Quality of Life Variations Among Adolescent Females Following Virtual Reality Games Approach

to compare the effects of virtual reality games, aerobic exercise, and dietary modifications on Quality of Life among adolescent females.

Study Overview

• Status: Completed
• Conditions: Obesity; Adolescent Obesity; Depression, Anxiety; Menstrual Pain; Body Fat Composition; Obesity and Obesity-related Medical Conditions
• Intervention / Treatment: Other: Aerobic exercise; Other: Diet Advice; Other: Virtual reality exercise

Detailed Description

The study will assess whether virtual reality games, aerobic exercise, and dietary modifications lead to significant differences in Quality of Life scores, and perceived exertion as measured by the Borg scale. Additionally, the study will evaluate whether these interventions produce varying impacts on psychological factors such as depression, anxiety, and stress, and on physical measurements like waist circumference (WC) and body fat composition.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • El-Mahaba Specialized Charity Polyclinics
  • Cairo, Egypt
    • Badr University in Cairo faculty of physical therapy
  • Zagazig, Egypt
    • Life clinic (Private Clinic) - Minya Al Qamh - Sharqia Governorate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Obese adolescent girls
• Class I Obesity (Body Mass Index from 30 to 34.99 kg/m2)
• Have regular menstruation
• Clinically and medically stable
• no impairment of sensation or other neurological or psychological problems

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Exercise; The group included 50 girls who received diet advice, aerobic and virtual reality exercises 3 times per week for 8 weeks. they received diet advice and aerobic exercises in form of cycle ergometer training (Each girl started session with a 5 min of warm-up. The exercise phase is performed at 65-75% of age-predicted peak heart rate using an orbitrack device for 20 minutes). Then This was followed by the main part, which consisted of 25 min of exercise when girl immersed in the game and did physical activities for the upper and lower extremities according to the game's requirements, and finally a 5 min cool-down part to lower the heart rate and end the session with static flexibility routines, the total session that would be applied about 50 min (including 30 mins of Virtual reality exercises)	Other: Aerobic exercise; aerobic exercises in form of cycle ergometer training (Each girl started session with a 5 min of warm-up. The exercise phase is performed at 65-75% of age-predicted peak heart rate using an orbitrack device for 20 minutes). Finally, a 5 min cool-down period is permitted, the total session that would be applied about 30 min.; Other: Diet Advice; Adolescent girls participated in the study receive diet advices based on a balanced low calorie diet (1500 Kcal); Other: Virtual reality exercise; Virtual reality game exercise involves 25 min of exercise where adolescent girl immersed in the game and did physical activities for the upper and lower extremities according to the game's requirements, and finally a 5 min cool-down part to lower the heart rate and end the session with static flexibility routines, the total session that would be applied about 30 min of Virtual reality exercises.
Active Comparator: Control group (aerobic exercise); This group serves as the control group, it included 50 girls who received diet advice and aerobic exercises in form of cycle ergometer training for 3 times per week for 8 weeks. Each girl started session with a 5 min of warm-up. The exercise phase is performed at 65-75% of age-predicted peak heart rate using an orbitrack device for 20 minutes. Finally, a 5 min cool-down period is permitted, the total session that would be applied about 30 min.	Other: Aerobic exercise; aerobic exercises in form of cycle ergometer training (Each girl started session with a 5 min of warm-up. The exercise phase is performed at 65-75% of age-predicted peak heart rate using an orbitrack device for 20 minutes). Finally, a 5 min cool-down period is permitted, the total session that would be applied about 30 min.; Other: Diet Advice; Adolescent girls participated in the study receive diet advices based on a balanced low calorie diet (1500 Kcal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	It is the weight (in kilograms) divided by the height (in meter squares)	From enrollment to the end of treatment at 8 weeks
Fat Mass	Body fat mass percentage measured by body composition analysis device	From enrollment to the end of treatment at 8 weeks
Body Water Content	Total body water content percentage measured by body composition analysis device.	From enrollment to the end of treatment at 8 weeks
Muscle mass	Body muscle mass percentage measured by body composition analysis device.	From enrollment to the end of treatment at 8 weeks
Waist Circumference	Waist circumference measured in centimeters, where the patient would be in standing position while investigator applied the tape round the abdomen at its narrowest point between the lower rib margin and top of iliac crest at the end of quiet expiration.	From enrollment to the end of treatment at 8 weeks
Waist hip ratio	It is the ratio between the waist circumference and the hip circumference. Where the waist circumference should be measured at the midpoint between the lower margin of the last palpable ribs and the top of the iliac crest, using a tape measurement. While, the hip circumference should be measured around the widest portion of the buttocks, with the tape parallel to the floor.	From enrollment to the end of treatment at 8 weeks
Borg Scale (rate of perceived exertion)	This is the modified Borg scale (rating from 0 to 10) where 0 means "no exertion at all" and 20 means "maximal exertion." When a measurement is taken, a number is chosen from the scale by the participant that best describes their perceived level of exertion during physical activity (Six-Minute walk test)	From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual pain by Visual Analogue Scale (VAS)	The VAS is a 10-point scale comprising a number from 0 through 10; 0 indicates no pain, and 10 indicates the worst imaginable pain. Adolescent girls participating in the study were instructed to choose a single number from the scale that best indicates their level of menstrual pain	From enrollment to the end of treatment at 8 weeks
Pediatric Quality of Life Inventory (PedsQL)	It is a 23-item generic health status instrument that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in adolescents. The PedsQL 4.0 has been proposed as a valid and reliable generic pediatric HRQOL measurement that can be used for self-reports in age groups ranging from 2 to 18 years and can also be used in clinical practice, clinical trials, and research, as well as school health settings, and community populations. It is a questionnaire for the child about child's physical, emotional, social, and school functioning in the past one month. On the PedsQL Generic Core Scales, for ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life).	From enrollment to the end of treatment at 8 weeks
Depression Score	Through the DAAS-21 scale (Depression, Anxiety and Stress scoring and degree) It consists of 21 questions, seven questions for depression, seven for anxiety and seven for stress assessment. The DASS is a quantitative measure of distress along the 3 axes of depression, anxiety and stress.	From enrollment to the end of treatment at 8 weeks
Anxiety Score	Through the DAAS-21 scale (Depression, Anxiety and Stress scoring and degree) It consists of 21 questions, seven questions for depression, seven for anxiety and seven for stress assessment. The DASS is a quantitative measure of distress along the 3 axes of depression, anxiety and stress.	From enrollment to the end of treatment at 8 weeks
Stress Score	Through the DAAS-21 scale (Depression, Anxiety and Stress scoring and degree) It consists of 21 questions, seven questions for depression, seven for anxiety and seven for stress assessment. The DASS is a quantitative measure of distress along the 3 axes of depression, anxiety and stress.	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Mina Atef Georgui Elias
• Investigators: Study Chair: Doaa Saeed, PhD, Lecturer Dept. of PT for Women's Health Faculty of Physical Therapy Badr University in Cairo, Egypt; Principal Investigator: Radwa S Abdulrahman, PhD, Ass. Prof. Dept. of PT for Pediatric, 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: Wael OA Abd El-Khalek, PhD, Lecturer, Dept. of Basic Sciences, Faculty of Physical Therapy, Badr University in Cairo, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Obesity; Aerobic exercise; Quality of Life; Anxiety; Stress; Adolescent Obesity; Diet; Adolescent girls; Menstrual Pain; DASS-21; Body Fat Composition; Virtual reality Games
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Nutrition Disorders; Overnutrition; Body Weight; Behavioral Symptoms; Overweight; Pelvic Pain; Menstruation Disturbances; Obesity; Depression; Pediatric Obesity; Dysmenorrhea
• Other Study ID Numbers: IRB00014233-7 (Other Identifier: Faculty of Physical Therapy, Badr University in Cairo)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No