- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07576738
Investigation of the Effects of Aerobic Exercise Training and Virtual Reality-Based Games on Children
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,
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Province
-
Gaziantep, Province, Turkey (Türkiye), 27410
- Hasan Kalyoncu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: fonksiyonel kapasite
The 6-minute walk test was used to measure functional capacity.
This test is performed at the person's own walking speed.
|
The exercises consisted of 10 minutes of warm-up exercises, 20 minutes of moderate-intensity aerobic exercises, and 10 minutes of cool-down exercises.
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.
|
|
Active Comparator: Fiziksel Aktivite Seviyesi
The Children's Physical Activity Scale was used to assess the physical activity levels of the children included in the study.
|
The exercises consisted of 10 minutes of warm-up exercises, 20 minutes of moderate-intensity aerobic exercises, and 10 minutes of cool-down exercises.
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.
|
|
Active Comparator: katılım
Participation assessments were conducted using the Child and Adolescent Participation Questionnaire.
|
The exercises consisted of 10 minutes of warm-up exercises, 20 minutes of moderate-intensity aerobic exercises, and 10 minutes of cool-down exercises.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
2 weeks before the start of the work
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
last review
Time Frame: Immediately after the completion of the 12-week training
|
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).
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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
|
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.
|
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
|
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. |
When the final assessments are complete and all the data is collected
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: neslihan torun kızmaz, doctor physiotherapist, Hasan Kalyoncu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HasanKUniversitesi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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