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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. 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).
  2. 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.
  3. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • FSU College of Human Sciences

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
Other: 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).
Experimental: Loaded-Whole Body Vibration (WBVT)
Externally loaded lower-body exercise training on a vibration platform
Other: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Autonomic Function
Time Frame: 6 weeks
Heart rate variability through electrocardiogram.
6 weeks
Blood Pressures
Time Frame: 6 weeks
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida State University

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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