Functional Assessment and Sleep Apnea in Obese Children and Adolescents

NCT ID: NCT05563311

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2023-03-30

Brief Summary

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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

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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

Conditions

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Obstructive Sleep Apnea Balance Obesity, Childhood

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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high-intensity interval training

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

Group Type EXPERIMENTAL

Exercise on High-intensity interval training

Intervention Type OTHER

3 times a week, for 8 weeks

Interventions

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Exercise on High-intensity interval training

3 times a week, for 8 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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LUCIANA MARIA MALOSA SAMPAIO

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luciana Malosa

Role: STUDY_DIRECTOR

University of Nove de Julho

Locations

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Luciana Malosa

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 25479861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31245939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31642432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18209913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18972242 (View on PubMed)

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). 2018 Feb;52:1-6. doi: 10.1016/j.clinbiomech.2017.12.010. Epub 2017 Dec 21.

Reference Type BACKGROUND
PMID: 29291461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30087252 (View on PubMed)

Other Identifiers

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Obese Children and Adolescents

Identifier Type: -

Identifier Source: org_study_id

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