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
• 负责人: Yuri Agrawal
• 金额: $ 51.49万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-15 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10341139
• 关键词: Adherence; Adult; Adverse event; Affect; Age; Alzheimer' s Disease; Alzheimer' s disease patient; Blinded; Brain; Calendar; Caregivers; Clinical Research; Clinical Trials; Cognition; Cognitive; Data; Effectiveness; Elderly; Enrollment; Equilibrium; Event; Exercise; Financial compensation; Fostering; Gait; Goals; Gold; Head; High Prevalence; Hospitalization; Impaired cognition; Impairment; Infrastructure; Injury; Institutionalization; Intervention; Labyrinth; Maps; Measures; Mediating; Memory; Morbidity - disease rate; Multicenter Trials; Observational Study; Operative Surgical Procedures; Outcome; Participant; Patient Recruitments; Patients; Pharmaceutical Preparations; Phase; Physical therapy; Physiology; Play; Positioning Attribute; Prevalence; Public Health; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Rehabilitation therapy; Research; Research Assistant; Resources; Risk; Risk Factors; Role; Rotation; Sampling; Sensory; System; Testing; Vestibular loss; Work; active control; base; clinical practice; clinically significant; cognitive skill; comorbidity; comparative efficacy; design; effective intervention; experience; fall risk; falls; follow-up; improved; mortality; novel; pilot trial; prospective; recruit; treatment center

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.

项目摘要 已知患有阿尔茨海默氏病（AD）的患者的平衡和步态障碍更大，并且两倍 相对于健康老年人的跌倒率（60-70％vs 〜30％）。目前，有效的干预措施很少 存在管理和减轻广告中的跌倒，不幸的是，跌倒仍然是 AD患者的发病率，制度化和死亡率。最近的研究表明AD患者 相对于年龄匹配的对照组，前庭障碍的患病率高两个（〜50％）（〜25％） 患病率）。此外，在一项正在进行的观察性研究的试点数据中，我们表明了前庭 损失与AD患者的跌倒率增加有关。前庭疗法（VT）是一个完善的 前庭损失的治疗，包括基于物理治疗的练习 降低前庭功能的补偿。 VT可有效改善平衡和降低跌倒风险 具有前庭障碍的认知直觉患者。但是，VT是否可以有效改进 从未探索过前庭损失的AD患者的平衡和减少跌幅。在这项研究中，我们 提案对100例有前庭AD的患者的VT随机对照试验 损害。我们将将患者1：1随机为VT的标准课程（每周1个疗程，持续8周）或 进行主动控制符合努力和持续时间。我们将比较VT与主动控制的效率 一年一度的事件跌幅。我们还将研究VT之间的潜在中间结果 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的目标） - 了解VT可能影响跌倒率的潜在机制。我们假设 该VT将在降低相对于主动控制的1年事件降低率方面具有初步效率 干预100例中度AD患者的便利样本。我们还将探讨是否 VT相对于主动控制干预，在改善平衡和认知方面具有初步效率。 为了完成拟议的研究，我们将从记忆和阿尔茨海默氏症中招募100名患者 治疗中心是约翰·霍普金斯（Johns Hopkins）的广告临床研究资源。瀑布是一个 AD患者的灾难性结果。如果此试点试验随后是III期多中心试验 VT在减少跌倒中受益的有力证据，这种低风险的干预可能是广泛的 由现有的劳动力和基础设施传播和实施，并产生大量 广告临床实践的持续变化。