N/A
N=102
Role of a Novel Exercise Program to Prevent Post-thrombotic Syndrome
Acute Deep Vein Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT02148029 ↗Enrolled (actual)
102
Serious AEs
22.6%
Results posted
Oct 2024
Primary outcome: Primary: 2-year Change in Villalta Score — -1.5; -0.5 units on a scale — p=0.34
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise (Other); Standard Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-year Change in Villalta Score |
-1.5; -0.5 | 0.34 |
| PRIMARY 2-year Change in VEINES-QOL Summary Score |
6.4; 6.9 | 0.89 |
| SECONDARY 2-year Change in SF-36 Domain Scores |
20.2; 14.4; 5.2; 10.2; 3.1; 5.8 | 0.43 |
| SECONDARY 3-month Percent-change in Thrombus Volume |
-35.9; -69.8 | 0.27 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02148029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.