Virtual Reality Intervention in Children With Hyperlipidemia

NCT ID: NCT07344389

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2026-04-10

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.

Detailed Description

Hyperlipidemia in childhood is an increasingly prevalent metabolic disorder associated with early initiation of the atherosclerotic process and an elevated risk of cardiovascular disease in adulthood. Since atherosclerosis begins in childhood, early identification and management of hyperlipidemia, particularly through lifestyle-based interventions, are critical for long-term cardiovascular health. Regular physical activity is known to positively influence lipid metabolism by reducing triglyceride levels, increasing high-density lipoprotein cholesterol, and improving endothelial function. However, adherence to long-term exercise and lifestyle recommendations in children is often limited due to low motivation and sedentary behaviors.

Virtual reality-based exercise interventions offer an innovative and engaging approach to increase physical activity participation in children. By providing immersive, interactive, and gamified environments, virtual reality applications can enhance motivation, enjoyment, and adherence to exercise programs. Virtual reality training integrates core principles of motor learning, including task repetition, goal-oriented movement, multisensory feedback, and active participation, which are essential for improving physical function and promoting sustained behavioral change.

This prospective randomized controlled study is designed to investigate the effects of an 8-week virtual reality-based exercise program on physical and functional outcomes in children with hyperlipidemia. Participants will be randomly allocated to either a virtual reality training group or a control group using computer-based randomization software. All assessments will be conducted by an assessor blinded to group allocation. To minimize confounding effects related to nutrition, participants in both groups will continue their usual dietary management throughout the study period.

The intervention group will participate in virtual reality-based exercise sessions twice weekly for eight weeks, with each session lasting approximately 40 minutes. Training will be delivered using the Microsoft Kinect system, a markerless motion capture technology capable of detecting and analyzing three-dimensional body movements in real time. The system enables participants to interact with virtual environments through whole-body movements and provides immediate visual and auditory feedback. Exercise sessions will include a variety of game-based activities that promote aerobic exercise, dynamic balance, coordination, and functional movement patterns. The intensity and content of the sessions are designed to support cardiovascular fitness while maintaining engagement and enjoyment.

Outcome assessments will be performed at baseline, immediately after the 8-week intervention period, and at an 8-week follow-up to examine both short-term and sustained effects of the intervention. The study evaluates changes in body composition, physical activity level, functional capacity, balance, speed and agility, flexibility, body image perception, and participation across home, school, and community settings, in accordance with the International Classification of Functioning, Disability and Health (ICF) framework.

Participation is a key component of child development and health, encompassing involvement in daily life situations and social roles. Children with chronic health conditions often experience reduced participation, influenced by both personal and environmental factors. Despite the growing prevalence of pediatric hyperlipidemia, participation patterns and environmental influences in this population have not been adequately explored. This study aims to address this gap by examining participation outcomes alongside physical and functional measures.

By integrating virtual reality-based exercise into the management of pediatric hyperlipidemia, this study seeks to determine whether an engaging, technology-assisted intervention can improve physical health parameters while also supporting participation and functional involvement in daily life. The findings may contribute to the development of innovative, child-centered rehabilitation and preventive strategies for managing hyperlipidemia and reducing long-term cardiovascular risk.

Conditions

Hyperlipidemia in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental Group: Virtual Reality Training Group

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.

Group Type: EXPERIMENTAL

Virtual Reality Training

Intervention Type: 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.

Control Group: Conventional Physiotherapy Home Exercise Group

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.

Group Type: ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type: 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.

Interventions

Virtual Reality Training

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.

Intervention Type: OTHER

Conventional Physiotherapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Duygu Korkem

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2024-424

Identifier Type: -

Identifier Source: org_study_id