Role of a Novel Exercise Program to Prevent Post-thrombotic Syndrome

新型运动计划对预防血栓后综合症的作用

• 批准号: 9071859
• 负责人: Brajesh K Lal
• 金额: --
• 依托单位: BALTIMORE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9071859
• 关键词: Activities of Daily Living; Acute; Aerobic; Alteplase; Anesthesia procedures; Anticoagulation; Blood; Blood Vessels; Blood flow; Cardiovascular system; Chronic; Clinical; Clinical Trials; Control Groups; Critical Care; Deep Vein Thrombosis; Economics; Epidemiology; Exercise; Femoral vein; Fibrinolysis; Goals; Health Care Costs; Health Surveys; Healthcare; Hemorrhage; Hour; Human; Incidence; Intervention; Leg; Lower Extremity; Maintenance; Measures; Modeling; Muscle; Obstruction; Operative Surgical Procedures; Outcome Measure; Pain; Pathogenesis; Patients; Physical therapy exercises; Plasminogen Activator Inhibitor 1; Plethysmography; Postphlebitic Syndrome; Prevalence; Prevention; Procedures; Process; Protocols documentation; Pulmonary Embolism; Pump; Quality of life; Randomized; Randomized Clinical Trials; Recruitment Activity; Reflux; Regression Analysis; Relative (related person); Residual state; Resolution; Risk; Role; Severities; Surgical Injuries; Symptoms; Testing; Therapeutic Intervention; Thrombectomy; Thrombus; Tissues; Training; Training Programs; Ultrasonography; Upper Extremity; Veins; Venous; Venous Insufficiency; Vent; Veterans; Work; base; bench to bedside; clinically significant; disability; flexibility; follow-up; health economics; hemodynamics; improved; mouse model; muscle strength; novel; novel therapeutic intervention; patient oriented; pressure; prevent; primary outcome; productivity loss; programs; public health relevance; repaired; restoration; standard care; thrombolysis

DESCRIPTION (provided by applicant): Despite standard care, 25%-50% of patients with acute deep vein thrombosis (DVT) progress to chronic post- thrombotic syndrome (PTS) resulting in significant disability, loss of productivity, and healthcare costs. This is a problem encountered frequently among our numerous Veterans undergoing surgery, anesthesia, traumatic and acute injury, and surgical critical care. Venous valvular reflux from an organized thrombus is the primary cause of PTS. Veins with rapid and complete thrombus resolution have a lower incidence of reflux. We have observed that thrombus resolution is enhanced by increased blood flow and that moderate upper or lower extremity exercise result in increased venous blood flow. Hence, we postulate that a progressive exercise training program in patients with DVT will increase lower extremity venous flow, accelerate thrombus resolution, and decrease the risk of PTS. The primary hypothesis is that increased blood flow across the thrombus (induced by supervised exercise) will accelerate thrombus resolution and decrease PTS. The overall goal is to determine whether exercise can lower the risk of PTS in patients with acute DVT, and to investigate possible mechanisms by which this occurs. We propose a 2-year randomized clinical trial of standard therapy compared to standard therapy plus exercise in patients with acute lower extremity DVT. Aim 1 will test whether a 3-month exercise training program prevents PTS and improves quality of life over 2 years of follow-up. Patients with acute lower extremity DVT (iliac-femoral-popliteal) will be randomized to standard therapy (control group receiving: anticoagulation, compression, ambulation ad-lib) alone, or to exercise plus standard therapy. The study will recruit 164 patients to achieve 80% power to detect a 50% decrease in prevalence of PTS at 2 years, and a decrease in severity of PTS through 2 years of follow-up in the exercise group vs. standard care. Aim 2 will investigate mechanisms by which the exercise program may act to prevent PTS, namely systemic markers of fibrinolysis and thrombus resolution. Aim 3 will investigate alternate mechanisms of decreased PTS that are more direct results of the exercise therapy, namely: improving venous hemodynamics and functional capacity. Collectively, these results will allow us to understand the basis of a novel conceptual model that progressive aerobic and resistive exercise aids in the treatment of DVT and prevention of PTS through mechanisms of enhanced thrombus resolution, fibrinolytic and vascular repair, calf muscle pump action, and functional ability. This will be a novel therapeutic intervention for maintenance and restoration of tissue function after DVT.

描述(由申请人提供)： 尽管有标准的护理，25%-50%的急性深静脉血栓形成(DVT)患者进展为慢性血栓形成后综合征(PTS)，导致严重残疾、生产力损失和医疗成本。这是我们无数接受手术、麻醉、创伤和急性损伤以及外科危重护理的退伍军人经常遇到的问题。机化血栓形成的静脉瓣膜返流是PTS的主要原因。血栓快速完全消退的静脉返流发生率较低。我们已经观察到，增加血流量可以增强血栓的消退，适度的上肢或下肢运动会增加静脉血流量。因此，我们推测，在DVT患者中进行渐进性运动训练将增加下肢静脉血流量，加速血栓消退，降低PTS的风险。基本的假设是，血栓上的血流量增加(由有监督的运动引起)将加速血栓的溶解，降低PTS。总体目标是确定运动是否可以降低急性DVT患者PTS的风险，并调查其发生的可能机制。我们提出了一项为期两年的随机临床试验，比较标准疗法和标准疗法加运动对急性下肢深静脉血栓形成患者的疗效。目标1将测试为期3个月的运动训练计划是否在2年的随访中预防PTS并提高生活质量。急性下肢DVT患者将被随机分为两组，一组接受标准治疗(对照组接受抗凝、压迫、即刻行走)，另一组接受运动加标准治疗。这项研究将招募164名患者 通过两年的随访，运动组与标准护理组相比，达到80%的能力来检测PTS的患病率下降50%，PTS的严重程度下降。目的2将研究运动计划预防PTS的机制，即纤溶和血栓溶解的系统标记物。目的3将探讨运动疗法更直接的结果--PTS降低的替代机制，即：改善静脉血流动力学和功能能力。总之，这些结果将使我们理解一个新的概念模型的基础，即渐进性有氧和阻力运动通过增强血栓溶解、纤溶和血管修复、小腿肌泵作用和功能能力的机制来帮助治疗DVT和预防PTS。这将为DVT后组织功能的维持和恢复提供一种新的治疗干预手段。