Effect of Whole-body Vibration With or Without Localized Radiofrequency on Body Composition of Obese Female Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01329328
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : June 13, 2012
BIOS s.r.l., Milano, Italy
Information provided by (Responsible Party):
Carlo Zancanaro, Universita di Verona

Brief Summary:
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, balance and 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.

Condition or disease Intervention/treatment Phase
Obesity Device: vibrating platform (Bioplate RF) Not Applicable

Detailed Description:
  • recruitment of female obese subjects
  • baseline assessment (body composition with DXA, blood tests, balance and strength tests)
  • 3-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, blood tests, balance and strength tests)
  • data collation and analysis

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Vibrazione Corporea Totale Con o Senza Radiofrequenza Localizzata su Composizione Corporea, Adipe Sottocutaneo e Parametri Ormonali in Donne Obese
Study Start Date : July 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Intervention Details:
  • Device: vibrating platform (Bioplate RF)
    whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency
    Other Name: Bioplate RF vibrating platform

Primary Outcome Measures :
  1. Body composition [ Time Frame: 3 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

Secondary Outcome Measures :
  1. muscular strength [ Time Frame: 3 months ]
    evidence of changes in lower limbs muscular strength following 2 months of whole-body vibration

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01329328

Sponsors and Collaborators
Universita di Verona
BIOS s.r.l., Milano, Italy
Principal Investigator: Carlo Zancanaro, MD Universita di Verona

Responsible Party: Carlo Zancanaro, Professor, Universita di Verona Identifier: NCT01329328     History of Changes
Other Study ID Numbers: VIBROB
First Posted: April 5, 2011    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Carlo Zancanaro, Universita di Verona:
whole-body vibration
hormonal status
muscular strength