Effects of an Integrated Intervention Program on Neurocognition in Late-Middle-Aged and Older Adults Relative to ApoE Genotypes: An ERP Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Changes in neuroelectrical activities
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in neuroelectrical activities
时间窗: 60 minutes each at baseline and at month 6
The neuroelectrical activities during the computerized cognitive tasks is recorded and analyzed using the Neuroscan system. Changes in the neuroelectrical activities from baseline to end of the intervention (i.e., month 6) will be examined.
Inhibition: Changes in Stroop test performance
时间窗: 30 minutes each at the baseline and at month 6
The computerized Stroop test is administrated to assess participants' inhibitory function, and the changes in Stroop test performance from baseline to end of the intervention (i.e., month 6) will be examined.
次要结局
- ApoE genotype(5 minutes at baseline)
- Blood neurotrophic marker: Changes in brain-derived neurotrophic factor (BDNF) levels(5 minutes each at baseline and at month 6)
- Physical fitness measurements: Changes in muscular fitness(15 minutes each at baseline and at month 6)
- Psychosocial measures: Changes in sleeping quality(5 minutes each at baseline and at month 6)
- Physical fitness measurements: Changes in aerobic fitness(30 minutes each at baseline and at month 6)
- Psychosocial measures: Changes in health-related quality of life(10 minutes each at baseline and at month 6)
- Physical fitness measurements: Changes in flexibility(15 minutes each at baseline and at month 6)
- Psychosocial measures: Changes in mindfulness(5 minutes each at baseline and at month 6)
- Psychosocial measures: Changes in depression(5 min each at the Baseline-Assessment and at the Post-Assessment)
研究者
Yu-Kai Chang
Professor
National Taiwan Normal University