Functional Assessment and Sleep Apnea in Obese Children and Adolescents

May 6, 2024 updated by: LUCIANA MARIA MALOSA SAMPAIO, University of Nove de Julho

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01525-000
        • Luciana Malosa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea hypopnea index
Time Frame: 1 day
AHI
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional performance of children and adolescents (3 minute step test)
Time Frame: 1 day
numbers steps
1 day
Balance (balance assessments with Wii Balance board)
Time Frame: 1 day
COP
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obese Children and Adolescents

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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