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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00014233-7 | Other Identifier | Faculty of Physical Therapy, Badr University in Cairo |
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to compare the effects of virtual reality games, aerobic exercise, and dietary modifications on Quality of Life among adolescent females.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The study enrolls only biological females and will accept only cisgender girls.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Badr University in Cairo faculty of physical therapy | Cairo | Egypt | ||||
| El-Mahaba Specialized Charity Polyclinics |
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| Diet Advice | Other | Adolescent girls participated in the study receive diet advices based on a balanced low calorie diet (1500 Kcal) |
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| 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. |
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| 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 |
| 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 |
| Cairo |
| Egypt |
| Life clinic (Private Clinic) - Minya Al Qamh - Sharqia Governorate | Zagazig | Egypt |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D004412 | Dysmenorrhea |
| D063766 | Pediatric Obesity |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D015596 | Nutrition Assessment |
| D000088544 | Exergaming |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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