ObesityNCT01329328
Whole-body Vibration With or Without Localized Radiofrequency and Body Composition in Obese Female
A study testing vibrating platform (Bioplate RF) in people with Obesity, run by Universita di Verona.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- vibrating platform (Bioplate RF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: >25
- normal locomotion
- informed consent form signed
Who cannot join
- acute illness
- endocrine pathologies or diabetes mellitus
- vascular pathology
- pacemaker
- pregnancy
About this study
Official title: Effect of Whole-body Vibration With or Without Localized Radiofrequency on Body Composition and Subcutaneous Fat in Obese Females
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.
Read the 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
- Conditions
- Obesity
- Being tested
- vibrating platform (Bioplate RF)
- Keywords
- whole-body vibration, radiofrequency, muscular strength, exercise, body composition
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibrating platform (Bioplate RF)Device
Also called Bioplate RF vibrating platform
whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | NO VIBRATION EXERCISE |
| VIBRATION EXERCISE | Experimental | WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY Receives: 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 Receives: Device: vibrating platform (Bioplate RF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Secondary outcomes (1)
Muscular Strength
evidence of changes in lower limbs muscular strength following 2 months of whole-body vibration
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Bios S.r.l.
- Responsible party
- Principal investigator, Carlo Zancanaro, Universita di Verona
- Investigators
- Carlo Zancanaro, MD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329328
- Sponsor's protocol ID
- VIBROB
- Status last verified
- Sep 2020
- First submitted
- 1 Apr 2011
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-body Vibration With or Without Localized Radiofrequency on Body Composition and Subcutaneous Fat in Obese Females
- ClinicalTrials.gov ID
- NCT01329328
- Acronym / sponsor ID
- VIBROB
- Conditions
- Obesity
- Keywords
- whole-body vibration, radiofrequency, muscular strength, exercise, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Bios S.r.l.
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –NO VIBRATION EXERCISE |
| VIBRATION EXERCISE | Experimental | Device: vibrating platform (Bioplate RF)WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIOS, MILAN, ITALY |
| VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION | Experimental | Device: vibrating platform (Bioplate RF)WHOLE-BODY VIBRATION EXERCISE ON A VIBRATION DEVICE (BIOPLATE RF, BIO, MILAN, ITALY PLUS LOCAL ADMINISTRATION OF RADIOFREQUENCY |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI: >25
- normal locomotion
- informed consent form signed
Key exclusion criteria (5 listed)
- acute illness
- endocrine pathologies or diabetes mellitus
- vascular pathology
- pacemaker
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vibrating platform (Bioplate RF)Also: Bioplate RF vibrating platformwhole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency | Device | VIBRATION EXERCISE, VIBRATION EXERCISE PLUS RADIOFREQUENCY ADMINISTRATION |
Primary outcome
Body Composition
Time frame: 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
1 secondary outcome
Muscular Strength
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Zancanaro, MD principal investigator
Universita di Verona
Questions about this trial
What is this clinical trial studying?
A study testing vibrating platform (Bioplate RF) in people with Obesity, run by Universita di Verona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.