- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06800872
Whole Body Vibration Effects on Energy Expenditure in Obese Adolescents (VIBRAREEOB)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alessandro Sartorio, MD
- Phone Number: 2426 +390261911
- Email: sartorio@auxologico.it
Study Contact Backup
- Name: Luca Grappiolo, Dr.
- Phone Number: 2894 +390261911
- Email: luca.grappiolo@auxologico.it
Study Locations
-
-
Verbania
-
Oggebbio, Verbania, Italy, 28824
- Recruiting
- Istituto Auxologico Italiano IRCCS, Site Piancavallo
-
Contact:
- Alessandro Sartorio, MD
- Phone Number: 2426 +39-02619111
- Email: sartorio@auxologico.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Presence of cardiovascular, psychiatric, and musculoskeletal pathologies
- Absence of signed written consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control group
14 boys with obesity: standard in-hospital protocol of multidisciplinary metabolic rehabilitation
|
Standard in-hospital protocol of multidisciplinary metabolic rehabilitation
|
|
Experimental: Experimental group
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.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting energy expenditure
Time Frame: At baseline and after 3 weeks
|
Resting energy expenditure assessed through indirect calorimetry.
|
At baseline and after 3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01C413
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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