Obesity, ChildhoodPSICOFISADOLNCT06296407
Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach (PSICOFISADOLOB).
A study testing Standard metabolic integrated rehabilitation protocol - duration 3 weeks and Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks in people with Obesity, Childhood, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Standard metabolic integrated rehabilitation protocol - duration 3 weeks and Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 8 Aug 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Auxologico Italiano, Site Piancavallo
Oggebbio, Verbania, 28824
About this study
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
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.
Read the detailed description
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.
- Conditions
- Obesity, Childhood
- Being tested
- Standard metabolic integrated rehabilitation protocol - duration 3 weeks, Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks
- Keywords
- Obesity, Respiration, Physical activity, Psychophysical weel-being
- Medical subject headings
- Pediatric Obesity, Obesity, Respiratory Aspiration, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard metabolic integrated rehabilitation protocol - duration 3 weeksOther
Standard metabolic integrated rehabilitation protocol
Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeksOther
Standard metabolic integrated rehabilitation protocol + respiratory exercises (12 sessions [5 sessions/week for 3 weeks])
| Study group | Role | What they receive |
|---|---|---|
| Respiratory exercises | Experimental | Males and females with obesity on standard metabolic integrated rehabilitation protocol + respiratory exercises Receives: Other: Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks |
| Control | Active comparator | Males and females with obesity on standard metabolic integrated rehabilitation protocol Receives: Other: Standard metabolic integrated rehabilitation protocol - duration 3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
Assessed by tetrapolar impedance
Measured: At baseline and after 3 weeks of intervention
Fat-free mass
Assessed by tetrapolar impedance
Measured: At baseline and after 3 weeks of intervention
Maximal Inspiratory Pressure
Assessed by metabolimeter
Measured: At baseline and after 3 weeks of intervention
Maximal Expiratory Pressure
Assessed by metabolimeter
Measured: At baseline and after 3 weeks of intervention
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
Measured: At baseline and after 3 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start8 Aug 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296407
- Sponsor's protocol ID
- 01C319
- Acronym
- PSICOFISADOL
- Status last verified
- Apr 2025
- First submitted
- 29 Feb 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06296407
- Acronym / sponsor ID
- PSICOFISADOL / 01C319
- Conditions
- Obesity, Childhood
- Keywords
- Obesity, Respiration, Physical activity, Psychophysical weel-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory exercises | Experimental | Other: Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeksMales and females with obesity on standard metabolic integrated rehabilitation protocol + respiratory exercises |
| Control | Active comparator | Other: Standard metabolic integrated rehabilitation protocol - duration 3 weeksMales and females with obesity on standard metabolic integrated rehabilitation protocol |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard metabolic integrated rehabilitation protocol - duration 3 weeksStandard metabolic integrated rehabilitation protocol | Other | Control |
| Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeksStandard metabolic integrated rehabilitation protocol + respiratory exercises (12 sessions [5 sessions/week for 3 weeks]) | Other | Respiratory exercises |
Primary outcome
Fat mass
Time frame: At baseline and after 3 weeks of intervention
Assessed by tetrapolar impedance
Fat-free mass
Time frame: At baseline and after 3 weeks of intervention
Assessed by tetrapolar impedance
Maximal Inspiratory Pressure
Time frame: At baseline and after 3 weeks of intervention
Assessed by metabolimeter
Maximal Expiratory Pressure
Time frame: At baseline and after 3 weeks of intervention
Assessed by metabolimeter
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard metabolic integrated rehabilitation protocol - duration 3 weeks and Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks in people with Obesity, Childhood, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass (time frame: At baseline and after 3 weeks of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.