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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: vibrating platform (Bioplate RF)

• Registration Number: NCT01329328
• Lead Sponsor: 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, 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.

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 Timeline

• Study Start: 2010-07
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-05
• Status Verified: 2020-09
• Results First Submitted: 2020-09-03
• Results First Submitted QC: 2020-09-23
• Last Update Submitted: 2020-09-23
• Results First Posted: 2020-09-24
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION	vibrating platform (Bioplate RF)	WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIO, MILAN, ITALY PLUS LOCAL ADMINISTRATION OF RADIOFREQUENCY
VIBRATION EXERCISE	vibrating platform (Bioplate RF)	WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY

Primary Outcome Measures

Name	Time	Method
Body Composition	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

Secondary Outcome Measures

Name	Time	Method
Muscular Strength	2 months	evidence of changes in lower limbs muscular strength following 2 months of whole-body vibration