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Adolescent BehaviorH2PENCT05544370

H2 Physical Education: Promoting Cardiometabolic Health by 2 High Intensity Intervallic Training Protocol, Twice a Week at Physical Education

A study testing Intensive high intensity intervallic training group and Extensive high-intensity intervallic training in people with Adolescent Behavior, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Several risk factors associated with cardiovascular disease could be prevented or treated by means of physical activity from childhood. Among the physical exercise programs for the improvement of these variables we can highlight high-intensity interval training. Read more about this study

Who is it for?
Ages 12 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Adolescent Behavior
What is being tested?
Intensive high intensity intervallic training group and Extensive high-intensity intervallic training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteSpain
Study dates
12 Sep 2022to 30 Dec 2022
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 12 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • being in Compulsory Secondary Education
  • be active in the sessions of Physical Education

Who cannot join

  • presenting any musculoskeletal, neurological, cardiological, metabolic, rheumatic or previous history of spinal pathologies or with previous treatment

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Noelia G González-Gálvez, PhD.

    Murcia, 30010

Other trials in Spain

About this study

Several risk factors associated with cardiovascular disease could be prevented or treated by means of physical activity from childhood. Among the physical exercise programs for the improvement of these variables we can highlight high-intensity interval training. However, most of these studies have been carried out on overweight or obese athletes or schoolchildren and existing protocols on high intensity intervallic training are different. The main objective of the present research is to compare two high-intensity intervallic training protocols on body composition, heart rate, blood pressure, lipid profile, blood glucose, cardiovascular fitness, strength, quality of life, physical activity, enjoyment of physical activity and accident proneness in adolescents. The present investigation will be elaborated by a randomized-control trial design, with 2 experimental groups and a control group (CG). In each experimental groups a different protocol of high-intensity interval training is applied.

It is assessed cardiovascular capacity and strength. Body composition is assessed. Heart rate and blood pressure were also recorded. Lipid profile and blood glucose were obtained by blood sampling. Quality of life, sedentary and physical activity lifestyle, enjoyment of physical activity and Psychoeducational factors determining accident process are assessed.

Read the detailed description

Cardiovascular diseases are the leading cause of death today. These have been inversely correlated with physical activity and fitness in adults, children and adolescents. In this sense, certain risk factors associated with cardiovascular disease could be prevented or treated by means of physical activity from childhood. Traditionally, the benefits of physical activity on cardiovascular markers and physical fitness in children and adolescents have been described in research conducted with traditional aerobic exercise programs. Among the physical exercise programs for the improvement of these variables we can highlight high-intensity interval training. However, most of these studies have been carried out on overweight or obese athletes or schoolchildren. On the other hand, the existing protocols on high intensity intervallic training are different, there have been intensive and extensive protocols. Likewise, the investigations do not usually control the real intensity of work and it has been described that in most cases the participants do not manage to reach the described intensity, which indicates that they are not working at the level that is considered or they are working with an intensity of an extensive protocol while the duration is of an intensive protocol. In this sense, the objective of the present research is a) to know the effect of high intensity intervallic training on body composition, heart rate, blood pressure, lipid profile, glycemia, cardiovascular capacity, strength, quality of life, physical activity, enjoyment of physical activity and accident proneness in adolescents and b) to compare two high-intensity intervallic training protocols on body composition, heart rate, blood pressure, lipid profile, blood glucose, cardiovascular fitness, strength, quality of life, physical activity, enjoyment of physical activity and accident proneness in adolescents.

The present investigation will be elaborated by a randomized-control trial design, with 2 experimental groups and a control group (CG); with pre-test and post-test. Each experimental groups performance differences protocol of high-intensity interval training.

The inclusion criteria will be: a) being in Compulsory Secondary Education; b) not presenting any musculoskeletal, neurological, cardiological, metabolic, rheumatic or previous history of spinal pathologies or with previous treatment; c) be active in the sessions of Physical Education.

Primary outcome measure are cardiovascular capacity, strength of upper limbs and strength of lower limbs. These variables are tested with "Course Navette test", handgrip dynamometry and long jump test, respectively.

Secondary outcome measure are body composition and its assessed by height, weight, waist circumference, fat percentage, hydration, muscle mass, bone weight and visceral fat. The body mass index will be obtained by recording weight and height (BMI = Weight (kg) / height (cm) 2). Heart rate and blood pressure were also recorded. Lipid profile (high density lipoproteins, low density lipoproteins and triglycerides) and blood glucose were obtained by blood sampling. Quality of life are assessed through the "Kidscreen-27 questionnaire". The sedentary lifestyle as well as the level of physical activity will be evaluated through the Adolescent International Physical Activity Questionnaire (IPAQ).

The enjoyment of physical activity and a questionnaire on Psychoeducational factors determining accident proneness in adolescents were assessed.

Intensity was assessed during all sessions by means of a heart rate monitor for each adolescent.

The type of activity used to develop the training was continuous running. After the usual warm-up in physical education classes, one of the two high-intensity interval training protocols was applied. Both have the same work time but distributed in different ways and with different intensities.

The intensive high intensity intervallic training group performs 6 sets of 60 seconds of work and 60 seconds of rest. During the first two weeks we work at an intensity of 80-85% of the reserve heart rate during the work phase and 50-55% of the reserve heart rate during the rest time. In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 95-95% of the reserve heart rate.

The extensive high-intensity intervallic training group performs 3 sets of 120 seconds of work and 120 seconds of rest at an intensity of 70-75% of the reserve heart rate during the work phase and an intensity of 50-55% of the reserve heart rate during the rest phase. In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 80-85% of the reserve heart rate.

The program duration is 8 weeks and the frequency of intervention is 2 sessions per week.

Being tested
Intensive high intensity intervallic training group, Extensive high-intensity intervallic training
Keywords
adolescents, cardiovascular, strength, high intensity interval training, metabolic syndrome, physical activity
Medical subject headings
Adolescent Behavior, Metabolic Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive high intensity intervallic training groupBehavioural

    The intensive high intensity intervallic training group performs 6 sets of 60 seconds of work and 60 seconds of rest. During the first two weeks we work at an intensity of 80-85% of the reserve heart rate during the work phase and 50-55% of the reserve heart rate during the rest time. In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 95-95% of the reserve heart rate. The program duration is 8 weeks and the frequency of intervention is 2 sessions per week.

  • Extensive high-intensity intervallic trainingBehavioural

    The extensive high-intensity intervallic training group performs 3 sets of 120 seconds of work and 120 seconds of rest at an intensity of 70-75% of the reserve heart rate during the work phase and an intensity of 50-55% of the reserve heart rate during the rest phase. In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 80-85% of the reserve heart rate. The program duration is 8 weeks and the frequency of intervention is 2 sessions per week.

Study groups in NCT05544370
Study groupRoleWhat they receive
Intensive high intensity intervallic training groupExperimentalThe intensive high intensity intervallic training group performs 6 sets of 60 seconds of work and 60 seconds of rest. During the first two weeks we work at an intensity of 80-85% of the reserve heart rate during the work phase and 50-55% of the reserve heart rate during the rest time. In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 95-95% of the reserve heart rate. The program duration is 8 weeks and the frequency of intervention is 2 sessions per week.
Receives: Behavioral: Intensive high intensity intervallic training group
Extensive high-intensity intervallic training groupExperimentalThe extensive high-intensity intervallic training group performs 3 sets of 120 seconds of work and 120 seconds of rest at an intensity of 70-75% of the reserve heart rate during the work phase and an intensity of 50-55% of the reserve heart rate during the rest phase. In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 80-85% of the reserve heart rate. The program duration is 8 weeks and the frequency of intervention is 2 sessions per week.
Receives: Behavioral: Extensive high-intensity intervallic training
Control groupNo interventionThe control group will carry out their usual physical education classes which consist of games, jumping, moving, balance and different sports.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change to baseline to 8 week of Cardiovascular capacity

    Cardiovascular capacity is evaluated by means of the Course Navete test. A high value in this test refers to a better cardiovascular capacity.

    Measured: Two times. Baseline and 8 week later

  2. Change to baseline to 8 week of Manual clamping force

    Manual grip strength is assessed by means of dynamometry. The higher the value in this test, the greater the manual grip strength. It is recorded in kilograms.

    Measured: Two times. Baseline and 8 week later

  3. Change to baseline to 8 week of Long jump

    The long jump is recorded by means of a mobile application. A higher value in this test reflects greater strength in the lower extremities. It is recorded in centimeters.

    Measured: Two times. Baseline and 8 week later

Secondary outcomes (18)
  1. Change to baseline to 8 week of Height

    The size of the subject will be measured in centimeters.

    Measured: Two times. Baseline and 8 week later

  2. Change to baseline to 8 week of Weight

    The Weight of the subject will be measured in kilograms.

    Measured: Two times. Baseline and 8 week later

  3. Change to baseline to 8 week of Waist circumference

    The waist circumference of the subject will be measured in centimeters.

    Measured: Two times. Baseline and 8 week later

  4. Change to baseline to 8 week of Fat percentage

    The percentage of fat was assessed by bioimpedance.

