- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07283406
Effect of High-intensity Interval Training on Cardiometabolic Health and Physical Fitness in Young Adults With Obesity
Study Overview
Status
Conditions
Detailed Description
Obesity represents a serious public health problem, and its prevalence continues to rise worldwide. Numerous studies have documented the positive effects of moderate-intensity continuous training (MICT) on cardiovascular and metabolic health in individuals living with obesity; however, the effects of high-intensity interval training (HIIT) are still being explored.
Therefore, the objective of the present research protocol is to analyze and compare the effects of an MICT program and an HIIT program on cardiometabolic biomarkers and physical fitness in young adults with obesity.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jalisco
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Guadalajara, Jalisco, Mexico, 45650
- Centro Universitario de Tlajomulco, Universidad de Guadalajara
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Young adults
- BMI ≥ 30 kg/m^2" and < 40 kg/m^2
- Signed informed consent form
Exclusion Criteria:
- Participants who smoke
- Clinical diagnosis of hypothyroidism
- Clinical diagnosis of type 1 diabetes mellitus
- Clinical diagnosis of type 2 diabetes mellitus
- Clinical diagnosis of grade 3 obesity
- Clinical diagnosis of hypertension
- Clinical diagnosis of acute myocardial infarction or angina pectoris
- Use of nitrates and calcium channel blockers within 4 days prior to the start of the study
- Use of beta-blockers or hypoglycemic agents within 7 days prior to the intervention
- Pregnant women
- Breastfeeding women
- Men consuming more than 40 g of alcohol per day or women consuming more than 20 g per day
- Postural and biomechanical disorders (knee, foot, and spine)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: HIIT Group
This group will train for 12 weeks
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The HIIT group will undergo training for 12 weeks, with a frequency of three sessions per week, completing a total of 36 sessions.
Each session will include a 5-minute warm-up and a 5-minute cool-down at 50-60% of maximum heart rate (HRmax).
The training protocol will consist of 2-minute high-intensity intervals performed at 90-95% HRmax, corresponding to a Borg rating of perceived exertion (RPE) of 17-18, alternated with 2-minute recovery periods at 70% HRmax (RPE 12-14).
A total of five intervals will be completed per session, resulting in an overall high-intensity workload of 18 minutes.
All training sessions will be conducted on a stationary cycle ergometer
In addition, four educational sessions will be conducted to provide dietary recommendations to all participants.
These sessions will aim to promote balanced eating habits and to discourage the excessive consumption of ultra-processed foods or alcohol, as these factors could interfere with the intervention outcomes.
|
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Active Comparator: MICT Group
This group will train for 12 weeks
|
In addition, four educational sessions will be conducted to provide dietary recommendations to all participants.
These sessions will aim to promote balanced eating habits and to discourage the excessive consumption of ultra-processed foods or alcohol, as these factors could interfere with the intervention outcomes.
The MICT group will perform moderate-intensity continuous training at 60-70% HRmax, corresponding to an RPE of 12-14, for 35-45 minutes on a stationary cycleergometer.
Heart rate and physical activity levels will be continuously monitored in both groups using a chest-strap heart rate sensor (Polar H9, Polar Electro, Finland).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum oxygen uptake (VO₂max)
Time Frame: Baseline and after 12 weeks
|
VO₂max (ml/min/kg): Change from Baseline at 12 weeks, measured using a submaximal exercise test based on the Åstrand-Ryhming protocol
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Baseline and after 12 weeks
|
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Weight
Time Frame: Baseline and after 12 weeks
|
Weight (kg): Changes in weight from baseline to 12 weeks of intervention.
|
Baseline and after 12 weeks
|
|
Height
Time Frame: Baseline and after 12 weeks
|
Height (cm): Changes in height from baseline to 12 weeks of intervention.
|
Baseline and after 12 weeks
|
|
Body mass index (BMI)
Time Frame: Baseline and after 12 weeks
|
BMI (kg/m2): Change from Baseline at 12 weeks, calculated by: weight (kg)/ height (m^2)
|
Baseline and after 12 weeks
|
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Body fat percentage
Time Frame: Baseline and after 12 weeks
|
Body fat percentage (%): Changes in body fat assessed by bioelectrical impedance analysis (BIA)
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Baseline and after 12 weeks
|
|
Muscle mass percentage
Time Frame: Baseline and after 12 weeks
|
Muscle mass percentage (%): Changes in muscle mass measured using bioelectrical impedance analysis (BIA)
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Baseline and after 12 weeks
|
|
Waist circumference
Time Frame: Baseline and after 12 weeks
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Waist circumference (cm): Changes in waist circumference will be measured using a Lufkin measuring tape (USA) following the guidelines of the International Society for the Advancement of Kinanthropometry (ISAK)
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Baseline and after 12 weeks
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Waist-to-hip ratio
Time Frame: Baseline and after 12 weeks
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Waist-to-hip ratio: Changes in waist-to-hip ratio will be calculated by dividing the waist measurement by the hip measurement
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Baseline and after 12 weeks
|
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Glucose
Time Frame: Baseline and after 12 weeks
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Glucose (mg/dl): Changes from baseline to 12 weeks of intervention
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Baseline and after 12 weeks
|
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Triglycerides
Time Frame: Baseline and after 12 weeks
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Triglycerides (mg/dl): Changes from baseline to 12 weeks of intervention
|
Baseline and after 12 weeks
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Total cholesterol
Time Frame: Baseline and after 12 weeks
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Total cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention
|
Baseline and after 12 weeks
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HDL cholesterol
Time Frame: Baseline and after 12 weeks
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HDL cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention
|
Baseline and after 12 weeks
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LDL cholesterol
Time Frame: Baseline and after 12 weeks
|
LDL cholesterol (mg/dl): Changes from baseline to 12 weeks of intervention
|
Baseline and after 12 weeks
|
|
C-reactive protein (CRP)
Time Frame: Baseline and after 12 weeks
|
CRP (mg/dl): Changes from baseline to 12 weeks of intervention
|
Baseline and after 12 weeks
|
|
Systolic blood pressure (SBP)
Time Frame: Baseline and after 12 weeks
|
SBP (mmHg): Changes from baseline to 12 weeks of intervention
|
Baseline and after 12 weeks
|
|
Diastolic blood pressure (DBP)
Time Frame: Baseline and after 12 weeks
|
DBP (mmHg): Changes from baseline to 12 weeks of intervention
|
Baseline and after 12 weeks
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUTLAJO251028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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