- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07397702
Effects of HIIT and MICT Training on Cardiorespiratory Fitness, Testosterone/Cortisol Ratio, and Mental Health in Young Adults
Effects of HIIT and MICT Training on Cardiorespiratory Fitness, Testosterone/Cortisol Ratio, and Mental Health in Young Adults: an 8-week Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luis Jaime Orozco Milanez, M. Sc.
- Phone Number: +(52) 312 209 5656
- Email: lorozco2@ucol.mx
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
Sponsor
Investigators
- Study Chair: Pedro Julián Flores Moreno, Universidad de Colima
Publications and helpful links
General 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-23b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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