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临床试验/NCT06296407
NCT06296407已完成不适用

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

Istituto Auxologico Italiano2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年8月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Maximal Expiratory Pressure

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Respiratory exercises

Experimental

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

干预措施: Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks (Other)

Control

Active Comparator

Males and females with obesity on standard metabolic integrated rehabilitation protocol

干预措施: Standard metabolic integrated rehabilitation protocol - duration 3 weeks (Other)

结局指标

主要结局

Maximal Expiratory Pressure

时间窗: At baseline and after 3 weeks of intervention

Assessed by metabolimeter

Maximal Inspiratory Pressure

时间窗: At baseline and after 3 weeks of intervention

Assessed by metabolimeter

Fat-free mass

时间窗: At baseline and after 3 weeks of intervention

Assessed by tetrapolar impedance

Fat mass

时间窗: At baseline and after 3 weeks of intervention

Assessed by tetrapolar impedance

Interoceptive awareness

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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