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Exercise and Neurocognition in Adults Relative to ApoE Genotype

N

National Taiwan Normal University

Status

Enrolling

Conditions

Aging
Exercise Training
Neurocognitive Function

Treatments

Behavioral: Control Group
Behavioral: Integrated Intervention Group (IIG)

Study type

Interventional

Funder types

Other

Identifiers

NCT05101174
PACNL_IIP and Neurocog_ERP

Details and patient eligibility

About

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.

Full description

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).

Enrollment

120 estimated patients

Sex

All

Ages

45 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

Integrated Intervention Group (IIG)
Experimental group
Description:
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.
Treatment:
Behavioral: Integrated Intervention Group (IIG)
Control Group
Other group
Description:
The control group is invited to attend one 60-min online educational course per week for 6 months. Intervention: 60-min online educational program.
Treatment:
Behavioral: Control Group

Trial contacts and locations

2

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Central trial contact

Yu-Kai Chang, PhD

Data sourced from clinicaltrials.gov

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