Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311590740919 Date of Approval: 23/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect Of Virtual Reality Games Versus Aerobic Exercises On Body Composition And Quality Of Life In Obese Children
Official scientific title Effect Of Virtual Reality Games Versus Aerobic Exercises On Body Composition And Quality Of Life In Obese Children
Brief summary describing the background and objectives of the trial Obesity in children and adolescents is a global health hazard and likely to continue into adulthood associated with cardio metabolic and psychosocial comorbidity as well as premature mortality, using regular aerobic physical activity is expounded to significantly decrease causes of mortality upset. Exercise promotes a healthy system and improves energy expenditure. Recently virtual reality has been explored as an intervention to improve motor function in children, and hence improving metabolic rate posing reduction of deposition of fat. The aims of this study is to investigate the effect of different modalities on weight loss of obese adolescent.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 20/08/2022
Actual trial start date 31/08/2022
Anticipated date of last follow up 12/11/2022
Actual Last follow-up date 30/11/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Diet control group 3 sessions per week . 12 weeks Children of this group will take dietary control only to decrease fat and carbs 20 Active-Treatment of Control Group
Experimental Group virtual reality group 3 sessions per week 12 weeks Children in this group will receive virtual reality training using Kinect video games from easiest to hardest using Xbox 360 with Kinect 20
Experimental Group Aerobic group 3 sessions per week 12 weeks Children in this group of both sexes received diet advices and aerobic exercises in form of cycle ergometer training for 3 times per week for 12 weeks. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Sixty obese children of age ranged between 7 - 11 years. 2) Their BMI between 30 – 34.9 kg/m2 (Class A obesity) (Feingold et al., 2018). 3) All children were clinically and medically stable. 4) They had no impairment of sensation or other neurological or psychological problems. 5) They were able to understand and follow the instructions. 1) Visual and/or auditory defects. 2) Significant tightness and/or fixed deformity of lower limbs. 3) Neurological disorders that affect balance or mentality (e.g. epilepsy). 4) Children with advanced radiographic changes include: A- Bone destruction. B- Bony ankylosis. C- Knee joint sublaxation. D- Epiphysial fracture. 5) Congenital or acquired lower limb deformities in the lower limbs. 6) Cardiopulmonary dysfunction. 7) Under insulin therapy, uncontrolled bronchial asthma, anemia 8) Pathological causes of obesity (endocrinal, genetic syndromes...etc). Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 5 Year(s) 10 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/04/2022 Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
Zayat street Giza Giza 0003 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Body weight and height scale, Blood volume analysis, Body Composition Analyzer 12 weeks 3 month period
Secondary Outcome Three minute step test (3-MST), Pediatric Quality Of Life Inventory (PedsQL): 12 weeks 3 month period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Nutrition Institute Sayeda Zainab , Cairo governorate cairo 0002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Radwa Saeid Abdulrahman Zayat Giza 0003 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University Zayate Giza 0003 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Radwa Mahmoud radwasaeid@cu.edu.eg 00201027713662 Zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Professor of Pediatric Physical Therapy
Role Name Email Phone Street address
Public Enquiries Heba Abdul Gafar radwakku@gmail.com 01005056590 Zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Professor of Physical Therapy of Internal medicine
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mahdy radwakku@gmail.com 01007056624 zayat
City Postal code Country Position/Affiliation
Giza 0003 Egypt Professor of Physical Therapy of Internal Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data will be shared in this registration as soon it is finished by a third party who was not included in the study , documents would be given by URL or word file . Statistical Analysis Plan it will be shared after 12 months Access will be available by a third party that was not included in the study
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information