Physical Fitness and Hot Executive Function in Alzheimer's Risk

Recruiting

• Conditions: Executive Function (Cognition); Event-Related Potentials; Physical Fitness

• Registration Number: NCT07081269
• Lead Sponsor: National Taiwan Normal University

Brief Summary

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.

Study Timeline

• Study Start: 2025-01-10
• Study First Submitted: 2025-05-18
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-15
• Last Update Submitted: 2025-07-15
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in cardiorespiratory fitness	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	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	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	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	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 Outcome Measures

Name	Time	Method
Cognitive function (Mini-Mental State Examination, MMSE)	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.
Working memory (Digit Span Tests)	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.
ApoE genotype	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.
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	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.

Trial Locations

Locations (1)

National Taiwan Normal University; 🇨🇳 Taipei, Taiwan