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临床试验/NCT07081269
NCT07081269招募中不适用

Physical Fitness and Hot Executive Function in Alzheimer's Risk

National Taiwan Normal University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
1
主要终点
Changes in cardiorespiratory fitness

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Changes in cardiorespiratory fitness

时间窗: Approximately 25 minutes each at the baseline assessment and the 18-month follow-up post-assessment.

Cardiorespiratory fitness will be estimated using the YMCA submaximal cycle ergometer test at baseline (Baseline Assessment) and at the 18-month follow-up (Post Assessment). Changes in cardiorespiratory fitness between the Baseline and Post Assessments will be evaluated.

Changes in muscular fitness

时间窗: Approximately 25 minutes each at the baseline assessment and the 18-month follow-up post-assessment

Muscular fitness will be assessed via a standardized 8-10 repetition maximum protocol on chest-press and leg-press machines at baseline (Baseline Assessment) and at the 18-month follow-up (Post Assessment). Changes in muscular fitness between the Baseline and Post Assessments will be evaluated.

Change in cognitive flexibility-response time

时间窗: Approximately 30 minutes each at the baseline assessment and the 18-month follow-up post-assessment

Cognitive flexibility will be assessed via a task-switching test at baseline (Baseline Assessment) and at the 18-month follow-up (Post Assessment). Changes in response times on the task-switching test between Baseline and Post Assessments will be analyzed.

Change in cognitive flexibility-adcuracy

时间窗: Approximately 30 minutes each at the baseline assessment and the 18-month follow-up post-assessment

Cognitive flexibility will be assessed via a task-switching test at baseline (Baseline Assessment) and at the 18-month follow-up (Post Assessment). Changes in accuracy on the task-switching test between Baseline and Post Assessments will be analyzed.

Change in EEG activity

时间窗: Approximately 30 minutes each at the baseline assessment and the 18-month follow-up post-assessment

Concurrent EEG data recorded during task switching at baseline (Baseline Assessment) and at the 18-month follow-up (Post Assessment) will be processed and analyzed. Differences in EEG activity between Baseline and Post Assessments will be examined.

次要结局

  • Cognitive function (Mini-Mental State Examination, MMSE)(Approximately 15 minutes each at the baseline assessment and the 18-month follow-up post-assessment)
  • Working memory (Digit Span Tests)(Approximately 15 minutes each at the baseline assessment and the 18-month follow-up post-assessment)
  • ApoE genotype(5 minutes at the Baseline Assessment)
  • Physical activity (Taiwan version of the International Physical Activity Questionnaire, IPAQ)(Approximately 15 minutes each at the baseline assessment and the 18-month follow-up post-assessment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-Kai Chang

Principal Investigator

National Taiwan Normal University

研究点 (1)

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