ObesityNCT02679898
Whole Body Vibration and External Load Exercise Training on Cardiovascular and Autonomic Function in Obese Individuals
A study testing Unloaded-Whole Body Vibration (WBVT) and Loaded-Whole Body Vibration (WBVT) in people with Obesity, run by Florida State University at 1 site in United States.
Trial summary
Obesity is directly related to arterial dysfunction and negatively associated to muscle strength. High-intensity resistance exercise is the favored modality to offset muscle weakness, yet, adverse effects on arterial function (pulse wave velocity, wave reflection, and aortic and brachial blood pressures) have been… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Unloaded-Whole Body Vibration (WBVT) and Loaded-Whole Body Vibration (WBVT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Aug 2015
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 18 to 25 years of age
- Sedentary (less than 120 min per wk)
- 15 lean (Body mass index of 18-25 kg/m²)
- 45 overweight/obese (Body mass index of 27-39.9 kg/m²)
Who cannot join
- Younger than 18 or older than 25 years of age
- Body mass index lower than 18 or higher than 39.9
- Physically active or competitively active
- Smokers
- Pregnant
- Irregular menstrual cycle
- Use of dietary supplementations (e.g.,L-arginine,L-citrulline,antioxidants)
- Any contraindications to exercise and/or whole-body vibration exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
FSU College of Human Sciences
Tallahassee, Florida, 32306
About this study
Official title: The Effect of the Combination of Whole Body Vibration and External Load Exercise Training on Cardiovascular and Autonomic Function in Obese Individuals
Obesity is directly related to arterial dysfunction and negatively associated to muscle strength. High-intensity resistance exercise is the favored modality to offset muscle weakness, yet, adverse effects on arterial function (pulse wave velocity, wave reflection, and aortic and brachial blood pressures) have been observed. Conventional unloaded-whole body vibration training (WBVT) has improved arterial function in overweight/obese women but appears to be low-intensity. Nevertheless, the effects of moderate-intensity (by adding external load) WBVT on arterial and muscle function are unknown. Therefore, the purpose of this study was to examine whether loaded-WBVT would induce greater benefits than unloaded-WBVT on arterial and muscle function in young overweight/obese women. Furthermore, we examined whether these changes were similar to healthy lean young women.
Read the detailed description
The purpose of this study was to determine the effects of 6 weeks of loaded-WBVT on arterial stiffness, peripheral and aortic blood pressures, wave reflection, endothelial function, and muscle strength in overweight/obese women.
The specific aims of the study were:
- To examine whether 6 weeks of loaded-WBVT was more beneficial than unloaded-WBVT in decreasing cardiovascular risk factors by assessing arterial stiffness (aortic, leg, and systemic), aortic blood pressures and wave reflection, brachial blood pressures, autonomic function, endothelial function, and blood flow (leg and arm).
- To determine the extent to which 6 weeks of loaded-WBVT improved body composition measured by changes in fat and lean mass utilizing dual-energy x-ray absorptiometry and waist circumference.
- To evaluate the effect of 6 wees of loaded-WBVT on muscle strength by using the one-repetition maximum test (leg press and chest press exercises).
- Conditions
- Obesity
- Being tested
- Unloaded-Whole Body Vibration (WBVT), Loaded-Whole Body Vibration (WBVT)
- Keywords
- Arterial function, Whole-body vibration training, Aortic blood pressures, Wave reflection, Muscle strength, Endothelial function, Blood flow
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unloaded-Whole Body Vibration (WBVT)Other
The unloaded-WBVT intervention consists of four leg exercises performed dynamically over a vibrating platform 3 times/week for 6 weeks. Dynamic movements were performed with controlled movements starting from an upright position into a 90 and 120 degree knee angle, wide-stance squat, and maximal heel elevation. The training volume increased progressively by increasing the intensity of the vibration (30-35 Hz; low-high amplitude), duration of exercise (30-60 sec), number of sets per exercise (2-8), and total during of training session, while decreasing the rest periods (60-30 sec).
Loaded-Whole Body Vibration (WBVT)Other
The loaded-WBVT intervention consists of four leg exercises performed dynamically over a vibrating platform 3 times/week for 6 weeks. Importantly, an external load was applied to a weight vest to account for the necessary weight to perform a specific number of repetitions (progressed from 15-8 repetitions maximum during the 6 weeks). Dynamic movements were performed with controlled movements starting from an upright position into a 90 and 120 degree knee angle, wide-stance squat, and maximal heel elevation. The training volume increased progressively by increasing the intensity of the vibration (30-35 Hz; low-high amplitude), duration of exercise (30-60 sec), number of sets per exercise (2-8), and total during of training session, while decreasing the rest periods (60-30 sec).
| Study group | Role | What they receive |
|---|---|---|
| Lean Control | No intervention | This arm involves not making any changes to the subject's lifestyle at the moment of the start of the intervention and for 6 weeks. |
| Overweight/Obese Control | No intervention | This arm involves not making any changes to the subject's lifestyle at the moment of the start of the intervention and for 6 weeks. |
| Unloaded-Whole Body Vibration (WBVT) | Experimental | Lower-body exercise training on a vibration platform Receives: Other: Unloaded-Whole Body Vibration (WBVT) |
| Loaded-Whole Body Vibration (WBVT) | Experimental | Externally loaded lower-body exercise training on a vibration platform Receives: Other: Loaded-Whole Body Vibration (WBVT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
Aortic, leg, and systemic pulse wave velocity acquired through non-invasive sensors.
Measured: 6 weeks
Pressure Wave Reflection
Augmentation index acquired through radial tonometry.
Measured: 6 weeks
Secondary outcomes (5)
Body Composition
Measuring fat mass and lean mass from dual-energy x-ray absorptiometry.
Measured: 6 weeks
Muscle Strength
Using one-repetition maximum (1-RM) test for the leg press and chest press exercises.
Measured: 6 weeks
Autonomic Function
Heart rate variability through electrocardiogram.
Measured: 6 weeks
Blood Pressures
Non-invasive measures of brachial and aortic blood pressures.
Measured: 6 weeks
Endothelial Function
Non-invasive arm and leg blood flow using vascular ultrasound positioned on my skin at rest and during increased blood flow.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arturo Figueroa, Florida State University
- Investigators
- Arturo Figueroa, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679898
- Sponsor's protocol ID
- HSC201311173
- Status last verified
- Feb 2016
- First submitted
- 1 Feb 2016
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alvarez-Alvarado S, Jaime SJ, Ormsbee MJ, Campbell JC, Post J, Pacilio J, Figueroa A. Benefits of whole-body vibration training on arterial function and muscle strength in young overweight/obese women. Hypertens Res. 2017 May;40(5):487-492. doi: 10.1038/hr.2016.178. Epub 2017 Jan 12.
PubMed 28077859
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Combination of Whole Body Vibration and External Load Exercise Training on Cardiovascular and Autonomic Function in Obese Individuals
- ClinicalTrials.gov ID
- NCT02679898
- Acronym / sponsor ID
- HSC201311173
- Conditions
- Obesity
- Keywords
- Arterial function, Whole-body vibration training, Aortic blood pressures, Wave reflection, Muscle strength, Endothelial function, Blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Feb 2016 (estimated)
- 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.
Obesity is directly related to arterial dysfunction and negatively associated to muscle strength. High-intensity resistance exercise is the favored modality to offset muscle weakness, yet, adverse effects on arterial function (pulse wave velocity, wave reflection, and aortic and brachial blood pressures) have been observed. Conventional unloaded-whole body vibration training (WBVT) has improved arterial function in overweight/obese women but appears to be low-intensity. Nevertheless, the effects of moderate-intensity (by adding external load) WBVT on arterial and muscle function are unknown. Therefore, the purpose of this study was to examine whether loaded-WBVT would induce greater benefits than unloaded-WBVT on arterial and muscle function in young overweight/obese women. Furthermore, we examined whether these changes were similar to healthy lean young women.
Detailed description
The purpose of this study was to determine the effects of 6 weeks of loaded-WBVT on arterial stiffness, peripheral and aortic blood pressures, wave reflection, endothelial function, and muscle strength in overweight/obese women.
The specific aims of the study were:
- To examine whether 6 weeks of loaded-WBVT was more beneficial than unloaded-WBVT in decreasing cardiovascular risk factors by assessing arterial stiffness (aortic, leg, and systemic), aortic blood pressures and wave reflection, brachial blood pressures, autonomic function, endothelial function, and blood flow (leg and arm).
