Obstructive Sleep ApneaNCT05563311
Functional Assessment and Sleep Apnea in Obese Children and Adolescents
A study testing Exercise on High-intensity interval training in people with Obstructive Sleep Apnea and Balance, run by University of Nove de Julho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Balance, Obesity, Childhood
- What is being tested?
- Exercise on High-intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Sep 2021to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ≥ 6 to 17 years;
- Confirmed obesity children by body mass index acorrding to the age
Who cannot join
- orthopedic or neurological conditions that make it impossible to in a physical participation program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Conditions
- Obstructive Sleep Apnea, Balance, Obesity, Childhood
- Being tested
- Exercise on High-intensity interval training
- Keywords
- pediatric obesity, pediatric obstructive sleep apnea, Postural balance
- Medical subject headings
- Sleep Apnea, Obstructive, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise on High-intensity interval trainingOther
3 times a week, for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| high-intensity interval training | Experimental | 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 Receives: Other: Exercise on High-intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea hypopnea index
AHI
Measured: 1 day
Secondary outcomes (2)
Functional performance of children and adolescents (3 minute step test)
numbers steps
Measured: 1 day
Balance (balance assessments with Wii Balance board)
COP
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start20 Sep 2021
- Primary completion1 Oct 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUCIANA MARIA MALOSA SAMPAIO, University of Nove de Julho
- Investigators
- Luciana Malosa, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563311
- Sponsor's protocol ID
- Obese Children and Adolescents
- Status last verified
- May 2024
- First submitted
- 26 Sep 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25479861Atar 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 31245939Ye 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 31642432Greve 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 18209913Deforche 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 18972242Villarrasa-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 29291461Feito 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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment and Sleep Apnea in Obese Children and Adolescents After a Telerehabilitation Program
- ClinicalTrials.gov ID
- NCT05563311
- Acronym / sponsor ID
- Obese Children and Adolescents
- Conditions
- Obstructive Sleep Apnea, Balance, Obesity, Childhood
- Keywords
- pediatric obesity, pediatric obstructive sleep apnea, Postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-intensity interval training | Experimental | Other: Exercise on High-intensity interval trainingHigh-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 |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age ≥ 6 to 17 years;
- Confirmed obesity children by body mass index acorrding to the age
Key exclusion criteria (1 listed)
- orthopedic or neurological conditions that make it impossible to in a physical participation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise on High-intensity interval training3 times a week, for 8 weeks | Other | high-intensity interval training |
Primary outcome
Apnea hypopnea index
Time frame: 1 day
AHI
2 secondary outcomes
Functional performance of children and adolescents (3 minute step test)
Time frame: 1 day
Balance (balance assessments with Wii Balance board)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 25479861Magalhaes 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.
- Background: PubMed 31245939Atar 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.
- Background: PubMed 31642432Ye 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.
- Background: PubMed 18209913Greve 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.
- Background: PubMed 18972242Deforche 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.
- Background: PubMed 29291461Villarrasa-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.
- Background: PubMed 30087252Feito 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana Malosa study director
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise on High-intensity interval training in people with Obstructive Sleep Apnea and Balance, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea hypopnea index (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563311, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.