Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in at-risk Older Adults
Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimer's in at-risk Older Adults
批准号:
10696409
负责人:
Olu Olofinboba
金额:
$81.14万
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:
2023-09-30 至 2026-05-31
关键词:
AddressAdherenceAerobicAerobic ExerciseAffectAlzheimer&aposs DiseaseAlzheimer&aposs disease riskAmericanAttentionBehavior TherapyBiological MarkersBloodBusinessesCOVID-19 pandemicClinical TrialsClinical Trials DesignCognitionCognitiveCombined Modality TherapyCommunitiesDementiaDiseaseDoseDouble-Blind MethodElderlyEnvironmentEpidemicExerciseHabilitationHomeImpaired cognitionIndividualInterventionLaboratoriesLiquid substanceMeasuresMinnesotaModelingOutcomeParticipantPerformancePersonal SatisfactionPersonsPharmaceutical PreparationsPhasePopulations at RiskPrevention strategyPreventive MedicinePsyche structureRandomizedRehabilitation therapyReportingResearch Project GrantsRiskScienceSmall Business Innovation Research GrantTechnologyTestingTherapeuticTimeTravelUniversitiesUpdateWorkarmcognitive taskcognitive trainingcombatcommercializationcommunity settingcostcost effective treatmentdesignefficacy evaluationexercise trainingexergameexperienceflexibilityimprovedinnovationintervention deliveryneuroprotectionnovelpharmacologicpreferencepreservationpreventprimary outcomeprocessing speedprogramssatisfactionsecondary outcometelerehabilitationtherapy designusabilityuser-friendlyvirtual environmentvirtual reality
中文摘要
项目总结/摘要
阿尔茨海默病(AD)目前影响着600多万美国人,预计将影响1400万人
到2050年,成本将达到1.2万亿美元。尽管它的巨大影响和药理学的有限影响,
治疗,注意力已被带到非药物干预作为有前途的治疗策略
来预防认知能力下降有氧运动和认知训练,特别是结合使用时
代表AD风险人群认知的重要行为干预。预防医学
治疗是具有成本效益的策略,旨在保护心理能力,日常生活表现,
在疾病的早期阶段,个人的认知健康。拟议项目将以调查结果为基础
从第二阶段的试点,其中的可行性和有效性的虚拟现实认知训练(VRCT)相结合,
与同时有氧循环(有氧运动),证明了在临床试验。本临床试验
利用监督干预模式进行,这对于证明初步可行性很重要
和有效性,但在解决现实世界的可行性和可持续性方面存在局限性。目前,前两名
报告的参与社区或机构为基础的预防医学治疗的障碍,如
锻炼和认知训练包括旅行或时间承诺的负担。最近,
技术允许基于家庭的(异步)远程康复干预,如锻炼
训练被用作常规同步康复计划的补充或替代。
虽然远程康复是一种不断发展的治疗形式,但尚未在有AD风险的人或患有AD的人中进行研究。
游戏疗法为了使游戏成为一种可持续的预防AD的方法,
需要在基于家庭的(异步)环境中的可行性和有效性。为了扩大我们的影响力,
游戏的可销售性和打击这些参与障碍,可持续性和有效性,
必须解决家庭环境中的电子游戏问题。为了支持扩大覆盖范围,
本项目的目的是:1)开发一个功能齐全的VRCT版本
可以远程安装和更新以支持基于家庭的使用,
2)评估的可行性,有效性,和可持续性的游戏在家庭为基础的,异步的
远程康复设置通过临床试验。一旦功能齐全的远程安装的游戏,
更新能力已完成,临床试验,使用2:2析因设计将随机化104
有AD风险的社区老年人接受4种治疗方法之一治疗3个月:以家庭为基础(异步)
游戏,监督游戏,家庭异步有氧运动,或监督有氧运动
锻炼的这个项目是创新的,因为1)它解决了真实的世界使用游戏的障碍,这将
增加产品的可及性和市场性,2)临床试验采用金标准实验室,真实的
世界(“领域”),以及新的血液生物标志物的功效和可持续性评估的运动会。
英文摘要
Project Summary/Abstract
Alzheimer’s disease (AD) affects more than six million Americans currently and is projected to affect 14 million
at a cost of $1.2 trillion in 2050. Despite its tremendous impacts and the limited influence of pharmacological
therapies, attention has been brought to non-pharmacological interventions as promising therapeutic strategies
for the prevention of cognitive decline. Aerobic exercise and cognitive training, particularly when in combination
represent important behavioral interventions for cognition in persons at risk for AD. Both preventative medicine
therapies are cost-effective strategies and aim to preserve the mental abilities, daily living performance, and
cognitive well-being of individuals in the early stages of the disease. The proposed project will build on findings
from the Phase II pilot where the feasibility and efficacy of Virtual Reality Cognitive Training (VRCT) combined
with concurrent aerobic cycling (Exergame) was demonstrated in a clinical trial. This clinical trial was
conducted utilizing a supervised intervention model, which is important for demonstrating preliminary feasibility
and efficacy, but has limitations for addressing real-world feasibility and sustainability. Currently, the top two
reported barriers for participation in community or facility-based, preventive medicine therapies such as
exercise and cognitive training include burdens of travel or time commitment. Recently, advancements in
technology have allowed for home-based (asynchronous) telerehabilitation interventions such as exercise
training to be utilized as a supplement or replacement to conventional, synchronous rehabilitation programs.
Although telerehabilitation is a growing form of therapy, it has yet to be studied in persons at risk for AD or with
Exergame therapy. In order for Exergames to be a sustainable preventive medicine approach to AD, its
feasibility and efficacy in a home-based (asynchronous) setting is needed. In order to expand our reach and
marketability of the Exergame and combat these participation barriers, the sustainability and efficacy of
Exergames in a home-based environment must be addressed. In support of expanding the reach and
marketability of the Exergame, the purpose of this project is to: 1) develop a fully-featured version of the VRCT
aspect of the Exergame that can be installed and updated remotely in order to support home-based use and,
2) assess the feasibility, efficacy, and sustainability of the Exergame in a home-based, asynchronous
telerehabilitation setting via a clinical trial. Once the fully-featured Exergame with remote installation and
updating capacity has been completed, the clinical trial, using a 2:2 factorial design will randomize 104
community-dwelling older adults at risk of AD to one of four arms for 3 months: home-based (asynchronous)
Exergames, supervised Exergame, home-based asynchronous aerobic exercise, or supervised aerobic
exercise. This project is innovative as 1) it addresses barriers for the real world use of the Exergame, which will
increase the reach and marketability of the product, and 2) the clinical trial uses gold standard laboratory, real
world (“field”), and novel blood biomarker efficacy and sustainability assessments of the Exergames.
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