ExerciseNCT07397702
Effects of HIIT and MICT Training on Cardiorespiratory Fitness, Testosterone/Cortisol Ratio, and Mental Health in Young Adults
A study testing High-intensity interval training and Moderate-intensity continuous training in people with Exercise, run by Universidad de Colima.
Trial summary
This study will use a randomized, double-blind clinical trial to evaluate the effects of eight-week HIIT and MICT exercise programs on cardiorespiratory fitness, the testosterone/cortisol ratio, and mental health in 68 healthy, moderately active young adults aged 18 to 21. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- High-intensity interval training and Moderate-intensity continuous training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2026to 7 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 to 21.
- Lead a sedentary or moderately active lifestyle (IPAQ ≤600 METs-min/week).
- Subjects diagnosed by a physician as fit for physical exercise.
- Informed consent form signed by the study subjects.
Who cannot join
- Subjects with any motor disability.
- Pregnant women.
- Subjects with metabolic disorders.
- Subjects with chronic respiratory diseases such as asthma, emphysema, or cancer, obstructive pulmonary disease.
- Subjects with high blood pressure or arrhythmia.
- Failure to sign the informed consent form.
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- Subjects who are in a high-performance physical training program.
- Women with irregular menstrual cycles who take contraceptive medication to regulate their menstrual cycle.
- Consumption of caffeine, alcohol, and tobacco or use of electronic cigarettes.
- Subjects with a cyclical diagnosis of anxiety and depression by a specialist.
- Frequent consumption of alcoholic beverages (more than 7 drinks per week for women and more than 14 drinks per week for men) or a history of excessive alcohol consumption.
- Subjects who consume dietary supplements (caffeine, nitric oxide precursors, beta-alanine, creatine, sodium bicarbonate, or L-carnitine).
- Elimination criteria:
- Voluntary withdrawal from the study.
- Attendance at less than 80% of intervention sessions.
- Incomplete measurement schedule or insufficient sample size.
- Joint or muscle injuries caused by the training program.
- Overtraining syndrome.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of HIIT and MICT Training on Cardiorespiratory Fitness, Testosterone/Cortisol Ratio, and Mental Health in Young Adults: an 8-week Randomized Clinical Trial
This study will use a randomized, double-blind clinical trial to evaluate the effects of eight-week HIIT and MICT exercise programs on cardiorespiratory fitness, the testosterone/cortisol ratio, and mental health in 68 healthy, moderately active young adults aged 18 to 21. Participants will be assigned to parallel groups based on their sex and training type (HIIT men, HIIT women, MICT men, MICT women). The key metrics will be measured both before and after the intervention period to assess the impact of the different training regimens.
Read the detailed description
This randomized, double-blind clinical trial will investigate the effects of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on cardiorespiratory fitness and symptoms of anxiety and depression in high school students.
The study will recruit 68 male and female students, aged 15-19, who are moderately inactive. Participants will be randomized into HIIT or MICT groups, stratified by gender. The 8-week intervention consists of three weekly sessions: HIIT involves 10x1-minute high-intensity intervals, while MICT consists of 30 minutes of continuous running. Cardiorespiratory fitness (measured via the Course Navette test to estimate VO₂max) and mental health symptoms (using Beck inventories) will be assessed before and after the intervention.
The primary hypothesis is that HIIT will yield greater improvements in VO₂max and greater reductions in anxiety and depression symptoms compared to MICT. Statistical analysis will employ ANOVA and related tests to evaluate changes within and between groups, with a significance level set at p<0.05. The study aims to provide evidence for designing personalized exercise programs that optimize both physical and mental health in adolescents.
- Conditions
- Exercise
- Being tested
- High-intensity interval training, Moderate-intensity continuous training
- Keywords
- High-Intensity Interval Training, Aerobic Exercise, Testosterone, Cortisol, Anxiety Disorders, Depressive Disorder
- Medical subject headings
- Motor Activity, Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingOther
The intervention involves physical exercise with the aim of observing any changes that may occur in mental health and hormonal parameters. However, the magnitude of these effects and the type of exercise that is most effective in reducing symptoms of anxiety and depression are still unknown.
Moderate-intensity continuous trainingOther
The intervention involves physical exercise with the aim of observing any changes that may occur in mental health and hormonal parameters. However, the magnitude of these effects and the type of exercise that is most effective in reducing symptoms of anxiety and depression are still unknown.
| Study group | Role | What they receive |
|---|---|---|
| Group A: high-intensity interval training program | Experimental | High-intensity interval training (HIIT) sessions will consist of continuous running for a 5-minute warm-up at 75% of maximum heart rate (HRmax), followed by 10 repetitions of intermittent running in 1-minute intervals at 85-90% of HRmax, intercalated with 1-minute recovery periods at 50-60% of HRmax. There will be 3 sessions per week (75-minute weekly training). All HIIT intervention sessions end with a cool-down walk and stretching. Receives: Other: High-intensity interval training |
| Group B: moderate-intensity continuous training program | Active comparator | Moderate-intensity continuous training (MICT) sessions will consist of running continuously for 30 minutes at an intensity of 60-70% of HRmax, with a frequency of 3 sessions per week (60 minutes of training per week). All sessions with MICT intervention end with a cool-down walk and stretching. Receives: Other: Moderate-intensity continuous training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of anxiety from baseline to eight weeks.
The measurement of anxiety symptoms will be conducted using the Beck Anxiety Inventory (BAI) in printed format, which is a validated psychological tool used to assess the severity of anxiety symptoms in adults. The total score is interpreted on a scale from 0 to 63, where a score of 0 indicates the absence of anxiety symptoms, and higher scores reflect increasing levels of anxiety, with the upper values representing severe anxiety.
Measured: Baseline and week 8 of training.
Symptoms of depression from baseline to eight weeks.
The measurement of depression symptoms will be conducted using the Beck Depression Inventory (BDI) in printed format, which is a validated psychological tool used to assess the severity of depression symptoms in adults. The total score is interpreted on a scale from 0 to 63, where a score of 0 indicates the absence of depression symptoms, and higher scores reflect increasing levels of depression, with the upper values representing severe depression.
Measured: Baseline and week 8 of training.
Testosterone levels using the ELISA method
Testosterone and cortisol levels will also be determined in picograms per milliliter (pg/mL) using the enzyme-linked immunosorbent assay (ELISA) method, which is employed to quantify hormones, cytokines, and other proteins in blood or other biological fluids.
Measured: Baseline and week 8 of training.
Cortisol levels using the ELISA method
Cortisol levels will also be determined in picograms per milliliter (pg/mL) using the enzyme-linked immunosorbent assay (ELISA) method, which is employed to quantify hormones, cytokines, and other proteins in blood or other biological fluids.
Measured: Baseline and week 8 of training.
Cardiorespiratory capacity using VO₂max
Cardiorespiratory capacity will be assessed using the 20-meter run test, with maximal oxygen uptake (VO₂max), expressed in millilitres per minute per kilogram (mL/kg/min), as the main indicator. The test consists of running back and forth between two points separated by 20 meters, following a pace dictated by auditory signals; as the test progresses, the running speed gradually increases.
Measured: Baseline and week 8 of training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start25 May 2026 (estimated)
- Primary completion24 Jul 2026 (estimated)
- Study completion7 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Beck scales will be applied to assess anxiety and depression. Subsequently, cardiorespiratory fitness will be assessed by means of the Course Navette test, which consists of running at a progressive speed in 20 meters delimited following a sound signal until exhaustion, at the end of the test the final distance run is recorded and converted into VO2max. These measurements will be performed during week 0 (pre-training) and week 8 (post-training). Training intensity will be monitored by maximum heart rate (HRmax), using Polar H10 heart monitors, and will be complemented with the subjective perception of exertion scale, following the recommendations of the American College of Sports Medicine. Training programs: a) HIIT group: running 10 repetitions of 1-minute intervals at 85-90% of HRmax, interspersed with 1-minute recovery at 50-60% of HRmax. b) MICT group: perform 30 minutes of continuous aerobic running at 60-70% of HRmax, with a frequency of 3 weekly sessions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Colima
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Julian Flores Moreno, Universidad de Colima
- Investigators
- Pedro Julián Flores Moreno, Study chair, Universidad de Colima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397702
- Sponsor's protocol ID
- 2025-23b
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the plan to share information with other researchers through the publication of different articles that can be extracted from the research
Publications
Velasco-Orjuela GP, Dominguez-Sanchez MA, Hernandez E, Correa-Bautista JE, Triana-Reina HR, Garcia-Hermoso A, Pena-Ibagon JC, Izquierdo M, Cadore EL, Hackney AC, Ramirez-Velez R. Acute effects of high-intensity interval, resistance or combined exercise protocols on testosterone - cortisol responses in inactive overweight individuals. Physiol Behav. 2018 Oct 1;194:401-409. doi: 10.1016/j.physbeh.2018.06.034. Epub 2018 Jun 22.
PubMed 29940266Paolucci EM, Loukov D, Bowdish DME, Heisz JJ. Exercise reduces depression and inflammation but intensity matters. Biol Psychol. 2018 Mar;133:79-84. doi: 10.1016/j.biopsycho.2018.01.015. Epub 2018 Feb 3.
PubMed 29408464
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of HIIT and MICT Training on Cardiorespiratory Fitness, Testosterone/Cortisol Ratio, and Mental Health in Young Adults: an 8-week Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07397702
- Acronym / sponsor ID
- 2025-23b
- Conditions
- Exercise
- Keywords
- High-Intensity Interval Training, Aerobic Exercise, Testosterone, Cortisol, Anxiety Disorders, Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Universidad de ColimaUniversity, hospital or other
- Study start
- 25 May 2026 (estimated)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 7 Aug 2026 (estimated)
- First posted
- 9 Feb 2026 (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.
This study will use a randomized, double-blind clinical trial to evaluate the effects of eight-week HIIT and MICT exercise programs on cardiorespiratory fitness, the testosterone/cortisol ratio, and mental health in 68 healthy, moderately active young adults aged 18 to 21. Participants will be assigned to parallel groups based on their sex and training type (HIIT men, HIIT women, MICT men, MICT women). The key metrics will be measured both before and after the intervention period to assess the impact of the different training regimens.
Detailed description
This randomized, double-blind clinical trial will investigate the effects of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on cardiorespiratory fitness and symptoms of anxiety and depression in high school students.
The study will recruit 68 male and female students, aged 15-19, who are moderately inactive. Participants will be randomized into HIIT or MICT groups, stratified by gender. The 8-week intervention consists of three weekly sessions: HIIT involves 10x1-minute high-intensity intervals, while MICT consists of 30 minutes of continuous running. Cardiorespiratory fitness (measured via the Course Navette test to estimate VO₂max) and mental health symptoms (using Beck inventories) will be assessed before and after the intervention.
The primary hypothesis is that HIIT will yield greater improvements in VO₂max and greater reductions in anxiety and depression symptoms compared to MICT. Statistical analysis will employ ANOVA and related tests to evaluate changes within and between groups, with a significance level set at p<0.05. The study aims to provide evidence for designing personalized exercise programs that optimize both physical and mental health in adolescents.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Beck scales will be applied to assess anxiety and depression. Subsequently, cardiorespiratory fitness will be assessed by means of the Course Navette test, which consists of running at a progressive speed in 20 meters delimited following a sound signal until exhaustion, at the end of the test the final distance run is recorded and converted into VO2max. These measurements will be performed during week 0 (pre-training) and week 8 (post-training). Training intensity will be monitored by maximum heart rate (HRmax), using Polar H10 heart monitors, and will be complemented with the subjective perception of exertion scale, following the recommendations of the American College of Sports Medicine. Training programs: a) HIIT group: running 10 repetitions of 1-minute intervals at 85-90% of HRmax, interspersed with 1-minute recovery at 50-60% of HRmax. b) MICT group: perform 30 minutes of continuous aerobic running at 60-70% of HRmax, with a frequency of 3 weekly sessions.
| Arm | Type | Receives |
|---|---|---|
| Group A: high-intensity interval training program | Experimental | Other: High-intensity interval trainingHigh-intensity interval training (HIIT) sessions will consist of continuous running for a 5-minute warm-up at 75% of maximum heart rate (HRmax), followed by 10 repetitions of intermittent running in 1-minute intervals at 85-90% of HRmax, intercalated with 1-minute recovery periods at 50-60% of HRmax. There will be 3 sessions per week (75-minute weekly training). All HIIT intervention sessions end with a cool-down walk and stretching. |
| Group B: moderate-intensity continuous training program | Active comparator | Other: Moderate-intensity continuous trainingModerate-intensity continuous training (MICT) sessions will consist of running continuously for 30 minutes at an intensity of 60-70% of HRmax, with a frequency of 3 sessions per week (60 minutes of training per week). All sessions with MICT intervention end with a cool-down walk and stretching. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women aged 18 to 21.
- Lead a sedentary or moderately active lifestyle (IPAQ ≤600 METs-min/week).
