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Clinical Trials/NCT05336006
NCT05336006
Completed
Not Applicable

Clinical (BMI & MRI) and Biochemical (Adiponectin, Leptin, TNF-α & IL-6) Effects of High-intensity Aerobic Training With a High Protein Diet in Children With Obesity Following COVID-19 Infection.

Prince Sattam Bin Abdulaziz University1 site in 1 country76 target enrollmentMarch 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Obesity
Sponsor
Prince Sattam Bin Abdulaziz University
Enrollment
76
Locations
1
Primary Endpoint
Body mass index (BMI)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The coronavirus disease (COVID-19), is a communicable pandemic disease as stated by the world health organization (WHO), which has been affecting the world since December 2019. COVID-19 infected children develop the signs and symptoms of the disease, which can be exaggerated or life-threatening when associated with comorbidities like; obesity, sickle cell anemia, immune disorders, chromosomal abnormalities, chronic respiratory or cardiac problems, and congenital malformations.3 It is observed that children affected with COVID-19 who are physically inactive or in a sedentary lifestyle may induce and develop obesity. It is a major health concern in this pandemic situation, which can be addressed and treated with the use of appropriate physical training and proper dietary habits.

Detailed Description

Children confirmed with COVID-19 infection have some systemic illness, that might lead to children with obesity. They are advised to perform regular physical training and consume a proper diet to prevent and treat negative consequences. Therefore, different obesity management and weight reduction protocols are developed to control and prevent health problems and socio-economic issues associated with obesity. The management of this clinical condition has received very little attention, there is no well-defined exercise protocols or dietary prescription for this special population; therefore, there is a need for an elaborative trial in this field. Hence, the aim of this trial was to investigate and compare the clinical and psychological effects of integrated physical training with a high protein diet versus a low protein diet in community-dwelling COVID-19 infected children with obesity.

Registry
clinicaltrials.gov
Start Date
March 10, 2020
End Date
October 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gopal Nambi

Associate Professor

Prince Sattam Bin Abdulaziz University

Eligibility Criteria

Inclusion Criteria

  • Positively diagnosed COVID-19 children
  • age group of 5 - 12 years
  • Body mass index (BMI) between 85th to 99th percentiles

Exclusion Criteria

  • history of physical training,
  • taking medications,
  • recent surgeries,
  • fractures and joint problems in the lower extremity,
  • cardiac and respiratory problems,
  • neurological issues,
  • major psychiatric problems,
  • other systemic diseases,
  • contraindications for physical training and family with food restrictions

Outcomes

Primary Outcomes

Body mass index (BMI)

Time Frame: 6 months

For children, age adjusted BMI percentile (BMI %) was calculated, which is a reliable and valid measurement to measure the stage of obesity.

Secondary Outcomes

  • Muscle cross sectional area - CSA(6 months.)
  • Adiponectin(6 months)
  • Leptin(6 months)
  • TNF-α(6 months.)
  • IL-6(6 months.)

Study Sites (1)

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