AzTrials
AzTrials

Pediatric ObesityHIIT-PRO-kidsNCT06727500

Effects of HIIT and Concurrent HITT/Plyometric Training on Muscle-tendon Structure, Function and Metabolism in Pediatric Population With Obesity at Different Biological Maturation States (HIIT-PRO Kids).

A study testing HIIT plus plyometric training and HIIT in people with Pediatric Obesity and Training Effectiveness, run by Universidad Nacional Andres Bello at 1 site in Chile.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The randomized controlled trial will compare the effects of a High-intensity interval training (HIIT) protocol versus a HIIT plus plyometric training in the muscle-tendon structure function and metabolism of the pediatric population with obesity at different biological maturational stages (pre-to-age peak velocity… Read more about this study

Who is it for?
Ages 7 to 17 years
Conditions the study is for
Pediatric Obesity, Training Effectiveness
What is being tested?
HIIT plus plyometric training and HIIT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChile
Study dates
1 Apr 2025to 1 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 7 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Pediatric population with obesity determined by the body mass index by z-score (BMI-z) ≥ 2 standard deviations (SD) and ≤ 3.5 SD of the median for age and sex.
  • Pediatric population with -1 to -3 APHV (pre-APHV) and +1 to +3 APHV (post-APHV).

Who cannot join

  • Cognitive Disabilities.
  • Musculoskeletal condition that prevents regular physical activity.
  • Severe heart diseases that contraindicate the practice of physical activity.
  • Individuals who perform supervised exercise in the past six months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chile1 site, 1 recruiting
  • Exercise and Rehabilitation Sciences Institute, School of Physical Therapy, Faculty of Rehabilitation Sciences, Universidad Andres Bello, Santiago, Chile

    Santiago

    Rodrigo Ramirez-Campillo, MSc. PhD., +56951399868, rodrigo.ramirez@unab.cl

    Mauricio Inostroza-Mondaca, MSc., +56958483594, inostroza.mauro@gmail.com

    Recruiting

Other trials in Chile

About this study

Official title: Effects of HIIT and Concurrent HITT/Plyometric Training on Muscle-tendon Structure, Function and Metabolism in Pediatric Population With Obesity at Different Biological Maturation States (HIIT-PRO Kids): A Study Protocol of Randomized Controlled Trial

The randomized controlled trial will compare the effects of a High-intensity interval training (HIIT) protocol versus a HIIT plus plyometric training in the muscle-tendon structure function and metabolism of the pediatric population with obesity at different biological maturational stages (pre-to-age peak velocity [APHV] and post-APHV). Both groups perform baseline evaluations of the main and secondary outcomes and receive the intervention for twelve weeks, three times per week. Once the interventions are completed, the participants undergo the same evaluations they performed at baseline.

Read the detailed description

The prevalence of pediatric obesity increased 4.2-fold between 1976 and 2022, and it's expected to continue increasing toward 2030. Pediatric obesity is a public health problem due to its multiple metabolic comorbidities. Moreover, body weight and fat infiltration due to pediatric obesity negatively affect muscle-tendon structure, function, and metabolism, negatively impacting physical activity levels, active play, functional performance (e.g., jumping capacity), and quality of life. As a solution, HIIT protocols could decrease body weight and fat percentage and increase muscle oxidative capacity. The addition of plyometric training to HIIT protocols could generate the same effects as the HIIT protocol alone, with an additional enhancement in functional performance. However, the influence of biological maturation stages in the adaptations to training in pediatric population with obesity has been scarcely reported. Thus, throughout different biological maturation stages, such as pre-to-age peak velocity (APHV) (early stage of biological maturation) to post-APHV (final stage of biological maturation stage), an increase in testosterone, growth factors, and glycolytic metabolism capacity occurs. Therefore, the differences in the anabolic milieu and glycolytic metabolism between the pre-APHV and post-APHV could produce a differential capacity of training stimuli to modify the muscle-tendon, structure, function, and metabolism in these pediatric population with obesity. Therefore, this study aims to determine the effects of HIIT and concurrent HIIT and plyometric training in the muscle-tendon structure, function, and metabolism of the pediatric population with obesity in different maturation stages.

The study will be a parallel-group randomized controlled trial that compares the effects of HIIT versus HIIT plus plyometric training on muscle-tendon structure, function, and metabolism in the pediatric population pre-APHV and post-APHV with obesity in a public health setting. The primary outcome will be the Achilles tendon mechanical properties. We estimate a sample size of 10 participants per group and 40 in total.

