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NCT Number: NCT07397702

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

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.

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Key information

Conditions

Exercise Anxiety Disorders Behavior Depressive Disorder Mental Disorders Mood Disorders Motor Activity

Age range

18 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-intensity interval training

Other

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 Training

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis Jaime Orozco Milanez, M. Sc.

CONTACT

[email protected]

+(52) 312 209 5656

Sponsors and collaborators

Lead sponsor

Universidad de Colima

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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