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

Obesity, Childhood Clinical Trial

— PSICOFISADOL  

Official title:

Integrated Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach in Promoting the Condition of Psychophysical Well-being and the Performance of Physical Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296407
• Other study ID #: 01C319
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Istituto Auxologico Italiano
• Contact: Alessandro Sartorio, MD
• Phone: +390261911
• Email: sartorio[@]auxologico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Other:
• Standard metabolic integrated rehabilitation protocol - duration 3 weeks
Standard metabolic integrated rehabilitation protocol
• 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])

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano, Site Piancavallo	Oggebbio	Verbania

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat mass	Assessed by tetrapolar impedance	At baseline and after 3 weeks of intervention
Primary	Fat-free mass	Assessed by tetrapolar impedance	At baseline and after 3 weeks of intervention
Primary	Maximal Inspiratory Pressure	Assessed by metabolimeter	At baseline and after 3 weeks of intervention
Primary	Maximal Expiratory Pressure	Assessed by metabolimeter	At baseline and after 3 weeks of intervention
Primary	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