HormoneNCT07311460
HIIT, Steroid Hormones and Mental Health in Adolescents
A study testing High-intensity interval training (HIIT) program in people with Hormone, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 16 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hormone
- What is being tested?
- High-intensity interval training (HIIT) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Nov 2024to 25 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 16 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- male sex,
- age 14 to 16 years,
- normal weight according to the WHO child growth standards for BMI (BMI ≤ 85th percentile)
- parental approval.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Hormone
- Being tested
- High-intensity interval training (HIIT) program
- Keywords
- adolescences, hormones, training period, mental health, physical performance
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval training (HIIT) programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: High-intensity interval training (HIIT) program |
| Control group | No intervention | The participants in the control group maintained their normal daily activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone
Testosterone concentration, expressed in nmol/L, was analyzed using enzyme-linked immunosorbent assay (ELISA) kits (Monobind, Inc., Lake Forest, CA).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Before the start and after the completion of the 10 weeks of training program.
Secondary outcomes (2)
Maximal aerobic speed
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.
Measured: Before and after the 10 weeks of the training program.
Maximal oxygen consumption
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.
Measured: Before and after the 10 weeks of the training program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Nov 2024
- Primary completion25 Jan 2025
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HormoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Institute of Sports and Physical Education of Kef
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nejmeddine Ouerghi, High Institute of Sports and Physical Education of Kef
- Investigators
- Nejmeddine Ouerghi, Ph.D, Principal investigator, Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311460
- Sponsor's protocol ID
- HIIT-ADO-Stroid-H
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-intensity Interval Training on Selected Steroid Hormones and Psychological Features in Healthy Male Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07311460
- Acronym / sponsor ID
- HIIT-ADO-Stroid-H
- Conditions
- Hormone
- Keywords
- adolescences, hormones, training period, mental health, physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- High Institute of Sports and Physical Education of KefUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training (HIIT) group | Experimental | Behavioral: High-intensity interval training (HIIT) programThe 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. |
| Control group | No intervention | –The participants in the control group maintained their normal daily activities. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- male sex,
- age 14 to 16 years,
- normal weight according to the WHO child growth standards for BMI (BMI ≤ 85th percentile)
- parental approval.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval training (HIIT) programThe 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. | Behavioural | High-intensity interval training (HIIT) group |
Primary outcome
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).
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).
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.
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.
2 secondary outcomes
Maximal aerobic speed
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nejmeddine Ouerghi, Ph.D principal investigator
Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training (HIIT) program in people with Hormone, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 31 Dec 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 Tunisia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testosterone (time frame: One day before the start and two days after the completion of the 10 weeks of training program.). The study lists 4 primary outcomes in all. 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 31 Dec 2025.