    Measured: Two times. Baseline and 8 week later

  5. Change to baseline to 8 week of Hydration percentage

    The hydratation was assessed by bioimpedance.

    Measured: Two times. Baseline and 8 week later

  6. Change to baseline to 8 week of Muscle mass

    The muscle mass was assessed by bioimpedance. It was register in kilograms.

    Measured: Two times. Baseline and 8 week later

  7. Change to baseline to 8 week of Bone weight

    The bone weight was assessed by bioimpedance. It was register in kilograms.

    Measured: Two times. Baseline and 8 week later

  8. Change to baseline to 8 week of Visceral fat

    The visceral fat was assessed by bioimpedance. It was register in kilograms.

    Measured: Two times. Baseline and 8 week later

  9. Change to baseline to 8 week of Heart rate

    The heart rate is taken under a blood pressure and heart rate device and the value is given in number of beats per minute.

    Measured: Two times. Baseline and 8 week later

  10. Change to baseline to 8 week of systolic and diastolic Blood pressure

    Blood pressure (systolic and diastolic) is taken under a blood pressure and heart rate measuring device and the value is given in number of millimeters of mercury.

    Measured: Two times. Baseline and 8 week later

  11. Change to baseline to 8 week of Blood glucose

    Blood glucose lipoproteins is analyzed by blood extraction.

    Measured: Two times. Baseline and 8 week later

  12. Change to baseline to 8 week of High density lipoproteins

    High-density lipoproteins is analyzed by blood extraction.

    Measured: Two times. Baseline and 8 week later

  13. Change to baseline to 8 week of Low density lipoproteins

    Low-density lipoproteins is analyzed by blood extraction.

    Measured: Two times. Baseline and 8 week later

  14. Change to baseline to 8 week of Triglycerides

    Triglycerides is analyzed by blood extraction.

    Measured: Two times. Baseline and 8 week later

  15. Change to baseline to 8 week of Quality of life level

    Quality of life was assessed through the "Kidscreen-27 questionnaire" (assess health and subjective well-being in children and adolescents). This questionnaire report a score on a scale, with 5 option (never, a little, often, very often and always). The minimum value is 0 up to 100. A higher score on this test reflects a higher quality of life level. Higher score mean a better outcome.

    Measured: Two times. Baseline and 8 week later

  16. Change to baseline to 8 week of Sedentary and physical activity lifestyle

    The sedentary lifestyle as well as the level of physical activity will be evaluated through the Adolescent International Physical Activity Questionnaire (IPAQ).

    Measured: Two times. Baseline and 8 week later

  17. Change to baseline to 8 week of Enjoyment of physical activity

    The enjoyment of physical activity was measure by a questionaire.

    This questionnaire report a score on a scale, with 5 option (strongly disagree, somewhat disagree, neutral, somewhat agree and strongly agree). The minimum value is 0 up to 100. A higher score on this test reflects a higher enjoyment. Higher score mean a better outcome.

    Measured: Two times. Baseline and 8 week later

  18. Risk of Accident level

    Psychoeducational factors determining accident proneness in adolescents were assessed by questionaire. A higher score on this test reflects a higher risk of an adolescent accident. The questionnaire is composed of 4 factors. Factor 1. Perceived competence (from 8 to 48 points); Factor 2. Factor 3. Competitiveness (from 4 to 24 points), Factor 4. Risk-taking (from 4 to 24 points); and Factor 5. A higher score mean a high point in the factor.

    Measured: 8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start12 Sep 2022
  3. Primary completion30 Oct 2022
  4. Study completion30 Dec 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05544370
Sponsor's protocol ID
UCMurcia-H2PE
Acronym
H2PE
Status last verified
May 2024
First submitted
9 Sep 2022
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gonzalez-Galvez N, Vaquero-Cristobal R, Macia-Andreu MJ, Garcia-Tascon M, Soler-Marin A, Gallardo-Guerrero AM. Influence of physical fitness components on personality factors and risk perception of children and adolescents: a cross-sectional study. BMJ Open. 2023 Dec 10;13(12):e071995. doi: 10.1136/bmjopen-2023-071995.

    PubMed 38072471

Questions about this trial

What is this clinical trial studying?

A study testing Intensive high intensity intervallic training group and Extensive high-intensity intervallic training in people with Adolescent Behavior, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

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 2 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 8 May 2024. 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 Spain. 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 to baseline to 8 week of Cardiovascular capacity (time frame: Two times. Baseline and 8 week later). The study lists 3 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 NCT05544370, 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 8 May 2024.

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