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

Not Applicable

Recruiting

• Conditions: Obesity, Childhood
• Interventions: Other: Standard metabolic integrated rehabilitation protocol - duration 3 weeks; Other: Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks

• Registration Number: NCT06296407
• Lead Sponsor: Istituto Auxologico Italiano

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.

Study Timeline

• Study Start: 2023-08-08
• Status Verified: 2024-02
• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Study First Posted: 2024-03-06
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard metabolic integrated rehabilitation protocol - duration 3 weeks	Males and females with obesity on standard metabolic integrated rehabilitation protocol
Respiratory exercises	Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks	Males and females with obesity on standard metabolic integrated rehabilitation protocol + respiratory exercises

Primary Outcome Measures

Name	Time	Method
Maximal Expiratory Pressure	At baseline and after 3 weeks of intervention	Assessed by metabolimeter
Fat-free mass	At baseline and after 3 weeks of intervention	Assessed by tetrapolar impedance
Fat mass	At baseline and after 3 weeks of intervention	Assessed by tetrapolar impedance
Maximal Inspiratory Pressure	At baseline and after 3 weeks of intervention	Assessed by metabolimeter
Interoceptive awareness	At baseline and after 3 weeks of intervention	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

Trial Locations

Locations (1)

Istituto Auxologico Italiano, Site Piancavallo; 🇮🇹 Oggebbio, Verbania, Italy