- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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,
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Province
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Gaziantep, Province, Turquía (Türkiye), 27410
- Hasan Kalyoncu University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: fonksiyonel kapasite
The 6-minute walk test was used to measure functional capacity.
This test is performed at the person's own walking speed.
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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.
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Comparador activo: Fiziksel Aktivite Seviyesi
The Children's Physical Activity Scale was used to assess the physical activity levels of the children included in the study.
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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.
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Comparador activo: katılım
Participation assessments were conducted using the Child and Adolescent Participation Questionnaire.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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first review
Periodo de tiempo: 2 weeks before the start of the work
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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)
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2 weeks before the start of the work
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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last review
Periodo de tiempo: Immediately after the completion of the 12-week training
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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
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within-group comparison of results
Periodo de tiempo: When the final assessments are complete and all the data is collected
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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.
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When the final assessments are complete and all the data is collected
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comparison of results between groups
Periodo de tiempo: When the final assessments are complete and all the data is collected
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: neslihan torun kızmaz, doctor physiotherapist, Hasan Kalyoncu University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HasanKUniversitesi
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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