Child, OnlyNCT07576738
Investigation of the Effects of Aerobic Exercise Training and Virtual Reality-Based Games on Children
A study testing aerobic exercise group and Virtual Reality-Based Game group in people with Child, Only and Virtual Reality, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to investigate the effects of aerobic exercise training and virtual reality-based games on functional capacity, activity and participation. 63 children between the ages of 6-10, living under protection and care, were randomly assigned to participate in the study. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Virtual Reality, Aerobic Exercise
- What is being tested?
- aerobic exercise group and Virtual Reality-Based Game group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The following volunteers participated in the study
- Children residing in the Şahinbey and Şehitkamil Children's Homes Complex,
- Participants aged between 6 and 10 years old.
Who cannot join
- Children with neurological and psychological illnesses severe enough to prevent participation in exercise training,
- Children who have undergone surgery within the last 3 months,
- Children with learning disabilities,
- Children who perform moderate-intensity aerobic exercise for more than 150 minutes at least 3 days a week,
- Children with multiple organ dysfunction were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan Kalyoncu University
Gaziantep, Province, 27410
About this study
Official title: Investigation of the Effects of Aerobic Exercise Training and Virtual Reality-Based Games on Functional Capacity, Activity, and Participation in Children Between 6 and 10 Years of Age Under Protection and Care,
The study was conducted to investigate the effects of aerobic exercise training and virtual reality-based games on functional capacity, activity and participation. 63 children between the ages of 6-10, living under protection and care, were randomly assigned to participate in the study. Individuals in the aerobic exercise training and virtual reality-based game group received 24 training sessions, 2 days a week, for 12 weeks. The control group received no training and was asked to continue their normal lives. All study participants were assessed before and after the 12-week training.
Read the detailed description
The study was conducted to investigate the effects of aerobic exercise training and virtual reality-based games on functional capacity, activity and participation. 63 children (Aerobic exercise=21, virtual reality-based game=21, control=21) between the ages of 6-10, living under protection and care, were randomly assigned to participate in the study. Individuals in the aerobic exercise training and virtual reality-based game group received 24 training sessions, 2 days a week, for 12 weeks. The control group received no training and was asked to continue their normal lives. All study participants were assessed before and after the 12-week training. Functional capacity was assessed using the 6-minute walk test. Body image measurements were assessed using the Physical Self-Assessment Scale. Physical activity levels were assessed using the Physical Activity Scale. Participation was assessed using the Child and Adolescent Participation Survey.
- Conditions
- Child, Only, Virtual Reality, Aerobic Exercise
- Being tested
- aerobic exercise group, Virtual Reality-Based Game group
- Keywords
- Aerobic Exercise, virtual reality-based game, functional capacity, activity, participation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise groupOther
The exercises consisted of 10 minutes of warm-up exercises, 20 minutes of moderate-intensity aerobic exercises, and 10 minutes of cool-down exercises.
Virtual Reality-Based Game groupOther
Children in this group were given virtual reality-based games twice a week for 12 weeks, totaling 24 sessions, under the supervision of a specialist physiotherapist. Each session was planned to last 20-25 minutes. There would be 4-5 repetitions depending on the difficulty level of the games, with 1-minute rest breaks between each repetition.
| Study group | Role | What they receive |
|---|---|---|
| fonksiyonel kapasite | Active comparator | The 6-minute walk test was used to measure functional capacity. This test is performed at the person's own walking speed. Receives: Other: aerobic exercise group; Other: Virtual Reality-Based Game group |
| Fiziksel Aktivite Seviyesi | Active comparator | The Children's Physical Activity Scale was used to assess the physical activity levels of the children included in the study. Receives: Other: aerobic exercise group; Other: Virtual Reality-Based Game group |
| katılım | Active comparator | Participation assessments were conducted using the Child and Adolescent Participation Questionnaire. Receives: Other: aerobic exercise group; Other: Virtual Reality-Based Game group |
What is being measured
The primary outcome is the main question the study is designed to answer.
first review
All children who agreed to participate in the study underwent initial assessments. Functional capacity assessment was performed using the 6-minute walk test. Body image measurements were assessed using the Physical Self-Concept Scale(min:1-max:5). Physical activity levels were assessed using the Physical Activity Scale(min:1-max:5) Participation assessment was performed using the Child Adolescent Participation Questionnaire(min:0-max:4)
Measured: 2 weeks before the start of the work
Secondary outcomes (3)
last review
Final assessments have been conducted for all children who completed the 12-week training period. Functional capacity assessment was performed using the 6-minute walk test. Body image measurements were assessed using the Physical Self-Concept Scale(min:1-max:6). Physical activity levels were assessed using the Physical Activity Scale(min:1-max:5) Participation assessment was performed using the Child Adolescent Participation Questionnaire(min:0-max:4).
Measured: Immediately after the completion of the 12-week training
within-group comparison of results
The evaluations conducted at the end of the study showed that both interventions were effective in terms of functional capacity(6- minute walk test), physical activity level( Physical Activity Scale(min:1-max:5). participation (Child Adolescent Participation Questionnaire(min:0-max:4) body composition (Physical Self-Concept Scale min:1-max:6) and functionality parameters.
