Physical Training and Diet for Childhood Obesity

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04789525

Collaborator

(none)

Enrollment

Location

Arms

9.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is observed that children affected with COVID-19 who are physically inactive or in a sedentary lifestyle may induce and develop childhood obesity (CO). 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, it needs an elaborative trial in this field, so the aim of his study was to find the clinical and biochemical effects of high-intensity aerobic training with a high protein diet in childhood obesity following COVID-19 infection

Condition or Disease	Intervention/Treatment	Phase
Obesity, Childhood	Other: High-intensity aerobic training with high protein diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 10, 2020

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Dec 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A (high-intensity aerobic training with high protein diet )	Other: High-intensity aerobic training with high protein diet High-intensity aerobic training was given with 50 to 70 % of the maximum heart rate. the intervention started with 10 mins of warm-up exercise through stretching of upper and lower limb muscles. Subsequent to stretching, the subjects were asked to do 30 mins of exercises; consisting of 20 mins on the treadmill and 10 mins of cycle ergometer at 50 to 70 % of MHR, then with 10 mins of cool down.
Experimental: Group B(regular physical activities and taken regular diet)	Other: High-intensity aerobic training with high protein diet High-intensity aerobic training was given with 50 to 70 % of the maximum heart rate. the intervention started with 10 mins of warm-up exercise through stretching of upper and lower limb muscles. Subsequent to stretching, the subjects were asked to do 30 mins of exercises; consisting of 20 mins on the treadmill and 10 mins of cycle ergometer at 50 to 70 % of MHR, then with 10 mins of cool down.

Arm

Intervention/Treatment

Experimental: Group A (high-intensity aerobic training with high protein diet )

Other: High-intensity aerobic training with high protein diet

High-intensity aerobic training was given with 50 to 70 % of the maximum heart rate. the intervention started with 10 mins of warm-up exercise through stretching of upper and lower limb muscles. Subsequent to stretching, the subjects were asked to do 30 mins of exercises; consisting of 20 mins on the treadmill and 10 mins of cycle ergometer at 50 to 70 % of MHR, then with 10 mins of cool down.

Experimental: Group B(regular physical activities and taken regular diet)

Other: High-intensity aerobic training with high protein diet

Outcome Measures

Primary Outcome Measures

Body mass index [6 monthes]
For children, age adjusted BMI percentile (BMI %) was calculated

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

A positive diagnosis of COVID-19
Male children
5 - 12 years of age Body mass index (BMI).
Between 85t h to 99th percentiles were considered for childhood obesity.

Exclusion Criteria:

Subjects with a 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.
Any other systemic diseases, contraindications for physical training.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marwa Eid	Cairo		Egypt	2011

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marwa Eid, assistant professor of physical therapy for surgery, Cairo University

ClinicalTrials.gov Identifier:

NCT04789525

Other Study ID Numbers:

Obesity

First Posted:

Mar 9, 2021

Last Update Posted:

Mar 11, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Pediatric Obesity

Study Results

No Results Posted as of Mar 11, 2021