VETerans with Stroke Translating Exercise Programs (VET STEP)

描述（由申请人提供）： 摘要：这项为期四年的绩效审查提案在总体心血管危险因素减少计划的背景下，直接比较了两种明显不同的运动模式对退伍军人中风幸存者的功效。我们将深入了解如何将这些计划转化为 VA 社区环境（Loch Raven 社区门诊中心和 VA Perry Point），以及参与者在 12 个月内以平衡方式接受这两种干预措施时的理想启动顺序。我们假设，启动拟议的 12 个月交叉干预，先进行较高强度的跑步机训练 (HI-TM)（第 0-6 个月），然后进行较低强度的团体锻炼计划 (LILI)（第 6-12 个月），将对功能和行为结果产生最大的长期影响。具体来说，我们建议 HI-TM 将建立心血管健康和耐力的基线水平，以便 LILI 中的平衡和步态训练可以在第 6 个月至第 12 个月内得到最佳应用，以获得最大益处。相反，LILI 后继 HI-TM 的相反干预模式可能会在第 12 个月产生最大的心脏代谢适应，因为该组中的中风幸存者将在第 6 个月开始具有更高水平的基线功能能力的 HI-TM。具体目标是： (1) 直接比较 6 个月的 HI-TM、LILI 和 EC（教育控制）方案对残疾退伍军人中风幸存者的功能、心脏代谢、行为和生活质量结果的影响； (2) 评估实施顺序是否会影响 1 年交叉期内每个成果类别的收益； (3) 比较第 12-18 个月期间进行持续正式中心训练的队列与仅进行家庭锻炼的队列的所有结果增益的持久性和持续性。该提案由八个阶段组成，预计每个治疗组需要大约 20 - 21 个月才能完成。在第一阶段（正在进行）期间，我们将筛选并同意慢性中风患者（4 组，每组 30 人）。第二阶段将包括基线测试，包括评估峰值有氧能力、口服葡萄糖耐量、行走功能、平衡、自由生活体力活动、自我报告的体力活动、生活方式行为、运动的自我效能/结果预期、改变运动行为的准备阶段、功能状态和感知生活质量。然后志愿者被随机分配到 HI-TM、LILI 或 EC，为期 6 个月（第 3 阶段）。所有团体，包括 EC，都将接受循证教育和咨询，以遵守美国中风协会预防继发性中风的指南。在第 4 阶段，重复所有基线测试和分析。在第 5 阶段，两个治疗组开始额外 6 个月的交叉期，并在 12 个月时重复所有措施（第 6 阶段）。最后，第 7 阶段涉及探索性目标 3（由评审员建议），在此期间，一半参与者继续正式的以中心为基础的运动训练，以便在第 18 个月（第 8 阶段）与那些停止正式训练而转而接受基于家庭的运动建议的参与者进行比较。目标 3 将提供有关运动要求的重要初步信息，以在中风致残后的较长时间内增加或持久维持结果增益。该优异奖中提出的工作解决了许多因素，这些因素将有助于定义 VHS 内康复模型的新证据。目前的中风康复方法不能有效预防或逆转代谢健康、功能和活动模式下降的变化，导致生理和心理健康下降。拟议的研究将为将运动模式转化为社区提供基础证据，并有可能通过改变残疾退伍军人中风幸存者在中风后完成常规治疗后的咨询和过渡方式，最终改变当前的护理标准。 公共卫生相关性： 项目叙述：退伍军人管理局的患者护理使命是改善中风等致残事件后退伍军人的健康状况和生活质量。目前的研究将直接比较两种明显不同的运动范式（强调平衡和躯干稳定性的团体运动计划与高强度跑步机训练）在基于社区的新型退伍军人事务部环境中的应用。所有参与者都将接受有关中风的教育和降低中风风险的信息。这项优异提案的研究最终可能会改变当前的中风后护理标准，通过提供循证策略来管理残疾退伍军人中风幸存者在完成常规治疗后的咨询和过渡方式。本次优点审查提供的信息可以帮助未来规划多中心 VA 合作试验。

DESCRIPTION (provided by applicant): ABSTRACT: This four year Merit Review proposal directly compares the efficacy of two markedly different exercise models in veteran stroke survivors, within the context of an overall cardiovascular risk factor reduction program. We will gain insight into how these programs are translated into VA community settings (Loch Raven Community-Based Outpatient Center and VA Perry Point), as well as the ideal order of initiation when participants are exposed to both interventions in a counterbalance manner over 12 months. We hypothesize that initiating the proposed 12-month cross-over intervention with higher intensity treadmill training (HI-TM) (months 0-6) followed by a lower intensity group exercise program (LILI) (months 6-12) will result in the largest long-term impact on functional and behavioral outcomes. Specifically, we propose that HI-TM will establish a baseline level of cardiovascular fitness and endurance such that that the balance and gait training in LILI can be optimally applied for the greatest benefit in months 6 through 12. Conversely, the opposing intervention pattern of LILI followed by HI-TM may produce the greatest cardiometabolic adaptations by month 12, given that that stroke survivors in this group will start HI-TM at month 6 with a higher level of baseline functional competence. The Specific Aims are: (1) Directly compare the effects of 6-months HI-TM, LILI and EC (education control) regimens on functional, cardiometabolic, behavioral, and quality-of-life outcomes in disabled veteran stroke survivors; (2) Assess whether order of implementation impacts gains in each outcome category during a cross-over period to 1 year; (3) Compare the durability and continuation of all outcome gains in cohorts performing ongoing formal center-based training versus cohorts undergoing only home-based exercise during months 12-18. The proposal consists of eight phases that are estimated to take each treatment arm cohort approximately 20 - 21 months to complete. During phase 1 (ongoing) we will screen and consent chronic stroke patients (4 cohorts of 30 each). Phase 2 will consist of baseline testing that includes assessments of peak aerobic capacity, oral glucose tolerance, ambulatory function, balance, free-living physical activity, self-reported physical activity, lifestyle behaviors, self-efficacy/ outcome expectations for exercise, stage of readiness to change exercise behavior, functional status and perceived quality of life. Volunteers are then randomized to either HI-TM, LILI or EC for 6 months (phase 3). All groups, including EC, will receive evidence-based education and counseling for adherence to the American Stroke Association's guidelines for prevention of secondary stroke. In Phase 4, all baseline testing and analyses are repeated. In Phase 5, those in the two treatment arms commence with an additional 6-month cross- over period with all measures repeated at 12 months (Phase 6). Finally, Phase 7 relates to exploratory Aim 3 (suggested by reviewers) during which half of participants continue formal center-based exercise training for comparison at month 18 (Phase 8) with those who discontinue formal training in favor of home-based exercise recommendations. Aim 3 will provide important preliminary information on the exercise requirements for adding to or durably maintaining outcome gains over an extended period after disabling stroke. The work proposed in this Merit Award addresses a number of factors that will help define new evidence for rehabilitation models within the VHS. Current methods of stroke rehabilitation do not effectively prevent or reverse changes in metabolic fitness, function, and declining activity patterns, causing decrements to both physiological and psychological health. The proposed study will provide foundational evidence for translating exercise models into the community, with the potential to ultimately change the current standard of care by altering the way disabled veteran stroke survivors are counseled and transitioned following completion of conventional therapy post stroke. PUBLIC HEALTH RELEVANCE: Project Narrative: The VA patient care mission is to improve the health status and quality of life of veterans after disabling events such as stroke. The current study will directly compare the application of two markedly different exercise paradigms (group exercise programs that emphasize balance and truncal stability versus high-intensity treadmill training) in novel community-based VA settings. All enrollees will receive education regarding stroke and information on stroke risk reduction. The research from this Merit proposal could eventually change the current standard of post stroke care by providing evidenced-based strategies for managing the way disabled veteran stroke survivors are counseled and transitioned following completion of conventional therapy. The information provided by this Merit Review could aid the future planning for a multi- center VA cooperative trial.