Exercise and Neurocognition in Adults Relative to ApoE Genotype

NCT ID: NCT05101174

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-11

Study Completion Date

2025-09-30

Brief Summary

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The current project is a single-blinded, double-arm, 6-month randomized controlled trial aiming to assess the effects of a integrated intervention program on neurocognitive function with respect to event-related potential in adults aged 45-70 years. Additionally, the potential impacts of apolipoprotein epsilon-4 alleles and the brain-derived neurotrophic factor will be explored.

Detailed Description

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The current randomized clinical trial is designed to examine (1) whether a 6-month integrated intervention program (IIP) consisting of multiple exercise modalities, meditation, and social interaction could benefit neurocognitive function (e.g., inhibition) in middle-aged and older adults; (2) whether components of ERP will be influenced by the integrated intervention program; and (3) whether apolipoprotein E (ApoE) genotypes (ApoE e3/e4, ApoE e4/e4, ApoE e2/e2, ApoE e2/e3, ApoE e2/e4, and ApoE e3/e3), physical fitness, and brain-derived neurotrophic factor (BDNF) will influence the effects of an integrated intervention program on neurocognitive function and components of ERPs.

The study will randomly assign 100 eligible participants to either the IIP group or the control group in a 1:1 ratio. The IIP group will engage in 150 min of exercise per week, which consists of one 90-min on-site session and multiple online sessions, for 6 months. The control group will be invited to attend one 60-minutes online educational course per week for 6 months.

The neurocognitive function, the components of ERP, ApoE genotype, physical fitness, and BDNF will be assessed at the baseline (Baseline-Assessment) and the end of the 6-month intervention (Post-Assessment).

Conditions

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Exercise Training Neurocognitive Function Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Integrated Intervention Group (IIG)

The IIG attends 150 min exercise per week, which consists of one 90-min trainer-supervised program and multiple online sessions, for 6 months.

Intervention: aerobic exercise, resistance exercise, coordinative exercise, flexibility, social interaction, and meditation.

Group Type EXPERIMENTAL

Integrated Intervention Group (IIG)

Intervention Type BEHAVIORAL

The IIG attends 150 min exercise per week, which consists of one 90-min trainer-supervised session and multiple online sessions for 6 months. Each session consists of (1) warm-up, (2) resistance exercise and flexibility exercise, (3) resistance exercise and coordinative exercise from the "Eastern exercise" perspective, (4) social interaction exercise, and (5) cool-down and meditation.

Control Group

The control group is invited to attend one 60-min online educational course per week for 6 months.

Intervention: 60-min online educational program.

Group Type OTHER

Control Group

Intervention Type BEHAVIORAL

The Control Group is informed to maintain their lifestyles and invited to attend one 60-min online educational course per week. The participants are required to provide their physical activity behavior once every month for 6 months (6 times).

Interventions

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Integrated Intervention Group (IIG)

The IIG attends 150 min exercise per week, which consists of one 90-min trainer-supervised session and multiple online sessions for 6 months. Each session consists of (1) warm-up, (2) resistance exercise and flexibility exercise, (3) resistance exercise and coordinative exercise from the "Eastern exercise" perspective, (4) social interaction exercise, and (5) cool-down and meditation.

Intervention Type BEHAVIORAL

Control Group

The Control Group is informed to maintain their lifestyles and invited to attend one 60-min online educational course per week. The participants are required to provide their physical activity behavior once every month for 6 months (6 times).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
* Provide informed consent

Exclusion Criteria

* 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 or 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan Normal University

OTHER

Sponsor Role lead

Responsible Party

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Yu-Kai Chang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu-Kai Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Yu-Kai Chang

Taipei, , Taiwan

Site Status NOT_YET_RECRUITING

Yu-Kai Normal Chang

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Kai Chang, PhD

Role: CONTACT

+886277493220

Facility Contacts

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Yu-Kai Chang, PhD

Role: primary

+886277493220

Yu-Kai Chang

Role: primary

+886277493220

Other Identifiers

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PACNL_IIP and Neurocog_ERP

Identifier Type: -

Identifier Source: org_study_id