- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05652140
Cardiorespiratory Fitness, Apolipoprotein E Genotype, and Cognitive Functions: A Prospective Study
November 9, 2024 updated by: Yu-Kai Chang, National Taiwan Normal University
Cardiorespiratory Fitness and the Apolipoprotein E (ApoE) Genotype and Its Interaction With Cognitive Functions and Cognitive Decline in Late-Middle-Aged Older Adults: A Prospective Study
The current research project aims to investigate the interaction of cardiorespiratory fitness (CRF) and the ApoE genotype with neurocognitive functions.
Study Overview
Detailed Description
The current research project aims to investigate the interaction of cardiorespiratory fitness (CRF) and the ApoE genotype with neurocognitive functions. The three main purposes of the current research project seek to achieve:
- An exploration of the associations of, as well as the interactions between, CRF assessed at the Baseline Stage, and the ApoE genotype, along with cognitive functions in cognitively healthy late-middle-aged older adults.
- The employing of an event-related potential (ERP) to investigate the associations between the baseline CRF, the ApoE genotype, and cognitive functions in cognitively healthy late-middle-aged older adults, as well as the potential underlying neuroelectrical mechanisms.
- An investigation of the interactions between the changes of CRFs assessed at the Baseline and the Follow-Up Stages and the ApoE genotype in relation to neurocognitive function, as well as the underlying neuroelectrical mechanisms, in cognitively healthy late-middle-aged older adults.
Study Type
Observational
Enrollment (Actual)
159
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 106308
- Department of Physical Education and Sport Sciences, National Taiwan Normal University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Cognitively healthy late-middle-aged older adults recruited from the northern part of Taiwan.
Description
Inclusion Criteria:
- right handed
- no history of cardiorespiratory disease
- normal or corrected-to-normal vision based on the 20/20 standard
- no risk of performing physical activities, as measured by the Physical Activity Readiness Questionnaire
Exclusion Criteria:
- the scores of Mini-Mental Status Examination (MMSE) < 25 and cognitively intact upon study entry
- history of psychiatric or neurological diseases
- color-blindness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
High-Risk with increased CRF
ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages.
|
Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness.
|
|
High-Risk with decreased CRF
ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages.
|
Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness.
|
|
Low-Risk with increased CRF
Non-ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages.
|
Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness.
|
|
Low-Risk with decreased CRF
Non-ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages.
|
Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Inhibitory Performance: Stroop Task
Time Frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18
|
Inhibitory performance was assessed using the computerized Stroop task at the Baseline and at the Follow-Up assessments.
The difference in response time (RT) between the Baseline and the Follow-Up Stages was calculated as the index of the inhibitory performance.
|
30 minutes each at the Baseline and the Follow-Up visit at Month 18
|
|
Changes in Neuroelectrical Activities
Time Frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18
|
The neuroelectrical activities (P3 component) during the Stroop task were recorded and analyzed using the Neuroscan system.
The difference in P3 amplitudes of incongruent trials between the Baseline and the Follow-Up Stages was calculated as the index of the neuroelectrical index.
|
30 minutes each at the Baseline and the Follow-Up visit at Month 18
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants for Whom ApoE Genotype Was Determined
Time Frame: 5 minutes at the Baseline Stage.
|
Participants' ApoE genotype was determined based on the genetic biomarkers (rs429358 and rs7412)
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5 minutes at the Baseline Stage.
|
|
Physical Fitness Measurements: Changes in Aerobic Fitness
Time Frame: 30 minutes each at the Baseline and the Follow-Up visit at Month 18
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Participants' aerobic fitness was estimated using the submaximal cycle ergometer test at the baseline and at the follow-up assessments.
The difference in maximum oxygen consumption (VO2 max) between the Baseline and the Follow-Up Stages was calculated as the index of aerobic fitness.
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30 minutes each at the Baseline and the Follow-Up visit at Month 18
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Higher Order Executive Performance: Tower of London Test
Time Frame: 30 minutes each at the Baseline and the Follow-Up Stages.
|
Higher order executive performance was assessed using the Tower of London Test at the baseline and at the follow-up assessments.
Changes in higher order executive performance from Baseline to the Follow-Up Stages were assessed.
|
30 minutes each at the Baseline and the Follow-Up Stages.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Yu-Kai Chang, Ph.D., Department of Physical Education and Sport Sciences, National Taiwan Normal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
December 7, 2022
First Submitted That Met QC Criteria
December 7, 2022
First Posted (Actual)
December 15, 2022
Study Record Updates
Last Update Posted (Actual)
November 15, 2024
Last Update Submitted That Met QC Criteria
November 9, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- PACNL_APOE_PROSPECTIVE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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