Effects of HIIT and MICT Training on Cardiorespiratory Fitness, Testosterone/Cortisol Ratio, and Mental Health in Young Adults

February 4, 2026 updated by: Pedro Julian Flores Moreno, Universidad de Colima

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

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 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 (Estimated)

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.
76

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Luis Jaime Orozco Milanez, M. Sc.
  • Phone Number: +(52) 312 209 5656
  • Email: lorozco2@ucol.mx

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.
  • 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.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Group A: high-intensity interval training program
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.
Other: High-intensity interval training
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.
Active Comparator: Group B: moderate-intensity continuous training program
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.
Other: Moderate-intensity continuous training
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.

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
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.
Baseline and week 8 of training.
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.
Baseline and week 8 of training.
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.
Baseline and week 8 of training.
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.
Baseline and week 8 of training.
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.
Baseline and week 8 of training.

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.
Universidad de Colima

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.
  • Study Chair: Pedro Julián Flores Moreno, Universidad de Colima

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

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.
May 25, 2026

Primary Completion (Estimated)

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.
July 24, 2026

Study Completion (Estimated)

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.
August 7, 2026

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).
January 5, 2026

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.
February 4, 2026

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.
February 9, 2026

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.
February 9, 2026

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.
February 4, 2026

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.
February 1, 2026

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.
  • 2025-23b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the plan to share information with other researchers through the publication of different articles that can be extracted from the research

IPD Sharing Time Frame

The information will be available as of August 2026

IPD Sharing Access Criteria

To have access to these data, other researchers must be performing the same methodological design, so there is no point in sharing it with a different study design

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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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