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Clinical Trials/NCT06604429
NCT06604429CompletedNot Applicable

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

Mina Atef Georgui Elias3 sites in 1 country100 target enrollmentStarted: October 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
3
Primary Endpoint
Body mass index

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to 17 Years (Child)
Sex
Female
Accepts Healthy Volunteers
No

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.).

Arms & Interventions

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)

Intervention: Aerobic exercise (Other)

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)

Intervention: Diet Advice (Other)

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)

Intervention: Virtual reality exercise (Other)

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.

Intervention: Aerobic exercise (Other)

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.

Intervention: Diet Advice (Other)

Outcomes

Primary Outcomes

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)

Fat Mass

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

Body fat mass percentage measured by body composition analysis device

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.

Muscle mass

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

Body muscle mass percentage measured by body composition analysis device.

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.

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.

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

  • 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)

Investigators

Sponsor
Mina Atef Georgui Elias
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mina Atef Georgui Elias

Lecturer of Physical Therapy

Badr University

Study Sites (3)

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