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Completed

NCT Number: NCT06604429

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.

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Key information

Conditions

Obesity and Obesity-related Medical Conditions Adolescent Obesity Anxiety Disorders Behavior Behavioral Symptoms Body Fat Composition Body Weight Depression Depression, Anxiety Dysmenorrhea Menstrual Pain Menstruation Disturbances Mental Disorders Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Obesity Pelvic Pain Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Badr University in Cairo faculty of physical therapy, Cairo, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

Diet advice

Other

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

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.

Primary outcomes

  1. Body mass index

    Time frame: From enrollment to the end of treatment at 8 weeks

    It is the weight (in kilograms) divided by the height (in meter squares)

  2. Fat Mass

    Time frame: From enrollment to the end of treatment at 8 weeks

    Body fat mass percentage measured by body composition analysis device

  3. Body Water Content

    Time frame: From enrollment to the end of treatment at 8 weeks

    Total body water content percentage measured by body composition analysis device.

  4. Muscle mass

    Time frame: From enrollment to the end of treatment at 8 weeks

    Body muscle mass percentage measured by body composition analysis device.

  5. Waist Circumference

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

  6. Waist hip ratio

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

  7. Borg Scale (rate of perceived exertion)

    Time frame: From enrollment to the end of treatment at 8 weeks

    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)

Secondary outcomes

  1. Menstrual pain by Visual Analogue Scale (VAS)

    Time frame: From enrollment to the end of treatment at 8 weeks

    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

  2. Pediatric Quality of Life Inventory (PedsQL)

    Time frame: From enrollment to the end of treatment at 8 weeks

    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).

  3. Depression Score

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

  4. Anxiety Score

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

  5. Stress Score

    Time frame: From enrollment to the end of treatment at 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Mina Atef Georgui Elias

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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