will be delivered 5 times per week. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High-intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Year 7 students
Who cannot join
- Unable to perform high-intensity exercises due to existing medical contraindications
- Unable to understand the study procedures and provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a School-based High-intensity Interval Training Intervention in Adolescents: the PRO-HIIT Cluster Randomised Controlled Trial
A 12-week school-based high-intensity interval training intervention, with 8 classes of year 7 students randomly allocated to either intervention or control group. The interval training sessions will last for 6 to 10 minutes and will be delivered 5 times per week. Outcome variables will be physical activity, body composition, cardiorespiratory fitness, muscular strength, bone health, executive function, mental wellbeing, and academic performance, which will be measured pre- and post-intervention and two months after the intervention has been completed.
Read the detailed description
The purpose of this study is to: 1) evaluate the effectiveness of a 12-week school-based HIIT intervention on cardiorespiratory fitness (primary outcome), physical activity, body composition, muscular strength, bone health, executive function, wellbeing, enjoyment, affect, self-efficacy and academic performance among 12-13-year-old adolescents; 2) to examine the changes of these outcomes following a two-month unstructured summer holiday after the study has been completed; 3) to conduct a process evaluation for the study.
The study is a 12-week high-intensity interval training intervention, which is 6 to 10-minute in length and will be delivered 5 times per week among year 7 adolescents, at the start of physical education and physical activity lessons. We will examine the effectiveness of this intervention on outcomes, such as body composition, cardiorespiratory fitness, muscular health, bone health, cognitive function, mental wellbeing, and academic performance. In addition, The investigators will evaluate the fitness changes between school days (structured day) and a two-month summer holiday (unstructured days). This will be achieved by collecting data at three timepoints: pre- and post-intervention and after a 2-month (summer holiday) following the completion of the intervention.
The high-intensity interval training includes resistance-based exercises, such as jumping jacks, high knees, burpees, squat jumps, lunge jumps, and mountain climbers.
- Conditions
- Healthy
- Being tested
- High-intensity interval training, Control group
- Keywords
- school, adolescents, high-intensity interval training, randomised control trial, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
The experimental group will perform 6-to-10-minute of high-intensity interval training at the beginning of their physical education lessons or physical activity lessons.
Control groupBehavioural
The control group will maintain their normal behaviour, including regular physical education lessons and physical activity lessons.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training group | Experimental | The experimental group, which will perform high-intensity interval training (HIIT), 5 time per week for 12 weeks. Receives: Behavioral: High-intensity interval training |
| Control group | Active comparator | Control group, which will continue their normal physical activity, including their usual physical education classes. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
Cardiorespiratory fitness will be measured using 20-metre shuttle run. The 20-meter shuttle run requires participants to run back and forth between two lines positioned 20 meters apart. To complete a shuttle, participants must reach the other end before a designated beep sounds. The beep is set to allow the participants to start at 8.5 km/h and increase the speed by 0.5 km/h as indicated by a triple beep. The test concludes if a participant fails to complete two consecutive shuttles or volitionally discontinues.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Secondary outcomes (17)
Muscular strength
Upper and lower body strength will be assessed using hand grip and standing long jump, respectively. A digital dynamometer with an adjustable grip, with participants standing and elbow in 90-degree flexion, will be employed for measuring the upper body strength in kilogrammes. The test will be performed twice on both hands and an averaged number of the four measurements will be used for reporting. Standing long jump will be measured with an electrical tester, which has high sensitivity and greatly improved accuracy. Participants stand behind the start line with their feet apart and are allowed to swing their arms quickly to jump as far as possible. Each participant will have three attempts, with the best one recorded.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Wellbeing
The Chinese version of Strengths and Difficulties Questionnaire (SDQ) will be used to assess the behavioural and emotional outcomes of participants.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Enjoyment
Enjoyment of physical activity will be measured using physical activity enjoyment scale.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Motivation
Motivation to autonomously engage in physical activity will be assessed using a modified Behaviour Regulation in Exercise Questionnaire.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Affect
Affect will be assessed via a Chinese version of the International Positive and Negative Affect Schedule Short Form
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Academic performance
Academic performance will be evaluated by utilising the school's end-of-term academic examinations. The total score for the academic examinations of each participant during term one (January 2023) and term two (July 2024) will be obtained from the school to be used as pre-intervention and immediately post-intervention data for academic performance, respectively.
Measured: Baseline and immediately after the intervention
Height
Height will be measured in centimetres with a portable stadiometer.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Weight
Weight in kilograms will be determined with a Tanita device (Tanita Corp., Tokyo, Japan).
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
BMI
Weight and height will be combined to report BMI in kg/m^2
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Waist circumference
Waist circumference in centimetres will be measured using a tape.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Body fat percentage
Body fat percentage will be determined with a Tanita device (Tanita Corp., Tokyo, Japan).
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Physical activity
Physical activity for a subset of participants (n = 60) will be objectively assessed using GENEActiv wrist-worn accelerometers (Model GAT04, Activinsights Ltd, Cambridgeshire, England) over a span of four weeks, comprising one week before and after the intervention as well as the initial and concluding weeks of the intervention.
Measured: Baseline, first week and last week of the intervention and first week following the completion of the intervention.
Bone health
A heel ultrasound test will be performed via a Achilles heel ultrasound machine (GE Medical Systems Lunar, USA). Participants will be seated with one foot on the foot plate, and alcohol will be applied to ensure proper membrane contact. A transducer on one side of the heel will convert an electrical signal into a sound wave, which will pass through the heel to the other side and be received and analysed by another transducer.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Perceived physical ability
A 6-item validated Perceived Physical Ability Scale will be utilised to evaluate the PA-related self-efficacy. The items are structured in response scales having a 1- to 4-point format. High scores would indicate a high self-perception of physical ability, whereas low scores would reflect a low self-perception.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Flanker task
Participants' inhibition will be assessed using a modified Flanker task. In the task, participants respond as quickly and accurately as possible to the direction of the fish in the middle which is flanked by another four fishes that are either swimming towards the same direction (congruent) or opposite direction (incongruent) to the central target fish. Participants will be instructed to press the "F" button on the keyboard if the fish swims towards left or "J" if towards right. The task consists of 104 trials in total, with a 1-minute rest when participants finished the first 52 trials. The result will be reported and compared as reaction time and accuracy.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Visual 2-back task
Working memory will be assessed using a modified visual 2-back task. Stimuli are sequences of animals (i.e., pig, giraffe, panda, snail and duck) which will be presented on the screen one-by-one. Participants will be instructed to respond to the stimulus as quickly and accurately as possible by either press the "F" button on the keyboard if the stimulus is identical to the one that appeared two trials back or "J" if not. The task consists of 52 trials in total, with a 1-minute rest when participants finished the first 26 trials. The result will be reported and compared as reaction time and accuracy.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Colour-shape switch task
Cognitive flexibility will be evaluated by a modified version of colour-shape switch task. In the task, participants will be instructed to react as quickly and accurately as possible to press the "F" button or "J" on the keyboard, with the following cues: If the object is at the top of the screen: press "F" if it is blue, press "J" if it is green; If the object is at the bottom of the screen: press "F" if it is square, press "J" if it is triangular. The task consists of 128 trials in total, with a 1-minute rest when participants finished the first 64 trials. The result will be reported and compared as reaction time and accuracy.
Measured: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start26 Feb 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- China Scholarship Council, Ningbo University
- Responsible party
- Sponsor
- Investigators
- Craig Williams, PhD, Study chair, University of ExeterYaodong Gu, PhD, Study chair, Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374732
- Sponsor's protocol ID
- TY2024002
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Y, Barker AR, Adlam AR, Li M, Duncombe SL, Agbaje AO, Gu Y, Zhou H, Williams CA. Effectiveness of a school-based high-intensity interval training intervention in adolescents: study protocol of the PRO-HIIT cluster randomised controlled trial. Front Pediatr. 2024 Oct 29;12:1458610. doi: 10.3389/fped.2024.1458610. eCollection 2024.
PubMed 39534248
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a School-based High-intensity Interval Training Intervention in Adolescents: the PRO-HIIT Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06374732
- Acronym / sponsor ID
- TY2024002
- Conditions
- Healthy
- Keywords
- school, adolescents, high-intensity interval training, randomised control trial, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- China Scholarship Council, Ningbo University
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 12-week school-based high-intensity interval training intervention, with 8 classes of year 7 students randomly allocated to either intervention or control group. The interval training sessions will last for 6 to 10 minutes and will be delivered 5 times per week. Outcome variables will be physical activity, body composition, cardiorespiratory fitness, muscular strength, bone health, executive function, mental wellbeing, and academic performance, which will be measured pre- and post-intervention and two months after the intervention has been completed.
Detailed description
The purpose of this study is to: 1) evaluate the effectiveness of a 12-week school-based HIIT intervention on cardiorespiratory fitness (primary outcome), physical activity, body composition, muscular strength, bone health, executive function, wellbeing, enjoyment, affect, self-efficacy and academic performance among 12-13-year-old adolescents; 2) to examine the changes of these outcomes following a two-month unstructured summer holiday after the study has been completed; 3) to conduct a process evaluation for the study.
The study is a 12-week high-intensity interval training intervention, which is 6 to 10-minute in length and will be delivered 5 times per week among year 7 adolescents, at the start of physical education and physical activity lessons. We will examine the effectiveness of this intervention on outcomes, such as body composition, cardiorespiratory fitness, muscular health, bone health, cognitive function, mental wellbeing, and academic performance. In addition, The investigators will evaluate the fitness changes between school days (structured day) and a two-month summer holiday (unstructured days). This will be achieved by collecting data at three timepoints: pre- and post-intervention and after a 2-month (summer holiday) following the completion of the intervention.
The high-intensity interval training includes resistance-based exercises, such as jumping jacks, high knees, burpees, squat jumps, lunge jumps, and mountain climbers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training group | Experimental | Behavioral: High-intensity interval trainingThe experimental group, which will perform high-intensity interval training (HIIT), 5 time per week for 12 weeks. |
| Control group | Active comparator | Behavioral: Control groupControl group, which will continue their normal physical activity, including their usual physical education classes. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Year 7 students
Key exclusion criteria (2 listed)
- Unable to perform high-intensity exercises due to existing medical contraindications
- Unable to understand the study procedures and provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval trainingThe experimental group will perform 6-to-10-minute of high-intensity interval training at the beginning of their physical education lessons or physical activity lessons. | Behavioural | High-intensity interval training group |
| Control groupThe control group will maintain their normal behaviour, including regular physical education lessons and physical activity lessons. | Behavioural | Control group |
Primary outcome
Cardiorespiratory fitness
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Cardiorespiratory fitness will be measured using 20-metre shuttle run. The 20-meter shuttle run requires participants to run back and forth between two lines positioned 20 meters apart. To complete a shuttle, participants must reach the other end before a designated beep sounds. The beep is set to allow the participants to start at 8.5 km/h and increase the speed by 0.5 km/h as indicated by a triple beep. The test concludes if a participant fails to complete two consecutive shuttles or volitionally discontinues.
17 secondary outcomes
Muscular strength
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Wellbeing
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Enjoyment
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Motivation
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Affect
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Academic performance
Time frame: Baseline and immediately after the intervention
Height
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Weight
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
BMI
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Waist circumference
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Body fat percentage
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Physical activity
Time frame: Baseline, first week and last week of the intervention and first week following the completion of the intervention.
Bone health
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Perceived physical ability
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Flanker task
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Visual 2-back task
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Colour-shape switch task
Time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Derived from this study: PubMed 39534248Liu Y, Barker AR, Adlam AR, Li M, Duncombe SL, Agbaje AO, Gu Y, Zhou H, Williams CA. Effectiveness of a school-based high-intensity interval training intervention in adolescents: study protocol of the PRO-HIIT cluster randomised controlled trial. Front Pediatr. 2024 Oct 29;12:1458610. doi: 10.3389/fped.2024.1458610. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Williams, PhD study chair
University of Exeter
Yaodong Gu, PhD study chair
Ningbo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06374732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.