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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02626767
Other study ID # TEES-008/11
Secondary ID
Status Completed
Phase N/A
First received December 3, 2015
Last updated December 7, 2015
Start date February 2011
Est. completion date December 2011

Study information

Verified date December 2015
Source Teesside University
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

Low-volume high-intensity interval exercise training may improve aspects of health and fitness in young people, but interventions must be practical and engaging. The investigators examined the effect of a novel school-based low-volume high-intensity interval training programme on health, fitness and physical activity outcomes in adolescent school pupils. 101 English adolescents aged 13-14 years took part in the study. Participants were healthy male and female volunteers, recruited from four schools in Northeast England. Using a non-randomised design, two schools took part in the intervention, and two were assigned to the control. Those in the intervention group completed a 10-week school-based high-intensity interval exercise training programme. The intervention took place three times per week, and comprised of 4-7 repetitions of 45 s maximal effort exercise (boxing, dance, soccer and basketball drills), each interspersed with 90-s rest. Participants were encouraged to work maximally during the 45-s repetitions. Control participants were 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 were blood lipid and glucose levels, body composition, cardiorespiratory fitness, carotid intima-media thickness, physical activity levels, serum C-reactive protein levels and blood pressure.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 15 Years
Eligibility Inclusion Criteria:

1. Must attend one of the four schools that the study will take place in

2. Must be in the Year 9 English school year (aged 13-15 years)

3. Must provide parental consent and participant assent

4. 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 cardiac death

5. Condition or disorder which is communicable via blood

6. Pregnancy or likelihood of pregnancy

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Novel high-intensity interval exercise training
Please see information already included in the 'intervention' arm description.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Teesside University Liverpool John Moores University

Outcome

Type Measure Description Time frame Safety issue
Other Heart rate during high-intensity interval training exercise sessions Up to 10 weeks No
Primary Change from baseline (0 weeks) waist circumference at the post-intervention time point (10 weeks) Baseline (0 weeks) and post-intervention (10-weeks) No
Primary Change from baseline (0 weeks) blood lipids at the post-intervention time point (10 weeks) (assessed via finger prick blood sampling) Baseline (0 weeks) and post-intervention (10-weeks) No
Primary Change from baseline (0 weeks) blood glucose at the post-intervention time point (10 weeks) (assessed via finger prick blood sampling) Baseline (0 weeks) and post-intervention (10-weeks) No
Primary Change from baseline (0 weeks) blood pressure at the post-intervention time point (10 weeks) Baseline (0 weeks) and post-intervention (10-weeks) No
Primary Change from baseline (0 weeks) carotid artery intima-media thickness at the post-intervention time point (10 weeks) Baseline (0 weeks) and post-intervention (10-weeks) No
Primary Change from baseline (0 weeks) body mass index at the post-intervention time point (10 weeks) Baseline (0 weeks) and post-intervention (10-weeks) No
Primary Change from baseline (0 weeks) serum C-reactive protein at the post-intervention time point (10 weeks) Baseline (0 weeks) and post-intervention (10-weeks) No
Primary Change from baseline (0 weeks) 20m shuttle run test performance (indirect measure of cardiorespiratory fitness) at the post-intervention time point (10 weeks) Baseline (0 weeks) and post-intervention (10-weeks) No
Primary Change from baseline (0 weeks) daily physical activity levels (assessed via accelerometry) at the post-intervention time point (10 weeks) Baseline (0 weeks) and post-intervention (10-weeks) No
Primary Change from baseline (0 weeks) body weight at the post-intervention time point (10 weeks) Baseline (0 weeks) and post-intervention (10-weeks) No
Primary Change from baseline (0 weeks) percentage body fat at the post-intervention time point (10 weeks) Baseline (0 weeks) and post-intervention (10-weeks) No
Primary Change from baseline (0 weeks) skeletal muscle mass at the post-intervention time point (10 weeks) Baseline (0 weeks) and post-intervention (10-weeks) No
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