Меню
Идёт набор NCT04173715

Movement and Behaviours Measurement Study

— Наблюдательное Aging Physical Function Frailty Syndrome Physical Disability

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: Older Adults Group., Low Physical Function Status Group, Medium Physical Function Status Group, High Physical Function Status Group.
Кому может быть актуально
Состояния в реестре: Aging, Physical Function, Frailty Syndrome, Physical Disability. Базовые параметры: от 65 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
Испания
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 →

Официальное название

Validation of Cut-points to Estimate Sedentary Time and Physical Activity Intensities in Older Adults

Обзор

There are few studies that already have validated specific raw accelerometer cut-points for people over 65 years old. The purpose of the present study is to validate raw accelerometer cut points for general people over 65 years old and specific raw accelerometer cut points based on the functional status of older adults over 65 years old. The study will be carried out with an observational approach. Participants will be divided into 4 groups. First of them will be made grouping all subjects and the rest divided according to their functional status. They will perform different-intensity physical activities while wearing accelerometers attached to their body and wearing a portable gas analyser too. Their intensity will be assessed based on their own Rest Metabolic Rate (RMR). Energy expenditure and accelerations will be matched and, based on that, sedentary behaviour, light physical activity and moderate-to-vigorous physical activity cut-points will be derived.

Подробное описание

Knowledge on health implications of sedentary time and physical activity has been substantially improved in the last decades with accelerometer-based estimations. The popularity of these devices is partially explained by the capacity of objectively recording physical behaviors (e.g., sleep, sedentary time, physical activity…) during the whole day. The so-called "cut-point" approach is behind most of the research on physical activity with accelerometers. Cut-points provide metrics that are easy to understand, to translate to the public and to replicate by researchers in different settings. Usually, the minimum requirement is to use cut-points adapted to the age-group of the population of interest.

Under this paradigm, cut-points have been developed in all age-groups and with a variate set to data collection and processing protocols. However, some scenarios lack of available cut-points to implement, being older adults (\> 65 years) the population with less alternatives of cut-points to use. In this sense, studies with older adults choose cut-points developed in younger adults to classify physical activity intensities. Biomechanical and physiological differences between adults and older adults advise against using this strategy. Therefore, relative energy expenditure and functional status should be considered for future cut-points design. Moreover, must be also awarded that hardly any previous cut-points validation protocols have been performed in a free-living setting. For this reason, more studies following these designs seems necessary to improve cut-points population's validity. Missing all mentioned factors could lead to physical activity and sedentary behavior patterns misclassification in this population.

Вмешательства

  • Поведенческое Older Adults Group.
    Physical activity and energy expenditure quantification
  • Поведенческое Low Physical Function Status Group
    Physical activity and energy expenditure quantification
  • Поведенческое Medium Physical Function Status Group
    Physical activity and energy expenditure quantification
  • Поведенческое High Physical Function Status Group
    Physical activity and energy expenditure quantification

Первичные конечные точки

  • Rest Metabolic Rate [Срок оценки: Through study completion, an average of 1 year]
  • Energy expenditure during physical activity performance [Срок оценки: Through study completion, an average of 1 year]
  • Accelerometry [Срок оценки: Through study completion, an average of 1 year]
  • Physical function [Срок оценки: Through study completion, an average of 1 year]
  • Frailty Status [Срок оценки: Through study completion, an average of 1 year]
  • Physical Activity and Sedentary Behaviour Patterns. [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (2)
  • Heart Rate [Срок оценки: Through study completion, an average of 1 year]
  • Body composition [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • 65 years and older
  • Non-institutionalized
  • Physical function assessment (SPPB>3)

Критерии исключения

  • Have started an exercise program.
  • Mini-Mental Score < 18.
  • Presenting any physical activity contraindication.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Испания · 1 центр
  • Universidad de Castilla-La Mancha, Laboratorio de Actividad Física y Función Muscular — Toledo

Идентификаторы

NCT: NCT04173715 · CEIC-CHT-568

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