NCT02571322

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 19, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2017

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

12 months

First QC Date

September 28, 2015

Last Update Submit

March 2, 2017

Conditions

Body Composition, BeneficialPhysical Fitness

Outcome Measures

Primary Outcomes (4)

  • Change from baseline in body composition

    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

    Aerobic capacity and strength will be assessed by Graded Exercise Test

    Baseline,12 weeks and 24 weeks

  • Change from baseline in body strength

    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

    Bone mineral density will be assessed by DEXA scan

    Baseline,12 weeks and 24 weeks

Secondary Outcomes (4)

  • Change from baseline in physical activity

    Baseline,12 weeks and 24 weeks

  • Change from baseline in quality of life

    Baseline,12 weeks and 24 weeks

  • Change from baseline in systolic blood pressure

    Baseline,12 weeks and 24 weeks

  • Change from baseline in diastolic blood pressure

    Baseline,12 weeks and 24 weeks

Study Arms (2)

Whole Body Vibration training

EXPERIMENTAL

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

Aerobic Exercise

PLACEBO COMPARATOR

Aerobic exercise training for 12 weeks 3 times per week crossover to use of the HyperVibe Whole Body Vibration training device

Other: Aerobic Exercise

Interventions

HyperVibe Whole Body Vibration training deviceDEVICE

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.

Whole Body Vibration training
Aerobic ExerciseOTHER

Aerobic exercise session will last approximately thirty minutes. Starting training intensity will be specific to each participant based on his/her baseline fitness level.

Aerobic Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Miller School of Medicine, Clinical Research Building, Department of Psychiatry & Behavioral Sciences

Miami, Florida, 33136, United States

Location

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MeSH Terms

Conditions

Glucocorticoid Receptor Deficiency

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • John E Lewis, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 8, 2015

Study Start

January 19, 2016

Primary Completion

January 12, 2017

Study Completion

January 12, 2017

Last Updated

March 3, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)