ObesityVIBRAREEOBNCT06800872
Whole Body Vibration Effects on Energy Expenditure in Obese Adolescents
A study testing Multidisciplinary metabolic rehabilitation and Multidisciplinary metabolic rehabilitation + training with WBVE in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The main aim of the present study is to evaluate in a group of adolescents with obesity, hospitalized for a period of integrated metabolic rehabilitation (calorie restriction, aerobic physical activity, psychological counseling, nutritional re-education) lasting 3 weeks, the effects produced from a period of training… Read more about this study
- Who is it for?
- Ages 13 to 18 years, men only
- Conditions the study is for
- Obesity
- What is being tested?
- Multidisciplinary metabolic rehabilitation and Multidisciplinary metabolic rehabilitation + training with WBVE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jul 2024to 17 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male sex
- Age range 13-18 years
- Obesity (Body Mass Index Standard Deviation Score > 2)
- Hospitalization for a multidisciplinary program of integrated metabolic rehabilitation at the Division of Auxology, S. Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy
Who cannot join
- Presence of cardiovascular, psychiatric, and musculoskeletal pathologies
- Absence of signed written consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Auxologico Italiano IRCCS, Site Piancavallo
Oggebbio, Verbania, 28824
About this study
Official title: Effect of Body Vibration Sessions on Energy Expenditure at Rest and on Cardiovascular and Musculoskeletal Parameters in Obese Boys Hospitalized for a Multidisciplinary Program of Integrated Metabolic Rehabilitation
The main aim of the present study is to evaluate in a group of adolescents with obesity, hospitalized for a period of integrated metabolic rehabilitation (calorie restriction, aerobic physical activity, psychological counseling, nutritional re-education) lasting 3 weeks, the effects produced from a period of training with vibration stimulation on vibration platforms (Whole Body Vibration Exercise [WBVE]) on the resting energy expenditure (REE), assessed through indirect calorimetry. The results will be compared with those obtained in a control group, subjected to integrated metabolic rehabilitation alone.
Secondary aims of the study are to evaluate the effects of training with WBVE also on cardiovascular and musculoskeletal parameters, evaluated through specific functional tests, comparing them with those obtained in the control group.
Read the detailed description
The main aim of the present study is to evaluate in a group of adolescents with obesity, hospitalized for a period of integrated metabolic rehabilitation (calorie restriction, aerobic physical activity, psychological counseling, nutritional re-education) lasting 3 weeks, the effects produced from a period of training with vibration stimulation on vibration platforms (Whole Body Vibration Exercise [WBVE]) on the resting energy expenditure (REE), assessed through indirect calorimetry. The results will be compared with those obtained in a control group, subjected to integrated metabolic rehabilitation alone.
Secondary aims of the study are to evaluate the effects of training with WBVE also on cardiovascular and musculoskeletal parameters, evaluated through specific functional tests, comparing them with those obtained in the control group.
- Conditions
- Obesity
- Being tested
- Multidisciplinary metabolic rehabilitation, Multidisciplinary metabolic rehabilitation + training with WBVE
- Keywords
- Resting energy expenditure, Body vibration, Body composition, Functional tests
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary metabolic rehabilitationOther
Standard in-hospital protocol of multidisciplinary metabolic rehabilitation
Multidisciplinary metabolic rehabilitation + training with WBVEOther
Standard in-hospital protocol of multidisciplinary metabolic rehabilitation + 24 sessions (2 sessions per day) of 30 minutes each of training on a vibration platform (WBVE)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | 14 boys with obesity: standard in-hospital protocol of multidisciplinary metabolic rehabilitation Receives: Other: Multidisciplinary metabolic rehabilitation |
| Experimental group | Experimental | 14 boys with obesity: standard in-hospital protocol of multidisciplinary metabolic rehabilitation + 24 sessions (2 sessions per day) of 30 minutes each of training on a vibration platform. Receives: Other: Multidisciplinary metabolic rehabilitation + training with WBVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting energy expenditure
Resting energy expenditure assessed through indirect calorimetry.
Measured: At baseline and after 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start17 Jul 2024
- Primary completion17 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800872
- Sponsor's protocol ID
- 01C413
- Acronym
- VIBRAREEOB
- Status last verified
- Nov 2026
- First submitted
- 24 Jan 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Vibration Sessions on Energy Expenditure at Rest and on Cardiovascular and Musculoskeletal Parameters in Obese Boys Hospitalized for a Multidisciplinary Program of Integrated Metabolic Rehabilitation
- ClinicalTrials.gov ID
- NCT06800872
- Acronym / sponsor ID
- VIBRAREEOB / 01C413
- Conditions
- Obesity
- Keywords
- Resting energy expenditure, Body vibration, Body composition, Functional tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the present study is to evaluate in a group of adolescents with obesity, hospitalized for a period of integrated metabolic rehabilitation (calorie restriction, aerobic physical activity, psychological counseling, nutritional re-education) lasting 3 weeks, the effects produced from a period of training with vibration stimulation on vibration platforms (Whole Body Vibration Exercise [WBVE]) on the resting energy expenditure (REE), assessed through indirect calorimetry. The results will be compared with those obtained in a control group, subjected to integrated metabolic rehabilitation alone.
Secondary aims of the study are to evaluate the effects of training with WBVE also on cardiovascular and musculoskeletal parameters, evaluated through specific functional tests, comparing them with those obtained in the control group.
Detailed description
The main aim of the present study is to evaluate in a group of adolescents with obesity, hospitalized for a period of integrated metabolic rehabilitation (calorie restriction, aerobic physical activity, psychological counseling, nutritional re-education) lasting 3 weeks, the effects produced from a period of training with vibration stimulation on vibration platforms (Whole Body Vibration Exercise [WBVE]) on the resting energy expenditure (REE), assessed through indirect calorimetry. The results will be compared with those obtained in a control group, subjected to integrated metabolic rehabilitation alone.
Secondary aims of the study are to evaluate the effects of training with WBVE also on cardiovascular and musculoskeletal parameters, evaluated through specific functional tests, comparing them with those obtained in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Other: Multidisciplinary metabolic rehabilitation14 boys with obesity: standard in-hospital protocol of multidisciplinary metabolic rehabilitation |
| Experimental group | Experimental | Other: Multidisciplinary metabolic rehabilitation + training with WBVE14 boys with obesity: standard in-hospital protocol of multidisciplinary metabolic rehabilitation + 24 sessions (2 sessions per day) of 30 minutes each of training on a vibration platform. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male sex
- Age range 13-18 years
- Obesity (Body Mass Index Standard Deviation Score > 2)
- Hospitalization for a multidisciplinary program of integrated metabolic rehabilitation at the Division of Auxology, S. Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy
Key exclusion criteria (2 listed)
- Presence of cardiovascular, psychiatric, and musculoskeletal pathologies
- Absence of signed written consent
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 |
|---|---|---|
| Multidisciplinary metabolic rehabilitationStandard in-hospital protocol of multidisciplinary metabolic rehabilitation | Other | Control group |
| Multidisciplinary metabolic rehabilitation + training with WBVEStandard in-hospital protocol of multidisciplinary metabolic rehabilitation + 24 sessions (2 sessions per day) of 30 minutes each of training on a vibration platform (WBVE) | Other | Experimental group |
Primary outcome
Resting energy expenditure
Time frame: At baseline and after 3 weeks
Resting energy expenditure assessed through indirect calorimetry.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary metabolic rehabilitation and Multidisciplinary metabolic rehabilitation + training with WBVE in people with Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
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 4 inclusion and 2 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resting energy expenditure (time frame: At baseline and after 3 weeks). 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 6 Nov 2026.