Executive Function (Cognition)NCT07081269
Physical Fitness and Hot Executive Function in Alzheimer's Risk
An observational study of Executive Function (Cognition) and Event-Related Potentials, run by National Taiwan Normal University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Function (Cognition), Event-Related Potentials, Physical Fitness
- What is being tested?
- observation alone
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jan 2025to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is older adults aged 50-70.
Who may be able to join
- Age 50-70.
- Able to engage in fitness testing.
- Normal vision or corrected-to-normal vision.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan Normal University
Taipei
Chien-Heng Chu, PhD, +886277493224, cchu042@yahoo.com
About this study
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.
Read the 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.
- Being tested
- observation alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation aloneOther
Also called 1.5 year observation
No interventions will be conducted during the observation period, maintaining participants' normal daily living conditions.
| Study group | Role | What they receive |
|---|---|---|
| Older adults | Older adults, 50-70 years old. Receives: Other: observation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiorespiratory fitness
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.
Measured: Approximately 25 minutes each at the baseline assessment and the 18-month follow-up post-assessment.
Changes in muscular fitness
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.
Measured: Approximately 25 minutes each at the baseline assessment and the 18-month follow-up post-assessment
Change in cognitive flexibility-response time
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.
Measured: Approximately 30 minutes each at the baseline assessment and the 18-month follow-up post-assessment
Change in cognitive flexibility-adcuracy
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.
Measured: Approximately 30 minutes each at the baseline assessment and the 18-month follow-up post-assessment
Change in EEG activity
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.
Measured: Approximately 30 minutes each at the baseline assessment and the 18-month follow-up post-assessment
Secondary outcomes (4)
Cognitive function (Mini-Mental State Examination, MMSE)
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.
Measured: Approximately 15 minutes each at the baseline assessment and the 18-month follow-up post-assessment
Working memory (Digit Span Tests)
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.
Measured: Approximately 15 minutes each at the baseline assessment and the 18-month follow-up post-assessment
ApoE genotype
Apolipoprotein E (ApoE) genotype will be determined for each participant by genotyping the single nucleotide polymorphisms rs429358 and rs7412.
Measured: 5 minutes at the Baseline Assessment
Physical activity (Taiwan version of the International Physical Activity Questionnaire, IPAQ)
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.
Measured: Approximately 15 minutes each at the baseline assessment and the 18-month follow-up post-assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start10 Jan 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive Function (Cognition)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Kai Chang, National Taiwan Normal University
- Investigators
- Yu-Kai Chang, PhD, Study director, National Taiwan Normal UniversityChine-Heng Chu, PhD, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081269
- Sponsor's protocol ID
- PACNL_HPF_HEF
- Status last verified
- Jul 2025
- First submitted
- 18 May 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Fitness and Hot Executive Function in Alzheimer's Risk
- ClinicalTrials.gov ID
- NCT07081269
- Acronym / sponsor ID
- PACNL_HPF_HEF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults | – | Other: observation aloneOlder adults, 50-70 years old. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is older adults aged 50-70.
Key inclusion criteria (3 listed)
- Age 50-70.
- Able to engage in fitness testing.
- Normal vision or corrected-to-normal vision.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation aloneAlso: 1.5 year observationNo interventions will be conducted during the observation period, maintaining participants' normal daily living conditions. | Other | Older adults |
Primary outcome
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.
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.
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.
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.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yu-Kai Chang, PhD study director
National Taiwan Normal University
Chine-Heng Chu, PhD principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Executive Function (Cognition) and Event-Related Potentials, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chine-Heng Chu, PhD (+886277493224, cchu042@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cardiorespiratory fitness (time frame: Approximately 25 minutes each at the baseline assessment and the 18-month follow-up post-assessment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.