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.

项目概要/摘要 阿尔茨海默氏病 (AD) 和相关痴呆症引起的痴呆症病例呈上升趋势，而且在缺乏预防措施的情况下 一种治疗方法，其破坏性影响导致人们越来越多地呼吁扩大研究。行为干预，例如 作为锻炼，人们注意到它可以增强大脑健康，并有助于预防和治疗 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) 研究了运动游戏（Anderson-Hanley 等人，2012a），发现运动游戏 3 次后具有显着的认知益处 与仅骑传统自行车相比，骑虚拟现实增强自行车或“网络自行车”需要几个月的时间。 结果表明，付出同样的努力，在网络自行车上进行交互式身体和心理锻炼可以产生效果 比仅在固定自行车上进行体育锻炼具有更大的认知益处。此外，还有 23% 降低网络骑行者转向 MCI 的风险。在 NIA 资助的后续随机对照试验中，有氧运动 和认知运动研究（ACES；Anderson-Hanley，2018a），PI 和合作者致力于 在 MCI 患者中复制并扩展这一研究方向。然而，MCI 患者常常拒绝 注册时将前往自行车所在位置作为障碍。这引发了便携式、经济实惠的开发 基于平板电脑的原型：可配对的交互式身体和认知锻炼系统（iPACES） 配有适合家庭使用的桌下椭圆踏板。来自两个以上家庭试点试验（v1 和 v2）的数据 十几对老年人在 3 个月的踩踏板玩耍后发现执行功能显着改善 iPACES 神经锻炼游戏，而且不仅仅是游戏（Anderson-Hanley 等人，2018b；Wall 等人，2018）。 拟议的研究旨在：1）通过添加以下各项来增强 iPACES 的长期锻炼： 故事板（例如，州和国家的旅游旅行）、虚拟教练、智能手表通知以进行宣传 遵守情况以及平板电脑评估与远程数据采集的集成，2) 试点测试更新版本 iPACES，3) 对 120 名 MCI 护理人员进行了一项家庭多地点临床试验，比较了认知和认知能力 一年 iPACES（踏板游戏）的生物标志物结果，采用同步但非交互式的物理方法 和认知练习（PACE；边玩边踩踏板），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完善游戏提供指导 长期玩，强化与设备的接口（例如iPad和智能手表），并与 可靠且有效的无人值守的认知和行为电子评估。一项随机临床试验将 评估六个月的踏板播放 iPACES 的认知和日常影响，与仅使用 PACE 进行比较， 一年后也会评估使用情况和效果。结果将准备出版并用于 根据需要进行商业化，目标是为患者、家庭和医疗保健提供者提供 为 MCI 患者和护理人员提供额外工具，以保持大脑健康并遏制认知能力下降，所有这些都在 对抗痴呆症。