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.

项目总结/摘要 帕金森病（PD）是仅次于帕金森病的第二大最普遍的神经退行性疾病。 阿尔茨海默病的患病率估计在一般人群中为0.3%， 60岁以上的人（Getz & Levin，2017）。除了主要的运动特征 与这种疾病相关，PD患者也会出现认知能力下降。而 估计值各不相同（Goldman et al，2013），据估计，高达40%的PD患者将符合 轻度认知障碍的诊断标准，高达80%的人将发展为痴呆症。 在疾病过程中（肯尼等人，2022）。鉴于目前治疗的局限性， PD和缺乏一个完整的治愈，有一个强烈要求额外的研究，以有效的 干预措施，特别是那些可能减缓认知能力下降以及 痴呆（Cammisuli et al，2019）。目前，虽然多巴胺能药物和外科手术 DBS通常会改善一些运动症状（至少暂时）， 记录在案的神经心理学益处微乎其微。因此，人们呼吁生活方式 老年人的干预措施，以预防，延迟或改善认知能力下降， 非药物干预，如运动（Camisul et al，2019）。我们最初 一项随机对照试验（RCT）调查了老年人的运动游戏（Anderson-Hanley et 例如，2012 a），并显示了显着的认知效益后，三个月的踏板虚拟 现实增强自行车或“网络自行车”，与传统的踏板相比，只有。结果表明 对于同样的努力，在网络上进行互动的身体和精神锻炼可以产生 比单独在固定自行车上锻炼更大的认知益处。而且 在网络骑行者中，转化为MCI的风险降低了23%。PI和 合作者们一直在努力复制和扩展这一系列研究， 这引发了便携式，负担得起的平板电脑的发展， 原型：交互式身体和认知锻炼系统（iPACES）， 与一个在家里使用的桌子下椭圆踏板配对。来自家庭试点试验的数据（v1 & v2），发现执行功能显着改善后，3个月的踏板发挥在 iPACES神经运动游戏，比仅游戏更是如此（Anderson-Hanley等人，2018 b; Wall et 例如，2018年）。这项研究的目的是在帕金森氏症中复制和扩展这些发现。如果 根据数据，我们将追求为患者、家庭和医疗保健提供 为PD患者和护理人员提供了一种额外的工具，以保护大脑健康， 认知能力下降，都是为了对抗痴呆症。