The investigators aim to demonstrate the beneficial effects of HIIT plus plyometric training on the muscle-tendon structure and metabolism of the pediatric obesity population. Moreover, the researchers expected a difference in the adaptations provided by the training protocol between the pre-APHV and post-APHV groups.

Being tested
HIIT plus plyometric training, HIIT
Keywords
Pediatric obesity, High-intensity interval training, Tendon mechanical properties, Plyometric training, Biological maturation stages
Medical subject headings
Pediatric Obesity

What participants receive

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

  • HIIT plus plyometric trainingBehavioural

    The HIIT plus plyometric training will perform two weeks of exercise adaptation involving 25 minutes of MICT at 65% of maximal heart rate (HRmax) and 5 minutes of jumps in place at 5 - 6 of the EPinfant scale of Perceived exertion. The HIIT plus plyometric training will perform 15 minutes of HIIT and 5 minutes of jumps each session. The HIIT phase will be performed in a work recovery intensity at 85 and 50% of the HRmax. The work phase of jumps will be performed "all out," and the recovery phase will be performed at 5 - 6 of the EPinfant scale of perceived exertion. The work: recovery bouts will be progressed from 1:4 (15 seconds: 60 seconds) at weeks 3-6, to 1:3 (15 seconds: 45 seconds) at weeks 7-9, and to 1:3 (15 seconds: 30 seconds) at weeks 10-12. In all sessions, the rate of perceived exertion, heart rate, and exercise planning compliance will be measured.

  • HIITBehavioural

    The HIIT group will perform two weeks of exercise adaptation involving 30 minutes of moderate-intensity continuous training (MICT) at 65% of the maximal heart rate (HRmax) reached in the maximal oxygen consumption test. The HIIT group will perform 20 minutes of HIIT each session, with a work: recovery intensity at 85% and 50% of HRmax, respectively. The work: recovery bouts will be progressed from 1:4 (15 seconds:60 seconds) at weeks 3-6, to 1:3 (15 seconds:45 seconds) at weeks 7-9, and to 1:2 (15 seconds: 30 seconds) at weeks 10-12. In all sessions, the rate of perceived exertion, heart rate, and exercise planning compliance will be measured.

Study groups in NCT06727500
Study groupRoleWhat they receive
pre-PHV HIIT plus plyometric trainingExperimentalTwelve weeks, three times per week of HIIT plus plyometric training in a sample of obese pre-APHV (initial biological maturational stage).
Receives: Behavioral: HIIT plus plyometric training
post-APHV HIIT plus plyometric trainingExperimentalTwelve weeks, three times per week of HIIT plus plyometric training in a sample of obese post-APHV (final biological maturational stage).
Receives: Behavioral: HIIT plus plyometric training
pre-APHV HIITActive comparatorTwelve weeks, three times per week of HIIT in a sample of obese pre-APHV (initial biological maturational stage).
Receives: Behavioral: HIIT
post-APHV HIITActive comparatorTwelve weeks, three times per week of HIIT in a sample of obese post-APHV (initial biological maturational stage).
Receives: Behavioral: HIIT

What is being measured

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

  1. Achilles Tendon Stiffnes (N/mm)

    The stiffness will be estimated as the slope of the linear tendon elongation-force relationship above 50% of each participant's maximum attained force.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

Secondary outcomes (35)
  1. Achilles Tendon Young Modulus

    The Achilles tendon young modulus will be estimated as the slope of the linear tendon stress-strain relationship above 50% of each participant's maximum attained force.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  2. Achilles Tendon Force (N)

    The Achilles tendon force of the Achilles tendon will be calculated as the plantar flexors torque divided by the Achilles tendon moment arm plus the dorsiflexor contribution.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  3. Achilles Tendon Elongation (mm)

    Tendon elongation will be measured as the Achilles tendon myotendinous junction displacement (ArtUS, Telemed, Vilnius, Lithuania) from rest in the MIVC trials. The tendon lengthening will be normalized by the Achilles tendon moment arm.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  4. Achilles Tendon Stress (MPa)

    The tendon stress will be calculated as the ratio between the mean maximum attained force and the smallest cross-sectional area measured for each participant.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  5. Achilles Tendon Strain (%)

    The tendon strain will be calculated as the tendon elongation associated with the peak tendon force relative to its resting length.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  6. Gastrocnemius Medialis Thickness (mm)

    To determine the gastrocnemius medialis thickness, the children will be measured in a prone position with the knee fully extended and the ankle at 90°. A B-mode ultrasound (ArtUS, Telemed, Vilnius, Lithuania) will take images at 20%, 30%, and 40% of the tibial length, defined as the distance from the popliteal crease to the midpoint of the lateral malleolus. Muscle thickness will be defined as the perpendicular distance between superficial and deep aponeurosis.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  7. Gastrocnemius Medialis Pennation Angle (°)

    To determine the gastrocnemius medialis pennation angle, the children will be measured in a prone position with the knee fully extended and the ankle at 90°. A B-mode ultrasound (ArtUS, Telemed, Vilnius, Lithuania) will take images at 20%, 30%, and 40% of the tibial length, defined as the distance from the popliteal crease to the midpoint of the lateral malleolus. Pennation angle will be defined as the angle between the deep aponeurosis and the echoes of the interspace between the fibers bundles.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  8. Gastrocnemius Medialis Fascicle Length (mm)

    To determine the gastrocnemius medialis fascicle length, the children will be measured in a prone position with the knee fully extended and the ankle at 90°. A B-mode ultrasound (ArtUS, Telemed, Vilnius, Lithuania) will take images at 20%, 30%, and 40% of the tibial length, defined as the distance from the popliteal crease to the midpoint of the lateral malleolus. The fascicle length will be derived through the means of trigonometry using the values of muscle thickness and pennation angle.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  9. Gastrocnemius Medialis Echo-Intensity (U.A).

    To determine the gastrocnemius medialis echo-intensity, the children will be measured in a prone position with the knee fully extended and the ankle at 90°. A B-mode ultrasound (ArtUS, Telemed, Vilnius, Lithuania) will take images at 20%, 30%, and 40% of the tibial length, defined as the distance from the popliteal crease to the midpoint of the lateral malleolus. The echo intensity will be measured as the mean of pixel intensity in a region of interest.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  10. Plantar Flexors Maximal Isometric Voluntary Contraction (Nm)

    The MVIC will be assessed in a prone position with the knee fully extended with the ankle at 90° in a dynamometer (Isoforce, TUR, Germany). Participants will perform three submaximal contractions of the plantar flexors at 50%, 70%, and 90% of the MIVC and three attempts to reach the MIVC separated by 1 minute of rest. The participants will perform three attempts to reach the MIVC under the instruction to perform "as fast as possible".

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  11. Plantar Flexors Rate of Force Development (Nm/s)

    The participants will perform three attempts to reach the MIVC under the instruction to perform "as fast as possible." with this consideration, we will calculate the rate of force development (RFD) offline. The RFD will calculate the change in force per time interval at 50, 100, 200, and 400 ms using a custom-written program.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  12. Maxymal Oxygen Consumption (ml/kg/min)

    Participants will perform a treadmill (HP cosmos, LE 200 CE model, Germany) maximal oxygen consumption test (Cosmed, Quark CPET, Italy) until exhaustion. The VO2 peak will be taken at the highest 10 seconds average until exhaustion, and the gas exchange threshold (GET) will be calculated with the V-slope method.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  13. Oxygen Uptake Kinetics (s)

    To determine the VO2 kinetics, the participants will complete four "step" tests. The "step" test will consist of a transition for the rest to running at 90% of the GET for 6 minutes, to perform a second "step" test of the heart rate, VO2, dioxide carbon production (VCO2), and Ventilation minute (VE) will return to baseline levels. Throughout the 6 minutes running at 90% GET, phase II of the VO2 kinetics will be plotted against time.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  14. Muscle oxygenation kinetics

    During the four "step" test, a Moxy monitor (Moxy, fortiori LLC, Minnesota, USA) will be ubicated in the gastrocnemius medialis to measure the total hemoglobin and muscle oxygen saturation.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  15. Lipid Profile

    Venous blood samples will be collected after 8 to 12 hours of fasting. Data from the venous samples will be used to calculate the lipid profile (triglycerides, total cholesterol, LDL cholesterol, VLDL cholesterol and HDL cholesterol).

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  16. Glycemic Control

    Venous blood samples will be collected after 8 to 12 hours of fasting. Data from the venous samples will be used to calculate the glycemic control (glycemia, insulin). The HOMA-index will calculated by dividing fasting insulin (mU/L) by glycemia (mg/dl) / 405.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  17. Low-gradde Inflammation

    Venous blood samples will be collected after 8 to 12 hours of fasting. Data from the venous samples will be used to calculate the low-grade inflammation state by reactive C protein and IL-6.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  18. Blood Pressure

    A physician will measure blood pressure on an outpatient basis using equipment appropriate for the patient arm length and age. The obtained data will be classified by sex, height, and age according to the normative values provided in the clinical guidelines for the diagnosis and management of high blood pressure in the pediatric population.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  19. Standing Broad Jump (cm)

