Validating a New Machine-Learned Accelerometer Algorithm Using Doubly Labeled Water
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: Doubly-Labeled Water.
- Кому может быть актуально
- Состояния в реестре: Movement Disorders, Energy Metabolism. Базовые параметры: от 18 лет · 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
The purpose of this study is to validate previously developed physical function-clustered specific machine-learned accelerometer algorithms to estimate total daily energy expenditure (TDEE) in individuals with general movement and functional limitations.
Подробное описание
Current algorithms for examining accelerometer data were developed primarily using data from individuals without movement limitations or impairments. As such, the current available analytic algorithms are inadequate for use with individuals with limitations and impairments to estimate total daily energy expenditure (TDEE). The creation of a new algorithm that can accurately assess TDEE in individuals with movement limitations will be beneficial for future research examining physical activity interventions targeted to these individuals. This study will serve to validate a new algorithm that was developed specifically to analyze accelerometer data for individuals with movement limitations, and gauge the accuracy of the new algorithm's ability to accurately assess TDEE against one of the gold standards of TDEE measurement, the doubly labelled water technique.
Approximately 125 adults, 50 from Colorado, and 75 from Wisconsin, will participate in this study. Participants will complete three study visits. During the first visit, physical function will be assessed during a series of tests, and a dual-energy X-ray absorptiometry (DXA) scan will be performed to obtain information on body composition. During the second visit, the participant will complete a resting metabolic rate (RMR) examination, will consume a dose of doubly labeled water, and will provide urine and saliva samples. At the end of the second visit, participants will be given a set of accelerometers to wear for 8-10 days, and will be asked to complete a wear log for documentation. After 8-10 days have passed, during the final visit, participants will provide additional urine samples and return the accelerometers.
The hypothesis being tested is that physical function-clustered specific machine-learned accelerometer algorithms will produce more accurate and precise estimations of TDEE during free-living compared with healthy population derived accelerometer algorithms applied to diverse populations.
Вмешательства
- Другое Doubly-Labeled Water
All eligible participants will receive a dose of doubly-labeled water.
Первичные конечные точки
- Accuracy of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day). [Срок оценки: 8-10 days monitoring]
- Precision of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day). [Срок оценки: 8-10 days monitoring]
- Total Daily Energy Expenditure (TDEE) (via DLW) [Срок оценки: pre-dose; 4 hours and 5 hours post-dose, and 8-10 days post-dose]
Вторичные конечные точки (6)
- Resting Metabolic Rate (kcals/day) [Срок оценки: pre-dose]
- Fat free body mass (g) [Срок оценки: 7-14 days before dose]
- Modified Physical Performance Test (MPPT) [Срок оценки: 7-14 days before dose]
- Maximum hand grip strength [Срок оценки: 7-14 days before dose]
- Gait speed [Срок оценки: 7-14 days before dose]
- Temporospatial gait analysis [Срок оценки: 7-14 days before dose]
Критерии участия
Критерии включения
- must be 18+ years of age
- be able to ambulate on own, unassisted, on a regular basis
- speak and read English
- must have access to a working smart phone and a computer with internet access
Критерии исключения
- wheelchair reliant
- assistive walking device reliant (cannot walk for at least 50 feet without an assistive device)
- diagnosed uncontrolled hypertension (above 160/100 mgHg)
- diagnosed cognitive impairment or inability to follow study procedures such as Alzheimer's disease or dementia
- cannot take metabolic altering medications
- cannot be pregnant
- cannot be breastfeeding
- cannot use supplemental oxygen
- cannot completed required study activities for any reason
- cannot have a resting heart rate > 100 bpm or a resting blood pressure > 160 mgHg during Visit 1
- cannot weigh more than 450 lbs
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
США · 1 центр
- University of Wisconsin-Milwaukee — Milwaukee
Идентификаторы
NCT: NCT05736302 · 21.061 · R01CA215318