NCT06374732

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

March 20, 2024

Last Update Submit

April 23, 2025

Conditions

Keywords

schooladolescentshigh-intensity interval trainingrandomised control trialphysical activity

Outcome Measures

Primary Outcomes (1)

  • 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.

    Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.

Secondary Outcomes (17)

  • Muscular strength

    Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.

  • Wellbeing

    Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.

  • Enjoyment

    Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.

  • Motivation

    Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.

  • Affect

    Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.

  • +12 more secondary outcomes

Other Outcomes (2)

  • Confounding variables

    Maturity, subjectively measured physical activity and sleep will be measured at baseline, immediately after the intervention and two month following the cessation of the intervention.

  • Interview

    immediately after the intervention

Study Arms (2)

High-intensity interval training group

EXPERIMENTAL

The experimental group, which will perform high-intensity interval training (HIIT), 5 time per week for 12 weeks.

Behavioral: High-intensity interval training

Control group

ACTIVE COMPARATOR

Control group, which will continue their normal physical activity, including their usual physical education classes.

Behavioral: Control group

Interventions

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.

High-intensity interval training group
Control groupBEHAVIORAL

The control group will maintain their normal behaviour, including regular physical education lessons and physical activity lessons.

Control group

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Year 7 students

You may not qualify if:

  • Unable to perform high-intensity exercises due to existing medical contraindications
  • Unable to understand the study procedures and provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval TrainingControl Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Craig Williams, PhD

    University of Exeter

    STUDY CHAIR
  • Yaodong Gu, PhD

    Ningbo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2024

First Posted

April 19, 2024

Study Start

February 26, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations