- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07311460
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
28
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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.
Investigators
- 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)
November 1, 2024
Primary Completion (Actual)
January 25, 2025
Study Completion (Actual)
January 25, 2025
Study Registration Dates
First Submitted
November 20, 2025
First Submitted That Met QC Criteria
December 21, 2025
First Posted (Actual)
December 31, 2025
Study Record Updates
Last Update Posted (Actual)
December 31, 2025
Last Update Submitted That Met QC Criteria
December 21, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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