    The standing broad jump will be assessed following the alpha fitness protocol.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  20. Squat Jump (cm)

    The squat jump will be assessed with a contact platform

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  21. Countermovement Jump

    The countermovement jump will be assessed with a contact platform

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  22. Skeletal Muscle Mass (kg)

    A Bioimpedance device (InBody770 model, South Korea) will be used for the body composition analysis. Participants will be asked to avoid exercise, caffeine for ≥ 24 hours, and food or drinks for ≥4 hours before testing, with the exception of water, which could be consumed up to 45 minutes before testing.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  23. Fat mass (kg)

    A Bioimpedance device (InBody770 model, South Korea) will be used for the body composition analysis. Participants will be asked to avoid exercise, caffeine for ≥ 24 hours, and food or drinks for ≥4 hours before testing, with the exception of water, which could be consumed up to 45 minutes before testing.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  24. Fat mass percent (%)

    A Bioimpedance device (InBody770 model, South Korea) will be used for the body composition analysis. Participants will be asked to avoid exercise, caffeine for ≥ 24 hours, and food or drinks for ≥4 hours before testing, with the exception of water, which could be consumed up to 45 minutes before testing.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  25. Visceral Adipose Tissue (cm2)

    A Bioimpedance device (InBody770 model, South Korea) will be used for the body composition analysis. Participants will be asked to avoid exercise, caffeine for ≥ 24 hours, and food or drinks for ≥4 hours before testing, with the exception of water, which could be consumed up to 45 minutes before testing.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  26. Body weight (kg)

    Body weight were obtained using a SECA® beam balance

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  27. Body Height (cm)

    Body height were obtained using a SECA® stadiometer.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  28. Body Mass Index (Kg/m2)

    Based on the weight and height measurements, BMI and BMI-z scores were calculated.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  29. Waist circumference (cm)

    Waist circumference was measured using a non-stretchable measuring tape.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  30. Waist-to-height ratio

    Using the height and waist circumference, the waist-to-height ratio (WHtR) was calculated.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  31. Measurement of Quality of Life

    The Kidscreen-27 questionnaire will be used to assess the quality of life of the pediatric population with obesity. The questionnaire consists of five dimensions, allowing detailed profile information for physical well-being, psychological well-being, autonomy, parent relations, social support, peers, school, and environment. The questionnaire was validated in the Chilean pediatric population.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  32. Physical Literacy

    The Spanish Perceived Physical Literacy Inventory will be used to assess the physical literacy of children. The questionnaire consists of three items (sense of self and self-confidence, self-expression, communication with others, and knowledge and understanding) divided into nine questions. It was validated in the Spanish language.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  33. Enjoyment

    The Physical Activity Enjoyment Scale will be used to assess the enjoyment of the two different training programs. The questionnaire consists of 16 Likert-type questions, which were validated in the Spanish language and present a Cronbach's Alpha coefficient of 0.85, informing an internal consistency of the scale.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  34. Maturity Offset

    For the male pediatric population, the formula to determine the years for APHV will be: -7.99994 + (0.0036124) x (chronological age x height), and for the female pediatric population, it will be: -7.709133 + (0.0042232) x (chronological age x height). The pediatric population with a maturity offset of less than -1 will be determined as pre-APHV and greater than +1 as post-APHV.

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

  35. Physical Activity Levels

    The questionnaire of the "Instituto de Nutrición y Tecnología de los Alimentos" will be used to assess the physical activity levels. The questionnaire was validated in the Chilean population and consists of five items: hours spent lying down, hours spent in seated activities, number of blocks walked, daily hours spent in outdoor recreational games, and weekly hours of scheduled exercises or sports. Each category will be scored from 0 to 2, so the total score ranges from 0 to 10. The score of 5 presents a specificity value of 0.89 to determine the inactive pediatric population

    Measured: Previous (T0) and posterior to twelve weeks of training (T12).

Timeline

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

  1. First posted11 Dec 2024
  2. Study start1 Apr 2025
  3. Primary completion1 Aug 2025
  4. Study completion1 Sep 2026 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06727500
Sponsor's protocol ID
03-012025M
Acronym
HIIT-PRO-kids
Status last verified
Nov 2024
First submitted
2 Dec 2024
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing HIIT plus plyometric training and HIIT in people with Pediatric Obesity and Training Effectiveness, run by Universidad Nacional Andres Bello at 1 site in Chile.

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 4 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. 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 Chile. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achilles Tendon Stiffnes (N/mm) (time frame: Previous (T0) and posterior to twelve weeks of training (T12).). 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 5 Sep 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in