NCT07073651

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

July 10, 2025

Last Update Submit

July 10, 2025

Conditions

Keywords

ObesityBody mass indexVirtual Reality gamesaerobic exerciseadolescent obesityobese childrenModerate intensity aerobic exercisedietary advices

Outcome Measures

Primary Outcomes (5)

  • Body mass index

    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

    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

    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)

    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)

    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 Outcomes (1)

  • HDL ratio

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Virtual Reality Exercise

EXPERIMENTAL

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 AdvicesOther: Virtual reality games exercise

Moderate intensity aerobic exercise

ACTIVE COMPARATOR

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: Moderate Intensity Aerobic ExerciseOther: Dietary Advices

Interventions

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.

Moderate intensity aerobic exercise

The Obese adolescent children participated in the study received diet advices based on a balanced low calorie diet (1500 Kcal)

Moderate intensity aerobic exerciseVirtual Reality 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)

Virtual Reality Exercise

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Badr University in Cairo faculty of physical therapy

Cairo, Egypt

Location

El-Mahaba Specialized Charity Polyclinics.

Cairo, Egypt

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Radwa S Abdulrahman, PhD

    Ass. Prof. Dept. of PT for Pediatric, Faculty of Physical Therapy, Badr University in Cairo, Egypt.

    PRINCIPAL INVESTIGATOR
  • Hayam M Mahmoud, PhD

    Professor Dept. of PT for Neurology & Neurosurgery, Faculty of Physical Therapy, Cairo Univ. 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
  • Noha A Fouad, PhD

    Ass Prof Dept. of PT for Women's Health Faculty of Physical Therapy Badr University in Cairo, Egyp

    STUDY CHAIR
  • Mina AG Elias, PhD

    Department of Physical Therapy Ahmed Maher Teaching hospital, General Organization For Teaching Hospitals And Institutes (GOTHI)

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 18, 2025

Study Start

July 10, 2024

Primary Completion

May 31, 2025

Study Completion

June 30, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations