Physical Fitness and Hot Executive Function in Alzheimer's Risk

NCT ID: NCT07081269

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-10

Study Completion Date

2027-07-31

Brief Summary

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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

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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.

Conditions

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Executive Function (Cognition) Event-Related Potentials Physical Fitness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Older adults

Older adults, 50-70 years old.

observation alone

Intervention Type OTHER

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

Interventions

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observation alone

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

Intervention Type OTHER

Other Intervention Names

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1.5 year observation

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan Normal University

OTHER

Sponsor Role lead

Responsible Party

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Yu-Kai Chang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu-Kai Chang, PhD

Role: STUDY_DIRECTOR

National Taiwan Normal University

Chine-Heng Chu, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan Normal University

Locations

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National Taiwan Normal University

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chine-Heng Chu, PhD

Role: CONTACT

+886277493224

Facility Contacts

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Chien-Heng Chu, PhD

Role: primary

+886277493224

Other Identifiers

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PACNL_HPF_HEF

Identifier Type: -

Identifier Source: org_study_id

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