NCT04789525

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

March 5, 2021

Last Update Submit

March 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body mass index

    For children, age adjusted BMI percentile (BMI %) was calculated

    6 monthes

Study Arms (2)

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

EXPERIMENTAL
Other: High-intensity aerobic training with high protein diet

Group B(regular physical activities and taken regular diet)

EXPERIMENTAL
Other: High-intensity aerobic training with high protein diet

Interventions

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.

Group A (high-intensity aerobic training with high protein diet )Group B(regular physical activities and taken regular diet)

Eligibility Criteria

Age5 Years - 12 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale children.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of physical therapy for surgery

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 9, 2021

Study Start

March 10, 2020

Primary Completion

October 1, 2020

Study Completion

December 25, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations