NCT07081269

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jan 2025Jul 2027

Study Start

First participant enrolled

January 10, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

May 18, 2025

Last Update Submit

July 15, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    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)

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

  • Working memory (Digit Span Tests)

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

  • ApoE genotype

    5 minutes at the Baseline Assessment

  • 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

Study Arms (1)

Older adults

Older adults, 50-70 years old.

Other: observation alone

Interventions

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

Also known as: 1.5 year observation
Older adults

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population is older adults aged 50-70.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, Taiwan

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Yu-Kai Chang, PhD

    National Taiwan Normal University

    STUDY DIRECTOR
  • Chine-Heng Chu, PhD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chine-Heng Chu, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2025

First Posted

July 23, 2025

Study Start

January 10, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations