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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02759432
Other study ID # TEES-046/16
Secondary ID
Status Completed
Phase N/A
First received April 29, 2016
Last updated October 11, 2017
Start date May 2016
Est. completion date July 2016

Study information

Verified date October 2017
Source Teesside University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 11 Years to 13 Years
Eligibility Inclusion Criteria:

1. Must be in school Year 7 or 8 at the school where the study will take place

2. Must provide parental consent and participant assent

3. Must be free from exclusion criteria

Exclusion Criteria:

1. Symptoms of or known presence of heart disease or major atherosclerotic cardiovascular disease.

2. Condition or injury or co-morbidity affecting the ability to undertake exercise.

3. Diabetes mellitus

4. Early family history of sudden death

5. Pregnancy or likelihood of pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High-intensity interval exercise training


Locations

Country Name City State
United Kingdom Outwood Academy Ormesby Middlesbrough

Sponsors (1)

Lead Sponsor Collaborator
Teesside University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Heart rate during high-intensity interval exercise training sessions Up to 4 weeks
Other 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
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
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