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

NCT02148029 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-10-23

Study results available
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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.

Conditions

  • Acute Deep Vein Thrombosis

Interventions

OTHER

Exercise

Upper and Lower extremity exercise

OTHER

Standard Care

anticoagulation, compression, and ad-lib ambulation

Sponsors & Collaborators

  • University of Maryland

    collaborator OTHER

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Brajesh K Lal, MD · Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-15
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02148029 on ClinicalTrials.gov