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

NCT06604429 | Completed

• 1 other identifier: IRB00014233-7
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Menstrual pain by Visual Analogue Scale (VAS)

  From enrollment to the end of treatment at 8 weeks

• Pediatric Quality of Life Inventory (PedsQL)

  From enrollment to the end of treatment at 8 weeks

• Depression Score

  From enrollment to the end of treatment at 8 weeks

• Anxiety Score

  From enrollment to the end of treatment at 8 weeks

• Stress Score

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Virtual Reality Exercise

EXPERIMENTAL

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; Other: Diet Advice; Other: Virtual reality exercise

Control group (aerobic exercise)

ACTIVE COMPARATOR

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; Other: Diet Advice

Interventions

Aerobic exercise OTHER

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.

Control group (aerobic exercise); Virtual Reality Exercise

Diet Advice OTHER

Adolescent girls participated in the study receive diet advices based on a balanced low calorie diet (1500 Kcal)

Control group (aerobic exercise); Virtual Reality Exercise

Virtual reality exercise OTHER

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.

Virtual Reality Exercise

Eligibility Criteria

• Age: 12 Years - 17 Years
• Gender Eligibility Details: The study enrolls only biological females and will accept only cisgender girls.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Mina Atef Georgui Elias: lead

Study Sites (3)

Badr University in Cairo faculty of physical therapy

Cairo, Egypt

Location

El-Mahaba Specialized Charity Polyclinics

Cairo, Egypt

Location

Life clinic (Private Clinic) - Minya Al Qamh - Sharqia Governorate

Zagazig, Egypt

Location

MeSH Terms

Conditions

Obesity; Dysmenorrhea; Pediatric Obesity; Depression; Anxiety Disorders

Interventions

Exercise; Nutrition Assessment; Exergaming

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pathologic Processes; Pelvic Pain; Pain; Neurologic Manifestations; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Doaa Saeed, PhD

  Lecturer Dept. of PT for Women's Health Faculty of Physical Therapy Badr University in Cairo, Egypt

  STUDY CHAIR

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Physical Therapy

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: November 1, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

EG (3)