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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:
Collaborator:
BIOS s.r.l., Milano, Italy
Information provided by (Responsible Party):
Carlo Zancanaro, Universita di Verona
ClinicalTrials.gov Identifier:
NCT01329328
First received: April 1, 2011
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329328

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

No publications provided

Responsible Party: Carlo Zancanaro, Professor, Universita di Verona
ClinicalTrials.gov Identifier: NCT01329328     History of Changes
Other Study ID Numbers: VIBROB
Study First Received: April 1, 2011
Last Updated: June 12, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013