Role of a Novel Exercise Program to Prevent Post-thrombotic Syndrome (NCT02148029) | Clinical Trial Compass
CompletedNot Applicable
Role of a Novel Exercise Program to Prevent Post-thrombotic Syndrome
United States107 participantsStarted 2014-09-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
2-year Change in Villalta Score
Timeframe: Change from baseline to 2-year follow-up
2
2-year Change in VEINES-QOL Summary Score
Timeframe: Change from baseline to 2-year follow-up