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

Completed · Not applicable

Conditions studied: Acute Deep Vein Thrombosis

In brief

Despite standard care, 25%-50% of patients with clots in the deep veins of the arms and legs progress to chronic post-clot problems resulting in significant disability, loss of productivity, and healthcare costs. Reverse flow in the veins from an organizing clot is the primary cause of post-clot problems. Veins with early clot breakdown have a lower incidence of reverse flow. The investigators have observed that clot breakdown is enhanced by increased blood flow and that moderate arm and leg exercise result in increased venous blood flow. Hence, the investigators predict that a supervised exercise program in patients with deep vein clots could increase leg vein blood flow, accelerate clot breakdown, and decrease the risk of post clot problems. The primary hypothesis is that increased blood flow across the clot (induced by supervised exercise) will increase clot breakdown and decrease severity of post clot problems. The investigators are conducting a randomized clinical trial of standard therapy compared to progressive exercise training in patients with leg deep vein clots.

Key facts

Study ID

NCT02148029

Run by

VA Office of Research and Development

People needed

107

Starts

2014-09-15

Expected to finish

2021-08-31

Last updated by the study team

2024-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute Lower Extremity DVT
• DVT documented by ultrasound, CT/Magnetic Resonance imaging (MR) venogram, or conventional venogram
• Enrolled within 4 weeks of onset of symptoms
• Age 18 years or older

You may not qualify if…

• Peripheral arterial disease (disabling claudication, rest pain, tissue loss) with ankle brachial index (ABI)\<0.5
• Immediate need for thrombolysis/thrombectomy
• DVT involving the inferior vena cava (IVC)
• Contraindication to anticoagulation
• Contraindications to exercise training
• Medical illness interfering with evaluation/follow-up
• Life expectancy \<2 years
• Pregnancy
• Inability to walk
• Hemodynamically significant PE

Where it is running

• Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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