- Subjects diagnosed by a physician as fit for physical exercise.
- Informed consent form signed by the study subjects.
Key exclusion criteria (18 listed)
- Subjects with any motor disability.
- Pregnant women.
- Subjects with metabolic disorders.
- Subjects with chronic respiratory diseases such as asthma, emphysema, or cancer, obstructive pulmonary disease.
- Subjects with high blood pressure or arrhythmia.
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 trainingThe intervention involves physical exercise with the aim of observing any changes that may occur in mental health and hormonal parameters. However, the magnitude of these effects and the type of exercise that is most effective in reducing symptoms of anxiety and depression are still unknown. | Other | Group A: high-intensity interval training program |
| Moderate-intensity continuous trainingThe intervention involves physical exercise with the aim of observing any changes that may occur in mental health and hormonal parameters. However, the magnitude of these effects and the type of exercise that is most effective in reducing symptoms of anxiety and depression are still unknown. | Other | Group B: moderate-intensity continuous training program |
Primary outcome
Symptoms of anxiety from baseline to eight weeks.
Time frame: Baseline and week 8 of training.
The measurement of anxiety symptoms will be conducted using the Beck Anxiety Inventory (BAI) in printed format, which is a validated psychological tool used to assess the severity of anxiety symptoms in adults. The total score is interpreted on a scale from 0 to 63, where a score of 0 indicates the absence of anxiety symptoms, and higher scores reflect increasing levels of anxiety, with the upper values representing severe anxiety.
Symptoms of depression from baseline to eight weeks.
Time frame: Baseline and week 8 of training.
The measurement of depression symptoms will be conducted using the Beck Depression Inventory (BDI) in printed format, which is a validated psychological tool used to assess the severity of depression symptoms in adults. The total score is interpreted on a scale from 0 to 63, where a score of 0 indicates the absence of depression symptoms, and higher scores reflect increasing levels of depression, with the upper values representing severe depression.
Testosterone levels using the ELISA method
Time frame: Baseline and week 8 of training.
Testosterone and cortisol levels will also be determined in picograms per milliliter (pg/mL) using the enzyme-linked immunosorbent assay (ELISA) method, which is employed to quantify hormones, cytokines, and other proteins in blood or other biological fluids.
Cortisol levels using the ELISA method
Time frame: Baseline and week 8 of training.
Cortisol levels will also be determined in picograms per milliliter (pg/mL) using the enzyme-linked immunosorbent assay (ELISA) method, which is employed to quantify hormones, cytokines, and other proteins in blood or other biological fluids.
Cardiorespiratory capacity using VO₂max
Time frame: Baseline and week 8 of training.
Cardiorespiratory capacity will be assessed using the 20-meter run test, with maximal oxygen uptake (VO₂max), expressed in millilitres per minute per kilogram (mL/kg/min), as the main indicator. The test consists of running back and forth between two points separated by 20 meters, following a pace dictated by auditory signals; as the test progresses, the running speed gradually increases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 29940266Velasco-Orjuela GP, Dominguez-Sanchez MA, Hernandez E, Correa-Bautista JE, Triana-Reina HR, Garcia-Hermoso A, Pena-Ibagon JC, Izquierdo M, Cadore EL, Hackney AC, Ramirez-Velez R. Acute effects of high-intensity interval, resistance or combined exercise protocols on testosterone - cortisol responses in inactive overweight individuals. Physiol Behav. 2018 Oct 1;194:401-409. doi: 10.1016/j.physbeh.2018.06.034. Epub 2018 Jun 22.
- Results publication: PubMed 29408464Paolucci EM, Loukov D, Bowdish DME, Heisz JJ. Exercise reduces depression and inflammation but intensity matters. Biol Psychol. 2018 Mar;133:79-84. doi: 10.1016/j.biopsycho.2018.01.015. Epub 2018 Feb 3.
- Transforming mental health for allLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. the plan to share information with other researchers through the publication of different articles that can be extracted from the research
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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.
Pedro Julián Flores Moreno study chair
Universidad de Colima
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Moderate-intensity continuous training in people with Exercise, run by Universidad de Colima.
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 18 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: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Jaime Orozco Milanez, M. Sc. (+(52) 312 209 5656, lorozco2@ucol.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of anxiety from baseline to eight weeks. (time frame: Baseline and week 8 of training.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07397702, which also lists 2 linked publications.
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 9 Feb 2026.