Measuring Physical Activity With ActivPal
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: ActivPal.
- Кому может быть актуально
- Состояния в реестре: Neuromuscular Diseases. Базовые параметры: от 1 год · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Measuring Physical Activity Levels and Intensity Using an ActivPal™ Accelerometer in Adult and Pediatric Populations With Neuromuscular Diseases
Обзор
This study measures the level of physical activity in participants with neuromuscular disorders. The patient wears a small button like meter on their leg for a period of 1 week every 6 months over a period of 3 years. Participants will also have a physical exam, six minute walk test,vital signs and questionnaires.
Подробное описание
Routine physical activity can be an important indicator of health across an individual's life span. Nonetheless, the frequency of inactivity continues to be problematic for a large number of children and adolescents. Adding to that challenge, fatigue has been described as a typical symptom of neurological diseases and disorders Consumer wearables and accelerometers are becoming increasingly popular to track physical activities and monitor health and disease progression. With the increased adoption of activity trackers comes the increased generation of valuable individual-based data. Generated data has the potential to provide detailed insights into the user's behavior and lifestyle. Although methods for objectively measuring physical activity in children and adults in naturalistic settings are well established (i.e., accelerometry), they are most widely used on healthy individuals. Due to cost and technical requirements, these technologies are limited which effects their wide-scale use. Ultimately, this undermines efforts to evaluate physical activity changes and nuances among healthy and diseased populations. This is of particular interest in rare disease populations, specifically in neuromuscular diseases, where one can study a wide range of features that can be used to monitor an individual's sleep, vertical positioning, or overall physical activity. Tracking physical activity can help provide clinicians with a more accurate disease profile and help to identify possible interventions. Collection of this data could potentially provide valuable insight into an individual's daily routines, lifestyle, and behaviors.
Вмешательства
- Другое ActivPal
Participants will wear the activity meter (a small button like device) on their thigh for a period of 7 days at the following time-points: baseline, 6, 12, 18, 24, 30 and 36 months. The meter will be placed on their thigh at a research visit and mailed back to the study team after 7 days.
Первичные конечные точки
- Mean Activity Profile (measures time spent at various raw activity levels) [Срок оценки: Up to 3 years]
Вторичные конечные точки (1)
- Mean intensity Count (measures time spent in various actions such as rest, walking etc.) [Срок оценки: Up to 3 years]
Критерии участия
Критерии включения
- Patients with a clinically or genetically confirmed neuromuscular disorder
- Control subjects who do not have a neuromuscular disease.
- Participants at least 1 years of age.
Критерии исключения
- Participant has a condition, which in the opinion of the Investigator may compromise safety
- Participant has a condition, which in the opinion of the Investigator may compromise or compliance
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
США · 1 центр
- Columbia University Irving Medical Center — New York
Идентификаторы
NCT: NCT06084026 · AAAS6805 · R01AG062401 · U54NS078059