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.

项目总结/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增加，并且在缺乏治疗的情况下， 作为一种治疗方法，这种毁灭性的影响导致人们越来越多地呼吁扩大研究。行为干预，如 作为运动，已经注意到可以增强大脑健康，并且可以用于预防和补救 认知功能下降，如轻度认知功能障碍（MCI）。我们最初的随机对照试验（RCT） 研究了exergaming（Anderson-Hanley等人，2012 a），显示了三个月后的显著认知益处 与传统的脚踏车相比，骑虚拟现实增强自行车或“网络自行车”的时间长达数月。 结果表明，同样的努力，互动的身体和精神锻炼的网络周期可以产生 比单独在固定自行车上锻炼更大的认知益处。此外，还有23%的 降低了网络自行车运动员转化为MCI的风险。在一项后续的由美国国立卫生研究院资助的随机对照试验中， 和认知运动研究（ACES; Anderson-Hanley，2018 a），PI和合作者一直致力于 在轻度认知障碍患者身上重复并扩展这一研究路线。然而，MCI患者通常拒绝 注册引用旅行的位置的自行车作为一个障碍。这引发了一种便携式， 基于平板电脑的原型：交互式身体和认知锻炼系统（iPACES），可以配对 在家里使用的桌子下椭圆踏板。来自两个以上家庭试点试验（v1和v2）的数据 十几个老年人对，发现执行功能显着改善后，3个月的踏板发挥， iPACES神经运动游戏，比仅游戏更是如此（Anderson-Hanley等人，2018 b; Wall等人，2018年）。 拟议的研究旨在：1）通过增加iPACES增强长期锻炼：各种有趣的 故事板（例如，国家和国家的旅游），虚拟教练，智能手表通知，以促进 依从性，以及平板电脑评估与远程数据采集的集成，2）试点测试 iPACES，3）进行了一项家庭多中心临床试验，120对MCI护理人员对认知和 来自iPACES（踏板到游戏）一年的生物标志物结果，具有同步但非交互式的物理 和认知练习（PACE;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为改进游戏提供指导， 长期的游戏，强化与设备的接口（例如，iPad和智能手表），并与 可靠和有效的无人值守的认知和行为电子评估。随机临床试验将 评估六个月的踏板游戏iPACES的认知和日常影响，与仅使用PACE相比， 并评估一年后的使用情况和效果。结果将准备出版和使用， 商业化，如有必要，目标是为患者，家庭和医疗保健提供者提供一个 MCI患者和护理人员保护大脑健康和抑制认知能力下降的额外工具， 对抗痴呆症