Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296407
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-29
Brief Title:
Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach PSICOFISADOLOB
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSICOFISADOL
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
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 sessionsweek 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
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 sessionsweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None