Clinical trial NCT02571322: Whole Body Vibration Training on Body Composition
Official title: The Effect of Whole Body Vibration Training on Body Composition, Physical Fitness, and Quality of Life
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Body Composition, Beneficial
Physical Fitness
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: HyperVibe Pty Ltd
First posted: 2015-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in body composition
timeFrame: Baseline,12 weeks and 24 weeks
measure: Change from baseline in aerobic capacity
timeFrame: Baseline,12 weeks and 24 weeks
measure: Change from baseline in body strength
timeFrame: Baseline,12 weeks and 24 weeks
measure: Change from baseline in bone mineral density
timeFrame: Baseline,12 weeks and 24 weeks
Secondary outcomes:
measure: Change from baseline in physical activity
timeFrame: Baseline,12 weeks and 24 weeks
measure: Change from baseline in quality of life
timeFrame: Baseline,12 weeks and 24 weeks
measure: Change from baseline in systolic blood pressure
timeFrame: Baseline,12 weeks and 24 weeks
measure: Change from baseline in diastolic blood pressure
timeFrame: Baseline,12 weeks and 24 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine, Clinical Research Building, Department of Psychiatry & Behavioral Sciences
state: Florida
Study officials:
affiliation: University of Miami
name: John E Lewis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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