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/文摘