NCT07397702

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

May 25, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 5, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

High-Intensity Interval TrainingAerobic ExerciseTestosteroneCortisolAnxiety DisordersDepressive Disorder

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Baseline and week 8 of training.

Study Arms (2)

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.

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.

Other: Moderate-intensity continuous training

Interventions

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.

Group A: high-intensity interval training program

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.

Group B: moderate-intensity continuous training program

Eligibility Criteria

Age18 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • Paolucci 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.

Related Links

MeSH Terms

Conditions

Motor ActivityAnxiety DisordersDepressive Disorder

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

BehaviorMental DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pedro Julián Flores Moreno

    Universidad de Colima

    STUDY CHAIR

Central Study Contacts

Luis Jaime Orozco Milanez, M. Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph. D. in Science

Study Record Dates

First Submitted

January 5, 2026

First Posted

February 9, 2026

Study Start

May 25, 2026

Primary Completion

July 24, 2026

Study Completion

August 7, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The information will be available as of August 2026
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