Clinical trial NCT06604429: Quality of Life Variations Among Adolescent Females Following Virtual Reality Games Approach
Official title: Quality of Life Variations Among Adolescent Females Following Virtual Reality Games Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity and Obesity-related Medical Conditions
Menstrual Pain
Adolescent Obesity
Body Fat Composition
Obesity
Depression, Anxiety
Keywords: Obesity
Adolescent girls
Body Fat Composition
Menstrual Pain
Virtual reality Games
Aerobic exercise
Diet
Adolescent Obesity
Quality of Life
Depression
Anxiety
Stress
DASS-21
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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 \&amp; 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.).

Primary outcomes:
measure: Body mass index
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Fat Mass
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Body Water Content
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Muscle mass
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Waist Circumference
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Waist hip ratio
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Borg Scale (rate of perceived exertion)
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Menstrual pain by Visual Analogue Scale (VAS)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Depression Score
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Anxiety Score
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Stress Score
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr University in Cairo faculty of physical therapy
city: Cairo
country: Egypt
facility: El-Mahaba Specialized Charity Polyclinics
city: Zagazig
country: Egypt
facility: Life clinic (Private Clinic) - Minya Al Qamh - Sharqia Governorate
Study officials:
affiliation: Lecturer Dept. of PT for Women's Health Faculty of Physical Therapy Badr University in Cairo, Egypt
name: Doaa Saeed, PhD
role: STUDY_CHAIR
affiliation: Ass. Prof. Dept. of PT for Pediatric, Faculty of Physical Therapy, Badr University in Cairo, Egypt.
name: Radwa S Abdulrahman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor Dept. of PT for Neurology & Neurosurgery, Faculty of Physical Therapy, Cairo Univ. Egypt.
name: Hayam M Mahmoud, PhD
role: STUDY_CHAIR
affiliation: Lecturer, Dept. of Basic Sciences, Faculty of Physical Therapy, Badr University in Cairo, Egypt.
name: Wael OA Abd El-Khalek, PhD
role: STUDY_CHAIR
References: