- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02679898
Whole Body Vibration and External Load Exercise Training on Cardiovascular and Autonomic Function in Obese Individuals
February 8, 2016 updated by: Arturo Figueroa, Florida State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Tallahassee, Florida, United States, 32306
- FSU College of Human Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 21 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Lean Control
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.
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|
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No Intervention: Overweight/Obese Control
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.
|
|
|
Experimental: Unloaded-Whole Body Vibration (WBVT)
Lower-body exercise training on a vibration platform
|
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).
|
|
Experimental: Loaded-Whole Body Vibration (WBVT)
Externally loaded lower-body exercise training on a vibration platform
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial Stiffness
Time Frame: 6 weeks
|
Aortic, leg, and systemic pulse wave velocity acquired through non-invasive sensors.
|
6 weeks
|
|
Pressure Wave Reflection
Time Frame: 6 weeks
|
Augmentation index acquired through radial tonometry.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Composition
Time Frame: 6 weeks
|
Measuring fat mass and lean mass from dual-energy x-ray absorptiometry.
|
6 weeks
|
|
Muscle Strength
Time Frame: 6 weeks
|
Using one-repetition maximum (1-RM) test for the leg press and chest press exercises.
|
6 weeks
|
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Autonomic Function
Time Frame: 6 weeks
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Heart rate variability through electrocardiogram.
|
6 weeks
|
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Blood Pressures
Time Frame: 6 weeks
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Non-invasive measures of brachial and aortic blood pressures.
|
6 weeks
|
|
Endothelial Function
Time Frame: 6 weeks
|
Non-invasive arm and leg blood flow using vascular ultrasound positioned on my skin at rest and during increased blood flow.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
February 1, 2016
First Submitted That Met QC Criteria
February 8, 2016
First Posted (Estimate)
February 11, 2016
Study Record Updates
Last Update Posted (Estimate)
February 11, 2016
Last Update Submitted That Met QC Criteria
February 8, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC201311173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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