NCT06727500

Brief 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 \[APHV\] 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Apr 2025Sep 2026

First Submitted

Initial submission to the registry

December 2, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

September 5, 2025

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

December 2, 2024

Last Update Submit

August 28, 2025

Conditions

Keywords

Pediatric obesityHigh-intensity interval trainingTendon mechanical propertiesPlyometric trainingBiological maturation stages

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (35)

  • Achilles Tendon Young Modulus

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

  • Achilles Tendon Force (N)

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

  • Achilles Tendon Elongation (mm)

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

  • Achilles Tendon Stress (MPa)

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

  • Achilles Tendon Strain (%)

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

  • +30 more secondary outcomes

Study Arms (4)

pre-PHV HIIT plus plyometric training

EXPERIMENTAL

Twelve weeks, three times per week of HIIT plus plyometric training in a sample of obese pre-APHV (initial biological maturational stage).

Behavioral: HIIT plus plyometric training

post-APHV HIIT plus plyometric training

EXPERIMENTAL

Twelve weeks, three times per week of HIIT plus plyometric training in a sample of obese post-APHV (final biological maturational stage).

Behavioral: HIIT plus plyometric training

pre-APHV HIIT

ACTIVE COMPARATOR

Twelve weeks, three times per week of HIIT in a sample of obese pre-APHV (initial biological maturational stage).

Behavioral: HIIT

post-APHV HIIT

ACTIVE COMPARATOR

Twelve weeks, three times per week of HIIT in a sample of obese post-APHV (initial biological maturational stage).

Behavioral: HIIT

Interventions

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.

post-APHV HIIT plus plyometric trainingpre-PHV HIIT plus plyometric training
HIITBEHAVIORAL

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.

post-APHV HIITpre-APHV HIIT

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise and Rehabilitation Sciences Institute, School of Physical Therapy, Faculty of Rehabilitation Sciences, Universidad Andres Bello, Santiago, Chile

Santiago, Chile

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator: PhD. Rodrigo Ramirez-Campillo

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 11, 2024

Study Start

April 1, 2025

Primary Completion

August 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

September 5, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations