NCT07576738

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

April 28, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

Aerobic Exercisevirtual reality-based gamefunctional capacityactivityparticipation

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 weeks before the start of the work

Secondary Outcomes (3)

  • last review

    Immediately after the completion of the 12-week training

  • within-group comparison of results

    When the final assessments are complete and all the data is collected

  • comparison of results between groups

    When the final assessments are complete and all the data is collected

Study Arms (3)

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.

Other: aerobic exercise groupOther: 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.

Other: aerobic exercise groupOther: Virtual Reality-Based Game group

katılım

ACTIVE COMPARATOR

Participation assessments were conducted using the Child and Adolescent Participation Questionnaire.

Other: aerobic exercise groupOther: Virtual Reality-Based Game group

Interventions

The exercises consisted of 10 minutes of warm-up exercises, 20 minutes of moderate-intensity aerobic exercises, and 10 minutes of cool-down exercises.

Fiziksel Aktivite Seviyesifonksiyonel kapasitekatılım

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.

Fiziksel Aktivite Seviyesifonksiyonel kapasitekatılım

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Province, 27410, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • neslihan torun kızmaz, doctor physiotherapist

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

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
Doktor Fizyoterapist

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 8, 2026

Study Start

June 1, 2025

Primary Completion

September 15, 2025

Study Completion

December 1, 2025

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations