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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)

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:
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-08-11 至 2026-07-31
关键词:
AdherenceAffectAgeAlzheimer&aposs DiseaseAlzheimer&aposs disease related dementiaAttentionBehavioralCaregiversClinical TrialsCognitiveCognitive remediationComputer softwareDataDatabasesDecision MakingDementiaDestinationsDevelopmentDiagnosisDiseaseElderlyElectronicsEnrollmentExerciseFamilyFeedbackFundingGeneral PopulationGoalsHealth Insurance Portability and Accountability ActHealth PersonnelHomeImageImpaired cognitionIndividualInterventionInterviewLegal patentMaintenanceMarketingMemoryMethodologyMexicoMonitorMotivationMotorMovement Disorder Society Unified Parkinson&aposs Disease Rating ScaleMulti-Institutional Clinical TrialNeighborhoodsNeurodegenerative DisordersNeurologicNeuropsychologyNotificationOperative Surgical ProceduresParkinson DiseasePathway interactionsPatientsPerformancePeriodicalsPharmaceutical PreparationsPhasePhysical ExercisePhysical activityPilot ProjectsPlacebosPlayPopulationPostdoctoral FellowPreparationPrevalencePreventionPsyche structurePublishingRandomizedRandomized, Controlled TrialsResearchRiskShort-Term MemorySiteSymptomsSystemTabletsTrainingUpdateVideo GamesVisuospatialWorkarchive databrain healthcognitive benefitscommercializationcomparative efficacycoraldata archivedata integrationdigitaldigital treatmenteffective interventionefficacy evaluationexecutive functionexergameexperiencefightingfollow-upfootimprovedinnovationinput devicelifestyle interventionmild cognitive impairmentneuropathologynovelphase 2 studypilot testpilot trialportabilitypreservationpreventprototypeprovider networksrandomized, clinical trialsrecruitremediationremote assessmentskillssmart watchsoftware systemstoolusabilityvirtualvirtual coachvirtual reality

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中文摘要
翻译
项目摘要/摘要 帕金森病是仅次于帕金森病的第二大神经退行性疾病 阿尔茨海默病在普通人群中的患病率估计为0.3%,#年为1% 60岁以上的个人(Getz&Levin,2017)。除了基本的运动特征外, 与这种疾病相关的是,帕金森氏症患者也会经历认知能力下降。而当 估计各不相同(Goldman等人,2013),据估计,多达40%的PD患者将满足 轻度认知障碍的诊断标准,高达80%将发展为痴呆症 在疾病的过程中(Kenney等人,2022)。考虑到当前治疗方法的局限性 由于帕金森病缺乏彻底的治愈方法,因此有强烈的呼声要求进一步研究其有效性 干预,特别是那些可能减缓认知衰退以及转换为 痴呆(Cammisuli等人,2019年)。目前,虽然多巴胺能药物和外科手术 干预(DBS)通常会改善一些运动症状(至少是暂时的),有 最低限度的记录神经心理益处。因此,有一种生活方式的呼声 针对老年人的干预措施,通过以下途径预防、延缓或改善认知能力下降 非药理学干预,如运动(Camisul等人,2019年)。我们最初的 随机对照试验(RCT)调查老年人运动(Anderson-Hanley et Al.,2012a),并显示在三个月的虚拟踏板后显著的认知益处 与传统的脚踏车相比,现实增强了自行车或“赛车”。结果表明 对于同样的努力,在赛车上进行互动的体力和精神锻炼可以产生 比单独在固定自行车上进行体育锻炼对认知有更大的好处。此外,还有 在网络自行车手中,转换为MCI的风险降低了23%。圆周率和 合作者已经努力在不同疾病的患者中复制和扩展这一研究路线 神经疾病引发了便携式、负担得起的平板电脑的开发 原型:交互式身体和认知练习系统(IPACES),可以 配以桌下椭圆形踏板,可在家中使用。来自家庭试点试验的数据(v1和 V2),发现在3个月的踏板游戏后,执行功能显著改善 IPACES神经消耗游戏,而且比只玩游戏更多(Anderson-Hanley等人,2018b;Wall et Al.,2018年)。这项拟议的研究旨在将这些发现复制并推广到帕金森氏症中。 在数据的保证下,我们将追求为患者、家庭和医疗保健提供服务的目标 为PD患者和护理人员提供额外的工具,以保护大脑健康和遏制 认知能力下降,这一切都与痴呆症作斗争。
英文摘要
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.
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