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N/A N=102 Randomized Treatment

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

Acute Deep Vein Thrombosis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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