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 v3)

用于预防和治疗帕金森病导致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: 10698250
• 负责人: PAUL J ARCIERO
• 金额: $ 132.66万
• 依托单位: IPACES, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-11 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10698250
• 关键词: Adherence; Affect; Age; Alzheimer' s Disease; Alzheimer' s disease related dementia; Attention; Behavioral; Caregivers; Clinical Trials; Cognitive; Cognitive remediation; Computer software; Data; Databases; Decision Making; Dementia; Destinations; Development; Diagnosis; Disease; Elderly; Electronics; Enrollment; Exercise; Family; Feedback; Funding; General Population; Goals; Health Insurance Portability and Accountability Act; Health Personnel; Home; Image; Impaired cognition; Individual; Intervention; Interview; Legal patent; Maintenance; Marketing; Memory; Methodology; Mexico; Monitor; Motivation; Motor; Movement Disorder Society Unified Parkinson' s Disease Rating Scale; Multi-Institutional Clinical Trial; Neighborhoods; Neurodegenerative Disorders; Neurologic; Neuropsychology; Notification; Operative Surgical Procedures; Parkinson Disease; Pathway interactions; Patients; Performance; Periodicals; Pharmaceutical Preparations; Phase; Physical Exercise; Physical activity; Pilot Projects; Placebos; Play; Population; Postdoctoral Fellow; Preparation; Prevalence; Prevention; Psyche structure; Publishing; Randomized; Randomized, Controlled Trials; Research; Risk; Short-Term Memory; Site; Symptoms; System; Tablets; Training; Update; Video Games; Visuospatial; Work; archive data; brain health; cognitive benefits; commercialization; comparative efficacy; coral; data archive; data integration; digital; digital treatment; effective intervention; efficacy evaluation; executive function; exergame; experience; fighting; follow-up; foot; improved; innovation; input device; lifestyle intervention; mild cognitive impairment; neuropathology; novel; phase 2 study; pilot test; pilot trial; portability; preservation; prevent; prototype; provider networks; randomized, clinical trials; recruit; remediation; remote assessment; skills; smart watch; software systems; tool; usability; virtual; virtual coach; virtual reality

PROJECT SUMMARY/ABSTRACT Parkinson’s disease (PD) is the second most prevalent neurodegenerative disorder after Alzheimer’s disease with prevalence estimated at 0.3% in the general population and at 1% in individuals over age 60 (Getz & Levin, 2017). In addition to the cardinal motor features associated with this illness, individuals with PD also experience cognitive decline. While estimates vary (Goldman et al, 2013), it is estimated that up to 40% of PD patients would meet criteria for a diagnosis of mild cognitive impairment and that up to 80% will develop dementia over the course of the disease (Kenney et al, 2022). Given limitations in current treatments for PD and the lack of a complete cure, there is an outcry for additional research into effective interventions, particularly those that might slow cognitive decline as well as conversion to dementia (Cammisuli et al, 2019). At present, while dopaminergic medications and surgical interventions (DBS) often ameliorate some motoric symptoms (at least temporarily), there is minimal documented neuropsychological benefit. As result, there has been a call for lifestyle interventions for older adults to prevent, delay or ameliorate cognitive decline via non-pharmacological interventions such as exercise (Camisul et al, 2019). Our initial randomized controlled trial (RCT) investigated exergaming for older adults (Anderson-Hanley et al., 2012a), and 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. The PI and collaborators have worked to replicate and extend this line of research with patients with varied neurological conditions which 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), 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 replicate and extend these findings in Parkinson’s. If warranted by the data, we will pursue the goal of offering to patients, families, and healthcare providers an additional tool for PD patients and caregivers to preserve brain health and curb cognitive decline, all in the fight against dementia.

项目摘要/摘要 帕金森氏病（PD）是第二大流行的神经退行性疾病 阿尔茨海默氏病，普通人群估计为0.3％，在1％的患病率为0.3％ 60岁以上的个人（Getz＆Levin，2017年）。除了基本电机功能 与这种疾病相关，患有PD的人也会经历认知能力下降。尽管 估计有所不同（Goldman等，2013），据估计，多达40％的PD患者会满足 轻度认知障碍的诊断标准，高达80％的痴呆症的标准 在整个疾病过程中（Kenney等，2022）。当前治疗的限制 PD和缺乏完整的治愈方法，有一个强烈抗议 干预措施，尤其是那些可能会减慢认知能力下降以及转换为的干预措施 痴呆症（Cammisuli等，2019）。目前，多巴胺能药物和手术 干预措施（DBS）通常可以改善某些房间症状（至少暂时） 最少记录的神经心理学益处。结果，有一个呼吁生活方式 通过 非药理干预措施，例如运动（Camisul等，2019）。我们的最初 研究老年人的随机对照试验（RCT）（RCT）（Anderson-Hanley ET Al。，2012a），并在虚拟的三个月后揭示了明显的认知益处 与传统的踏板相比，现实增强了自行车或“网络循环”。结果表明 为了同样的努力，网络互动的互动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，那里 在网络单行者中，转化为MCI的风险降低了23％。 pi和 合作者已努力复制并扩展了这一研究，以多样化的患者 神经条件引发了便携式，负担得起的平板电脑的发展 原型：可以是交互式的物理和认知运动系统（ipaces） 与桌子不足的椭圆踏板配对，可在家使用。来自家庭试验试验的数据（v1＆ v2），发现执行功能在3个月的踏板到比赛中显着提高 ipaces Neuro-exergame，而不是仅游戏（Anderson-Hanley等，2018b; Wall et et and） Al。，2018）。拟议的研究旨在在帕金森氏症中复制和扩展这些发现。如果 根据数据的保证，我们将追求向患者，家庭和医疗保健提供的目标 提供商是PD患者和护理人员保存大脑健康和遏制的其他工具 认知能力下降，全都在与痴呆症的斗争中。