CClinicalTrials.gg
CompletedNCT05563311Updated May 8, 2024

Functional Assessment and Sleep Apnea in Obese Children and Adolescents

An interventional study of Exercise on High-intensity interval training in Obstructive Sleep Apnea, Balance and Obesity, Childhood, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 6 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Sep 2021, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
6 Years to 17 Years
Sex
All
01

Study 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
Read the 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
02

Conditions studied

  • Obstructive Sleep Apnea
  • Balance
  • Obesity, Childhood

Keywords

  • pediatric obesity
  • pediatric obstructive sleep apnea
  • Postural balance
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 13 is below the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

University of Nove de Julho is the lead sponsor of 239 studies on the registry; 51 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Age ≥ 6 to 17 years;

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

Exclusion criteria

Exclusion Criteria:

  • orthopedic or neurological conditions that make it impossible to in a physical participation program
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    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

    Other: Exercise on High-intensity interval training

Interventions

  • OtherExercise on High-intensity interval training

    3 times a week, for 8 weeks

06

What researchers measure

Primary outcomes

  1. Apnea hypopnea index

    AHI

    Time frame: 1 day

Secondary outcomes

  1. Functional performance of children and adolescents (3 minute step test)

    numbers steps

    Time frame: 1 day

  2. Balance (balance assessments with Wii Balance board)

    COP

    Time frame: 1 day

07

Study locations

1 site
  • Luciana Malosa
    São Paulo, 01525-000, Brazil
08

References and documents

Publications

  • 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. PubMed 25479861 ↗
  • 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. PubMed 31245939 ↗
  • 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. PubMed 31642432 ↗
  • 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. PubMed 18209913 ↗
  • 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. PubMed 18972242 ↗
  • 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. PubMed 29291461 ↗
  • 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. PubMed 30087252 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05563311
Lead sponsor
University of Nove de Julho
Responsible party
LUCIANA MARIA MALOSA SAMPAIO (Clinical Professor, University of Nove de Julho) — Principal investigator
First posted
Oct 3, 2022
Start date
Sep 20, 2021
Primary completion
Oct 1, 2022
Completion
Mar 30, 2023
Last update
May 8, 2024

Study contacts

Luciana Malosa
study director · University of Nove de Julho

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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