Neuro-exergaming for the prevention and remediation of decline due to Alzheimer's disease and related dementias: A clinical trial of the interactive Physical and Cognitive Exercise System (iPACES v3)

用于预防和治疗阿尔茨海默病和相关痴呆症引起的衰退的神经运动游戏：交互式身体和认知运动系统 (iPACES v3) 的临床试验

• 批准号: 10264165
• 负责人: PAUL J ARCIERO
• 金额: $ 111.7万
• 依托单位: IPACES, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10264165
• 关键词: Adherence; Aerobic; Alzheimer' s disease related dementia; Behavior; Behavior Therapy; Behavioral; Behavioral Model; Biological Markers; Caregivers; Clinical Trials; Cognition; Cognitive; Cognitive remediation; Communities; Computer software; Country; Data; Databases; Decision Making; Dementia; Destinations; Development; Dose; Elderly; Enrollment; Equipment; Exercise; Family; Family health status; Feedback; Funding; Goals; Health Insurance Portability and Accountability Act; Health Personnel; Home; Image; Impaired cognition; Insurance Carriers; Intervention; Interview; Letters; Location; Maintenance; Memory; Methodology; Monitor; Morphologic artifacts; Multi-Institutional Clinical Trial; Neighborhoods; Neuropsychology; Notification; Outcome; Patients; Performance; Periodicity; Phase; Physical Exercise; Physical activity; Pilot Projects; Placebos; Play; Preparation; Prevention; Psyche structure; Publications; Publishing; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Research; Research Personnel; Retirement; Risk; Sampling; Site; System; Tablets; Telephone; Testing; Training; Travel; United States National Institutes of Health; Update; Video Games; Visit; Work; archive data; base; brain health; cognitive benefits; cognitive change; commercialization; comparative efficacy; data archive; data integration; digital; efficacy evaluation; executive function; exergame; fight against; follow-up; improved; innovation; interest; medical schools; mild cognitive impairment; novel; phase 2 study; pilot trial; portability; preservation; prototype; provider networks; recruit; remediation; smart watch; therapy development; tool; usability; user-friendly; virtual; virtual coach; virtual reality

PROJECT SUMMARY/ABSTRACT Dementia cases due to Alzheimer's disease (AD) and related dementias are on the rise, and in the absence of a cure, the devastating impact has led to increased calls for expanded research. Behavioral interventions, such as exercise, have been noted to enhance brain health and can be useful in the prevention and remediation of cognitive decline, as in mild cognitive impairment (MCI). Our initial randomized controlled trial (RCT) investigated exergaming (Anderson-Hanley et al., 2012a), revealed significant cognitive benefit after three months of pedaling a virtual reality enhanced bike or “cybercycle,” compared with traditional pedaling only. Results suggest that for the same effort, interactive physical and mental exercise on a cybercycle can yield greater cognitive benefit than physical exercise alone on a stationary bike. Furthermore, there was a 23% reduction in risk of conversion to MCI among the cybercyclists. In a follow-up NIA-funded RCT, the Aerobic and Cognitive Exercise Study (ACES; Anderson-Hanley, 2018a), the PI and collaborators have worked to replicate and extend this line of research with patients with MCI. However, patients with MCI often declined to enroll citing travel to the location of the bike as a barrier. This sparked development of a portable, affordable tablet-based prototype: the interactive Physical and Cognitive Exercise System (iPACES) which can be paired with an under-table elliptical pedaler for in-home use. Data from in-home pilot trials (v1 & v2) by more than two dozen older adults pairs, found executive function significantly improved after 3-months of pedaling-to-play in the iPACES neuro-exergame, and more so than game-only (Anderson-Hanley et al., 2018b; Wall et al., 2018). The proposed research aims to: 1) enhance long-term exercise with iPACES via adding: a variety of interesting storyboards (e.g., tourist travel of states and countries), a virtual coach, smart watch notifications to promote adherence, and integration of tablet assessments with remote data capture, 2) pilot test the updated version of iPACES, 3) conduct an in-home multi-site clinical trial with 120 MCI-caregiver pairs comparing cognitive and biomarker outcomes from one-year of iPACES (pedal-to-play) with synchronous, but non-interactive physical and cognitive exercise (PACE; pedal-while-play), and 4) prepare results for publication and use in commercialization. Collaborators with wide-ranging expertise, will provide guidance in refining the games for long-term play, hardening the interface with equipment (e.g., iPad and smart-watch), and interfacing with reliable and valid unattended electronic assessment of cognition and behaviors. A randomized clinical trial will evaluate the cognitive and everyday impacts of six months of pedal-to-play iPACES, compared PACE-only, and use and effect after one year will also be assessed. Results will be prepared for publication and use in commercialization, as warranted, with the goal of offering to patients, families, and healthcare providers an additional tool for MCI patients and caregivers to preserve brain health and curb cognitive decline, all in the fight against dementia.

项目摘要/摘要 由于阿尔茨海默氏病（AD）和相关痴呆症引起的痴呆症病例正在上升，并且没有 治愈，毁灭性的影响导致增加了扩大研究的呼吁。行为干预，例如 作为锻炼，已经注意到可以增强大脑健康，并且可以在预防和修复中有用 认知能力下降，如轻度认知障碍（MCI）。我们最初的随机对照试验（RCT） 调查了埃克马林（Anderson-Hanley等，2012a），揭示了三个之后的认知益处 与传统的踏板相比，几个月的虚拟现实增强了自行车或“网络循环”。 结果表明，为了同样的努力，网络循环的互动性身体和心理锻炼可以产生 与仅在固定自行车上进行体育锻炼的认知益处更大。此外，有23％ 网络自由主义者中转化为MCI的风险降低。在随访的NIA资助RCT中，有氧运动 和认知运动研究（ACES； Anderson-Hanley，2018a），PI和合作者已努力 复制并扩展MCI患者的研究线。但是，MCI患者经常拒绝 以邀请前往自行车的位置作为障碍物而注册。这引发了便携式，负担得起的发展 基于平板电脑的原型：可以配对的交互式物理和认知锻炼系统（IP） 带有一个不足的椭圆踏板，用于室内使用。来自家中试验试验（V1＆V2）的数据超过两个 十几个老年人搭配，发现执行功能在3个月的踏板到比赛中显着提高 IPALES神经效果，而不是仅游戏（Anderson-Hanley等，2018b; Wall等，2018）。 拟议的研究目的是：1）通过添加：各种兴趣来增强IPACE的长期锻炼： 故事板（例如，国家和国家的旅游旅行），虚拟教练，智能手表通知以促进 依从性和平板电脑评估与远程数据捕获的集成，2）试验测试更新版本的版本 ipaces，3）进行一项在家中的多站点临床试验，比较认知和120个MCI护理人员对 与同步但非相互作用的物理的一年IPACES（踏板到游戏）的生物标志物结果 和认知练习（步伐；踏板以播放），4）准备出版和使用的结果 商业化。具有大型专业知识的合作者将为完善游戏提供指导 长期播放，用设备（例如iPad和智能观察）硬化界面，并与 一项随机临床试验将是对认知和行为的可靠且有效的无人值守的电子评估。 评估六个月的踏板到游戏的认知和每天影响，仅比较速度 一年后的使用和效果也将进行评估。结果将准备出版和使用 如有必要，商业化的目的是向患者，家庭和医疗保健提供者提供商业化 MCI患者和护理人员保留大脑健康和遏制认知能力下降的其他工具，所有这些都在 与痴呆症作斗争。