- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04296708
ExerCube Training on Executive Functions in Young Athletes
The Influence of a Ten-week ExerCube Training on Executive Functions as Well as on Training Motivation, Enjoyment and Mental Well-being in Young Athletes
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Zürich, Швейцария, 8093
- Institute of Human Movement Sciences and Sport, ETH Zürich
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Female and male
- Age between 15 to 20 years
- Young athletes (game sports)
- Healthy (self-reported)
- Able to provide written informed consent and understand instructions
Exclusion Criteria:
- History of cardiovascular issue that would prevent training participation
- Asthma (not controllable)
- Musculosceletal injuries that would prevent training participation
- Pain that would be reinforced by sportive activities
- Pregnancy
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: ExerCube group
The ExerCube is an immersive fitness game setting that combines innovative soft- and hardware designs with state of-the-art training concepts.
The ExerCube has three walls which serve as virtual reality projection screens and haptic interfaces.
The ExerCube is a playful physical-cognitive exergame training.
The user navigates a virtual environment/reality via whole body exercise.
The video game navigates the user and triggers various cognitive functions.
The used physical exercises are functionally and elicit the improvement of endurance and strength components.
Via different monitoring systems (points and heart rate), the game adapts to the individual abilities and training level to tailor workout intensity.
The ExerCube training consists of two sessions a week each session will last about 30 minutes of which 25 minutes will be pure playtime
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An exergame combines exercise and gaming in a holistic approach.
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Без вмешательства: Control group
The control group does not have any additional ExerCube training.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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FitLight
Временное ограничение: Before and after the intervention, within two weeks
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FitLight Trainer™ (Sports Corp. Ontario, Canada) is a commercially available product and consists of eight LED powered lights controlled by a wireless connection via a tablet.
The tablet is running on android version 4.2.2 and has in advance a FitLight Trainer™ software to interact with the lights.
With this software, it is possible to generate new specific light sequences.The FitLight allow the testing of executive functions depending on the programmed sequences.
The participants use whole-body movements of arms and legs to solve the programmes sequences.
Before the participants execute the main test, they perform a pre-test to minimize the learning effect and to get familiar with the test environment
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Before and after the intervention, within two weeks
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Test for Attentional Performance
Временное ограничение: Before and after the intervention, within two weeks
|
Initially the TAP (D-TAP 2.3 VL, PSYTEST, Psychologische Testsysteme, Herzogenrath, Germany) was developed to assess attentional deficits in a cerebral impaired population.
The participants perform a simple reaction task.The stimuli are presented on a screen of a personal computer.
Before the participants execute the main test, they perform a pre-test to minimize the learning effect and to get familiar with the test environment.
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Before and after the intervention, within two weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Situation Motivation Scale
Временное ограничение: Before and after the intervention, within two weeks
|
The Situation Motivation Scale was designed to assess the constructs of intrinsic motivation, identified regulation, external regulation and amotivation in field and laboratory settings. - 16 items graded on a 7-point Likert scale, a higher score means a better outcome |
Before and after the intervention, within two weeks
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Flow Short Scale
Временное ограничение: Before and after the intervention, within two weeks
|
The first 10 items measure the components of Flow-Experience as first described by Mihaly Csikszentmihalyi 1975. The items 11 - 13 measure Worry someone may have in the situation the measurement is made. - 13 items graded on a 7-point Likert scale, Item 1-10: a higher score means a better outcome, Item 11-13: a lower score means a better outcome |
Before and after the intervention, within two weeks
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Physical Activity Enjoyment Scale
Временное ограничение: Before and after the intervention, within two weeks
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The Physical Activity Enjoyment Scale was developed to measure physical activity enjoyment using college-aged students. The scale is a reliable and valid measure of enjoyment in physical activity environments. - 18 bipolar statements and a 7-point continuum, a higher score means a better outcome |
Before and after the intervention, within two weeks
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Warwick-Edinburgh Mental Well-being Scale
Временное ограничение: Before and after the intervention, within two weeks
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This mental well-being scale is a valid measurement at a population and on an individual level.
The questionnaire consists of 14 items and covers following aspects of mental health: positive affect (feelings of optimism, cheerfulness, and relaxation), satisfying interpersonal relationships, positive functioning (energy, clear thinking, self-acceptance, personal development, competence and autonomy).
A minimum score of 14 and a maximum score of 70 can be achieved, whereas a score from 51 can be assumed normal.
The higher the score is, the higher the level of mental well-being.
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Before and after the intervention, within two weeks
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Соавторы и исследователи
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
Другие идентификационные номера исследования
- EK 2019-N-161
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
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. .