- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02626767
Effect of Novel High-intensity Interval Training on Health and Fitness Outcomes in English Adolescents
December 7, 2015 updated by: Kathryn Weston, Teesside University
Effect of Novel High-intensity Interval Training on Cardiometabolic Health and Physical Activity Levels in English Adolescents: A School-based Exploratory Controlled Before-and-after Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
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
13 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must attend one of the four schools that the study will take place in
- Must be in the Year 9 English school year (aged 13-15 years)
- 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 cardiac death
- Condition or disorder which is communicable via blood
- 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 were required to complete a high-intensity interval exercise training intervention, which took place three time per week for 10 weeks.
The exercise sessions comprised of 4 to 7 repetitions of 45 s maximal effort exercise, based on boxing, dance, soccer and basketball drills), interspersed with 90-s rest.
During each repetitions participants were encouraged to reach >90% of their individual maximal heart rate.
Participants were asked to maintain their dietary habits throughout the intervention period.
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Please see information already included in the 'intervention' arm description.
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No Intervention: Control
Participants were asked to maintain their usual diet, physical education and physical activity habits during the intervention period and were not aware that an exercise intervention was taking place at other study sites.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline (0 weeks) waist circumference at the post-intervention time point (10 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
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Baseline (0 weeks) and post-intervention (10-weeks)
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Change from baseline (0 weeks) blood lipids at the post-intervention time point (10 weeks) (assessed via finger prick blood sampling)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
|
Baseline (0 weeks) and post-intervention (10-weeks)
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Change from baseline (0 weeks) blood glucose at the post-intervention time point (10 weeks) (assessed via finger prick blood sampling)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
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Baseline (0 weeks) and post-intervention (10-weeks)
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Change from baseline (0 weeks) blood pressure at the post-intervention time point (10 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
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Baseline (0 weeks) and post-intervention (10-weeks)
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Change from baseline (0 weeks) carotid artery intima-media thickness at the post-intervention time point (10 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
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Baseline (0 weeks) and post-intervention (10-weeks)
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Change from baseline (0 weeks) body mass index at the post-intervention time point (10 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
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Baseline (0 weeks) and post-intervention (10-weeks)
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Change from baseline (0 weeks) serum C-reactive protein at the post-intervention time point (10 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
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Baseline (0 weeks) and post-intervention (10-weeks)
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Change from baseline (0 weeks) 20m shuttle run test performance (indirect measure of cardiorespiratory fitness) at the post-intervention time point (10 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
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Baseline (0 weeks) and post-intervention (10-weeks)
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Change from baseline (0 weeks) daily physical activity levels (assessed via accelerometry) at the post-intervention time point (10 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
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Baseline (0 weeks) and post-intervention (10-weeks)
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Change from baseline (0 weeks) body weight at the post-intervention time point (10 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
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Baseline (0 weeks) and post-intervention (10-weeks)
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Change from baseline (0 weeks) percentage body fat at the post-intervention time point (10 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
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Baseline (0 weeks) and post-intervention (10-weeks)
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Change from baseline (0 weeks) skeletal muscle mass at the post-intervention time point (10 weeks)
Time Frame: Baseline (0 weeks) and post-intervention (10-weeks)
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Baseline (0 weeks) and post-intervention (10-weeks)
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate during high-intensity interval training exercise sessions
Time Frame: Up to 10 weeks
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Up to 10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathryn L Weston, PhD, Teesside University, Middlesbrough,UK
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
February 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
December 3, 2015
First Submitted That Met QC Criteria
December 7, 2015
First Posted (Estimate)
December 10, 2015
Study Record Updates
Last Update Posted (Estimate)
December 10, 2015
Last Update Submitted That Met QC Criteria
December 7, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- TEES-008/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Only group level data will be published from this study.
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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