Cardiorespiratory Fitness, Apolipoprotein E Genotype, and Cognitive Functions: A Prospective Study

NCT05652140 | Completed Results DMC

• 1 other identifier: PACNL_APOE_PROSPECTIVE
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

The current research project aims to investigate the interaction of cardiorespiratory fitness (CRF) and the ApoE genotype with neurocognitive functions.

Conditions

Aging; Cognitive Change

Keywords

physical fitness; Apolipoprotein E; event-related potential

Outcome Measures

Primary Outcomes (2)

• Changes in Inhibitory Performance: Stroop Task

  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

  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 Outcomes (2)

• Number of Participants for Whom ApoE Genotype Was Determined

  5 minutes at the Baseline Stage.

• Physical Fitness Measurements: Changes in Aerobic Fitness

  30 minutes each at the Baseline and the Follow-Up visit at Month 18

Other Outcomes (1)

• Changes in Higher Order Executive Performance: Tower of London Test

  30 minutes each at the Baseline and the Follow-Up Stages.

Study Arms (4)

High-Risk with increased CRF

ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages.

Other: Data collections

High-Risk with decreased CRF

ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages.

Other: Data collections

Low-Risk with increased CRF

Non-ApoE e4 carriers with increased CRF from Baseline to the Follow-Up Stages.

Other: Data collections

Low-Risk with decreased CRF

Non-ApoE e4 carriers with decreased CRF from Baseline to the Follow-Up Stages.

Other: Data collections

Interventions

Data collections OTHER

Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness.

High-Risk with decreased CRF; High-Risk with increased CRF; Low-Risk with decreased CRF; Low-Risk with increased CRF

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cognitively healthy late-middle-aged older adults recruited from the northern part of Taiwan.

You may qualify if:

• 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

You may not qualify if:

• the scores of Mini-Mental Status Examination (MMSE) \< 25 and cognitively intact upon study entry
• history of psychiatric or neurological diseases
• color-blindness

Sponsors & Collaborators

• National Taiwan Normal University: lead

Study Sites (1)

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

Taipei, 106308, Taiwan

Location

Limitations and Caveats

Due to the substantial overlapping of the study period with the COVID-19 pandemic, a larger-than-expected number of participants withdrew following the completion of the baseline stage.

Results Point of Contact

• Title: Dr. Yu-Kai Chang
• Organization: Department of Physical Education and Sport Sciences, National Taiwan Normal University

yukaichangnew@gmail.com

+886277493223

Study Officials

• Yu-Kai Chang, Ph.D.

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: July 1, 2018
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 15, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-11

Locations

TW (1)