Multi-Domain Exercise and Memory in Adults Relative to ApoE Genotype: A fMRI Study

NCT05068271 | Unknown

• 1 other identifier: PACNL_WEBFIT: Memory & fMRI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The current project utilizes a single-blinded, double arm, 6-month randomized controlled trial to assess the effects of a multi-domain exercise program on memory performance, as well as cortical activities during the memory tasks in cognitively intact adults (i.e., 45-70 years). In addition, the potential moderator role of apolipoprotein epsilon-4 (ApoE e4) status and the mediator role of the brain-derived neurotrophic factor (BDNF) will be explored.

Conditions

Exercise Training; Executive Function; Aging

Keywords

multiple fitness; meditation; mindfulness; Apolipoprotein E; aging; magnetic resonance images; memory

Outcome Measures

Primary Outcomes (3)

• Changes in functional MRI indices

  Functional MRI assessments will be conducted at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment) to measure participants' brain functionalities. Changes in functional MRI indices between the Baseline-Assessment and Post-Assessment will be assessed.

  60 min each at the Baseline-Assessment and at the Post-Assessment

• Changes in working memory performance: N-back working memory task

  Working memory performance will be assessed using the computerized n-back working memory task at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment). A total of 6 blocks with 108 trials (18 trials each block) will be utilized in the current study. Changes in working memory performance between the Baseline-Assessment and Post-Assessment will be assessed.

  30 min assessment time at the Baseline-Assessment and at the Post-Assessment

• Changes in episodic memory performance: Relational and item-specific encoding and recognition test

  Episodic memory performance will be assessed using the relational and item-specific encoding and recognition test at the baseline (Baseline-Assessment) and at the end of the 6-month intervention (Post-Assessment). Changes in episodic memory performance between the Baseline-Assessment and Post-Assessment will be assessed.

  30 min each session at the Baseline-Assessment and at the Post-Assessment

Secondary Outcomes (10)

• ApoE genotype

  5 min at the Baseline Assessment

• Changes in blood neurotrophic marker: Brain-derived neurotrophic factor (BDNF)

  5 min each at the Baseline-Assessment and at the Post-Assessment

• Physical fitness measurements: Changes in aerobic fitness

  20 min each at the Baseline-Assessment and at the Post-Assessment

• Physical fitness measurements: Changes in muscular fitness

  15 min each at the Baseline-Assessment and at the Post-Assessment

• Physical fitness measurements: Changes in flexibility

  15 min each at the Baseline-Assessment and at the Post-Assessment

Study Arms (2)

Multi-Domain Exercise Program

EXPERIMENTAL

Time: 6 months, total of 150 min of exercise per week. Intervention: aerobic training, muscular fitness training, balance, flexibility, meditation, and social interaction.

Behavioral: Multi-Domain Exercise Program

Control Group

OTHER

Time: 6 months, total of 60 min of online educational course per week. Intervention: educational materials relating to the effects of exercise on cognitive function and aging-related cognitive decline.

Behavioral: Control Group

Interventions

Multi-Domain Exercise Program BEHAVIORAL

The multi-domain exercise consisted of the main exercise (e.g., aerobic exercise, resistance exercise, flexibility training, and coordinative exercise), social interaction, and meditation. Participants are encouraged to engage in 150 min exercise per week consisting of one 90-min on-site session and multiple online sessions for 6 months.

Multi-Domain Exercise Program

Control Group BEHAVIORAL

The "usual physical activity group," as the control group, is informed to maintain their lifestyles. In addition, participants are invited to attend one 60-min online educational course per week. The logs of physical activity behavior will be obtained from the participants once per month during the intervention period.

Control Group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal or corrected-to-normal vision
• Able to speak and read Chinese
• Scores of Mini-Mental Status Examination \>= 25
• Physical Activity Readiness Questionnaire score \< 0
• Able to conduct the exercise with moderate intensity
• Meet the criteria to undergo magnetic resonance imaging
• Provide informed consent

You may not qualify if:

• Diagnosed or self-reported cognitive problems (e.g., mild cognitive impairment or dementia)
• Diagnosed or self-reported physical disease (e.g., untreated hypertension and chronic heart disease, stroke, brain tumor, musculoskeletal disorders, other exercise contradictions)
• Diagnosed or self-reported major psychiatric illness (e.g., major depression, schizophrenia)
• Diagnosed or self-reported neurodegenerative disease (e.g., Alzheimer's disease and other dementias, Parkinson's disease (PD) and PD-related disorders, Huntington's disease)
• History of alcohol or drug abuse
• History of chemotherapy
• Traveling consecutively for three weeks or more during the study
• Unwillingness to be randomized to one of the two groups
• Currently participating in another study trial
• Participants will be excluded if s/he has a contraindication to fMRI scanning, such as aneurysm clip, implanted neural stimulator, cochlear implant, any implanted device, cardiac pacemaker. To ensure volunteers are eligible for the current project, they will be asked to fill out a questionnaire to inform whether they have conditions (e.g. paralyzed hemidiaphragm) or present unnecessary risks (e.g., pregnancy) during the recruitment period.

Sponsors & Collaborators

• National Taiwan Normal University: lead

Study Sites (2)

Yu-Kai Chang

Taipei, 106, Taiwan

NOT YET RECRUITING

National Taiwan Normal University

Taipei, 162, Taiwan

RECRUITING

Related Publications (1)

• Chang YK, Erickson KI, Aghjayan SL, Chen FT, Li RH, Shih JR, Chang SH, Huang CM, Chu CH. The multi-domain exercise intervention for memory and brain function in late middle-aged and older adults at risk for Alzheimer's disease: A protocol for Western-Eastern Brain Fitness Integration Training trial. Front Aging Neurosci. 2022 Aug 18;14:929789. doi: 10.3389/fnagi.2022.929789. eCollection 2022.

  PMID: 36062144 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yu-Kai Chang, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Kai Chang, PhD

CONTACT

+886277493220; yukaichangnew@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: October 5, 2021
• Study Start: April 12, 2022
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)