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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. 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.
  2. 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.
  3. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Taiwan
      • Taipei, Taiwan, 106308
        • Department of Physical Education and Sport Sciences, National Taiwan Normal University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
High-Risk with increased CRF
ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages.
Other: Data collections
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.
Other: Data collections
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.
Other: Data collections
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.
Other: Data collections
Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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
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.
30 minutes each at the Baseline and the Follow-Up visit at Month 18

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan Normal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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