- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02759432
Effect of a 4-week Fun Fast Interval Training (FFIT) Activity Programme on Physical Fitness and Quality of Life in Adolescent School Pupils
October 11, 2017 updated by: Kathryn Weston, Teesside University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Middlesbrough, United Kingdom, TS30RH
- Outwood Academy Ormesby
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 13 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Must be in school Year 7 or 8 at the school where the study will take place
- Must provide parental consent and participant assent
- Must be free from exclusion criteria
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
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No Intervention: Control
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: Baseline (0 weeks) and post-intervention (4 weeks)
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Cardiorespiratory fitness will be indirectly assessed by participants performing the 20 m shuttle run test.
Test performance is expressed in number of shuttle completed
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Baseline (0 weeks) and post-intervention (4 weeks)
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Change from baseline (0 weeks) leg power (assessed via standing broad jump performance at the post-intervention time point (4 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (4 weeks)
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Leg power will be assessed by participants performing a standing broad jump test.
Test performance is expressed as distance jumped.
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Baseline (0 weeks) and post-intervention (4 weeks)
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Change from baseline (0 weeks) upper body strength (assessed via handgrip dynamometer performance) at the post-intervention time point (4 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (4 weeks)
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Upper body strength will be assessed by participants performing the handgrip dynamometer test.
Test performance is expressed as grip strength measured in kilogrammes.
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Baseline (0 weeks) and post-intervention (4 weeks)
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Change from baseline (0 weeks) in 10 m running speed (assessed via 10 m sprint performance at) the post-intervention time point (4 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (4 weeks)
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10 m running speed will be assessed by participants completing a 10 m running sprint.
Test performance is expressed in seconds.
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Baseline (0 weeks) and post-intervention (4 weeks)
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Change from baseline (0 weeks) in 20 m running speed (assessed via 20 m sprint performance at) the post-intervention time point (4 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (4 weeks)
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20 m running speed will be assessed by participants completing a 20 m running sprint.
Test performance is expressed in seconds.
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Baseline (0 weeks) and post-intervention (4 weeks)
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Change from baseline (0 weeks) waist circumference at the post-intervention time point (4 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (4 weeks)
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Measurements will be expressed in centimetres.
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Baseline (0 weeks) and post-intervention (4 weeks)
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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)
Time Frame: Baseline (0 weeks) and post-intervention (4 weeks)
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Baseline (0 weeks) and post-intervention (4 weeks)
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate during high-intensity interval exercise training sessions
Time Frame: Up to 4 weeks
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Up to 4 weeks
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Rating of perceived exertion (assessed via the Children's scale of perceived exertion [Robertson et al., 2000) during high intensity interval exercise training sessions
Time Frame: Up to 4 weeks
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Up to 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathryn L Weston, PhD, Teesside University, Middlesbrough, UK
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
April 29, 2016
First Submitted That Met QC Criteria
May 2, 2016
First Posted (Estimate)
May 3, 2016
Study Record Updates
Last Update Posted (Actual)
October 12, 2017
Last Update Submitted That Met QC Criteria
October 11, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TEES-046/16
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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