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NCT Number: NCT07081269

Physical Fitness and Hot Executive Function in Alzheimer's Risk

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.

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Key information

Conditions

Executive Function (Cognition) Event-related Potentials Physical Fitness

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan Normal University

Taipei, Taiwan

Location status: Recruiting

Location contact

Chien-Heng Chu, PhD

CONTACT

[email protected]

+886277493224

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation alone

Other

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

Other names: 1.5 year observation

Primary outcomes

  1. Changes in cardiorespiratory fitness

    Time frame: 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.

  2. Changes in muscular fitness

    Time frame: 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.

  3. Change in cognitive flexibility-response time

    Time frame: 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.

  4. Change in cognitive flexibility-adcuracy

    Time frame: 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.

  5. Change in EEG activity

    Time frame: 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.

Secondary outcomes

  1. 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

    The Mini-Mental State Examination (MMSE), a 30-item cognitive screening tool yielding a total score of 0-30, will be administered at baseline (Baseline Assessment) and at the 18-month follow-up (Post Assessment). Changes in MMSE total scores between Baseline and Post Assessments will be analyzed.

  2. Working memory (Digit Span Tests)

    Time frame: Approximately 15 minutes each at the baseline assessment and the 18-month follow-up post-assessment

    Working memory will be assessed via the Digit Span subtest of the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III), in which participants verbally reproduce auditorily presented digit sequences in their original (forward) or reverse (backward) order, at baseline (Baseline Assessment) and at the 18-month follow-up (Post Assessment). Changes in MMSE total scores between Baseline and Post Assessments will be analyzed.

  3. ApoE genotype

    Time frame: 5 minutes at the Baseline Assessment

    Apolipoprotein E (ApoE) genotype will be determined for each participant by genotyping the single nucleotide polymorphisms rs429358 and rs7412.

  4. 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

    Physical activity will be assessed via the Taiwanese version of the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at baseline (Baseline Assessment) and at the 18-month follow-up (Post Assessment). Changes in IPAQ-SF scores between Baseline and Post Assessments will be analyzed.

Study contacts

Contact information is provided by the study sponsor or research team.

Chine-Heng Chu, PhD

CONTACT

[email protected]

+886277493224

Sponsors and collaborators

Lead sponsor

National Taiwan Normal University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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