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Hyperlipidemia in ChildrenNCT07344389

Virtual Reality Intervention in Children With Hyperlipidemia

A study testing Virtual Reality Training and Conventional Physiotherapy in people with Hyperlipidemia in Children, run by Hacettepe University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 14 years
Conditions the study is for
Hyperlipidemia in Children
What is being tested?
Virtual Reality Training and Conventional Physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
15 Jan 2026to 10 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

Official title: The Effect of Virtual Reality Application on Body Composition, Functional Capacity, Balance, and Participation in Children With Hyperlipidemia

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.

Read more

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.

Read the 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.

Being tested
Virtual Reality Training, Conventional Physiotherapy
Keywords
Hyperlipidemia, Virtual Reality Training, Pediatric Rehabilitation, Physical Activity, Participation
Medical subject headings
Hyperlipidemias, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality TrainingOther

    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.

  • Conventional PhysiotherapyOther

    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.

Study groups in NCT07344389
Study groupRoleWhat they receive
Experimental Group: Virtual Reality Training GroupExperimentalParticipants 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.
Receives: Other: Virtual Reality Training
Control Group: Conventional Physiotherapy Home Exercise GroupActive comparatorParticipants 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.
Receives: Other: Conventional Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Weight

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

    Measured: 8 week

  2. 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.

    Measured: 8 week

  3. 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.

    Measured: 8 week

  4. 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.

    Measured: 8 week

  5. 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).

    Measured: 8 week

  6. 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.

    Measured: 8 week

Secondary outcomes (5)
  1. Body Image

    Body image will be measured using the Children's Body Image Scale. There are separate versions of the scale for boys and girls. The scale contains 7 gender-specific images in anatomical position. There are 7 male and 7 female photos on the scale for each version. Each photo represents a different BMI range. The images are ranked from A to G according to increasing BMI.

    Measured: 8 week

  2. Static Balance

    Balance will be assessed using the Flamingo Balance Test. The test requires a wooden beam measuring 50 cm in length and 4 cm in height, and a stopwatch. Participants will be asked to stand barefoot on the beam for one minute, balancing on one leg while the other leg is flexed at the knee and held with the hand on the same side, mimicking a flamingo stance. Before the test, one practice trial will be provided to familiarize the child with the procedure. The test begins with a start command and is interrupted each time balance is lost, defined as the free leg touching the ground. After each loss of balance, the test is resumed until a total of one minute is completed. The score is recorded as the number of balance attempts within one minute. If balance is lost more than 15 times within 30 seconds or if the child falls, the test is terminated and a score of zero is recorded. The test is performed for both legs.

    Measured: 8 week

  3. Dynamic balance

    Dynamic balance will be assessed using the Y Balance Test. Participants will stand on one leg with both hands placed on their hips, positioning the great toe of the stance foot at the center starting line. While maintaining single-leg stance, participants will reach as far as possible with the free limb in the anterior, posteromedial, and posterolateral directions. The maximum reach distance in each direction will be measured with a measuring tape and recorded. The procedure will be repeated for the opposite lower extremity. Trials will be repeated if the participant fails to maintain balance, moves or lifts the stance foot, touches the ground with the reaching foot before reaching the maximum distance, or fails to return the reaching foot to the starting position. Lower extremity length will be measured from the anterior superior iliac spine to the medial malleolus for score normalization. The composite reach distance will be calculated as [(maximum anterior + maximum posteromedial +

    Measured: 8 week

  4. Speed and agility

    Speed and agility will be assessed using the Single-Leg Side Hop Test on the preferred leg. Participants will stand on their preferred leg with their hands placed on their hips, while the non-stance leg is held in neutral hip position with the knee flexed at 90 degrees. While maintaining this position, participants will be instructed to hop laterally to the right and left of a marked line as many times as possible within 15 seconds. A stopwatch will be used to time the test, and the number of correctly performed hops will be recorded. The test will be terminated if the participant removes their hands from their hips or if the stance foot loses its position or drops below the required level.

    Measured: 8 week

  5. Flexibility

    Flexibility will be assessed using the Sit-and-Reach Test. This test is commonly used to evaluate flexibility of the hamstring and posterior lower limb muscle groups. Participants will be barefoot and dressed in comfortable clothing, seated on the floor in a long-sitting position with the ankles positioned in neutral. They will be instructed to lean forward from the hips and reach as far as possible without bending the knees, holding the final position for approximately two seconds. The test will be performed twice, and the best distance reached will be recorded in centimeters.

    Measured: 8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start15 Jan 2026 (estimated)
  3. Primary completion20 Mar 2026 (estimated)
  4. Study completion10 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07344389
Sponsor's protocol ID
2024-424
Status last verified
Jan 2026
First submitted
26 Dec 2025
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Training and Conventional Physiotherapy in people with Hyperlipidemia in Children, run by Hacettepe University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight (time frame: 8 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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