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Effect of Concurrent and Aerobic Exercise on VO2max, Strength, and Body Composition in Overweight and Obese Adults

Primary Purpose

Healthy Volunteers

Status
Recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Concurrent exercise
Aerobic exercise
Sponsored by
Universidad de Antioquia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers focused on measuring Obesity, Concurrent exercise, Combined training, Circuit-Based Exercise, Cardiorespiratory fitness, Muscle Strength, Body Composition

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad de AntioquiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concurrent exercise

Aerobic exercise

Arm Description

Strength component (circuit-based exercise) 7 exercises: General (2 sets of 15-18 Rep, OMNI-Resistance Exercise Scale 4-5, x 10 s) 180 s Block (3 sets of 12-15 Rep, OMNI-Resistance Exercise Scale 5-6, x 10 s) 70 s Concentrated (3 sets of 10-12 Rep, OMNI-Resistance Exercise Scale 7-8, x 15 s) 110 s Aerobic component Low-to-moderate-intensity continuous training: 16 min to 18 min (< VT 1) Interval training: in a block (> VT 2) 5 bouts of 30 s loads. Work:rest ratio: 1:1 4 bouts of 45 s loads. Work:rest ratio: 1:1 5 bouts of 50 s loads. Work:rest ratio: 2:1 4 bouts of 60 s loads. Work:rest ratio: 2:1 3 bouts of 70 s loads. Work:rest ratio: 2:1 4 bouts of 80 s loads. Work:rest ratio: 2:1

Low-to-moderate-intensity continuous training: 36 min (< VT 1) Interval training: in two blocks (> VT 2) 5 bouts of 35 s loads. Work:rest ratio: 1:1 4 bouts of 45 s loads. Work:rest ratio: 1:1 4 bouts of 60 s loads. Work:rest ratio: 2:1 3 bouts of 75 s loads. Work:rest ratio: 2:1 4 bouts of 80 s loads. Work:rest ratio: 2:1

Outcomes

Primary Outcome Measures

Change in maximal oxygen consumption
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.

Secondary Outcome Measures

Change in mean propulsive velocity
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).
Change in maximum velocity
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).
Change in peak maximum power
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).
Change in body fat
Body fat (%), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Change in muscle mass
Muscle mass (kg), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Change in visceral fat level
Visceral fat level (>10 high, <10 low), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Change in body weight
Body weight (kg), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Change in waist circumference
Waist circumference (cm), will be obtained using a tape measure (SECA).

Full Information

First Posted
May 2, 2023
Last Updated
May 23, 2023
Sponsor
Universidad de Antioquia
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1. Study Identification

Unique Protocol Identification Number
NCT05867498
Brief Title
Effect of Concurrent and Aerobic Exercise on VO2max, Strength, and Body Composition in Overweight and Obese Adults
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
November 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Concurrent and aerobic physical exercise are recognized strategies for the treatment of overweight and obesity. The interventions of these modalities have been performed with cardiovascular machines or guided execution in their majority, making it possible to improve the health of this population; however, the studies have used high-cost equipment that is not very accessible to the general population. For this reason, we propose to compare the effects of two 12-week programs: concurrent vs. aerobic, using an innovative methodology with musicalized and outdoor activities, little approached by research. The polarized training intensity distribution model, usually used in sports and now applied to physical activity to improve VO2max, muscular strength, and body composition, will be used to determine which intervention is superior in improving these variables.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Obesity, Concurrent exercise, Combined training, Circuit-Based Exercise, Cardiorespiratory fitness, Muscle Strength, Body Composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concurrent exercise
Arm Type
Experimental
Arm Description
Strength component (circuit-based exercise) 7 exercises: General (2 sets of 15-18 Rep, OMNI-Resistance Exercise Scale 4-5, x 10 s) 180 s Block (3 sets of 12-15 Rep, OMNI-Resistance Exercise Scale 5-6, x 10 s) 70 s Concentrated (3 sets of 10-12 Rep, OMNI-Resistance Exercise Scale 7-8, x 15 s) 110 s Aerobic component Low-to-moderate-intensity continuous training: 16 min to 18 min (< VT 1) Interval training: in a block (> VT 2) 5 bouts of 30 s loads. Work:rest ratio: 1:1 4 bouts of 45 s loads. Work:rest ratio: 1:1 5 bouts of 50 s loads. Work:rest ratio: 2:1 4 bouts of 60 s loads. Work:rest ratio: 2:1 3 bouts of 70 s loads. Work:rest ratio: 2:1 4 bouts of 80 s loads. Work:rest ratio: 2:1
Arm Title
Aerobic exercise
Arm Type
Active Comparator
Arm Description
Low-to-moderate-intensity continuous training: 36 min (< VT 1) Interval training: in two blocks (> VT 2) 5 bouts of 35 s loads. Work:rest ratio: 1:1 4 bouts of 45 s loads. Work:rest ratio: 1:1 4 bouts of 60 s loads. Work:rest ratio: 2:1 3 bouts of 75 s loads. Work:rest ratio: 2:1 4 bouts of 80 s loads. Work:rest ratio: 2:1
Intervention Type
Behavioral
Intervention Name(s)
Concurrent exercise
Intervention Description
Strength component (circuit-based exercise) and aerobic component (based on musicalized and outdoor activities).
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
Low-to-moderate-intensity continuous training and interval training based on musicalized and outdoor activities.
Primary Outcome Measure Information:
Title
Change in maximal oxygen consumption
Description
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.
Time Frame
Baseline and 12-weeks
Secondary Outcome Measure Information:
Title
Change in mean propulsive velocity
Description
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).
Time Frame
Baseline and 12-weeks
Title
Change in maximum velocity
Description
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).
Time Frame
Baseline and 12-weeks
Title
Change in peak maximum power
Description
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).
Time Frame
Baseline and 12-weeks
Title
Change in body fat
Description
Body fat (%), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Time Frame
Baseline and 12-weeks
Title
Change in muscle mass
Description
Muscle mass (kg), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Time Frame
Baseline and 12-weeks
Title
Change in visceral fat level
Description
Visceral fat level (>10 high, <10 low), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Time Frame
Baseline and 12-weeks
Title
Change in body weight
Description
Body weight (kg), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Time Frame
Baseline and 12-weeks
Title
Change in waist circumference
Description
Waist circumference (cm), will be obtained using a tape measure (SECA).
Time Frame
Baseline and 12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felipe Madrid-Zapata, MSc
Phone
573148461524
Email
felipe.madridz@udea.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Jhonatan Orozco, MSc
Phone
573122889195
Email
jhonatan.orozcoo@udea.edu.co
Facility Information:
Facility Name
Universidad de Antioquia
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
50010
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Víctor H Arboleda-Serna, PhD
Phone
5742199286
Email
victor.arboleda@udea.edu.co
First Name & Middle Initial & Last Name & Degree
Felipe Madrid-Zapata, MSc
First Name & Middle Initial & Last Name & Degree
Jhonatan Orozco-Osorio, MSc
First Name & Middle Initial & Last Name & Degree
Víctor H Arboleda-Serna, PhD

12. IPD Sharing Statement

Learn more about this trial

Effect of Concurrent and Aerobic Exercise on VO2max, Strength, and Body Composition in Overweight and Obese Adults

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