Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach (PSICOFISADOLOB).

NCT06296407 | Completed

• 1 other identifier: 01C319
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Specifically, the project aims to pursue the following objectives:

1. 1.To evaluate in male and female adolescents with obesity the interaction between different psycho-body aspects such as respiration - posture - self-perception and affectivity and tolerance to physical exercise;
2. 2.To evaluate in a subgroup of male and female adolescents the effectiveness of exercises aimed at respiratory muscles and of respiratory consciousness on the parameters above indicated and on their interaction.

Conditions

Obesity, Childhood

Keywords

Obesity; Respiration; Physical activity; Psychophysical weel-being

Outcome Measures

Primary Outcomes (5)

• Fat mass

  Assessed by tetrapolar impedance

  At baseline and after 3 weeks of intervention

• Fat-free mass

  Assessed by tetrapolar impedance

  At baseline and after 3 weeks of intervention

• Maximal Inspiratory Pressure

  Assessed by metabolimeter

  At baseline and after 3 weeks of intervention

• Maximal Expiratory Pressure

  Assessed by metabolimeter

  At baseline and after 3 weeks of intervention

• Interoceptive awareness

  Assessed by Multidimensional Assessment of Interoceptive Awareness Scale, with a self-report survey composed of 32 items with a Likert scale composed of 5 points scale

  At baseline and after 3 weeks of intervention

Study Arms (2)

Respiratory exercises

EXPERIMENTAL

Males and females with obesity on standard metabolic integrated rehabilitation protocol + respiratory exercises

Other: Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks

Control

ACTIVE COMPARATOR

Males and females with obesity on standard metabolic integrated rehabilitation protocol

Other: Standard metabolic integrated rehabilitation protocol - duration 3 weeks

Interventions

Standard metabolic integrated rehabilitation protocol - duration 3 weeks OTHER

Standard metabolic integrated rehabilitation protocol

Control

Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks OTHER

Standard metabolic integrated rehabilitation protocol + respiratory exercises (12 sessions \[5 sessions/week for 3 weeks\])

Respiratory exercises

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• BMI standard deviation score (SDS) \> 2;
• absence of structured programs of physical activity (regular activity for more than 120min/week) for the 6 months before the study;
• absence of signs/symptoms related to cardiovascular, respiratory, gastrointestinal, skeletal-muscle pathologies contraindicated for the test execution

You may not qualify if:

• BMI standard deviation score (SDS) \< 2;
• presence of structured programs of physical activity (regular activity for more than 120min/week) for the 6 months before the study;
• presence of signs/symptoms related to cardiovascular, respiratory, gastrointestinal, skeletal-muscle pathologies contraindicated for the test execution

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Respiratory Aspiration; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Behavior

Study Design

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

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: August 8, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

IT (1)