Whole-body Vibration With or Without Localized Radiofrequency and Body Composition in Obese Female

September 23, 2020 updated by: Carlo Zancanaro, Universita di Verona

Effect of Whole-body Vibration With or Without Localized Radiofrequency on Body Composition and Subcutaneous Fat in Obese Females

The aim of this study is to evaluate the effect of whole-body vibration in the presence or absence of localized radiofrequency on body composition in obese female subjects. Moreover, strength tests will be performed. The study hypothesis is that whole-body vibration induces positive changes in body composition i.e., reduction of fat mass and increase of lean mass with associated increase in performance. The possible additive role of radiofrequency will also be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • recruitment of female obese subjects
  • baseline assessment (body composition with dual energy x-ray absorptiometry (DXA) and strength tests)
  • 2-mo whole body vibration training (2 sessions a week, 30 min per session) with or without local delivery of radiofrequency (two randomly selected groups)
  • final assessment (body composition with DXA and strength tests)
  • data collation and analysis

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • BMI: >25
  • normal locomotion
  • informed consent form signed

Exclusion Criteria:

  • acute illness
  • endocrine pathologies or diabetes mellitus
  • vascular pathology
  • pacemaker
  • pregnancy

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: CONTROL
NO VIBRATION EXERCISE
EXPERIMENTAL: VIBRATION EXERCISE
WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY
Device: vibrating platform (Bioplate RF)
whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency
Other Names:
  • Bioplate RF vibrating platform
EXPERIMENTAL: VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION
WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIO, MILAN, ITALY PLUS LOCAL ADMINISTRATION OF RADIOFREQUENCY
Device: vibrating platform (Bioplate RF)
whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency
Other Names:
  • Bioplate RF vibrating platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: 2 months
Evidence of changes in body composition (three-compartment model as assessed by dual-energy X-ray absorptiometry) after two months of whole-body vibration with or without application of localized radiofrequency
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular Strength
Time Frame: 2 months
evidence of changes in lower limbs muscular strength following 2 months of whole-body vibration
2 months

Collaborators and Investigators

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

Sponsor

Universita di Verona

Collaborators

BIOS s.r.l., Milano, Italy

Investigators

  • Principal Investigator: Carlo Zancanaro, MD, Universita di Verona

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

July 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 4, 2011

First Posted (ESTIMATE)

April 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VIBROB

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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