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

NCT ID: NCT06296407

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-08
• Study Completion Date: 2024-07-31

Brief Summary

Specifically, the project aims to pursue the following objectives:

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. 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.

The final objective of this project is to define and propose "take home" specific respiratory exercises to promote greater body awareness and a condition of psychophysical well-being stable over time, creating a condition that can favor further interventions on obesity. Finally, the project aims to build solid scientific bases to insert respiratory exercise among the intervention guidelines to prevent and reduce obesity, particularly youth obesity.

Detailed Description

Objectives:

Specifically, the project aims to pursue the following objectives:

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. 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.

The final objective of this project is to define and propose "take home" specific respiratory exercises to promote greater body awareness and a condition of psychophysical well-being stable over time, creating a condition that can favor further interventions on obesity. Finally, the project aims to build solid scientific bases to insert respiratory exercise among the intervention guidelines to prevent and reduce obesity, particularly youth obesity. Material and Methods:

Participants:

24 males and females with obesity, aged between 12 and 18 years enrolled at the Division of Auxologia, Hospital San Giuseppe, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy.

The participants are subdivided randomly into two subgroups: i. one control group (12 male and female adolescents) follows the standard metabolic integrated rehabilitation protocol and ii. an experimental group (12 male and female adolescents) who, in addition to the standard protocol, performs 12 sessions (5 sessions/week for 3 weeks) of 30 minutes each of respiratory exercises. The exercise definition are based on recent studies performed on obese patients (Batrakoulis 2022 a-b; Calcaterra et al., 2013-2014) and on different patient populations where the respiratory dysfunction is a primary or secondary pathology component (Bernardi et al., 2002). All the exercises are adapted to the examined population and guided and monitored by expert staff.

Conditions

Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Respiratory exercises

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Control

Males and females with obesity on standard metabolic integrated rehabilitation protocol

Group Type: ACTIVE_COMPARATOR

Standard metabolic integrated rehabilitation protocol - duration 3 weeks

Intervention Type: OTHER

Standard metabolic integrated rehabilitation protocol

Interventions

Standard metabolic integrated rehabilitation protocol - duration 3 weeks

Standard metabolic integrated rehabilitation protocol

Intervention Type: OTHER

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

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Auxologico Italiano, Site Piancavallo

Oggebbio, Verbania, Italy

Countries

Italy

Other Identifiers

01C319

Identifier Type: -

Identifier Source: org_study_id