- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03300895
High-intensity Interval Training on Cardiorespiratory Fitness in Overweight Women
Effect of Low-volume High-intensity Interval Training on Cardiorespiratory Fitness and Total Body Fat in Overweight Women
High-intensity interval training (HIIT) is currently considered one of the most effective strategies to improved cardiorespiratory fitness, which is recognized as a protective factor for cardiovascular diseases and metabolic diseases such as overweight and obesity. However, current evidence is still limited and requires clarity (frequency, time per session and intensity) regarding to greater increases attributed to HIIT.
The aim of this study is to compare the effect of a low-volume high-intensity interval training versus a moderate-intensity continuous exercise on maximal oxygen consumption in overweight women 18 to 44 years old.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Thirty-six women will be randomly assigned to one of two aerobic exercise on a real-life setting supervised for a physical activity instructor. The interventions will performed three times a week for ten-weeks (on alternate days).
The first two weeks will correspond to the conditioning period (30 minutes between 55-65% of maximum heart rate (HRmax). From week three, 18 participants will perform 30 minutes of continuous exercise at an intensity between 65-75 % of HRmax, and the remaining 18 will complete 21.5 minutes of interval exercise at an intensity between 90-95% of HRmax, with recoveries between 50-55% of HRmax.
All Participants will be evaluated to measure their maximal oxygen consumption, total body fat, waist circumference, body mass index, systolic blood pressure, diastolic blood pressure, prior to start the interventions and at the end of the program (week 11).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Antioquia
-
Medellín, Antioquia, Colombia
- Universidad de Antioquia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Overweight (≥ 25 kg/m-2) women 18 to 44 years.
- Healthy volunteers.
- Perform ≤ 600 Met/min/week.
Exclusion Criteria:
- Perform high-intensity interval exercise in the last six month.
- Smoker.
- History of asthma.
- History of diabetes.
- History of hypertension.
- History of cardiovascular disease.
- History of coronary heart disease.
- Arrhythmias.
- Personal history of surgical procedures in the last three months
- Uncontrolled non-communicable diseases
- Under medical treatment with anticoagulants, beta-blockers, calcium antagonists, bronchodilators, and/or steroids.
- Psychological, neuromotor and/or osteo-muscular conditions that may affect participation in an exercise program.
- Psychoactive drug abuse.
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 |
---|---|
Experimental: High-intensity interval training
|
21.5 minutes of high-intensity interval exercise at an intensity between 90-95 of HRmax (15x30 s), with recoveries at 50-60% of HRmax (14x60 s).
24 sessions, 3x weekly of walking and running outdoors on a sports field in a supervised manner.
|
Active Comparator: Moderate-intensity continuous exercise
|
30 minutes of continuous exercise at an intensity between 65-75% of HRmax.
24 sessions, 3x weekly of walking and jogging outdoors on a sports field in a supervised manner
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in maximal oxygen consumption
Time Frame: Baseline and after 10 weeks
|
Maximal oxygen consumption will be obtained using a graded exercise test on a treadmill (Trackmaster® model TMX 425C) using a portable K4b2 gas analyzer (Cosmed Inc., IL, USA)
|
Baseline and after 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total body fat
Time Frame: Baseline and after 10 weeks
|
Total body fat will be obtained using an Omron® HBF-510 (Omron Healthcare, Inc. Bannockburn, IL, USA) bioelectrical impedance machine.
|
Baseline and after 10 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- HIIT2-AFIS-UdeA
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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