Measured: When the final assessments are complete and all the data is collected
comparison of results between groups
In intergroup assessments, it was found that the aerobic exercise group was more effective than the virtual reality-based game group in activity, body structure and functionality, and participation assessments.
It was found that the virtual reality-based game group was more effective than the aerobic exercise training group in activity, body structure and functionality, and participation assessments.
Measured: When the final assessments are complete and all the data is collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Jun 2025
- Primary completion15 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Torun Kızmaz, Hasan Kalyoncu University
- Investigators
- neslihan torun kızmaz, doctor physiotherapist, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576738
- Sponsor's protocol ID
- HasanKUniversitesi
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Aerobic Exercise Training and Virtual Reality-Based Games on Functional Capacity, Activity, and Participation in Children Between 6 and 10 Years of Age Under Protection and Care,
- ClinicalTrials.gov ID
- NCT07576738
- Acronym / sponsor ID
- HasanKUniversitesi
- Conditions
- Child, Only, Virtual Reality, Aerobic Exercise
- Keywords
- Aerobic Exercise, virtual reality-based game, functional capacity, activity, participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was conducted to investigate the effects of aerobic exercise training and virtual reality-based games on functional capacity, activity and participation. 63 children between the ages of 6-10, living under protection and care, were randomly assigned to participate in the study. Individuals in the aerobic exercise training and virtual reality-based game group received 24 training sessions, 2 days a week, for 12 weeks. The control group received no training and was asked to continue their normal lives. All study participants were assessed before and after the 12-week training.
Detailed description
The study was conducted to investigate the effects of aerobic exercise training and virtual reality-based games on functional capacity, activity and participation. 63 children (Aerobic exercise=21, virtual reality-based game=21, control=21) between the ages of 6-10, living under protection and care, were randomly assigned to participate in the study. Individuals in the aerobic exercise training and virtual reality-based game group received 24 training sessions, 2 days a week, for 12 weeks. The control group received no training and was asked to continue their normal lives. All study participants were assessed before and after the 12-week training. Functional capacity was assessed using the 6-minute walk test. Body image measurements were assessed using the Physical Self-Assessment Scale. Physical activity levels were assessed using the Physical Activity Scale. Participation was assessed using the Child and Adolescent Participation Survey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fonksiyonel kapasite | Active comparator | Other: aerobic exercise group, Other: Virtual Reality-Based Game groupThe 6-minute walk test was used to measure functional capacity. This test is performed at the person's own walking speed. |
| Fiziksel Aktivite Seviyesi | Active comparator | Other: aerobic exercise group, Other: Virtual Reality-Based Game groupThe Children's Physical Activity Scale was used to assess the physical activity levels of the children included in the study. |
| katılım | Active comparator | Other: aerobic exercise group, Other: Virtual Reality-Based Game groupParticipation assessments were conducted using the Child and Adolescent Participation Questionnaire. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The following volunteers participated in the study
- Children residing in the Şahinbey and Şehitkamil Children's Homes Complex,
- Participants aged between 6 and 10 years old.
Key exclusion criteria (5 listed)
- Children with neurological and psychological illnesses severe enough to prevent participation in exercise training,
- Children who have undergone surgery within the last 3 months,
- Children with learning disabilities,
- Children who perform moderate-intensity aerobic exercise for more than 150 minutes at least 3 days a week,
- Children with multiple organ dysfunction were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise groupThe exercises consisted of 10 minutes of warm-up exercises, 20 minutes of moderate-intensity aerobic exercises, and 10 minutes of cool-down exercises. | Other | Fiziksel Aktivite Seviyesi, fonksiyonel kapasite, katılım |
| Virtual Reality-Based Game groupChildren in this group were given virtual reality-based games twice a week for 12 weeks, totaling 24 sessions, under the supervision of a specialist physiotherapist. Each session was planned to last 20-25 minutes. There would be 4-5 repetitions depending on the difficulty level of the games, with 1-minute rest breaks between each repetition. | Other | Fiziksel Aktivite Seviyesi, fonksiyonel kapasite, katılım |
Primary outcome
first review
Time frame: 2 weeks before the start of the work
All children who agreed to participate in the study underwent initial assessments. Functional capacity assessment was performed using the 6-minute walk test. Body image measurements were assessed using the Physical Self-Concept Scale(min:1-max:5). Physical activity levels were assessed using the Physical Activity Scale(min:1-max:5) Participation assessment was performed using the Child Adolescent Participation Questionnaire(min:0-max:4)
3 secondary outcomes
last review
Time frame: Immediately after the completion of the 12-week training
within-group comparison of results
Time frame: When the final assessments are complete and all the data is collected
comparison of results between groups
Time frame: When the final assessments are complete and all the data is collected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
neslihan torun kızmaz, doctor physiotherapist principal investigator
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise group and Virtual Reality-Based Game group in people with Child, Only and Virtual Reality, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
first review (time frame: 2 weeks before the start of the work). 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 8 May 2026.