NCT02759432

Brief Summary

Low-volume high-intensity interval exercise training may improve aspects of health and fitness in young people, but the effect of this type of exercise on quality of life has yet to be assessed. The investigators aim to examine the effect of a 4-week school-based low-volume high-intensity interval training programme (called the Fun Fast Interval Training \[FFIT\] activity project) on physical fitness and quality of life in adolescent school pupils. Approximately 145 English adolescents aged 11-12 years will be approached and invited to take part in the study. Participants will be healthy female volunteers, recruited from one school in Northeast England. Using a non-randomised design, one school year group will be assigned to take part in the intervention, and a second year group assigned to the control condition.Those in the intervention group will complete a 4-week school-based high-intensity interval exercise training programme. The intervention will take place twice per week, and comprise of 6-8 repetitions of 45 s maximal effort exercise (boxing, running, soccer and basketball drills), each interspersed with 90-s rest. Participants will be encouraged to work maximally during the 45-s repetitions. Control participants will be instructed not to change their lifestyle, dietary or physical activity habits during the intervention period, and maintain their normal school physical education routine. Study outcomes will be 20 m shuttle run test performance, health-related quality of life, standing broad jump performance, hand dynamometer performance, waist circumference and 10 m and 20 m sprint performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

April 29, 2016

Last Update Submit

October 11, 2017

Conditions

Keywords

high-intensity interval trainingadolescentsphysical fitnessquality of lifeschool-based intervention

Outcome Measures

Primary Outcomes (7)

  • Change from baseline (0 weeks) cardiorespiratory fitness (assessed via the 20 m shuttle run test performance test) at the post-intervention time point (4 weeks)

    Cardiorespiratory fitness will be indirectly assessed by participants performing the 20 m shuttle run test. Test performance is expressed in number of shuttle completed

    Baseline (0 weeks) and post-intervention (4 weeks)

  • Change from baseline (0 weeks) leg power (assessed via standing broad jump performance at the post-intervention time point (4 weeks)

    Leg power will be assessed by participants performing a standing broad jump test. Test performance is expressed as distance jumped.

    Baseline (0 weeks) and post-intervention (4 weeks)

  • Change from baseline (0 weeks) upper body strength (assessed via handgrip dynamometer performance) at the post-intervention time point (4 weeks)

    Upper body strength will be assessed by participants performing the handgrip dynamometer test. Test performance is expressed as grip strength measured in kilogrammes.

    Baseline (0 weeks) and post-intervention (4 weeks)

  • Change from baseline (0 weeks) in 10 m running speed (assessed via 10 m sprint performance at) the post-intervention time point (4 weeks)

    10 m running speed will be assessed by participants completing a 10 m running sprint. Test performance is expressed in seconds.

    Baseline (0 weeks) and post-intervention (4 weeks)

  • Change from baseline (0 weeks) in 20 m running speed (assessed via 20 m sprint performance at) the post-intervention time point (4 weeks)

    20 m running speed will be assessed by participants completing a 20 m running sprint. Test performance is expressed in seconds.

    Baseline (0 weeks) and post-intervention (4 weeks)

  • Change from baseline (0 weeks) waist circumference at the post-intervention time point (4 weeks)

    Measurements will be expressed in centimetres.

    Baseline (0 weeks) and post-intervention (4 weeks)

  • Change from baseline (0 weeks) health-related quality of life (assessed via completion of the Kid-Kindl questionnaire [Ravens-Sieberer & Bullinger, 2000] at the post-intervention time point (4 weeks)

    Baseline (0 weeks) and post-intervention (4 weeks)

Other Outcomes (2)

  • Heart rate during high-intensity interval exercise training sessions

    Up to 4 weeks

  • Rating of perceived exertion (assessed via the Children's scale of perceived exertion [Robertson et al., 2000) during high intensity interval exercise training sessions

    Up to 4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention group will complete a 4-week school-based high-intensity interval exercise training programme. The intervention will take place twice per week, and comprise of 6-8 repetitions of 45 s maximal effort exercise (boxing, running, soccer and basketball drills), each interspersed with 90-s rest. Participants will be encouraged to work maximally during the 45-s repetitions.

Other: High-intensity interval exercise training

Control

NO INTERVENTION

Participants in the control group will be instructed not to change their lifestyle, dietary or physical activity habits during the intervention period, and maintain their normal school physical education routine

Interventions

Eligibility Criteria

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

You may qualify if:

  • Must be in school Year 7 or 8 at the school where the study will take place
  • Must provide parental consent and participant assent

You may not qualify if:

  • Symptoms of or known presence of heart disease or major atherosclerotic cardiovascular disease.
  • Condition or injury or co-morbidity affecting the ability to undertake exercise.
  • Diabetes mellitus
  • Early family history of sudden death
  • Pregnancy or likelihood of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outwood Academy Ormesby

Middlesbrough, TS30RH, United Kingdom

Location

Study Officials

  • Kathryn L Weston, PhD

    Teesside University, Middlesbrough, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 3, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations