Healthy VolunteersNCT05867498
Effect of Concurrent and Aerobic Exercise on VO2max, Strength, and Body Composition in Overweight and Obese Adults
A study testing Concurrent exercise and Aerobic exercise in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Concurrent exercise and Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteColombia
- Study dates
- 17 Apr 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 59 years old.
- BMI >25.0.
- Waist circumference ≥85cm in women, and ≥94cm in men.
- Individuals participating voluntarily.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Concurrent exercise, Aerobic exercise
- Keywords
- Obesity, Concurrent exercise, Combined training, Circuit-Based Exercise, Cardiorespiratory fitness, Muscle Strength, Body Composition
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent exerciseBehavioural
Strength component (circuit-based exercise) and aerobic component (based on musicalized and outdoor activities).
Aerobic exerciseBehavioural
Low-to-moderate-intensity continuous training and interval training based on musicalized and outdoor activities.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent exercise | Experimental | 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 Receives: Behavioral: Concurrent exercise |
| Aerobic exercise | Active comparator | * 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 Receives: Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12-weeks
Secondary outcomes (8)
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).
Measured: Baseline and 12-weeks
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).
Measured: Baseline and 12-weeks
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).
Measured: Baseline and 12-weeks
Change in body fat
Body fat (%), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Measured: Baseline and 12-weeks
Change in muscle mass
Muscle mass (kg), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Measured: Baseline and 12-weeks
Change in visceral fat level
Visceral fat level (>10 high, <10 low), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Measured: Baseline and 12-weeks
Change in body weight
Body weight (kg), will be obtained using an InBody 270 body composition analyzer (InBody, USA).
Measured: Baseline and 12-weeks
Change in waist circumference
Waist circumference (cm), will be obtained using a tape measure (SECA).
Measured: Baseline and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start17 Apr 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Arboleda Serna, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867498
- Sponsor's protocol ID
- CT-AE AFIS-UdeA
- Status last verified
- Oct 2023
- First submitted
- 2 May 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05867498
- Acronym / sponsor ID
- CT-AE AFIS-UdeA
- Conditions
- Healthy Volunteers
- Keywords
- Obesity, Concurrent exercise, Combined training, Circuit-Based Exercise, Cardiorespiratory fitness, Muscle Strength, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent exercise | Experimental | Behavioral: Concurrent exerciseStrength 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 |
| Aerobic exercise | Active comparator | Behavioral: Aerobic exercise* 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 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 59 years old.
- BMI >25.0.
- Waist circumference ≥85cm in women, and ≥94cm in men.
- Individuals participating voluntarily.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concurrent exerciseStrength component (circuit-based exercise) and aerobic component (based on musicalized and outdoor activities). | Behavioural | Concurrent exercise |
| Aerobic exerciseLow-to-moderate-intensity continuous training and interval training based on musicalized and outdoor activities. | Behavioural | Aerobic exercise |
Primary outcome
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.
8 secondary outcomes
Change in mean propulsive velocity
Time frame: Baseline and 12-weeks
Change in maximum velocity
Time frame: Baseline and 12-weeks
Change in peak maximum power
Time frame: Baseline and 12-weeks
Change in body fat
Time frame: Baseline and 12-weeks
Change in muscle mass
Time frame: Baseline and 12-weeks
Change in visceral fat level
Time frame: Baseline and 12-weeks
Change in body weight
Time frame: Baseline and 12-weeks
Change in waist circumference
Time frame: Baseline and 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent exercise and Aerobic exercise in people with Healthy Volunteers, run by Universidad de Antioquia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal oxygen consumption (time frame: Baseline and 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.