Overview

This trial is active, not recruiting.

Conditions body composition, beneficial, physical fitness
Treatments hypervibe whole body vibration training device, aerobic exercise
Sponsor University of Miami
Collaborator HyperVibe Pty Ltd
Start date April 2016
End date December 2017
Trial size 7 participants
Trial identifier NCT02571322, 20150524

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Use of the HyperVibe Whole Body Vibration training device for 12 weeks 3 times per week crossover to aerobic exercise
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 training for 12 weeks 3 times per week crossover to use of the HyperVibe Whole Body Vibration training device
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.

Primary Outcomes

Measure
Change from baseline in body composition
time frame: Baseline,12 weeks and 24 weeks
Change from baseline in aerobic capacity
time frame: Baseline,12 weeks and 24 weeks
Change from baseline in body strength
time frame: Baseline,12 weeks and 24 weeks
Change from baseline in bone mineral density
time frame: Baseline,12 weeks and 24 weeks

Secondary Outcomes

Measure
Change from baseline in physical activity
time frame: Baseline,12 weeks and 24 weeks
Change from baseline in quality of life
time frame: Baseline,12 weeks and 24 weeks
Change from baseline in systolic blood pressure
time frame: Baseline,12 weeks and 24 weeks
Change from baseline in diastolic blood pressure
time frame: Baseline,12 weeks and 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title The Effect of Whole Body Vibration Training on Body Composition, Physical Fitness, and Quality of Life
Principal investigator John E Lewis, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Miami.