Clinical trial NCT05101174: Exercise and Neurocognition in Adults Relative to ApoE Genotype
Official title: Effects of an Integrated Intervention Program on Neurocognition in Late-Middle-Aged and Older Adults Relative to ApoE Genotypes: An ERP Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Training
Neurocognitive Function
Aging
Keywords: physical fitness
meditation
social interaction
Apolipoprotein E
aging
event-related potential
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Inhibition: Changes in Stroop test performance
timeFrame: 30 minutes each at the baseline and at month 6
measure: Changes in neuroelectrical activities
timeFrame: 60 minutes each at baseline and at month 6
Secondary outcomes:
measure: ApoE genotype
timeFrame: 5 minutes at baseline
measure: Blood neurotrophic marker: Changes in brain-derived neurotrophic factor (BDNF) levels
timeFrame: 5 minutes each at baseline and at month 6
measure: Physical fitness measurements: Changes in aerobic fitness
timeFrame: 30 minutes each at baseline and at month 6
measure: Physical fitness measurements: Changes in muscular fitness
timeFrame: 15 minutes each at baseline and at month 6
measure: Physical fitness measurements: Changes in flexibility
timeFrame: 15 minutes each at baseline and at month 6
measure: Psychosocial measures: Changes in mindfulness
timeFrame: 5 minutes each at baseline and at month 6
measure: Psychosocial measures: Changes in depression
timeFrame: 5 min each at the Baseline-Assessment and at the Post-Assessment
measure: Psychosocial measures: Changes in sleeping quality
timeFrame: 5 minutes each at baseline and at month 6
measure: Psychosocial measures: Changes in health-related quality of life
timeFrame: 10 minutes each at baseline and at month 6
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Yu-Kai Normal Chang
city: Taipei
country: Taiwan
facility: Yu-Kai Chang
Study officials:
affiliation: Department of Physical Education and Sport Sciences, National Taiwan Normal University
name: Yu-Kai Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: