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Recruiting NCT07081269

Physical Fitness and Hot Executive Function in Alzheimer's Risk

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observation alone.
Who it may be relevant to
Registry conditions: Executive Function (Cognition), Event-Related Potentials, Physical Fitness. Basic parameters: 50 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • National Taiwan Normal University — Taipei

Identifiers

NCT: NCT07081269 · PACNL_HPF_HEF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