Functional Assessment and Sleep Apnea in Obese Children and Adolescents

Obstructive Sleep Apnea Clinical Trial

Official title:

Functional Assessment and Sleep Apnea in Obese Children and Adolescents After a Telerehabilitation Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563311
• Other study ID #: Obese Children and Adolescents
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: September 2022
• Source: University of Nove de Julho
• Contact: josiane germano
• Phone: 5511999998398
• Email: josiane_germano[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: March 30, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Balance
• Obesity, Childhood
• Obstructive Sleep Apnea
• Pediatric Obesity
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Exercise on High-intensity interval training
3 times a week, for 8 weeks

Locations

Country	Name	City	State
Brazil	Luciana Malosa	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

Atar M, Pirgon Ö, 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. — View 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. — View 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). pii: E76. doi: 10.3390/sports6030076. Review. — View 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. — View Citation

Magalhães 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. Review. Portuguese. — View Citation

Villarrasa-Sapiña I, Álvarez-Pitti J, Cabeza-Ruiz R, Redón P, Lurbe E, García-Massó 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. — View 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. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea hypopnea index	AHI	1 day
Secondary	Functional performance of children and adolescents (3 minute step test)	numbers steps	1 day
Secondary	Balance (balance assessments with Wii Balance board)	COP	1 day