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NCT02148029 · ClinicalTrials.gov registry record · NA
Role of a Novel Exercise Program to Prevent Post-thrombotic Syndrome
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 107
- Enrollment target
NCT02148029: Completed NA study, sponsored by VA Office of Research and Development.
NCT02148029 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 107 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02148029, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 107 participants
- Enrollment target
Study 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.
Primary Outcome
The Villalta score quantifies severity of symptoms and can be used to diagnose Post-Thrombotic Syndrome (PTS). The Villalta score quantifies severity of symptoms and can be used to diagnose Post-Thrombotic Syndrome (PTS). Higher Villalta scores denote more severe symptoms and greater likelihood of PTS. The outcome measure is not the score itself, but change in scores over time, calculated by subtracting the baseline score from the score at the 2-year follow-up. The range of the Villalta score
Interventions
- OTHER Exercise
- OTHER Standard Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2014-09-15 |
| Est. Completion | 2021-08-31 |
| Phase | NA |
What the finished NCT02148029 record still lists
NCT02148029 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Exercise is the first listed.
NCT02148029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02148029 about?
NCT02148029 is a clinical study titled "Role of a Novel Exercise Program to Prevent Post-thrombotic Syndrome". 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 pro...
What is the current status of trial NCT02148029?
This trial is currently completed. It is a NA study. The enrollment target is 107 participants. The study started on 2014-09-15. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT02148029?
The interventions under investigation include: Exercise (OTHER), Standard Care (OTHER).
Who is sponsoring clinical trial NCT02148029?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02148029's enrollment target sits among peer trials
107 830th of 2000 higher than 1,171 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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