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Completed

NCT Number: NCT06296407

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

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Auxologico Italiano, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

About this study

Objectives:

Specifically, the project aims to pursue the following objectives:

  • 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;
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard metabolic integrated rehabilitation protocol - duration 3 weeks

Other

Standard metabolic integrated rehabilitation protocol

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

Other

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

Primary outcomes

  1. Fat mass

    Time frame: At baseline and after 3 weeks of intervention

    Assessed by tetrapolar impedance

  2. Fat-free mass

    Time frame: At baseline and after 3 weeks of intervention

    Assessed by tetrapolar impedance

  3. Maximal Inspiratory Pressure

    Time frame: At baseline and after 3 weeks of intervention

    Assessed by metabolimeter

  4. Maximal Expiratory Pressure

    Time frame: At baseline and after 3 weeks of intervention

    Assessed by metabolimeter

  5. Interoceptive awareness

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study 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

Acronym: PSICOFISADOL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2024
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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