Preventing Loss of Independence through Exercise (PLIE) in Persons with Dementia

 描述（由申请人提供）： 这项研究的目的是进行一项随机对照试验（RCT），以测试一种名为“通过运动预防独立性丧失”（Preventing Loss of Independence through Exercise，简称PADI）的新型综合运动计划对老年退伍军人的功能和生活质量的有效性。痴呆症是一种毁灭性的疾病，影响近十分之一的老年退伍军人（约100万人）。目前的痴呆症药物对功能和生活质量的影响很小，并且不会阻止或减缓疾病进程;然而，越来越多的证据表明，行为干预（如运动）对痴呆症患者有各种有益的影响。神经科学和实验心理学的最新发现，虽然痴呆症患者的外显记忆（有意识地回忆新信息的能力）受损，但内隐记忆（通常通过重复暴露发生的无意识学习）相对保留。因此，程序性记忆（无意识的程序学习）的训练重点是建立力量和能力，以执行日常功能最需要的运动（例如，从坐到站的安全过渡）。此外，为了最大限度地发挥培训的好处，健身中心整合了东西方运动模式的元素，以培养正念的身体意识和加强社会联系。我们最近在加利福尼亚州旧金山弗朗西斯科的一家成人日间健康中心完成了一项关于康复计划的试点研究，发现与该机构的常规护理相比，该计划与认知功能、身体表现和生活质量的临床有意义的改善以及护理人员负担的减轻有关。这项拟议的研究将使我们能够在这些令人兴奋的试点研究结果的基础上，在北方加州的成人日间健康中心进行全面的随机对照试验。大多数VA医疗中心目前与社区组织签订合同，为符合条件的痴呆症退伍军人提供成人日间医疗保健。因此，本研究的研究中心将是与San弗朗西斯科VA（SFVA）或Palo Alto VA（PAVA）签订了当前合同的成人日间健康中心。 在每个中心内，研究参与者将被随机分配接受运动干预计划（45分钟，每周2天，6个月）或运动护理（UC）对照（标准中心活动，45分钟，每周2天，6个月）（N=144，72/组）。我们的共同主要结局将是6个月认知功能（阿尔茨海默病评估量表-认知子量表，ADAS-cog）、独立性（功能独立性测量，QOL）和生活质量（阿尔茨海默病生活质量，QOL-AD）的变化。护理者负担的变化（护理者负担量表，CBI）将作为次要结局进行检查。我们还建议确定在干预期后6个月内是否维持了顺铂的效果;因此，将在基线、6个月和12个月时评估所有结局。拟议的项目将解决一个至关重要的退伍军人健康问题，与优化老年痴呆症退伍军人的功能状态和生活质量有关。它直接响应于 申请请求（RFA）RX-14-011（肌萎缩侧索硬化症，帕金森病和阿尔茨海默病研究RR&D Merit Review Award），其中确定了“开创性的新的和创新的康复方法，以恢复功能并改善患有[这些]神经退行性疾病的退伍军人的生活质量”作为“主要焦点”。“许多患者和护理人员目前认为，在帮助痴呆症患者维持功能和生活质量方面做得很少。我们提出的研究将利用严格的研究方法来测试一个高度创新和有前途的新计划对老年痴呆症患者的疗效。如果我们的计划成功，我们将与退伍军人事务部和社区组织合作，更广泛地实施残疾人权利。

 DESCRIPTION (provided by applicant): The goal of the proposed study is to perform a randomized, controlled trial (RCT) to test the efficacy of a novel integrative exercise program called Preventing Loss of Independence through Exercise (PLIÉ) on function and quality of life in older Veterans living in the community with dementia. Dementia is a devastating condition that affects nearly 1 in 10 older veterans (~1 million individuals). Current dementia medications have minimal impact on function and quality of life and do not stop or slow the disease course; however, there is growing evidence that behavioral interventions such as exercise have a variety of beneficial effects in individuals with dementia. PLIÉ was developed based on recent discoveries in neuroscience and experimental psychology that have found that, although explicit memory (the ability to consciously recall new information) is impaired in individuals with dementia, implicit memory (unconscious learning that typically occurs through repeated exposure) is relatively preserved. Therefore, PLIÉ focuses on training procedural memory (unconscious learning of procedures) to build the strength and capacity to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing). In addition, to maximize the benefits of the training, PLIÉ integrates elements of Eastern and Western exercise modalities to develop mindful body awareness and enhance social connection. We have recently completed a pilot study of the PLIÉ program at an adult day health center in San Francisco, CA, finding that it was associated with clinically meaningful improvements in cognitive function, physical performance and quality of life as well as reduced caregiver burden when compared with usual care at the facility. The proposed study will enable us to build on these exciting pilot study results by performing a full-scale RCT at adult day health centers in Northern California. Most VA Medical Centers currently contract with community-based organizations to provide adult day health care to eligible Veterans with dementia. Therefore, sites for the current study will be adult day health centers that have current contracts with either the San Francisco VA (SFVA) or Palo Alto VA (PAVA). Within each center, study participants will be randomly assigned to receive the PLIÉ intervention program (45 minutes, 2 days/week, 6 months) or Usual Care (UC) control (standard center activities, 45 minutes, 2 days/week, 6 months) (N=144, 72/group). Our co-primary outcomes will be 6-month change in cognitive function (Alzheimer's Disease Assessment Scale - cognitive subscale, ADAS-cog), independence (Functional Independence Measure, FIM) and quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). Changes in caregiver burden (Caregiver Burden Inventory, CBI) will be examined as a secondary outcome. We also propose to determine whether the effects of PLIÉ are maintained over 6 months after the intervention period; thus, all outcomes will be assessed at baseline, 6 months and 12 months. The proposed project will address a critically important Veterans' health problem related to optimizing functional status and quality of life in older Veterans with dementia. It is directly responsive to Request for Applications (RFA) RX-14-011 (RR&D Merit Review Award for Research on Amyotrophic Lateral Sclerosis, Parkinson's Disease and Alzheimer's Disease), which has identified "pioneering new and innovative rehabilitation methodologies to restore function and improve quality of life for Veterans living with [these] neurodegenerative diseases" as a "major focus." Many patients and caregivers currently feel that little is being done to help individuals with dementia maintain function and quality of life. Our proposed study will utilize rigorous research methods to test the efficacy of a highly innovative and promising new program for older adults with dementia. If our program is successful, we will work with VA and community-based organization to implement PLIÉ more broadly.