High-intensity Interval TrainingNCT02626767
Effect of Novel High-intensity Interval Training on Health and Fitness Outcomes in English Adolescents
A study testing Novel high-intensity interval exercise training in people with High-intensity Interval Training, run by Teesside University.
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… Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- High-intensity Interval Training
- What is being tested?
- Novel high-intensity interval exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- High-intensity Interval Training
- Being tested
- Novel high-intensity interval exercise training
- Keywords
- high-intensity interval training, adolescents, school-based exercise, cardiometabolic health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel high-intensity interval exercise trainingOther
Please see information already included in the 'intervention' arm description.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Novel high-intensity interval exercise training |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (0 weeks) waist circumference at the post-intervention time point (10 weeks)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Change from baseline (0 weeks) blood lipids at the post-intervention time point (10 weeks) (assessed via finger prick blood sampling)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Change from baseline (0 weeks) blood glucose at the post-intervention time point (10 weeks) (assessed via finger prick blood sampling)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Change from baseline (0 weeks) blood pressure at the post-intervention time point (10 weeks)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Change from baseline (0 weeks) carotid artery intima-media thickness at the post-intervention time point (10 weeks)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Change from baseline (0 weeks) body mass index at the post-intervention time point (10 weeks)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Change from baseline (0 weeks) serum C-reactive protein at the post-intervention time point (10 weeks)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Change from baseline (0 weeks) 20m shuttle run test performance (indirect measure of cardiorespiratory fitness) at the post-intervention time point (10 weeks)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Change from baseline (0 weeks) daily physical activity levels (assessed via accelerometry) at the post-intervention time point (10 weeks)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Change from baseline (0 weeks) body weight at the post-intervention time point (10 weeks)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Change from baseline (0 weeks) percentage body fat at the post-intervention time point (10 weeks)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Change from baseline (0 weeks) skeletal muscle mass at the post-intervention time point (10 weeks)
Measured: Baseline (0 weeks) and post-intervention (10-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High-intensity Interval TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool John Moores University
- Responsible party
- Principal investigator, Kathryn Weston, Teesside University
- Investigators
- Kathryn L Weston, PhD, Principal investigator, Teesside University, Middlesbrough,UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626767
- Sponsor's protocol ID
- TEES-008/11
- Status last verified
- Dec 2015
- First submitted
- 3 Dec 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only group level data will be published from this study.
Publications
Weston KL, Azevedo LB, Bock S, Weston M, George KP, Batterham AM. Effect of Novel, School-Based High-Intensity Interval Training (HIT) on Cardiometabolic Health in Adolescents: Project FFAB (Fun Fast Activity Blasts) - An Exploratory Controlled Before-And-After Trial. PLoS One. 2016 Aug 3;11(8):e0159116. doi: 10.1371/journal.pone.0159116. eCollection 2016.
PubMed 27486660
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02626767
- Acronym / sponsor ID
- TEES-008/11
- Conditions
- High-intensity Interval Training
- Keywords
- high-intensity interval training, adolescents, school-based exercise, cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- Liverpool John Moores University
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Novel high-intensity interval exercise trainingParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel high-intensity interval exercise trainingPlease see information already included in the 'intervention' arm description. | Other | Intervention |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Derived from this study: PubMed 27486660Weston KL, Azevedo LB, Bock S, Weston M, George KP, Batterham AM. Effect of Novel, School-Based High-Intensity Interval Training (HIT) on Cardiometabolic Health in Adolescents: Project FFAB (Fun Fast Activity Blasts) - An Exploratory Controlled Before-And-After Trial. PLoS One. 2016 Aug 3;11(8):e0159116. doi: 10.1371/journal.pone.0159116. eCollection 2016.
- Individual participant dataSharing planned: No. Only group level data will be published from this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn L Weston, PhD principal investigator
Teesside University, Middlesbrough,UK
Questions about this trial
What is this clinical trial studying?
A study testing Novel high-intensity interval exercise training in people with High-intensity Interval Training, run by Teesside University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02626767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.