- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05867498
Effect of Concurrent and Aerobic Exercise on VO2max, Strength, and Body Composition in Overweight and Obese Adults
Concurrent and Aerobic Exercise Programs Based on the Polarized Training Intensity Distribution Model on Maximal Oxygen Consumption, Strength, and Body Composition in Overweight and Obese Adults: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Twenty-eight people (women and men) will be randomly assigned to a concurrent exercise group (intervention group) and an aerobic exercise group (comparator group), with fourteen people per group. These interventions will be performed for 12 weeks, 3 times per week, with a duration of 60 minutes per session. The first 8 minutes will be of general and specific joint mobility preparing the participants for the central part which will be 47 minutes, and will end with 5 minutes of return to calm.
The concurrent exercise group sessions will have two components, lasting 47 minutes. One of them will be strength exercises with a time of 23 minutes, to perform 7 exercises. In the first four weeks, it will be a general circuit, composed of 2 sets, 15 to 18 repetitions, for 60 seconds, with micro-pauses of 10 seconds between exercises, and 3 minutes between sets. In weeks 5 to 8, it will be a block circuit, consisting of 3 sets, 12 to 15 repetitions, for 45 seconds, with micro-pauses of 10 seconds between exercises and 70 seconds between sets. For weeks 9 to 12, it will be a concentrated circuit, consisting of 3 sets, 8 to 12 repetitions, for 35 seconds, with micro-pauses of 15 seconds between exercises and 110 seconds between sets.
The aerobic component will have a duration equal to the strength component (24 minutes). A variable continuous method will be applied for the first 18 minutes through rumba-aerobic (ballroom and folkloric dance steps), at an intensity lower than the ventilatory threshold 1 (VT 1). For the remaining 6 minutes, an intervallic method will be used at an intensity > VT 2, with combat gestures (fists, knees, and plantar flexions). Progression of the loads during the 12 weeks of intervention: Weeks 1 and 2: 5 loads of 30 seconds and 30 seconds of recovery.
Weeks 3 and 4: 4 loads of 45 seconds and 45 seconds of recovery. Weeks 5 to 7: 5 loads of 50 seconds and 25 seconds of recovery. Week 8: 4 loads of 60 seconds and 30 seconds of recovery. Weeks 9 to 11: 3 loads of 70 seconds and 35 seconds of recovery. Week 12: 4 loads of 80 and 40 seconds of recovery.
The aerobic group, will perform the same methods, rumba steps, combat gestures, intensities, and time of the central part of the aerobic component of the concurrent exercise group, but will be differentiated by performing in the continuous method for a duration of 36 minutes and in the interval method will have the following progression:
Weeks 1 and 2: 2 blocks by 5 loads of 35 seconds and 35 seconds of recovery. Weeks 3 and 4: 2 blocks by 4 loads of 45 seconds and 45 seconds of recovery. Weeks 5 to 8: 2 blocks by 4 loads of 60 seconds and 30 seconds of recovery. Weeks 9 to 11: 2 blocks by 3 loads of 75 seconds and 37.5 seconds of recovery. Week 12: 2 blocks by 4 loads of 80 seconds and 40 seconds of recovery.
All participants will have their maximal oxygen consumption, muscle strength, and body composition evaluated before the beginning of week 1 and at the end of week 12.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Felipe Madrid-Zapata, MSc
- Phone Number: 573148461524
- Email: felipe.madridz@udea.edu.co
Study Contact Backup
- Name: Jhonatan Orozco, MSc
- Phone Number: 573122889195
- Email: jhonatan.orozcoo@udea.edu.co
Study Locations
-
-
Antioquia
-
Medellín, Antioquia, Colombia, 50010
- Universidad de Antioquia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 to 59 years old.
- BMI >25.0.
- Waist circumference ≥85cm in women, and ≥94cm in men.
- Individuals participating voluntarily.
Exclusion Criteria:
- History of cardiovascular and pulmonary disease.
- Uncontrolled psychiatric problems.
- People under treatment with anticoagulants, beta-blockers, calcium antagonists, and bronchodilators.
- Having osteo-muscular problems that may affect participation in exercise sessions.
- Pregnant women.
- People with a nutritional plan for weight loss.
- Smokers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aerobic exercise
|
Low-to-moderate-intensity continuous training and interval training based on musicalized and outdoor activities.
|
Experimental: Concurrent exercise
Strength component (circuit-based exercise) 7 exercises:
Aerobic component
|
Strength component (circuit-based exercise) and aerobic component (based on musicalized and outdoor activities).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in maximal oxygen consumption
Time Frame: Baseline and 12-weeks
|
A graded exercise test on a cycle ergometer (ERGO-FIT, Germany) will obtain maximal oxygen consumption (VO2max) using a METAMAX 3B gas analyzer (CORTEX, Germany).
VO2max will be reported in ml/kg/min.
|
Baseline and 12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean propulsive velocity
Time Frame: Baseline and 12-weeks
|
Mean propulsive velocity (m/s), will be assessed by a progressive half squat test on a Smith machine, with a T-Force System linear encoder (ERGOTECH, Spain).
|
Baseline and 12-weeks
|
Change in maximum velocity
Time Frame: Baseline and 12-weeks
|
Maximum velocity (m/s), will be assessed by a progressive half squat test on a Smith machine, with a T-Force System linear encoder (ERGOTECH, Spain).
|
Baseline and 12-weeks
|
Change in peak maximum power
Time Frame: Baseline and 12-weeks
|
Peak maximum power (W), will be assessed by a progressive half squat test on a Smith machine, with a T-Force System linear encoder (ERGOTECH, Spain).
|
Baseline and 12-weeks
|
Change in body fat
Time Frame: Baseline and 12-weeks
|
Body fat (%), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
|
Baseline and 12-weeks
|
Change in muscle mass
Time Frame: Baseline and 12-weeks
|
Muscle mass (kg), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
|
Baseline and 12-weeks
|
Change in visceral fat level
Time Frame: Baseline and 12-weeks
|
Visceral fat level (>10 high, <10 low), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
|
Baseline and 12-weeks
|
Change in body weight
Time Frame: Baseline and 12-weeks
|
Body weight (kg), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
|
Baseline and 12-weeks
|
Change in waist circumference
Time Frame: Baseline and 12-weeks
|
Waist circumference (cm), will be obtained using a tape measure (SECA).
|
Baseline and 12-weeks
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT-AE AFIS-UdeA
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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