NCT01329328

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2011

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

September 24, 2020

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

April 1, 2011

Results QC Date

September 3, 2020

Last Update Submit

September 23, 2020

Conditions

Keywords

whole-body vibrationradiofrequencymuscular strengthexercisebody composition

Outcome Measures

Primary Outcomes (1)

  • Body Composition

    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 Outcomes (1)

  • Muscular Strength

    2 months

Study Arms (3)

CONTROL

NO INTERVENTION

NO VIBRATION EXERCISE

VIBRATION EXERCISE

EXPERIMENTAL

WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY

Device: vibrating platform (Bioplate RF)

VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION

EXPERIMENTAL

WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIO, MILAN, ITALY PLUS LOCAL ADMINISTRATION OF RADIOFREQUENCY

Device: vibrating platform (Bioplate RF)

Interventions

whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency

Also known as: Bioplate RF vibrating platform
VIBRATION EXERCISEVIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Prof. Carlo Zancanaro
Organization
University of Verona

Study Officials

  • Carlo Zancanaro, MD

    Universita di Verona

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 5, 2011

Study Start

July 1, 2010

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

September 24, 2020

Results First Posted

September 24, 2020

Record last verified: 2020-09