Neuro-exergaming for the Prevention and Remediation of Decline Due to Parkinson's Disease: Clinical Trial of the Interactive Physical and Cognitive Exercise System (iPACES-PD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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), to evaluate effects for persons with Parkinson's Disease (PD). Participants will include persons with PD, and potentially, also their co-residing partner, who will exercise at home or accessible location, 3-5 times per week for at least 6 months, with follow-up one month after the main intervention. All participation is "remote" (completed at home, or location of choice), utilizing either one's own equipment ("bring-your-own-devices" BYODs: pedaler, phone/tablet, smart-watch) or some equipment which may be supplied by the grant-funded study and shipped directly to the home; all study measures are completed remotely (e.g., via phone app, website, biometric device, videoconference, email, snail mail, etc.).
详细描述
A specific aim is to evaluate the effects of iPACES for persons with Parkinson's Disease, while also examining 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
- •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); Spanish language option anticipated soon
- •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, etc.)
- •significant uncontrolled tremor 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 3 months
cognitive function composite score from neuropsychological tests (e.g., Stroop); higher scores on the standardized composite would be centered around zero, and higher scores would indicate better performance
everyday function
时间窗: change from baseline to 3 months
subjective cognitive function in everyday living (e.g., Ecological Validity Scale); higher scores would indicate better outcomes
次要结局
- biomarker(change from baseline to 3 months)
- visuospatial function(change from baseline to 3 months)
- PD-ADLs(change from baseline to 3 months)