VETerans with Stroke Translating Exercise Programs (VET STEP)

描述(由申请人提供)： 摘要：这项为期四年的功绩评估提案直接比较了两种截然不同的运动模式在中风老兵幸存者中的疗效，这两种运动模式是在整体心血管危险因素降低计划的背景下进行的。我们将深入了解这些计划如何转化为退伍军人管理局社区环境(基于乌鸦湖社区的门诊中心和退伍军人佩里点)，以及当参与者在12个月内平衡地接触到这两种干预措施时的理想启动顺序。我们假设，以高强度跑步机训练(HI-TM)(0-6个月)启动拟议的12个月交叉干预，然后进行低强度集体锻炼(LILI)(6-12个月)将对功能和行为结果产生最大的长期影响。具体地说，我们建议HI-TM将建立一个心血管健康和耐力的基线水平，以便LILI的平衡和步态训练可以在6到12个月内最佳地应用，以获得最大的益处。相反，相反的干预模式，LILI然后HI-TM可能会在12个月前产生最大的心脏代谢适应，因为这组中风幸存者将在6个月开始进行HI-TM，并具有更高的基线功能能力水平。研究的具体目标是：(1)直接比较为期6个月的HI-TM、LILI和EC(教育控制)方案对残疾老兵中风幸存者的功能、心脏代谢、行为和生活质量结果的影响；(2)评估实施顺序是否影响到1年内每一结果类别的收益；(3)比较在12-18个月期间接受持续正式中心训练的队列和只接受家庭锻炼的队列的所有结果收益的持久性和持续性。该提案包括八个阶段，估计每个治疗组需要大约20-21个月的时间才能完成。在第一阶段(正在进行)中，我们将筛查并同意慢性中风患者(4个队列，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、步行功能、平衡性、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、准备改变运动行为的阶段、功能状态和感知的生活质量。然后志愿者被随机分到HI-TM、LILI或EC，为期6个月(阶段3)。所有群体，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。在阶段4中，重复所有基线测试和分析。在第5阶段，两个治疗机构的患者开始有另外6个月的交接期，所有措施在12个月时重复(第6阶段)。最后，阶段7涉及探索性目标3(由评价者建议)，在此期间，一半的参与者在第18个月(阶段8)继续进行以中心为基础的正式运动训练，以便与那些停止正式训练而倾向于家庭运动建议的人进行比较。AIM 3将提供重要的初步信息，说明在中风致残后的较长时间内增加或持久保持结果收益的运动要求。该奖项中提出的工作涉及许多因素，这些因素将有助于为VHS内的康复模式确定新的证据。目前的中风康复方法不能有效地预防或逆转新陈代谢适应性、功能和活动模式下降的变化，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式转化为社区提供基础证据，有可能通过改变中风后完成常规治疗后对残疾老兵中风幸存者进行咨询和过渡的方式，最终改变目前的护理标准。 公共卫生相关性： 项目简介：退伍军人管理局患者护理任务是为了改善退伍军人在中风等致残事件后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锻炼模式(强调平衡和躯干稳定性的集体锻炼计划与高强度跑步机训练)在基于社区的新型退伍军人管理局环境中的应用。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。这项来自Merit提案的研究可能最终改变目前中风后护理的标准，通过提供基于证据的策略来管理在完成常规治疗后对残疾的中风老兵幸存者进行咨询和过渡的方式。此功绩评估提供的信息可能有助于未来多中心退伍军人管理局合作试验的规划。

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.