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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06296407
Acronym
PSICOFISADOL
Enrollment
24
Registered
2024-03-06
Start date
2023-08-08
Completion date
2024-07-31
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

Keywords

Obesity, Respiration, Physical activity, Psychophysical weel-being

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.

Interventions

OTHERStandard metabolic integrated rehabilitation protocol - duration 3 weeks

Standard metabolic integrated rehabilitation protocol

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

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

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fat massAt baseline and after 3 weeks of interventionAssessed by tetrapolar impedance
Fat-free massAt baseline and after 3 weeks of interventionAssessed by tetrapolar impedance
Maximal Inspiratory PressureAt baseline and after 3 weeks of interventionAssessed by metabolimeter
Maximal Expiratory PressureAt baseline and after 3 weeks of interventionAssessed by metabolimeter
Interoceptive awarenessAt baseline and after 3 weeks of interventionAssessed 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026