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 由于阿尔茨海默病(AD)和相关痴呆症而导致的痴呆症病例正在上升，在缺乏 作为一种治愈方法，这种毁灭性的影响导致了更多要求扩大研究的呼声。行为干预，如 作为运动，已被认为可以增强大脑健康，并可用于预防和治疗高血压 认知功能减退，如轻度认知障碍(MCI)。我们最初的随机对照试验(RCT) 对运动游戏的调查(Anderson-Hanley等人，2012a)显示，在三个月后 与只踩传统自行车相比，你需要几个月的时间来踩虚拟现实增强自行车或“赛车”。 结果表明，在同样的努力下，在网络周期上进行互动的体力和脑力锻炼可以产生 比单独在固定自行车上进行体育锻炼对认知有更大的好处。此外，还有23%的人 赛车手改用MCI的风险降低。在NIA资助的后续RCT中，有氧 和认知练习研究(ACES；Anderson-Hanley，2018a)，PI和合作者致力于 在MCI患者中复制和推广这一研究路线。然而，MCI患者往往拒绝 报名时以出行地点的自行车为障碍。这引发了一种便携的、负担得起的 基于平板电脑的原型：可配对的交互式物理和认知练习系统(IPACES) 配有桌下椭圆形踏板，可在家中使用。来自家庭试点试验(v1和v2)的数据减少两个以上 十几对年长的成年人发现，在3个月的踏板游戏后，执行功能显著改善 IPACES神经消耗游戏，而且比只玩游戏更多(Anderson-Hanley等人，2018b；Wall等人，2018年)。 拟议的研究旨在：1)通过增加各种有趣的项目来增强iPACES的长期锻炼 故事板(例如，各州和国家的旅游旅行)、虚拟教练、智能手表通知以促进 遵守并将平板电脑评估与远程数据捕获相集成，2)试行测试更新版本 IPACES，3)对120对MCI-照顾者进行家庭多点临床试验，比较认知和 IPACES(踏板到游戏)在同步但非交互物理环境下一年的生物标志物结果 和认知练习(速度；边玩边踩)，以及4)准备结果以供出版和使用 商业化。具有广泛专业知识的合作者将提供指导，以完善游戏 长期播放，强化与设备(如iPad和智能手表)的接口，并与 可靠有效的认知和行为无人值守电子评估。一项随机的临床试验将 评估六个月踏板游戏iPACEs对认知和日常生活的影响，与仅使用速度的iPACEs进行比较， 并将在一年后对其使用和效果进行评估。结果将准备用于出版和使用 商业化，目标是为患者、家属和医疗保健提供者提供 为MCI患者和照顾者提供的额外工具，以保护大脑健康和遏制认知能力下降，所有这些都在 与痴呆症作斗争。