Water-based Activity to Enhance Recall in Veterans: A Randomized Clinical Trial

增强退伍军人回忆能力的水基活动：一项随机临床试验

• 批准号: 10627837
• 负责人: Jennifer Kaci Fairchild
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10627837
• 关键词: Activities of Daily Living; Address; Age; Alzheimer' s Disease; Alzheimer' s disease risk; Area; Attention; Biological; Brain-Derived Neurotrophic Factor; Cardiopulmonary; Cardiovascular Physiology; Cardiovascular system; Caring; Clinical; Clinical Trials; Cognition; Cognitive; Data; Dementia; Development; Education; Educational Materials; Elderly; Epidemic; Exclusion; Exercise; Freedom; Future; Gender; Genetic; Genotype; Guidelines; Healthcare Systems; Impaired cognition; Impairment; Injury; Intervention; Knowledge; Light; Long-Term Effects; Measures; Mediating; Mediator; Medical; Memory; Movement; Muscle; Musculoskeletal; Nerve Degeneration; Neurodegenerative Disorders; Neuropsychology; Outcome; Oxygen Consumption; Participant; Persons; Pharmacological Treatment; Phase; Physical Exercise; Physical Fitness; Plasma; Populations at Risk; Prevalence; Randomized; Randomized, Controlled Trials; Recommendation; Rehabilitation therapy; Research; Risk; Short-Term Memory; Single-Blind Study; Stress; Structure; Testing; Training; Training Programs; Treadmill Tests; Veterans; Visit; Vulnerable Populations; Walking; Water; Weight-Bearing state; access restrictions; active method; brain health; cognitive benefits; cognitive function; cognitive training; comorbidity; comparative efficacy; cost; demented; design; effective therapy; efficacious intervention; efficacy evaluation; executive function; exercise capacity; exercise program; exercise training; experience; flexibility; follow-up; functional disability; improved; lifestyle intervention; meetings; mild cognitive impairment; non-demented; novel; predicting response; prevent; randomized, clinical trials; success; treatment arm; treatment as usual; treatment effect; treatment response

The primary research question of the proposed study is this: Is a water-based exercise plus cognitive training intervention efficacious in improving cognitive outcomes for Veterans with Mild Cognitive Impairment (MCI)? We address the need to improve cognitive function in this vulnerable population through a novel combined training program that will combine two interventions: water-based exercise and cognitive training. The proposed four-year randomized controlled trial will compare water-based exercise + cognitive training (WATER+CT) to a Usual Care Control Condition (UC). The primary aim of the proposed research is to evaluate the efficacy of WATER+CT to improve cognitive function in Veterans with MCI. Secondary aims of the proposed research are: 1) to evaluate the efficacy of WATER+CT to improve peak oxygen consumption and 2) to evaluate the durability of the cognitive benefits derived from WATER+CT. Exploratory aims of the proposed research are to evaluate moderators and mediators of treatment response. These aims will be tested in a single-blind randomized controlled trial that will compare the efficacy of WATER+CT to UC. This trial will include 190 Veterans meeting criteria for MCI age 50-90 with half randomized to WATER+CT and half randomized to UC. For the WATER+CT condition, the exercise training (i.e., WATER) consists of a six-month long individualized exercise program of water-based exercises. During this phase, Veterans will come to thrice-weekly group sessions at Aquatic Therapy Center at the VA Palo Alto Health Care System (VAPAHCS). After completion of the exercise program, Veterans will begin classroom-based cognitive training at the VAPAHCS for up to two months. The CT is based on an efficacious training program that is structured around two components, pre-training and mnemonic training, both of which have been used successfully in persons with MCI. Veterans randomized to the UC control condition will receive educational materials about brain health in addition to their usual care, which is the care they would typically receive in the VA. After completion of the active treatment phase, Veterans will transition to the six-month long follow-up phase. At the end of the six-month long follow-up phase, participants will return to the VA for a final follow-up visit. Participants will complete a variety of neuropsychological measures taping into areas of cognition such as attention, executive functioning, and memory. Participants will also undergo physical fitness assessments including a 6-minute walk test and an exercise treadmill test. To study possible predictors of response to treatment, we will also collect biological (cardiovascular functioning and BDNF plasma levels) and genetic data (APOE and BDNF genotypes) from these participants. We hope to provide evidence of the efficacy of an exercise training augmentation for cognitive training thus laying the groundwork for future VA health care system wide deployment of a lifestyle intervention to prevent Alzheimer’s disease.

拟议研究的主要研究问题是：基于水的运动加认知吗？ 训练干预可有效改善轻度认知退伍军人的认知结果 损伤（MCI）？我们通过以下方式解决改善这一弱势群体认知功能的需求： 一种新颖的综合训练计划，将结合两种干预措施：水上运动和认知训练 拟议的四年随机对照试验将比较水中运动+认知训练。 训练（水+CT）到常规护理控制条件（UC） 拟议研究的主要目的。 旨在评估 WATER+CT 对改善患有继发性轻度认知障碍 (MCI) 退伍军人认知功能的功效。 拟议研究的目的是： 1) 评估 WATER+CT 改善峰值血氧的功效 消耗量；2) 评估 WATER+CT 带来的认知益处的持久性。 拟议研究的探索性目的是评估治疗的调节因素和中介因素 回复。 这些目标将在一项单盲随机对照试验中进行测试，该试验将比较以下药物的功效 水+CT 至 UC 该试验将包括 190 名符合 MCI 年龄 50-90 岁标准的退伍军人，其中一半是退伍军人。 随机分配至 WATER+CT，一半随机分配至 UC 对于 WATER+CT 条件，进行练习。 训练（即水）包括为期六个月的个性化水基锻炼计划 在此阶段，退伍军人将参加每周三次的水上疗法小组课程。 VA 帕洛阿尔托医疗保健系统 (VAPAHCS) 中心 完成锻炼计划后， 退伍军人将在 VAPAHCS 开始为期长达两个月的课堂认知培训。 基于有效的培训计划，该计划由两个组成部分构成：预培训和培训 助记训练，这两种方法都已成功用于患有 MCI 的退伍军人随机。 达到 UC 控制条件的除了平时的教育材料外，还将收到有关大脑健康的教育材料 护理，这是他们在完成积极治疗后通常会在退伍军人管理局接受的护理。 阶段，退伍军人将过渡到为期六个月的后续阶段。 后续阶段，参与者将返回 VA 进行最后的后续访问。 参与者将完成各种涉及认知领域的神经心理学测量，例如 参与者还将接受注意力、执行功能和记忆力评估。 包括 6 分钟步行测试和跑步机运动测试，以研究可能的反应预测因素。 治疗时，我们还将收集生物（心血管功能和 BDNF 血浆水平）和遗传信息 我们希望提供来自这些参与者的数据（APOE 和 BDNF 基因型）的有效性证据。 增强认知训练的运动训练，从而为未来 VA 医疗保健奠定基础 在全系统范围内部署生活方式干预措施来预防阿尔茨海默病。