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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329328
First Posted: April 5, 2011
Last Update Posted: June 13, 2012
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.
Collaborator:
BIOS s.r.l., Milano, Italy
Information provided by (Responsible Party):
Carlo Zancanaro, Universita di Verona
  Purpose
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 Intervention
Obesity Device: vibrating platform (Bioplate RF)

Study Type: Interventional
Study Design: 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

Further study details as provided by Carlo Zancanaro, Universita di Verona:

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


Enrollment: 40
Study Start Date: July 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
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
  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • acute illness
  • endocrine pathologies or diabetes mellitus
  • vascular pathology
  • pacemaker
  • pregnancy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01329328


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

Responsible Party: Carlo Zancanaro, Professor, Universita di Verona
ClinicalTrials.gov Identifier: NCT01329328     History of Changes
Other Study ID Numbers: VIBROB
First Submitted: April 1, 2011
First Posted: April 5, 2011
Last Update Posted: June 13, 2012
Last Verified: June 2012

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