- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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,
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Province
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Gaziantep, Province, Турция (Туркие), 27410
- Hasan Kalyoncu University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: 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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Активный компаратор: 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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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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first review
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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last review
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: neslihan torun kızmaz, doctor physiotherapist, Hasan Kalyoncu University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HasanKUniversitesi
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .