Functional Assessment and Sleep Apnea in Obese Children and Adolescents

Sponsor
University of Nove de Julho (Other)
Overall Status
Recruiting
CT.gov ID
NCT05563311
Collaborator
(none)
13
1
1
18.3
0.7

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise on High-intensity interval training
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Functional Assessment and Sleep Apnea in Obese Children and Adolescents After a Telerehabilitation Program
Actual Study Start Date :
Sep 20, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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
3 times a week, for 8 weeks

Outcome Measures

Primary Outcome Measures

  1. Apnea hypopnea index [1 day]

    AHI

Secondary Outcome Measures

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

    numbers steps

  2. Balance (balance assessments with Wii Balance board) [1 day]

    COP

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
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:
  • orthopedic or neurological conditions that make it impossible to in a physical participation program

Contacts and Locations

Locations

Site City State Country Postal Code
1 Luciana Malosa São Paulo Brazil 01525-000

Sponsors and Collaborators

  • University of Nove de Julho

Investigators

  • Study Director: Luciana Malosa, University of Nove de Julho

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
LUCIANA MARIA MALOSA SAMPAIO, Clinical Professor, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT05563311
Other Study ID Numbers:
  • Obese Children and Adolescents
First Posted:
Oct 3, 2022
Last Update Posted:
Oct 3, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by LUCIANA MARIA MALOSA SAMPAIO, Clinical Professor, University of Nove de Julho
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2022