Response of Lipid Profile to Virtual Reality Games Versus Moderate Aerobic Exercise Training in Children With Obesity

July 10, 2025 updated by: Mina Atef Georgui Elias, Badr University
This trial is aiming to study the effect of virtual reality video gaming in comparison with moderate intensity aerobic exercises on lipid profile in children with Obesity

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will assess whether virtual reality games, dietary advices and moderate intensity aerobic exercise lead to significant differences in lipid profile in class I obese adolescent children. Additionally, the study will examine whether these interventions has impacts on the children body mass index.

Study Type

Interventional

Enrollment (Actual)

120

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

  • Egypt
      • Cairo, Egypt
        • Badr University in Cairo faculty of physical therapy
      • Cairo, Egypt
        • El-Mahaba Specialized Charity Polyclinics.

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Obese adolescent children
  • age from 11 to 18 years old only.
  • Class I Obesity (Body Mass Index from 30 to 34.99 kg/m2)
  • Clinically and medically stable
  • Without any impairment of sensation or other neurological or psychological problems.

Exclusion Criteria:

  • Adolescents with visual and/or auditory defects
  • Normal weight adolescent children (Body Mass Index from 18 to 24.99 kg/m2) or below average weight (BMI less than 18 kg/m2) or Class II and III Obesity (BMI above 35 kg/m2)
  • Children with significant tightness and/or deformity of upper or lower limbs
  • Participants with neurological disorders that affect balance or mentality (e.g. epilepsy).
  • Adolescents with advanced radiographic changes include: Bone destruction, Bony ankylosis, Knee joint subluxation, and Epiphysial fracture)
  • Any lower limb deformities in the lower limbs.
  • Participants with cardiopulmonary diseases.
  • Diabetic children or those under insulin therapy, uncontrolled bronchial asthma, anemia, and Pathological causes of obesity (endocrinal, genetic syndromes...etc.).

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Exercise
The experimental group included 60 adolescent obese children of both genders (class I obesity, BMI: 30-34.99) who received diet advices and virtual reality exercises 5 times per week for 12 weeks. Each participating child started the session with 5 minutes warming up exercises then followed by the main part which was consisted of 30 min of exercise where the child played the game using virtual reality X-Box and did different physical activities that included both the upper and lower extremities according to the game's requirements, and after that a 5 min cool-down part that involved some static flexibility exercise to allow the heart rate to lower, the total session that would be applied about 40 min (including 30 mins of Virtual reality exercises)
Other: Dietary Advices
The Obese adolescent children participated in the study received diet advices based on a balanced low calorie diet (1500 Kcal)
Other: Virtual reality games exercise
Virtual reality games exercises 5 times per week for 12 weeks. Each participating child started the session with 5 minutes warming up exercises then followed by the main part which was consisted of 30 min of exercise where the child played the game using virtual reality X-Box and did different physical activities that included both the upper and lower extremities according to the game's requirements, and after that a 5 min cool-down part that involved some static flexibility exercises to allow the heart rate to lower, the total session that would be applied about 40 min (including 30 mins of Virtual reality exercises)
Active Comparator: Moderate intensity aerobic exercise
This group serves as the control group, it included 60 adolescent obese children of both genders (class I obesity, BMI: 30-34.99) who received diet advice and moderate intensity aerobic exercises (using treadmill training) 5 times per week for 12 weeks. Each participating child started the session with 5 minutes of warming-up exercises. Then the main exercise phase is performed at 50-60% of age-predicted peak heart rate using a treadmill for 30 minutes. Finally, a 5 min cool-down period is allowed, the total session took 40 minutes.
Other: Dietary Advices
The Obese adolescent children participated in the study received diet advices based on a balanced low calorie diet (1500 Kcal)
Other: Moderate Intensity Aerobic Exercise
moderate intensity aerobic exercises (using treadmill training) 5 times per week for 12 weeks. Each participating child started the session with 5 minutes of warming-up exercises. Then the main exercise phase is performed at 50-60% of age-predicted peak heart rate using a treadmill for 30 minutes. Finally, a 5 min cool-down period is allowed, the total session took 40 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: From enrollment to the end of treatment at 12 weeks
It is the weight (in kilograms) divided by the height (in meter squares)
From enrollment to the end of treatment at 12 weeks
Serum triglycerides
Time Frame: From enrollment to the end of treatment at 12 weeks
Level of triglycerides fats in blood in measured in laboratory using venous blood sample
From enrollment to the end of treatment at 12 weeks
Total Cholesterol
Time Frame: From enrollment to the end of treatment at 12 weeks
Level of total cholesterol in blood in measured in laboratory using venous blood sample
From enrollment to the end of treatment at 12 weeks
High Density Lipoproteins (HDL)
Time Frame: From enrollment to the end of treatment at 12 weeks
High Density Lipoproteins (HDL) cholesterol fats are measured in laboratory using a venous blood sample
From enrollment to the end of treatment at 12 weeks
Low Density Lipoproteins (LDL)
Time Frame: From enrollment to the end of treatment at 12 weeks
Low Density Lipoproteins (LDL) cholesterol fats are measured in laboratory using a venous blood sample
From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HDL ratio
Time Frame: From enrollment to the end of treatment at 12 weeks
The number of total cholesterol divided by high-density lipoprotein (HDL)
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

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

Sponsor

Badr University

Investigators

  • Principal Investigator: Radwa S Abdulrahman, PhD, Ass. Prof. Dept. of PT for Pediatric, Faculty of Physical Therapy, Badr University in Cairo, Egypt.
  • Study Chair: Wael OA Abd El-Khalek, PhD, Lecturer, Dept. of Basic Sciences, Faculty of Physical Therapy, Badr University in Cairo, Egypt.
  • Study Chair: Hayam M Mahmoud, PhD, Professor Dept. of PT for Neurology & Neurosurgery, Faculty of Physical Therapy, Cairo Univ. Egypt
  • Study Chair: Noha A Fouad, PhD, Ass Prof Dept. of PT for Women's Health Faculty of Physical Therapy Badr University in Cairo, Egyp
  • Principal Investigator: Mina AG Elias, PhD, Department of Physical Therapy Ahmed Maher Teaching hospital, General Organization For Teaching Hospitals And Institutes (GOTHI)
  • Study Chair: Ashraf H Saleh, PhD, Prof Dept. of PT for Surgery and Burn, Faculty of Physical Therapy Badr University in Cairo, Egyp
  • Study Chair: Mona M Abdelkhalek, PhD, Ass. Prof. Dept. of PT for Internal Medicine, Faculty of Physical Therapy, Badr University in Cairo, Egypt.

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)

July 10, 2024

Primary Completion (Actual)

May 31, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

July 10, 2025

First Submitted That Met QC Criteria

July 10, 2025

First Posted (Estimated)

July 18, 2025

Study Record Updates

Last Update Posted (Estimated)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00014233-8

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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