Virtual Reality Intervention in Children With Hyperlipidemia

NCT07344389 | Not Yet Recruiting

• 1 other identifier: 2024-424
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children with hyperlipidemia have elevated blood lipid levels, which increase the risk of developing cardiovascular diseases later in life. Since the atherosclerotic process begins in childhood, early identification and effective management of risk factors such as physical inactivity are essential. Regular physical activity has been shown to improve lipid profiles, reduce cardiovascular risk, and support healthy body composition in children. However, long-term lifestyle and medical treatments may reduce motivation and participation, especially in pediatric populations. Virtual reality-based exercise programs provide an engaging and interactive environment that can increase motivation and active participation in rehabilitation. Virtual reality applications allow children to perform functional movements through game-based activities while receiving visual and auditory feedback, which may enhance motor learning, balance, and functional capacity. These applications are widely used in pediatric rehabilitation and have the potential to improve adherence to exercise programs. Participation in daily life activities at home, school, and in the community is an important component of child development. According to the International Classification of Functioning, Disability and Health (ICF), participation refers to involvement in life situations. Children with chronic health conditions may experience limitations in participation due to physical, environmental, or motivational factors. However, participation levels of children with hyperlipidemia have not been sufficiently investigated. The purpose of this study is to investigate the effects of a virtual reality-based exercise program on body composition, functional capacity, balance, and participation in children with hyperlipidemia. The findings of this study may contribute to the development of effective, enjoyable, and sustainable rehabilitation approaches for improving physical health and participation in daily life activities in this population.

Conditions

Hyperlipidemia in Children

Keywords

Hyperlipidemia; Virtual Reality Training; Pediatric Rehabilitation; Physical Activity; Participation

Outcome Measures

Primary Outcomes (6)

• Body Weight

  Body weight will be measured using the Tanita body composition analyzer (MC-780MA) and recorded in kilograms.

  8 week

• Physical activity

  Children's physical activity levels will be assessed using the Physical Activity Questionnaire for Children (PAQ-C). The PAQ-C is a self-report instrument designed to evaluate general physical activity levels in children and adolescents over the previous 7 days. It consists of 10 items, of which 9 are used to calculate the activity score. The first item includes a culturally adapted activity checklist consisting of 14 common activities and is scored on a 5-point scale (1 = no activity, 5 = 7 times or more). The remaining 8 items assess physical activity during specific periods of the day or week, such as physical education classes, recess, after school, evenings, and weekends, and are also rated on a 5-point scale. The final PAQ-C score is calculated as the mean of items 1-9, with higher scores indicating higher levels of physical activity.

  8 week

• Functional capacity

  Functional capacity will be assessed using the Six-Minute Walk Test (6MWT). The 6MWT is a simple, practical, and objective exercise test widely used to evaluate functional exercise capacity in children. Participants will be instructed to wear comfortable clothing and appropriate footwear. They will rest before the test, and heart rate, blood pressure, oxygen saturation (SpO₂), and perceived dyspnea using the Modified Borg Scale will be recorded before and after the test. Participants will be asked to walk back and forth along a marked 30-meter flat corridor for six minutes, aiming to cover the longest possible distance. Standardized verbal encouragement will be provided at each minute. The total distance walked in six minutes will be recorded in meters.

  8 week

• Participation

  Participation and environmental factors will be assessed using the Participation and Environment Measure for Children and Youth (PEM-CY). The PEM-CY is a parent-reported questionnaire designed to evaluate participation of children and adolescents aged 5-17 years in home, school, and community settings, as well as environmental influences on participation. The participation section includes 10 activities for the home setting, 5 for the school setting, and 10 for the community setting. For each activity, parents report the frequency of participation over the past four months, the child's level of involvement using a five-point Likert scale, and whether they desire a change in the child's participation. The PEM-CY has demonstrated acceptable validity and reliability in Turkish populations.

  8 week

• Body Mass Index (BMI)

  Body mass index will be calculated as body weight divided by height squared (kg/m²) using measurements obtained from the Tanita body composition analyzer (MC-780MA).

  8 week

• Body Fat Composition

  Body fat composition will be assessed using the Tanita body composition analyzer (MC-780MA). Measurements will include total body fat percentage (%) and total body fat mass (kg), which together will be used to evaluate changes in overall adiposity.

  8 week

Secondary Outcomes (5)

• Body Image

  8 week

• Static Balance

  8 week

• Dynamic balance

  8 week

• Speed and agility

  8 week

• Flexibility

  8 week

Study Arms (2)

Experimental Group: Virtual Reality Training Group

EXPERIMENTAL

Participants allocated to the experimental group will receive a virtual reality-based exercise program in addition to continuing their usual dietary regimen. The intervention will be delivered for 8 weeks, twice per week, with each session lasting 40 minutes. Virtual reality training will be provided using an interactive system designed to promote physical activity through game-based exercises. All assessments will be conducted by a blinded assessor.

Other: Virtual Reality Training

Control Group: Conventional Physiotherapy Home Exercise Group

ACTIVE COMPARATOR

Participants allocated to the control group will continue their usual dietary regimen and will receive general conventional physiotherapy exercises designed for home practice. These exercises will be demonstrated to the participants and their families at baseline. No virtual reality training will be provided to this group. All assessments will be conducted by a blinded assessor.

Other: Conventional Physiotherapy

Interventions

Virtual Reality Training OTHER

The intervention consists of an 8-week virtual reality-based exercise program using the Microsoft Kinect system for children with hyperlipidemia. Sessions will be conducted twice per week, each lasting 40 minutes. The Kinect system will track participants' three-dimensional body movements in real time using an infrared depth sensor and RGB camera. Game-based activities will be projected onto a wall, and participants will perform exercises by interacting with virtual tasks such as boat navigation and ball games. The system will provide real-time visual feedback to reinforce correct movements and correct improper movement patterns. The program is designed to promote physical activity, improve motor skills, and support cardiovascular fitness in an engaging and enjoyable environment.

Experimental Group: Virtual Reality Training Group

Conventional Physiotherapy OTHER

Participants in the control group will continue their usual dietary regimen and receive a conventional physiotherapy home exercise program. The program will consist of general exercises aimed at maintaining physical activity and functional capacity and will be demonstrated to the participants and their caregivers at baseline. No virtual reality-based intervention will be provided during the study period. Participants will be encouraged to perform the exercises at home throughout the 8-week study duration.

Control Group: Conventional Physiotherapy Home Exercise Group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 8-14
• Diagnosed with hyperlipidemia
• No condition preventing physical activity in the past seven days
• Children and families who volunteer to participate in the study will be included.

You may not qualify if:

• Children with any physical, neurological, or cognitive illness
• Children who do not wish to participate in the study
• Children who do not complete the assessment will be excluded

Sponsors & Collaborators

• Hacettepe University: lead

MeSH Terms

Conditions

Hyperlipidemias; Motor Activity

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 15, 2026
• Study Start: January 15, 2026
• Primary Completion: March 20, 2026
• Study Completion: April 10, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share