EXPERT Trial: Exercise to Prevent Post-thrombotic Syndrome Elicited by Recent Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Villalta PTS score
研究概览
简要总结
The purpose of this pilot study is to assess the feasibility of determining the effects of a structured exercise program started two to four weeks after diagnosis of a first episode lower-extremity deep vein thrombosis (DVT) for a period of 12 weeks in reducing the incidence of post-thrombotic syndrome (PTS).
详细描述
Deep Vein Thrombosis (DVT) affects nearly 300,000 people in the U.S. each year. DVT of the leg results in PTS in up to 65% of patients,despite receiving appropriate medical management with anticoagulant therapy.
PTS, caused by persistent venous outflow obstruction and venous valvular dysfunction, may result in symptoms of leg pain, swelling, heaviness and cramping especially with prolonged standing.
All eligible patients with documented first-episode DVT interested in participating will undergo medical screening and a screening treadmill test prior to enrollment between two and four weeks post DVT diagnosis. All patients will be provided and asked to wear class II (30 to 40mmHg) knee length compression hose daily during the entire trial.
The formal exercise training includes both a supervised walking program and a home-based walking program for 12 weeks with follow-up at 26 weeks. Blood tests will be taken to measure levels of indicators of inflammation at baseline, week 4, week 12, and week 26. The primary outcomes will be the feasibility of the exercise program and the incidence of post-thrombotic syndrome at 26 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First episode lower extremity DVT (proximal or distal) documented by ultrasound, CT angiogram or venogram within last 4 weeks.
- •Treatment with LMWH, or unfractionated heparin (UFH) followed by warfarin adjusted to keep INR 2 to 3 for at least 3 months, or LMWH given in therapeutic doses as sole therapy.
- •Age 21 to 75 years old.
排除标准
- •Recurrent DVT.
- •Treatment of DVT with systemic or catheter-directed thrombolysis Contraindications to exercise training according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.,).
- •Life expectancy < 1 year.
- •Pregnancy.
- •Geographic inaccessibility.
- •Screening (pre-randomization) exercise stress test demonstrating contraindication to exercise training (see exclusion #2).
- •Cognitive dysfunction assessed by mini-mental status exam (score < 24).
- •Inability to walk.
结局指标
主要结局
Villalta PTS score
时间窗: at 26 weeks
次要结局
- PTS, venous valvular reflux, VEINES, MOS SF-36, maximal treadmill test, 6-minute walk, and blood analysis(at 12 weeks)
研究者
Suman Rathbun
Professor of Medicine
University of Oklahoma