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Recruiting NCT06800872

Whole Body Vibration Effects on Energy Expenditure in Obese Adolescents

No phase Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multidisciplinary metabolic rehabilitation, Multidisciplinary metabolic rehabilitation + training with WBVE.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 13 years — 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Other Multidisciplinary metabolic rehabilitation
    Standard in-hospital protocol of multidisciplinary metabolic rehabilitation
  • Other Multidisciplinary metabolic rehabilitation + training with WBVE
    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)

Primary outcome measures

  • Resting energy expenditure [Time frame: At baseline and after 3 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Istituto Auxologico Italiano IRCCS, Site Piancavallo — Oggebbio

Identifiers

NCT: NCT06800872 · 01C413

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