Cognitive and Aerobic Resilience for the Brain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Average participant self-ratings of intervention acceptability.
研究概览
简要总结
This is a randomized controlled trial (RCT) of the effectiveness of cognitive and exercise training versus control condition on cognitive function in older adults with mild cognitive impairment (MCI).
详细描述
Exercise and cognitive training hold promise for delaying progression of MCI. Exercise improves cognitive ability, brain function, and brain structure in older adults. Cognitive training has been shown to durably improve mental abilities and functional status in older adults. In addition, persons with MCI respond to some forms of cognitive training just as robustly as healthy older adults.
This pilot study is a 4 group design with a home-based multi-modal physical exercise intervention, cognitive training, combined cognitive and physical training, and a social contact control enrolling older adults with MCI.
This pilot study is designed to be consistent with current recommended approaches to establishing trial feasibility. If the aims are achieved, it will provide a conceptual and practical rationale to support a large, multi-site, randomized clinical trial to test the efficacy of combined physical and cognitive training in delaying time to a clinical diagnosis of dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjective memory complaint
- •minimal impairment in daily function per Functional Activity Questionnaire (FAQ)
- •sedentary
- •English speaking
- •access to telephone
排除标准
- •dementia or Alzheimer disease
- •stroke, past 12 months
- •myocardial infarction, past 12 months
- •Parkinson disease
- •multiple sclerosis
- •brain tumor, infection, or surgery
- •brain injury with > 30 minute LOC
- •schizophrenia
- •bipolar disorder
- •cancer with short life expectancy
- •current chemotherapy or radiation therapy
- •depression
- •alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men
- •prescription of Aricept or Namenda, past or present
- •self-reported difficulty reading a newspaper (low visual acuity)
- •low hearing or communicative ability (examiner-rated) that would interfere with interventions and outcome assessments
- •prior involvement in similar cognitive training studies, programs, or online training
- •prior use of online brain training or brain fitness programs
- •unable to pass the Exercise Assessment and Screening for You (EASY)
- •living in nursing home
- •scheduling conflicts with intervention schedule
- •unwilling to use a computer or be on video conferencing
- •Baseline blood pressure of Systolic > 180
- •Baseline blood pressure of Diastolic > 100
- •Baseline pulse of < 40 or > 100
- •unable to provide informed consent
结局指标
主要结局
Average participant self-ratings of intervention acceptability.
时间窗: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.
Average of individual Likert self-ratings of the interventions (where 1 = very unenjoyable, 2 = not enjoyable, 3 = neutral, 4 = enjoyable, and 5 = very enjoyable) for each session of the 12-week intervention.
Participant adherence to treatment.
时间窗: From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first.
Number of training sessions attended divided by the the total number of sessions available.
Participant adherence to outcome assessment.
时间窗: End of treatment at 12-weeks.
Number of participants completing the post-training outcome assessment divided by the total number randomized.
Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, and list learning.
时间窗: End of treatment at 12-weeks.
The cognitive composite is derived from: WAIS-IV Symbol Search, Trail Making Test Part B, and Rey Auditory Verbal Learning Test.
Number of participants with study-related adverse events (AE) by treatment arm.
时间窗: From enrollment through end of treatment at 12-weeks.
次要结局
未报告次要终点
研究者
Frederick Unverzagt
Professor
Indiana University