CClinicalTrials.gg
CompletedNCT06296407PSICOFISADOLUpdated Apr 30, 2025

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

An interventional study of Standard metabolic integrated rehabilitation protocol - duration 3 weeks and Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks in Obesity, Childhood, sponsored by Istituto Auxologico Italiano. Completed at 1 site in Italy. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by Istituto Auxologico Italiano · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Aug 2023, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity, Childhood

Keywords

  • Obesity
  • Respiration
  • Physical activity
  • Psychophysical weel-being
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 24 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Respiratory exercises

    Males and females with obesity on standard metabolic integrated rehabilitation protocol + respiratory exercises

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

  • Active comparator
    Control

    Males and females with obesity on standard metabolic integrated rehabilitation protocol

    Other: Standard metabolic integrated rehabilitation protocol - duration 3 weeks

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 \[5 sessions/week for 3 weeks\])

06

What researchers measure

Primary outcomes

  1. Fat mass

    Assessed by tetrapolar impedance

    Time frame: At baseline and after 3 weeks of intervention

  2. Fat-free mass

    Assessed by tetrapolar impedance

    Time frame: At baseline and after 3 weeks of intervention

  3. Maximal Inspiratory Pressure

    Assessed by metabolimeter

    Time frame: At baseline and after 3 weeks of intervention

  4. Maximal Expiratory Pressure

    Assessed by metabolimeter

    Time frame: At baseline and after 3 weeks of intervention

  5. 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

    Time frame: At baseline and after 3 weeks of intervention

07

Study locations

1 site
  • Istituto Auxologico Italiano, Site Piancavallo
    Oggebbio, Verbania 28824, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06296407
Lead sponsor
Istituto Auxologico Italiano
Responsible party
Sponsor
First posted
Mar 6, 2024
Start date
Aug 8, 2023
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update
Apr 30, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion