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Clinical Trials/NCT06800872
NCT06800872RecruitingNot Applicable

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

Istituto Auxologico Italiano1 site in 1 country28 target enrollmentStarted: July 17, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
28
Locations
1
Primary Endpoint
Resting energy expenditure

Study Overview

Brief 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 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
13 Years to 18 Years (Child, Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Arms & Interventions

Control group

Experimental

14 boys with obesity: standard in-hospital protocol of multidisciplinary metabolic rehabilitation

Intervention: Multidisciplinary metabolic rehabilitation (Other)

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.

Intervention: Multidisciplinary metabolic rehabilitation + training with WBVE (Other)

Outcomes

Primary Outcomes

Resting energy expenditure

Time Frame: At baseline and after 3 weeks

Resting energy expenditure assessed through indirect calorimetry.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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