NCT06800872

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable obesity

Timeline
2mo left

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Jul 2024Jul 2026

Study Start

First participant enrolled

July 17, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

January 24, 2025

Last Update Submit

March 25, 2026

Conditions

Keywords

Resting energy expenditureBody vibrationBody compositionFunctional tests

Outcome Measures

Primary Outcomes (1)

  • Resting energy expenditure

    Resting energy expenditure assessed through indirect calorimetry.

    At baseline and after 3 weeks

Study Arms (2)

Control group

EXPERIMENTAL

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

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.

Other: Multidisciplinary metabolic rehabilitation + training with WBVE

Interventions

Standard in-hospital protocol of multidisciplinary metabolic rehabilitation

Control group

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)

Experimental group

Eligibility Criteria

Age13 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of cardiovascular, psychiatric, and musculoskeletal pathologies
  • Absence of signed written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Alessandro Sartorio, MD

CONTACT

Luca Grappiolo, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2025

First Posted

January 30, 2025

Study Start

July 17, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations