Whole Body Vibration Training on Body Composition

March 2, 2017 updated by: John E. Lewis, University of Miami

The Effect of Whole Body Vibration Training on Body Composition, Physical Fitness, and Quality of Life

The purpose of the study is to determine the effect of whole-body vibration (WBV) on body composition, physical fitness, and quality of life.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to determine the effect of whole-body vibration (WBV) on body composition, physical fitness, and quality of life.Twenty healthy adult males and females (ages 18-65) with no contraindications for exercise training will be recruited to participate in the study. Subjects will participate in a randomized, crossover trial for 24 weeks. Subjects will be assigned to either: (1) WBV for the first 12 weeks and then aerobic exercise training for the second 12 weeks 3 times per week (n=10) or (2) aerobic exercise training for the first 12 weeks and then WBV for the second 12 weeks 3 times per week (n=10). Subjects will be assessed at baseline and at 12 and 24 weeks on aerobic capacity (estimated VO2max), upper and lower body strength (1-repetition maximum on bench press and leg press, respectively), compartmental and total body fat mass, fat free mass, and bone mineral density (using dual energy x-ray absorptiometry (DEXA)), body mass index (height relative to weight), weight, skin fold and body part circumferences, resting blood pressure and pulse, and subjective health-related quality of life (SF-36). Participants will be trained and assessed at the University of Miami Miller School of Medicine UHealth Fitness and Wellness Center, in UHealth Champions Executive Medicine, and in the Department of Psychiatry and Behavioral Sciences.

No substantial psychological, medical, or social risks exist to the participants. Although all measures to protect confidentiality will be put in place, the possibility exists that electronic data could be jeopardized. In the remote case that such event occurs, it will be immediately reported to the Institutional Review Board (IRB).

Exercise has been shown to be safe among every population, including those with chronic diseases and/or other complications. A DEXA scan is the equivalent of about 4 extra days' worth of naturally-occurring radiation.

The use of the HyperVibe WBV training device should be harmless without any known negative effects, as WBV is even lower risk than aerobic exercise, as the participant simply stands on the platform without moving while being exposed to full-body vibration. The system is completely non-invasive, and no serious, untoward side effects have been reported to the manufacturer (HyperVibe) of this system. All study personnel will follow instructions for operating the system. Participants will incur no additional appreciable psychological or social risks by participating in this study.

The results obtained in this study may demonstrate a way to increase exercise efficiency through the use of WBV in helping overweight/obese participants to lose weight, gain muscular weight, and improve physical fitness levels. By participating in the study, subjects may improve their overall health status in a unique approach to exercise training. The minimal risk of participating in this study is reasonable because the potential information gained can be worthwhile for helping people to lose weight, which is significant, given the inordinate prevalence of overweight/obesity and its co morbid chronic diseases in the United States today.

Study Type

Interventional

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

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine, Clinical Research Building, Department of Psychiatry & Behavioral 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

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women ages 18 to 65 years old
  2. Interest in participating in a study to investigate the effects of a novel exercise training style
  3. Willing to follow recommendations for participating in the study
  4. Able to provide informed consent to participate in the study

Exclusion Criteria:

  1. Women who are pregnant or attempting pregnancy during the next 24 weeks
  2. Anyone with a cardiovascular, orthopedic, or other physical condition that would be contraindicated for an exercise training program
  3. Any condition where WBV is contraindicated, e.g., seizure disorder
  4. Currently enrolled in another exercise intervention research study
  5. Currently undergoing internal defibrillation, like with an implantable heart device
  6. Erratic, accelerated, or mechanically controlled irregular heart rhythms
  7. Atrial fibrillation/flutter
  8. Atrioventricular block
  9. Recently had dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and fluorescein
  10. Any implanted electronic device

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole Body Vibration training
Use of the HyperVibe Whole Body Vibration training device for 12 weeks 3 times per week crossover to aerobic exercise
Device: HyperVibe Whole Body Vibration training device
Standing on the HyperVibe platform during WBV training will cause repetitive upward movements of platform to be felt by participant.Thus the participant will feel a whole body vibration, as the name of training implies. Each session will last approximately fifteen minutes.
Placebo Comparator: Aerobic Exercise
Aerobic exercise training for 12 weeks 3 times per week crossover to use of the HyperVibe Whole Body Vibration training device
Other: Aerobic Exercise
Aerobic exercise session will last approximately thirty minutes. Starting training intensity will be specific to each participant based on his/her baseline fitness level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in body composition
Time Frame: Baseline,12 weeks and 24 weeks
Body composition will be evaluated by DEXA scan which measure fat free mass , total body and compartmental fat mass
Baseline,12 weeks and 24 weeks
Change from baseline in aerobic capacity
Time Frame: Baseline,12 weeks and 24 weeks
Aerobic capacity and strength will be assessed by Graded Exercise Test
Baseline,12 weeks and 24 weeks
Change from baseline in body strength
Time Frame: Baseline,12 weeks and 24 weeks
Overall upper and lower body strength will be assessed by one-repetition maximum strength tests
Baseline,12 weeks and 24 weeks
Change from baseline in bone mineral density
Time Frame: Baseline,12 weeks and 24 weeks
Bone mineral density will be assessed by DEXA scan
Baseline,12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in physical activity
Time Frame: Baseline,12 weeks and 24 weeks
Physical activity will be assessed with International Physical Activity Questionnaire (IPAQ). The IPAQ items are structured to provide individual domain specific scores for walking, moderate-intensity, and vigorous activity within the domains of work, transportation, domestic chores and gardening, and leisure-time. The tool asks about the time spent doing a specific physical activity in the last 7 days. For total scores, the duration (in minutes) and frequency for all types of activities in all domains are summed, while specific domain scores are calculated by the summation of the walking, moderate-intensity and vigorous-intensity activities within the specific domain. For activity-specific scores, the scores for the specific type of activity across domains are added. To measure the volume of activity, each type of activity is weighted by its energy requirement defined as the metabolic equivalent of task-minute (MET-min).
Baseline,12 weeks and 24 weeks
Change from baseline in quality of life
Time Frame: Baseline,12 weeks and 24 weeks
The SF-36 (v2) Health Survey provides psychometrically-based physical and mental health summary measures and a preference-based health utility index. It is a generic measure that does not target a specific age, disease, or treatment group.
Baseline,12 weeks and 24 weeks
Change from baseline in systolic blood pressure
Time Frame: Baseline,12 weeks and 24 weeks
Systolic blood pressure will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis
Baseline,12 weeks and 24 weeks
Change from baseline in diastolic blood pressure
Time Frame: Baseline,12 weeks and 24 weeks
Diastolic blood pressure will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis
Baseline,12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

HyperVibe Pty Ltd

Investigators

  • Principal Investigator: John E Lewis, Ph.D., University of Miami

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 (Actual)

January 19, 2016

Primary Completion (Actual)

January 12, 2017

Study Completion (Actual)

January 12, 2017

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 20150524

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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