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Идёт набор NCT07081269

Physical Fitness and Hot Executive Function in Alzheimer's Risk

— Наблюдательное Executive Function (Cognition) Event-Related Potentials Physical Fitness

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: observation alone.
Кому может быть актуально
Состояния в реестре: Executive Function (Cognition), Event-Related Potentials, Physical Fitness. Базовые параметры: 50 лет — 70 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
Тайвань
Следующий шаг
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Обзор

This 18-month study tracks how physical fitness relates to executive function in older adults, aiming to determine if fitness improvements predict better cognitive performance. Participants complete assessments at baseline and 18 months, including cardiorespiratory fitness (YMCA bike test), muscle strength (chest and leg press tests), and executive function (computer tasks with brain activity recording via EEG). Additional measures include physical activity questionnaires, cognitive screening (MMSE), memory tests (digit span), demographics (age, sex, education), and blood tests for APOE ε4 gene status. No exercise program will be provided, allowing observation of natural fitness-cognition relationships in daily life.

Подробное описание

This prospective observational study examines associations between health-related physical fitness and behavioral/electrophysiological indices of cool and hot executive function in older adults over 18 months. The primary objective is to determine whether changes in physical fitness components predict concurrent changes in executive function domains.

Assessment Protocol: Participants complete comprehensive evaluations at baseline and 18-month follow-up, including: (1) cardiorespiratory fitness via YMCA submaximal cycle ergometry; (2) muscular strength through one-repetition maximum testing (chest press, leg press); and (3) executive function using computerized task-switching paradigms with simultaneous electroencephalography. Secondary measures include demographics (age, sex, education), physical activity levels (International Physical Activity Questionnaire-Taiwan Short Form), global cognition (Mini-Mental State Examination), and working memory (digit span forward/backward). Additionally, Apolipoprotein E ε4 (APOE ε4) genotype will be examined as a potential moderator of fitness-cognition relationships.

Вмешательства

  • Другое observation alone
    No interventions will be conducted during the observation period, maintaining participants' normal daily living conditions.

Первичные конечные точки

  • Changes in cardiorespiratory fitness [Срок оценки: Approximately 25 minutes each at the baseline assessment and the 18-month follow-up post-assessment.]
  • Changes in muscular fitness [Срок оценки: Approximately 25 minutes each at the baseline assessment and the 18-month follow-up post-assessment]
  • Change in cognitive flexibility-response time [Срок оценки: Approximately 30 minutes each at the baseline assessment and the 18-month follow-up post-assessment]
  • Change in cognitive flexibility-adcuracy [Срок оценки: Approximately 30 minutes each at the baseline assessment and the 18-month follow-up post-assessment]
  • Change in EEG activity [Срок оценки: Approximately 30 minutes each at the baseline assessment and the 18-month follow-up post-assessment]
Вторичные конечные точки (4)
  • Cognitive function (Mini-Mental State Examination, MMSE) [Срок оценки: Approximately 15 minutes each at the baseline assessment and the 18-month follow-up post-assessment]
  • Working memory (Digit Span Tests) [Срок оценки: Approximately 15 minutes each at the baseline assessment and the 18-month follow-up post-assessment]
  • ApoE genotype [Срок оценки: 5 minutes at the Baseline Assessment]
  • Physical activity (Taiwan version of the International Physical Activity Questionnaire, IPAQ) [Срок оценки: Approximately 15 minutes each at the baseline assessment and the 18-month follow-up post-assessment]

Критерии участия

Критерии включения

  • Age 50-70.
  • Able to engage in fitness testing.
  • Normal vision or corrected-to-normal vision.

Критерии исключения

  • Suffering from cardiopulmonary-related diseases.
  • Suffering from cognitive, neurological or psychiatric disorders (e.g., dementia, Parkinson's disease, epilepsy, depression, schizophrenia, etc.).
  • Suffering from infectious diseases (e.g., hepatitis, human immunodeficiency virus or Creutzfeldt-Jakob disease).
  • Having a history of drug or alcohol abuse.
  • Having colour vision deficiency (e.g., colour blindness).
  • Having a family history of aneurysm.
  • Taking medications that affect brain function.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Тайвань · 1 центр
  • National Taiwan Normal University — Taipei

Идентификаторы

NCT: NCT07081269 · PACNL_HPF_HEF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