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Merit Review提案直接比较了两种明显不同的运动模式在退伍军人中风幸存者中的疗效，在整体心血管风险因素降低计划的背景下。我们将深入了解这些计划是如何转化为VA社区设置（洛赫乌鸦社区为基础的门诊中心和VA佩里角），以及理想的启动顺序时，参与者都暴露在一个平衡的方式超过12个月的干预措施。我们假设，启动拟议的12个月交叉干预，先进行高强度跑步机训练（HI-TM）（0-6个月），然后进行低强度团体运动计划（LILI）（6-12个月），将对功能和行为结果产生最大的长期影响。具体而言，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6至12个月内最佳地应用。相反，LILI后HI-TM的相反干预模式可能在第12个月产生最大的心脏代谢适应，因为该组中的卒中幸存者将在第6个月开始HI-TM，基线功能能力水平较高。具体目标是：（1）直接比较6个月HI-TM、LILI和EC的效果（教育对照）方案对残疾退伍军人卒中幸存者的功能、心脏代谢、行为和生活质量结局的影响;（2）评估实施顺序是否影响1年交叉期内每个结局类别的获益;（3）比较在12-18个月期间进行持续的正式基于中心的训练的队列与仅进行基于家庭的锻炼的队列中所有结果增益的持久性和持续性。该提案包括8个阶段，估计每个治疗组队列需要大约20 - 21个月才能完成。在第1阶段（正在进行中），我们将筛选并同意慢性卒中患者（4个队列，每组30例）。第2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、步行功能、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组6个月（第3阶段）。包括EC在内的所有团体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，重复所有基线检测和分析。在第5阶段，两个治疗组中的受试者开始额外的6个月交叉期，在12个月时重复所有测量（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，一半的参与者继续正式的基于中心的运动训练，以在第18个月（第8阶段）与那些停止正式训练的人进行比较，以支持基于家庭的运动建议。目标3将提供关于运动要求的重要初步信息，以便在致残性卒中后的较长时间内增加或持久维持结局增益。这项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中康复模型的新证据。目前的中风康复方法不能有效地预防或逆转代谢适应性、功能和活动模式下降的变化，从而导致生理和心理健康的下降。这项拟议的研究将为将运动模型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接受咨询和过渡的方式，最终改变目前的护理标准。

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.