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

NCT ID: NCT06604429

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-11-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity and Obesity-related Medical Conditions Menstrual Pain Adolescent Obesity Body Fat Composition Obesity Depression, Anxiety

Keywords

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Obesity Adolescent girls Body Fat Composition Menstrual Pain Virtual reality Games Aerobic exercise Diet Adolescent Obesity Quality of Life Depression Anxiety Stress DASS-21

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type 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.

Diet Advice

Intervention Type OTHER

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

Virtual reality exercise

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Aerobic exercise

Intervention Type 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.

Diet Advice

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Diet Advice

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.).
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mina Atef Georgui Elias

OTHER

Sponsor Role lead

Responsible Party

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Mina Atef Georgui Elias

Lecturer of Physical Therapy

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Doaa Saeed, PhD

Role: STUDY_CHAIR

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

Radwa S Abdulrahman, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Hayam M Mahmoud, PhD

Role: STUDY_CHAIR

Professor Dept. of PT for Neurology & Neurosurgery, Faculty of Physical Therapy, Cairo Univ. Egypt.

Wael OA Abd El-Khalek, PhD

Role: STUDY_CHAIR

Lecturer, Dept. of Basic Sciences, Faculty of Physical Therapy, Badr University in Cairo, Egypt.

Locations

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Badr University in Cairo faculty of physical therapy

Cairo, , Egypt

Site Status

El-Mahaba Specialized Charity Polyclinics

Cairo, , Egypt

Site Status

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

Zagazig, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB00014233-7

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00014233-7

Identifier Type: -

Identifier Source: org_study_id