HIIT, Steroid Hormones and Mental Health in Adolescents

December 21, 2025 updated by: Nejmeddine Ouerghi, High Institute of Sports and Physical Education of Kef

The Effects of High-intensity Interval Training on Selected Steroid Hormones and Psychological Features in Healthy Male Adolescents: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

High-intensity interval training (HIIT) is a time-efficient method for improving physical fitness in youth. However, limited evidence exists regarding its effects on testosterone and cortisol levels, testosterone:cortisol ratio, and mental health outcomes during adolescence, a critical period of development. This study was to investigate the effect of a HIIT intervention on cardiorespiratory fitness (CRF, expressed as maximal aerobic speed and maximal oxygen consumption), hormonal, and mental health markers in male adolescents. Twenty-eight healthy male adolescents (age, 14.9±0.74 yrs.) were randomized to a HIIT group (HIITG, n=15) or a non-training control group (CG, n=13). 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% MAS) between bouts. Pre- and post-intervention assessments included CRF (VO2max), hormonal markers (testosterone, cortisol, and testosterone:cortisol ratio), and mental health markers (depression, anxiety and stress scores).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Boulifa
      • El Kef, Boulifa, Tunisia, 7100
        • Tunisia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-intensity interval training (HIIT) group
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
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.
No Intervention: Control group
The participants in the control group maintained their normal daily activities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Testosterone
Time Frame: One day before the start and two days after the completion of the 10 weeks of training program.
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
Time Frame: One day before the start and two days after the completion of the 10 weeks of training program.
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
Time Frame: One day before the start and two days after the completion of the 10 weeks of training program.
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)
Time Frame: Before the start and after the completion of the 10 weeks of training program.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximal aerobic speed
Time Frame: Before and after the 10 weeks of the training program.
Maximal aerobic speed (MAS), expressed in km/h, was determined using the incremental running test (20-m shuttle run test) as previously described by (Léger et al. 1982). The test was designed to assess the aerobic capacity of schoolchildren, healthy adolescents, and adults.
Before and after the 10 weeks of the training program.
Maximal oxygen consumption
Time Frame: Before and after the 10 weeks of the training program.
Maximal oxygen consumption (VO2max), expressed in mL/kg/min, was determined using the incremental running test (20-m shuttle run test) as previously described by (Léger et al. 1982). The test was designed to assess the aerobic capacity of schoolchildren, healthy adolescents, and adults.
Before and after the 10 weeks of the training program.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
High Institute of Sports and Physical Education of Kef

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIIT-ADO-Stroid-H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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