- To determine the extent to which 6 weeks of loaded-WBVT improved body composition measured by changes in fat and lean mass utilizing dual-energy x-ray absorptiometry and waist circumference.
- To evaluate the effect of 6 wees of loaded-WBVT on muscle strength by using the one-repetition maximum test (leg press and chest press exercises).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lean Control | No intervention | –This arm involves not making any changes to the subject's lifestyle at the moment of the start of the intervention and for 6 weeks. |
| Overweight/Obese Control | No intervention | –This arm involves not making any changes to the subject's lifestyle at the moment of the start of the intervention and for 6 weeks. |
| Unloaded-Whole Body Vibration (WBVT) | Experimental | Other: Unloaded-Whole Body Vibration (WBVT)Lower-body exercise training on a vibration platform |
| Loaded-Whole Body Vibration (WBVT) | Experimental | Other: Loaded-Whole Body Vibration (WBVT)Externally loaded lower-body exercise training on a vibration platform |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- 18 to 25 years of age
- Sedentary (less than 120 min per wk)
- 15 lean (Body mass index of 18-25 kg/m²)
- 45 overweight/obese (Body mass index of 27-39.9 kg/m²)
Key exclusion criteria (8 listed)
- Younger than 18 or older than 25 years of age
- Body mass index lower than 18 or higher than 39.9
- Physically active or competitively active
- Smokers
- Pregnant
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 |
|---|---|---|
| Unloaded-Whole Body Vibration (WBVT)The unloaded-WBVT intervention consists of four leg exercises performed dynamically over a vibrating platform 3 times/week for 6 weeks. Dynamic movements were performed with controlled movements starting from an upright position into a 90 and 120 degree knee angle, wide-stance squat, and maximal heel elevation. The training volume increased progressively by increasing the intensity of the vibration (30-35 Hz; low-high amplitude), duration of exercise (30-60 sec), number of sets per exercise (2-8), and total during of training session, while decreasing the rest periods (60-30 sec). | Other | Unloaded-Whole Body Vibration (WBVT) |
| Loaded-Whole Body Vibration (WBVT)The loaded-WBVT intervention consists of four leg exercises performed dynamically over a vibrating platform 3 times/week for 6 weeks. Importantly, an external load was applied to a weight vest to account for the necessary weight to perform a specific number of repetitions (progressed from 15-8 repetitions maximum during the 6 weeks). Dynamic movements were performed with controlled movements starting from an upright position into a 90 and 120 degree knee angle, wide-stance squat, and maximal heel elevation. The training volume increased progressively by increasing the intensity of the vibration (30-35 Hz; low-high amplitude), duration of exercise (30-60 sec), number of sets per exercise (2-8), and total during of training session, while decreasing the rest periods (60-30 sec). | Other | Loaded-Whole Body Vibration (WBVT) |
Primary outcome
Arterial Stiffness
Time frame: 6 weeks
Aortic, leg, and systemic pulse wave velocity acquired through non-invasive sensors.
Pressure Wave Reflection
Time frame: 6 weeks
Augmentation index acquired through radial tonometry.
5 secondary outcomes
Body Composition
Time frame: 6 weeks
Muscle Strength
Time frame: 6 weeks
Autonomic Function
Time frame: 6 weeks
Blood Pressures
Time frame: 6 weeks
Endothelial Function
Time frame: 6 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 11 Feb 2016.
- Derived from this study: PubMed 28077859Alvarez-Alvarado S, Jaime SJ, Ormsbee MJ, Campbell JC, Post J, Pacilio J, Figueroa A. Benefits of whole-body vibration training on arterial function and muscle strength in young overweight/obese women. Hypertens Res. 2017 May;40(5):487-492. doi: 10.1038/hr.2016.178. Epub 2017 Jan 12.
- Individual participant dataSharing planned: No
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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.
Arturo Figueroa principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unloaded-Whole Body Vibration (WBVT) and Loaded-Whole Body Vibration (WBVT) in people with Obesity, run by Florida State University at 1 site in United States.
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 5 inclusion and 8 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 11 Feb 2016. 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 United States. 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?
Arterial Stiffness (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02679898, which also lists 1 linked publication.
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 11 Feb 2016; AzTrials last refreshed its copy on 1 Nov 2026.