AdolescentsNCT04022642
Effects of HIIT Integrated in PE Classes, on Physical Condition, Physical Activity and Motivation for Exercise
A study testing High-Intensity Interval Training in people with Adolescents, run by University of Évora at 1 site in Portugal.
Trial summary
Levels of activity and physical condition among adolescents are low, increasing the risk of chronic diseases. The most recent literature suggests that physical activity and physical condition are correlated with improved biopsychosocial variables of the young. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescents
- What is being tested?
- High-Intensity Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 sitePortugal
- Study dates
- 16 Sep 2019to 13 Mar 2020
- 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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students enrolled in years 10-12
Who cannot join
- Students will be ineligible if they do not provide parental consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a High-Intensity Interval Training Program Integrated in High-School Physical Education Classes, on Physical Condition, Physical Activity and Motivation for Exercise
Levels of activity and physical condition among adolescents are low, increasing the risk of chronic diseases. The most recent literature suggests that physical activity and physical condition are correlated with improved biopsychosocial variables of the young. The School and, concretely, the Physical Education classes are privileged spaces, promoters of positive changes for the rest of the life. HIIT is an efficient alternative to the invested time compared to aerobic training, being a powerful stimulus in improving cardiorespiratory performance, muscles oxidative capacity and sensitivity to insulin. This study intends to verify the effectiveness and feasibility in the implementation of HIIT in High-School Physical Education classes. The activity levels and physical condition of the adolescents will be evaluated and identified, before and after 16 weeks of implementation of the training program, as well as their effects on the motivation for the practice.
- Conditions
- Adolescents
- Being tested
- High-Intensity Interval Training
- Keywords
- HIIT, Adolescents, Physical Exercise, Health, Motivation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval TrainingOther
The program will be applied in the first 10-15 minutes of each PE class, twice a week, including a brief warm-up, ranged from 14 to 20 intervals, adopting a 2:1 work to rest ratio (ie, 30-s work, followed by 30-s rest)
A cut-point of >=90% of maximal heart rate was used as our criterion for satisfactory compliance to high-intensity exercise
In order to estimate effort, fatigue and training load, a subjective effort scale will be used throughout each session. The heart rate will be monitored throughout the session in real time through Bluetooth technology.
Actigraph accelerometers (wGT3X-BT), randomly distributed by the students in each session, will be used to characterize the intensity of the sessions.
| Study group | Role | What they receive |
|---|---|---|
| HIIT Group | Experimental | Two HIIT sessions delivered at the beginning of Physical education classes Receives: Other: High-Intensity Interval Training |
| Control Group | No intervention | Usual programmed Physical education classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Cardio-respiratory fitness at 4 months
Assessed by Yo-Yo Intermitent Recovery Test 1(Tanner \& Gore, 2014)
Measured: 4 months
Change from 4 months Cardio-respiratory fitness at 6 months
Assessed by Yo-Yo Intermitent Recovery Test 1(Tanner \& Gore, 2014)
Measured: 6 months
Change from baseline Muscular Strength at 4 months
Assessed using push-up and curl-up tests (Plowman, 2013)
Measured: 4 months
Change from 4 months Muscular Strength at 6 months
Assessed using push-up and curl-up tests (Plowman, 2013)
Measured: 6 months
Change from baseline Body Mass Index (BMI) at 4 months
Assessed by Height and Weight (Dobbelsteyn, Joffres, MacLean, \& Flowerdew, 2001)
Measured: 4 months
Change from 4 months Body Mass Index (BMI) at 6 months
Assessed by Height and Weight (Dobbelsteyn, Joffres, MacLean, \& Flowerdew, 2001)
Measured: 6 months
Change from baseline Physical Activity at 4 months
Assessed by International Physical Activity Questionnaire (iPAQ), and accelerometry (Actigraph - wGT3X-BT)
Measured: 4 months
Change from 4 months Physical Activity at 6 months
Assessed by International Physical Activity Questionnaire (iPAQ), and accelerometry (Actigraph - wGT3X-BT)
Measured: 6 months
Change from baseline Motivation at 4 months
Assessed by Behavioral Regulation In Exercise Questionnaire (Cid et al., 2018).
Measured: 4 months
Change from 4 months Motivation at 6 months
Assessed by Behavioral Regulation In Exercise Questionnaire (Cid et al., 2018).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start16 Sep 2019
- Primary completion15 Oct 2019
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Responsible party
- Principal investigator, André Filipe Paulino da Silva Bento, University of Évora
- Investigators
- André Bento, Principal investigator, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022642
- Sponsor's protocol ID
- SFRH/BD/136869/2018
- Status last verified
- Nov 2020
- First submitted
- 10 Jul 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a High-Intensity Interval Training Program Integrated in High-School Physical Education Classes, on Physical Condition, Physical Activity and Motivation for Exercise
- ClinicalTrials.gov ID
- NCT04022642
- Acronym / sponsor ID
- SFRH/BD/136869/2018
- Conditions
- Adolescents
- Keywords
- HIIT, Adolescents, Physical Exercise, Health, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Collaborators
- Agency for Science, Technology and Research
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 17 Jul 2019 (actual)
- 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.
Levels of activity and physical condition among adolescents are low, increasing the risk of chronic diseases. The most recent literature suggests that physical activity and physical condition are correlated with improved biopsychosocial variables of the young. The School and, concretely, the Physical Education classes are privileged spaces, promoters of positive changes for the rest of the life. HIIT is an efficient alternative to the invested time compared to aerobic training, being a powerful stimulus in improving cardiorespiratory performance, muscles oxidative capacity and sensitivity to insulin. This study intends to verify the effectiveness and feasibility in the implementation of HIIT in High-School Physical Education classes. The activity levels and physical condition of the adolescents will be evaluated and identified, before and after 16 weeks of implementation of the training program, as well as their effects on the motivation for the practice.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT Group | Experimental | Other: High-Intensity Interval TrainingTwo HIIT sessions delivered at the beginning of Physical education classes |
| Control Group | No intervention | –Usual programmed Physical education classes |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students enrolled in years 10-12
Key exclusion criteria (1 listed)
- Students will be ineligible if they do not provide parental consent to participate
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 |
|---|---|---|
| High-Intensity Interval TrainingThe program will be applied in the first 10-15 minutes of each PE class, twice a week, including a brief warm-up, ranged from 14 to 20 intervals, adopting a 2:1 work to rest ratio (ie, 30-s work, followed by 30-s rest) A cut-point of >=90% of maximal heart rate was used as our criterion for satisfactory compliance to high-intensity exercise In order to estimate effort, fatigue and training load, a subjective effort scale will be used throughout each session. The heart rate will be monitored throughout the session in real time through Bluetooth technology. Actigraph accelerometers (wGT3X-BT), randomly distributed by the students in each session, will be used to characterize the intensity of the sessions. | Other | HIIT Group |
Primary outcome
Change from baseline Cardio-respiratory fitness at 4 months
Time frame: 4 months
Assessed by Yo-Yo Intermitent Recovery Test 1(Tanner \& Gore, 2014)
Change from 4 months Cardio-respiratory fitness at 6 months
Time frame: 6 months
Assessed by Yo-Yo Intermitent Recovery Test 1(Tanner \& Gore, 2014)
Change from baseline Muscular Strength at 4 months
Time frame: 4 months
Assessed using push-up and curl-up tests (Plowman, 2013)
Change from 4 months Muscular Strength at 6 months
Time frame: 6 months
Assessed using push-up and curl-up tests (Plowman, 2013)
Change from baseline Body Mass Index (BMI) at 4 months
Time frame: 4 months
Assessed by Height and Weight (Dobbelsteyn, Joffres, MacLean, \& Flowerdew, 2001)
Change from 4 months Body Mass Index (BMI) at 6 months
Time frame: 6 months
Assessed by Height and Weight (Dobbelsteyn, Joffres, MacLean, \& Flowerdew, 2001)
Change from baseline Physical Activity at 4 months
Time frame: 4 months
Assessed by International Physical Activity Questionnaire (iPAQ), and accelerometry (Actigraph - wGT3X-BT)
Change from 4 months Physical Activity at 6 months
Time frame: 6 months
Assessed by International Physical Activity Questionnaire (iPAQ), and accelerometry (Actigraph - wGT3X-BT)
Change from baseline Motivation at 4 months
Time frame: 4 months
Assessed by Behavioral Regulation In Exercise Questionnaire (Cid et al., 2018).
Change from 4 months Motivation at 6 months
Time frame: 6 months
Assessed by Behavioral Regulation In Exercise Questionnaire (Cid et al., 2018).
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 3 Nov 2020.
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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.
André Bento principal investigator
University of Évora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Training in people with Adolescents, run by University of Évora at 1 site in Portugal.
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 1 inclusion and 1 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Cardio-respiratory fitness at 4 months (time frame: 4 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020.