Clinical trial NCT05563311: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Balance
Obesity, Childhood
Keywords: pediatric obesity
pediatric obstructive sleep apnea
Postural balance
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Apnea hypopnea index
timeFrame: 1 day
Secondary outcomes:
measure: Functional performance of children and adolescents (3 minute step test)
timeFrame: 1 day
measure: Balance (balance assessments with Wii Balance board)
timeFrame: 1 day
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Luciana Malosa
Study officials:
affiliation: University of Nove de Julho
name: Luciana Malosa
role: STUDY_DIRECTOR
References:
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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.
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.
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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.
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). 2018 Feb;52:1-6. doi: 10.1016/j.clinbiomech.2017.12.010. Epub 2017 Dec 21.
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.