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
项目摘要/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
在2050年耗资1.2万亿美元。尽管它的影响巨大,而药理学的影响有限
作为有希望的治疗策略,非药物干预已经引起了人们的注意
用于预防认知功能衰退。有氧运动和认知训练,特别是当两者结合时
代表了对AD高危人群认知的重要行为干预。两者都是预防性医学
治疗是具有成本效益的策略,目的是保持智力、日常生活能力和
疾病早期个体的认知健康状况。拟议的项目将以调查结果为基础
从第二阶段试点中将虚拟现实认知训练(VRCT)的可行性和有效性结合起来
在临床试验中,同时进行了有氧自行车运动(出力游戏)。这项临床试验是
利用监督干预模式进行,这对于论证初步可行性很重要
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,排名前两位的
据报道,参与以社区或设施为基础的预防性医学治疗存在障碍,例如
锻炼和认知训练包括旅行或时间承诺的负担。最近,在这方面的进展
技术已经使家庭(异步)远程康复干预成为可能,例如锻炼
培训作为常规同步康复计划的补充或替代。
尽管远程康复是一种日益增长的治疗形式,但它尚未在AD高危人群或
施展游戏疗法。为了使游戏成为治疗阿尔茨海默病的可持续预防医学方法,其
在家庭(异步)环境中的可行性和有效性是必要的。为了扩大我们的触角,
游戏和消除这些参与障碍的市场化,可持续性和有效性
必须解决在家庭环境中锻炼游戏的问题。支持扩大覆盖范围和
该项目的目的是:1)开发一个功能齐全的VRCT版本
可以被远程安装和更新以支持基于家庭的使用的出力游戏的方面,
2)评估以家庭为基础的异步式运动游戏的可行性、有效性和可持续性
通过临床试验建立远程康复环境。一次功能齐全的带有远程安装和
容量更新已完成,临床试验采用2:2析因设计,将104人随机
社区居住的有AD风险的老年人在3个月内从四个手臂中的一个:在家(异步)
运动游戏、有监督的运动游戏、基于家庭的异步有氧运动或有监督的有氧运动
锻炼身体。这个项目的创新之处在于:1)它解决了EffGame在现实世界中使用的障碍,这将
增加产品的覆盖面和可销售性,2)临床试验使用黄金标准实验室,REAL
世界(“领域”),以及新的血液生物标记物的效力和可持续性评估的体力游戏。
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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