NCT07311460

Brief Summary

The purpose of study was to investigate the effect of a high-intensity interval training (HIIT) intervention on cardiorespiratory fitness (CRF), hormonal, and mental health markers in male adolescents. The main question it aims to answer is: Does HIIT improve CRF, hormonal (testosterone and cortisol levels, testosterone:cortisol ratio), and mental health (depression, anxiety and stress scores) markers. Researchers will compare HIIT (designed to experimental group) to non-training intervention (designed to control group) to see if the training program works to improve the health status. HIIT consisted of three sessions per week for 10 weeks, comprising of three sets of four to eight bouts of 30-s runs at high intensity \[100-110% of maximal aerobic speed (MAS)\], interspersed with 30-s recovery runs at low intensity (50% of MAS) between bouts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
Last Updated

December 31, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 20, 2025

Last Update Submit

December 21, 2025

Conditions

Keywords

adolescenceshormonestraining periodmental healthphysical performance

Outcome Measures

Primary Outcomes (4)

  • Testosterone

    Testosterone concentration, expressed in nmol/L, was analyzed using enzyme-linked immunosorbent assay (ELISA) kits (Monobind, Inc., Lake Forest, CA).

    One day before the start and two days after the completion of the 10 weeks of training program.

  • Cortisol

    Cortisol concentration, expressed in nmol/L, was analyzed using enzyme-linked immunosorbent assay (ELISA) kits (Monobind, Inc., Lake Forest, CA).

    One day before the start and two days after the completion of the 10 weeks of training program.

  • The testosterone/cortisol ratio

    The testosterone/cortisol ratio (T/C) was calculated by dividing the testosterone value by the cortisol value for each participant.

    One day before the start and two days after the completion of the 10 weeks of training program.

  • Depression, Anxiety, and Stress Scale - 21 items (DASS-21)

    The DASS-21 is a self-report questionnaire that assesses symptoms of depression, anxiety, and stress (Lai et al., 2015). Each item is scored from 0 to 3, yielding a total score ranging from 0 to 63. Higher scores indicate worse psychological symptoms (greater levels of depression, anxiety, or stress). In the present study, we used the Arabic version of the DASS-21, which has been validated and shown to have good psychometric properties (Moussa et al., 2017), to ensure linguistic and cultural appropriateness for assessing adolescents' psychological well-being.

    Before the start and after the completion of the 10 weeks of training program.

Secondary Outcomes (2)

  • Maximal aerobic speed

    Before and after the 10 weeks of the training program.

  • Maximal oxygen consumption

    Before and after the 10 weeks of the training program.

Study Arms (2)

High-intensity interval training (HIIT) group

EXPERIMENTAL

The HIIT group performed a HIIT program consisting of three sessions per week for 10 weeks, including three sets of four to eight bouts of 30-second runs at high intensity (100-110% of maximal aerobic speed, MAS), interspersed with 30-second recovery runs at low intensity (50% MAS) between bouts.

Behavioral: High-intensity interval training (HIIT) program

Control group

NO INTERVENTION

The participants in the control group maintained their normal daily activities.

Interventions

The HIIT program consisted of three sessions per week for 10 weeks, comprising of three sets of four to eight bouts of 30-s runs at high intensity \[100-110% of maximal aerobic speed (MAS)\], interspersed with 30-s recovery runs at low intensity (50% MAS) between bouts.

High-intensity interval training (HIIT) group

Eligibility Criteria

Age14 Years - 16 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • male sex,
  • age 14 to 16 years,
  • normal weight according to the WHO child growth standards for BMI (BMI ≤ 85th percentile)
  • parental approval.

You may not qualify if:

  • medical conditions contraindicating intense physical exercise
  • non-compliance with the training program
  • habitual physical activity exceeding school physical education lessons
  • current or recent (within 3 months) dietary supplementation or restriction
  • incomplete data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tunisia

El Kef, Boulifa, 7100, Tunisia

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nejmeddine Ouerghi, Ph.D

    Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 31, 2025

Study Start

November 1, 2024

Primary Completion

January 25, 2025

Study Completion

January 25, 2025

Last Updated

December 31, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations