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

Completed

Conditions

Intervention / Treatment

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

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

      • 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

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)
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

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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