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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：
Yuri Agrawal
金额：
$ 51.49万
依托单位：
JOHNS HOPKINS UNIVERSITY
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：
https://reporter.nih.gov/project-details/10611308
关键词：
Adherence Adult Adverse event Affect Age Alzheimer&apos s Disease Alzheimer&apos s disease patient Blinded Brain Calendar Caregivers Clinical Research Clinical Trials Cognition Cognitive Compensation Data Effectiveness Elderly Enrollment Equilibrium Event Exercise Fostering Gait Goals 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, Controlled Trials Rehabilitation therapy Research Research Assistant Resources Risk Risk Factors Role Rotation Sampling Sensory System Testing Vestibular loss Work active control clinical practice clinically significant cognitive skill comorbidity comparative efficacy design effective intervention experience fall risk falls follow-up improved innovation mortality novel pilot trial prospective randomized, clinical trials recruit treatment 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.

项目总结