Clinical trial NCT06296407: Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach (PSICOFISADOLOB).
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Keywords: Obesity
Respiration
Physical activity
Psychophysical weel-being
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Fat mass
timeFrame: At baseline and after 3 weeks of intervention
measure: Fat-free mass
timeFrame: At baseline and after 3 weeks of intervention
measure: Maximal Inspiratory Pressure
timeFrame: At baseline and after 3 weeks of intervention
measure: Maximal Expiratory Pressure
timeFrame: At baseline and after 3 weeks of intervention
measure: Interoceptive awareness
timeFrame: At baseline and after 3 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano, Site Piancavallo
state: Verbania
Study officials:
References: