Clinical trial of vestibular therapy to reduce falls in patients with Alzheimer's disease
前庭疗法减少阿尔茨海默病患者跌倒的临床试验
基本信息
- 批准号:10611308
- 负责人:
- 金额:$ 51.49万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-02-15 至 2023-07-31
- 项目状态:已结题
- 来源:
- 关键词:AdherenceAdultAdverse eventAffectAgeAlzheimer&aposs DiseaseAlzheimer&aposs disease patientBlindedBrainCalendarCaregiversClinical ResearchClinical TrialsCognitionCognitiveCompensationDataEffectivenessElderlyEnrollmentEquilibriumEventExerciseFosteringGaitGoalsHeadHigh PrevalenceHospitalizationImpaired cognitionImpairmentInfrastructureInjuryInstitutionalizationInterventionLabyrinthMapsMeasuresMediatingMemoryMorbidity - disease rateMulticenter TrialsObservational StudyOperative Surgical ProceduresOutcomeParticipantPatient RecruitmentsPatientsPharmaceutical PreparationsPhasePhysical therapyPhysiologyPlayPositioning AttributePrevalencePublic HealthRandomizedRandomized, Controlled TrialsRehabilitation therapyResearchResearch AssistantResourcesRiskRisk FactorsRoleRotationSamplingSensorySystemTestingVestibular lossWorkactive controlclinical practiceclinically significantcognitive skillcomorbiditycomparative efficacydesigneffective interventionexperiencefall riskfallsfollow-upimprovedinnovationmortalitynovelpilot trialprospectiverandomized, clinical trialsrecruittreatment center
项目摘要
Project summary
Patients with Alzheimer’s disease (AD) are known to have greater balance and gait impairment and double
the rate of falls relative to healthy older adults (60-70% vs ~30%). Currently, few effective interventions
exist to manage and mitigate falls in AD, and unfortunately, falls continue to be one of the primary drivers of
morbidity, institutionalization, and mortality among AD patients. Recent studies have shown that AD patients
have a two-fold higher prevalence of vestibular impairment (~50%) relative to age-matched controls (~25%
prevalence). Additionally, in pilot data from an ongoing observational study, we have shown that vestibular
loss is associated with an increased rate of falls in AD patients. Vestibular therapy (VT) is a well-established
treatment for vestibular loss, and consists of physical therapy-based exercises designed to foster
compensation for reduced vestibular function. VT is effective in improving balance and reducing fall risk in
cognitively-intact patients with vestibular impairment. However, whether VT could be effective in improving
balance and reducing falls in AD patients with vestibular loss has never been explored. In this study, we
propose a randomized controlled trial of VT in 100 patients with mild-moderate AD who have vestibular
impairment. We will randomize patients 1:1 to a standard course of VT (1 session per week for 8 weeks) or
to an active control matched for effort and duration. We will compare the efficacy of VT vs. active control
primarily on 1-year incident fall rate. We will also investigate potential intermediate outcomes between VT
and falls – specifically balance outcomes (a predicted target of VT) and spatial cognitive outcomes (a novel
target of VT) – to understand potential mechanisms by which VT may influence fall rates. We hypothesize
that VT will have preliminary efficacy in reducing 1-year incident fall rates relative to an active control
intervention in a convenience sample of 100 patients with mild-moderate AD. We will also explore whether
VT has preliminary efficacy in improving balance and cognition relative to the active control intervention.
To accomplish the proposed study, we will recruit 100 patients from the Memory and Alzheimer’s
Treatment Center, a well-established AD clinical research resource at Johns Hopkins. Falls are a
disastrous outcome in patients with AD. If this pilot trial followed by a Phase III multi-center trial provide
strong evidence for the benefit of VT in reducing falls, this low-risk intervention could be widely
disseminated and implemented by an existing workforce and infrastructure, and produce substantial,
sustained change in AD clinical practice.
项目概要
众所周知,阿尔茨海默病 (AD) 患者的平衡能力和步态障碍更严重,并且双倍
相对于健康老年人的跌倒率(60-70% vs ~30%)。目前有效的干预措施还很少
存在用于管理和减轻 AD 跌倒的风险,不幸的是,跌倒仍然是 AD 的主要驱动因素之一
AD 患者的发病率、住院治疗和死亡率。最近的研究表明,AD 患者
与年龄匹配的对照组(约 25%)相比,前庭障碍患病率(约 50%)高出两倍
流行率)。此外,在一项正在进行的观察性研究的试点数据中,我们已经表明前庭
损失与 AD 患者跌倒率增加有关。前庭疗法(VT)是一种成熟的治疗方法
治疗前庭丧失,包括基于物理治疗的练习,旨在促进
补偿前庭功能下降。 VT 可有效改善平衡并降低跌倒风险
认知功能完整且前庭功能障碍的患者。然而,VT是否能有效改善
平衡和减少前庭丧失的 AD 患者跌倒的情况尚未被探索过。在这项研究中,我们
提议对 100 名患有前庭功能障碍的轻中度 AD 患者进行 VT 随机对照试验
损害。我们将按照 1:1 的比例将患者随机分配至标准 VT 疗程(每周 1 次,持续 8 周)或
与努力和持续时间相匹配的主动控制。我们将比较 VT 与主动控制的功效
主要是一年的事故下降率。我们还将研究 VT 之间潜在的中间结果
和跌倒——特别是平衡结果(VT 的预测目标)和空间认知结果(一种新颖的
VT 目标)——了解 VT 影响跌倒率的潜在机制。我们假设
相对于主动对照,VT 将在降低 1 年事故下降率方面具有初步功效
对 100 名轻度至中度 AD 患者的方便样本进行干预。我们还将探讨是否
VT相对主动控制干预在改善平衡和认知方面具有初步功效。
为了完成拟议的研究,我们将招募 100 名记忆和阿尔茨海默病患者
治疗中心是约翰霍普金斯大学完善的 AD 临床研究资源。瀑布是一个
AD 患者的灾难性后果。如果该试点试验随后进行 III 期多中心试验提供
有强有力的证据证明 VT 在减少跌倒方面的益处,这种低风险干预措施可以广泛应用
由现有的劳动力和基础设施传播和实施,并产生大量的、
AD 临床实践的持续变化。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Yuri Agrawal其他文献
Yuri Agrawal的其他文献
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{{ truncateString('Yuri Agrawal', 18)}}的其他基金
Impact of vestibular loss on central vestibular pathways in aging adults
前庭丧失对老年人中枢前庭通路的影响
- 批准号:
10274617 - 财政年份:2021
- 资助金额:
$ 51.49万 - 项目类别:
Impact of vestibular loss on central vestibular pathways in aging adults
前庭丧失对老年人中枢前庭通路的影响
- 批准号:
10487441 - 财政年份:2021
- 资助金额:
$ 51.49万 - 项目类别:
Impact of vestibular loss on central vestibular pathways in aging adults
前庭丧失对老年人中枢前庭通路的影响
- 批准号:
10643891 - 财政年份:2021
- 资助金额:
$ 51.49万 - 项目类别:
Clinical trial of vestibular therapy to reduce falls in patients with Alzheimer's disease
前庭疗法减少阿尔茨海默病患者跌倒的临床试验
- 批准号:
10341139 - 财政年份:2021
- 资助金额:
$ 51.49万 - 项目类别:
Impact of vestibular loss on central vestibular pathways in aging adults
前庭丧失对老年人中枢前庭通路的影响
- 批准号:
10990150 - 财政年份:2021
- 资助金额:
$ 51.49万 - 项目类别:
Clinical trial of vestibular therapy to reduce falls in patients with Alzheimer's disease
前庭疗法减少阿尔茨海默病患者跌倒的临床试验
- 批准号:
10993253 - 财政年份:2021
- 资助金额:
$ 51.49万 - 项目类别:
Contribution of sensorimotor function to risk and pathogenic mechanisms of Alzheimer's disease and related dementias
感觉运动功能对阿尔茨海默病和相关痴呆的风险和致病机制的贡献
- 批准号:
10318172 - 财政年份:2019
- 资助金额:
$ 51.49万 - 项目类别:
Contribution of sensorimotor function to risk and pathogenic mechanisms of Alzheimer's disease and related dementias
感觉运动功能对阿尔茨海默病和相关痴呆的风险和致病机制的贡献
- 批准号:
10534237 - 财政年份:2019
- 资助金额:
$ 51.49万 - 项目类别:
Does vestibular loss predict falls in patients with Alzheimer's Disease?
前庭丧失是否预示着阿尔茨海默病患者会跌倒?
- 批准号:
9915832 - 财政年份:2018
- 资助金额:
$ 51.49万 - 项目类别:
Does vestibular loss predict falls in patients with Alzheimer's Disease?
前庭丧失是否预示着阿尔茨海默病患者会跌倒?
- 批准号:
9763435 - 财政年份:2018
- 资助金额:
$ 51.49万 - 项目类别:
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