The Interactive Physical and Cognitive Exercise System (iPACES v3) to Benefit Brain Health in Mild Cognitive Impairment (MCI): A Randomized Clinical Trial of Neuro-exergaming Pedal-to-play (iPACES) vs Pedal-while-play (PACE)
试验速览
- 阶段
- 不适用
- 发起方
- iPACES LLC
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- executive function
研究概览
简要总结
The primary purpose of this study is to attempt to replicate and extend promising pilot findings regarding the cognitive benefits of in-home neuro-exergaming with iPACES (interactive Physical and Cognitive Exercise System v3) for persons with mild cognitive impairment (MCI). Participants will include persons with MCI and their co-residing partner who both exercise at home 3-5 times per week for at least 6 months and are followed through one year. All participation is "remote" (completed at home), with all equipment (pedaler, tablet, etc.) supplied directly to the home, and with all study measures completed via videoconference and mail.
详细描述
A specific aim is to evaluate the potentially unique contribution of combining mental and physical exercise in an interactive way: "pedal-to-play" (iPACES), as compared with non-interactive, but simultaneous: "pedal-while-play" (PACE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50 years of age or older
- •co-residing study partner (spouse, adult child, roommate in same home) willing to participate in the study as an exercising participant as well
- •self or partner meets criteria for MCI (per site staff/MD/neuropsychologist and confirmed by study-administered Montreal Cognitive Assessment; MoCA; score = between 16-26, non-inclusive; Milani, 2018)
- •available for participation for one year (tablet surveys, videoconference evaluations)
- •willing and able to exercise 3-5 times per week for at least 6 months
- •can pedal an under-table elliptical
- •can read off of a small tablet screen
- •proficient in English (speaking and reading for completion of interview, surveys, game)
- •can participate in testing and read and operate tablet touch screen (adequate hearing, vision, speech)
- •written approval from primary care physician and cardiologist (if applicable) to participate in exercise for this study
- •can provide informed consent
排除标准
- •already exercising at recommended levels (45 min of moderate intensity aerobic exercise 5-7x/wk)
- •significant history of cardiovascular problems
- •significant history of stroke
- •significant history of memory problems (e.g., dementia/Alzheimer's)
- •significant history of other neurological condition (e.g., seizures, Parkinson's, etc.)
- •tremor (idiopathic) such that would interfere with touch-screen use required throughout the study (surveys, game-play, etc.)
- •not prone to cybersickness (e.g., "car sickness" or problems with "screen time")
- •cannot provide informed consent (i.e., when phone screened with the Impaired Decision Making Capacity screen)
结局指标
主要结局
executive function
时间窗: change from baseline to 6 months
cognitive function composite score from neuropsychological tests (e.g., Stroop)
everyday function
时间窗: change from baseline to 6 months
subjective cognitive function in everyday living (e.g., Ecological Validity Scale)
次要结局
- biomarker(change from baseline to 6 months)