The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

项目总结 目标。我们的目标是在我们的初步工作的基础上，展示一种改进的饮食 停止高血压的方法(ModDASH)饮食计划与标准运动计划相结合将是 更好地对周围动脉疾病(PAD)患者进行全面治疗，以改善步行、局部微血管 功能和血管炎症。 明确的目标。我们建议测试modDASH饮食计划与一项 运动计划(modDASH+Ex)改善PAD患者的运动和血管结局 和跛行，超出了锻炼计划(Ex)的标准治疗。我们的中心假设是 ModDASH+Ex方案通过改善运动提高PAD患者康复疗效 结果、健康相关生活质量(HRQOL)、局部微血管功能和血管炎症等 而不是标准的Ex计划。这一与临床相关的假设将通过以下目标进行检验： 目标1(运动结果)。PAD患者步行能力和高分辨率生活质量变化的比较 遵循合并的modDASH+Ex计划和代表护理标准的Ex计划 治疗。 目标2(局部和全身血管结果)。比较局部微血管的变化 接受modDASH+Ex联合治疗的患者的下肢功能和炎症情况 遵循《前任》计划。 目的3.探讨局部微血管功能和血管改变的致病机制 炎症是在modDASH+Ex后行走改变之前的生理机制 和Ex计划，以及modDASH+Ex计划之后的变化是否更具预测性。 方法：研究方法。这是一项为期3个月的、以患者为导向的、翻译的、随机比较的有效性研究 对照试验。共有184名患者将被随机分为modDASH+Ex计划(N=92)或Ex计划 程序(N=92)。所有患者将进行为期3个月的居家步行，患者被随机分配到 ModDASH+Ex计划将逐步增加他们每天的水果和蔬菜供应量，最多增加3-4份 在计划期间高于基线的服务。 临床意义。如果成功，将modDASH饮食计划与在家锻炼相结合 该计划将是一种新颖和创新的行为模式，以最佳地改善高峰步行时间、HRQOL、局部 PAD患者微血管功能与血管炎症的关系。这些改进可能会影响临床 通过降低主要心血管和下肢不良事件的长期风险，PAD的进程。

PROJECT SUMMARY Objective. Our objective is to build on our preliminary work that demonstrates a modified dietary approaches to stop hypertension (modDASH) eating plan combined with a standard exercise program will be a better overall treatment for patients with peripheral artery disease (PAD) to improve walking, local microvascular function, and vascular inflammation. Specific Aims. We propose to test the efficacy of a modDASH dietary program combined with an exercise program (modDASH+Ex) to improve exercise and vascular outcome measures in patients with PAD and claudication beyond that of the standard treatment of an exercise program (Ex). Our central hypothesis is that the modDASH+Ex program improves the efficacy to rehabilitate PAD patients by improving exercise outcomes, health-related quality of life (HRQoL), local microvascular function, and vascular inflammation more than the standard Ex program. This clinically relevant hypothesis will be tested through the following aims: Aim 1 (Exercise Outcomes). To compare the changes in ambulation and HRQoL in PAD patients following the combined modDASH+Ex program, and following the Ex program which represents standard of care treatment. Aim 2 (Local and Systemic Vascular Outcomes). To compare the changes in local microvascular function of the lower extremities and inflammation in patients following the combined modDASH+Ex program, and following the Ex program. Aim 3. To explore the causal mechanism that changes in local microvascular function and vascular inflammation are physiologic mechanisms that precede changes in ambulation following the modDASH+Ex and Ex programs, and whether changes are more predictive following modDASH+Ex program. Methods. This is a 3-month, patient-oriented, translational, comparative effectiveness randomized controlled trial. A total of 184 patients will be randomized into either the modDASH+Ex program (N=92) or the Ex program (N=92). All patients will perform home-based walking for 3 months, and patients randomized to the modDASH+Ex program will progressively increase their daily servings of fruits and vegetables by up to 3-4 servings above baseline during the program. Clinical Significance. If successful, combining the modDASH eating plan with a home-based exercise program will be a novel and innovative behavioral paradigm to optimally improve peak walking time, HRQoL, local microvascular function and vascular inflammation in PAD patients. These improvements could impact the clinical course of PAD by reducing long-term risks of major adverse cardiovascular and lower extremity events.