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Functional Assessment and Sleep Apnea in Obese Children and Adolescents

Primary Purpose

Obstructive Sleep Apnea, Balance, Obesity, Childhood

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise on High-intensity interval training
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring pediatric obesity, pediatric obstructive sleep apnea, Postural balance

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age ≥ 6 to 17 years;

  • Confirmed obesity children by body mass index acorrding to the age

Exclusion Criteria:

  • orthopedic or neurological conditions that make it impossible to in a physical participation program

Sites / Locations

  • Luciana MalosaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

high-intensity interval training

Arm Description

High-intensity interval training describes physical exercise that is characterized by brief, intermittent bursts of vigorous activity, interspersed with periods of rest or low-intensity exercise

Outcomes

Primary Outcome Measures

Apnea hypopnea index
AHI

Secondary Outcome Measures

Functional performance of children and adolescents (3 minute step test)
numbers steps
Balance (balance assessments with Wii Balance board)
COP

Full Information

First Posted
September 26, 2022
Last Updated
September 28, 2022
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT05563311
Brief Title
Functional Assessment and Sleep Apnea in Obese Children and Adolescents
Official Title
Functional Assessment and Sleep Apnea in Obese Children and Adolescents After a Telerehabilitation Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Childhood obesity increases significantly, and determines several complications in childhood and adulthood, and the worldwide prevalence of childhood obesity has shown a rapid increase in recent decades. The severity of obesity-related risk factors is directly linked to body fat topography, and variations in body fat distribution in obese children can be of high value in predicting future health risks, like of cardiovascular disease in adulthood. There is a potential correlation between obesity and sleep disorders, increasing the predisposition to obstructive sleep apnea syndrome, that is a frequent complication, affecting up to 80% of obese children and adolescents. In relation to postural control, and that anthropometric indicators interfere with children's postural balance, already verified by balance assessment using computerized dynamic posturography. Several studies show that physical activity in childhood and adolescence can influence healthy habits in adulthood. Children and youth ages 5 to 17 should accumulate at least 60 minutes of moderate to vigorous-intensity physical activity daily. It is important to emphasize that the COVID-19 has impacted every aspect of healthcare delivery, and therefore Telerehabilitation has been satisfactorily addressed in reabilitation In the exercise recommendations for children, exercise programs performing aerobic and resistance exercises at a high level of intensity, on a frequent basis (3-5 days a week) for 30-80 minutes, seeking intensity of 50-90% of the maximum heart rate (HRmax), can be used and are shown to be efficient for the treatment of obesity. Therefore the High-intensity interval training (HIIT) describes physical exercise that is characterized by brief, intermittent bursts of vigorous activity, interspersed with periods of rest, cab generate favorable metabolic adaptations on sleep and body weight loss. Outcome Measures: Primary Outcome Measures The effects of high-intensity interval training (HIIT) and high-intensity functional training (HIFT) through Telerehabilitation on body composition and Obstructive sleep apnea (assessed by body mass index and bioimpedanceand polysomnography type 4) Secondary Outcome Measures Functional performance of children and adolescents (3 minute step test) Balance (balance assessments with Wii Balance board) Inclusion Criteria: Age ≥ 6 to 17 years; Confirmed obesity children by body mass index acorrding to the age
Detailed Description
Outcome Measures: Primary Outcome Measures - The effects of high-intensity interval training (HIIT) and high-intensity functional training (HIFT) through Telerehabilitation on body composition and Obstructive sleep apnea (assessed by body mass index and bioimpedance and polysomnography type 4) Secondary Outcome Measures Functional performance of children and adolescents (3 minute step test) Balance (balance assessments with Wii Balance board) Inclusion Criteria: Age ≥ 6 to 17 years; Confirmed obesity children by body mass index acorrding to the age

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Balance, Obesity, Childhood
Keywords
pediatric obesity, pediatric obstructive sleep apnea, Postural balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high-intensity interval training
Arm Type
Experimental
Arm Description
High-intensity interval training describes physical exercise that is characterized by brief, intermittent bursts of vigorous activity, interspersed with periods of rest or low-intensity exercise
Intervention Type
Other
Intervention Name(s)
Exercise on High-intensity interval training
Intervention Description
3 times a week, for 8 weeks
Primary Outcome Measure Information:
Title
Apnea hypopnea index
Description
AHI
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Functional performance of children and adolescents (3 minute step test)
Description
numbers steps
Time Frame
1 day
Title
Balance (balance assessments with Wii Balance board)
Description
COP
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 6 to 17 years; Confirmed obesity children by body mass index acorrding to the age Exclusion Criteria: orthopedic or neurological conditions that make it impossible to in a physical participation program
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
josiane germano
Phone
5511999998398
Email
josiane_germano@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana Malosa
Phone
5511996002075
Email
lucianamalosa@uni9.pro.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana Malosa
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Director
Facility Information:
Facility Name
Luciana Malosa
City
São Paulo
ZIP/Postal Code
01525-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josiane Germano luiz
Phone
5511999998398
Email
josiane_germano@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25479861
Citation
Magalhaes EI, Sant'Ana LF, Priore SE, Franceschini Sdo C. [Waist circumference, waist/height ratio, and neck circumference as parameters of central obesity assessment in children]. Rev Paul Pediatr. 2014 Sep;32(3):273-81. doi: 10.1590/0103-0582201432320. Epub 2014 Oct 3.
Results Reference
background
PubMed Identifier
31245939
Citation
Atar M, Pirgon O, Buyukgebiz A. Sleep Disorders and Obesity in Childhood: A New Component in Solving Obesity. Pediatr Endocrinol Rev. 2019 Jun;16(4):441-451. doi: 10.17458/per.vol16.2019.apb.sleepdisordersobesitychildhood.
Results Reference
background
PubMed Identifier
31642432
Citation
Ye XH, Chen H, Kang XG, Zhang Q. [Association between obesity and sleep disorders among children in Lanzhou, China]. Zhongguo Dang Dai Er Ke Za Zhi. 2019 Oct;21(10):987-991. doi: 10.7499/j.issn.1008-8830.2019.10.007. Chinese.
Results Reference
background
PubMed Identifier
18209913
Citation
Greve J, Alonso A, Bordini AC, Camanho GL. Correlation between body mass index and postural balance. Clinics (Sao Paulo). 2007 Dec;62(6):717-20. doi: 10.1590/s1807-59322007000600010.
Results Reference
background
PubMed Identifier
18972242
Citation
Deforche BI, Hills AP, Worringham CJ, Davies PS, Murphy AJ, Bouckaert JJ, De Bourdeaudhuij IM. Balance and postural skills in normal-weight and overweight prepubertal boys. Int J Pediatr Obes. 2009;4(3):175-82. doi: 10.1080/17477160802468470.
Results Reference
background
PubMed Identifier
29291461
Citation
Villarrasa-Sapina I, Alvarez-Pitti J, Cabeza-Ruiz R, Redon P, Lurbe E, Garcia-Masso X. Relationship between body composition and postural control in prepubertal overweight/obese children: A cross-sectional study. Clin Biomech (Bristol, Avon). 2018 Feb;52:1-6. doi: 10.1016/j.clinbiomech.2017.12.010. Epub 2017 Dec 21.
Results Reference
background
PubMed Identifier
30087252
Citation
Feito Y, Heinrich KM, Butcher SJ, Poston WSC. High-Intensity Functional Training (HIFT): Definition and Research Implications for Improved Fitness. Sports (Basel). 2018 Aug 7;6(3):76. doi: 10.3390/sports6030076.
Results Reference
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Functional Assessment and Sleep Apnea in Obese Children and Adolescents

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