The effects of a novel, non-ischemic and pain-free exercise intervention in peripheral artery disease

新型非缺血、无痛运动干预治疗外周动脉疾病的效果

• 批准号: 10659755
• 负责人: Andrew W Gardner
• 金额: $ 50.13万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10659755
• 关键词: Acute; Adherence; Affect; Age Years; American; Biological Markers; Blood Pressure; Blood Vessels; Blood flow; C-reactive protein; Clinical; Comparative Effectiveness Research; Dropout; Exercise; Exercise Therapy; Functional disorder; Goals; Home; Inflammation; Institute of Medicine (U.S.); Intermittent Claudication; Investigation; Ischemia; Knowledge; Leg; Lower Extremity; Meta-Analysis; Methods; Monitor; Muscle; Outcome; Oxidative Stress; Oxygen; Pain; Pain Free; Pain in lower limb; Patients; Peripheral arterial disease; Persons; Physical Function; Production; Publishing; Quality of life; Randomized; Randomized, Controlled Trials; Reactive Oxygen Species; Recommendation; Reflex action; Seminal; Speed; Stimulus; Structure; Symptoms; Testing; Time; Walking; Work; active lifestyle; claudication; clinically relevant; clinically significant; comparative effectiveness; cost; efficacious intervention; exercise adherence; exercise intervention; exercise prescription; exercise program; exercise rehabilitation; exercise training; health related quality of life; improved; innovation; mortality; novel; oxidized low density lipoprotein; patient oriented; primary outcome; programs; response; secondary outcome; standard of care; treadmill; treatment strategy; walking program; walking speed

PROJECT SUMMARY/ABSTRACT Objective. Our objective is to build on our preliminary work that a Non-IsChemic Exercise (NICE) program will be a better treatment for patients with peripheral artery disease (PAD) to improve ambulation, health-related quality of life (HRQoL), microvascular function, and systemic vascular biomarkers than a Standard painful exercise program. Specific Aims. We propose to test our central hypothesis that the NICE intervention performed without inducing leg ischemia and its’ damaging sequela will be a superior exercise paradigm to increase peak walking time and HRQoL more than the Standard ischemic and painful exercise paradigm via greater improvement in microvascular mechanisms. 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 randomized to either the NICE slow walking program or to the Standard program of ischemic and painful exercise. Aim 2a (Vascular Outcomes) To compare the changes in local microvascular function of the lower extremities, inflammation and oxidative stress in patients following the NICE program, and following the Standard ischemic and painful program. Aim 2b (Exploratory Aim) To explore whether the changes in local microvascular function and systemic vascular biomarkers are associated with the changes in peak walking time following the NICE and Standard programs, and whether the association is stronger following the NICE program. Methods. This is a 3-month, patient-oriented, translational, comparative effectiveness randomized controlled trial. One-hundred patients will be randomized into either the NICE program (N=50) or the Standard exercise program (N=50). All patients will perform supervised treadmill walking for 3 months. Patients randomized to the NICE program will walk intermittently at a slow speed of approximately 1.4 mph for only 2-3 minute bouts that do not elicit claudication pain. Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain. Clinical Significance. If successful, the NICE program which consists of slow-paced walking that does not elicit leg ischemia or pain will be a novel and innovative exercise program, and will be the exercise paradigm of choice to optimally improve peak walking time, HRQoL, local microvascular function, inflammation, and oxidative stress in PAD patients. These improvements could impact the clinical course of PAD by leading to healthier and more active lifestyles.

项目摘要/摘要 客观的。我们的目标是基于我们的初步工作，该工作是非缺血性练习（NICE）计划的 对于外围动脉疾病（PAD）的患者，将是更好的治疗方法，以改善救护车，与健康有关 生活质量（HRQOL），微血管功能和全身血管生物标志物比标准痛苦 锻炼计划。 具体目标。我们建议测试我们的核心假设，即良好的干预措施没有 引起腿部缺血及其损害后遗症将是一个较高的运动范式，以增加峰值步行 时间和HRQOL比标准缺血性和痛苦的运动范式多得多。 微血管机制。该临床相关假设将通过以下目的进行检验： AIM 1（锻炼结果）比较PAD患者的卧床和HRQOL的变化 随机分配到良好的慢步行计划或缺血性和痛苦运动的标准程序。 AIM 2A（血管结局）比较下部的局部微血管功能的变化 良好程序之后的患者的四肢，炎症和氧化应激，并遵循标准 缺血和痛苦的程序。 AIM 2B（探索性目的）探索局部微血管功能和全身性的变化是否发生 血管生物标志物与良好和标准之后的高峰步行时间变化有关 程序，以及协会是否遵循NICE计划更强大。 方法。这是一个3个月，面向患者的，翻译，比较有效性随机的 对照试验。一百名患者将被随机分为NICE计划（n = 50）或标准 锻炼计划（n = 50）。所有患者将进行监督的跑步机步行3个月。患者随机分配 到NICE程序将以大约1.4英里 /小时的速度间歇性行走仅2-3分钟。 这不会引起lau不平的痛苦。随机进行标准计划的患者将间歇性行走 速度约为2 mph至接近最大的laurauration疼痛。 临床意义。如果成功，则包括慢节奏步行的好程序 不引起腿部缺血或痛苦将是一个新颖而创新的运动计划，这将是锻炼范式 选择的选择，可最佳地改善高峰步行时间，HRQOL，局部微血管功能，注射和氧化 PAD患者的压力。这些改进可能会导致更健康和 更积极的生活方式。