Role of a Novel Exercise Program to Prevent Post-thrombotic Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/16/2019 |
| Start Date: | July 1, 2014 |
| End Date: | December 31, 2020 |
| Contact: | Miriam J Smyth, PhD |
| Email: | miriam.smyth@va.gov |
| Phone: | (410) 605-7130 |
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.
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.
Standard anticoagulation therapy for acute deep vein thrombosis (DVT) reflects the current
short term focus on preventing pulmonary embolism (PE) and recurrent DVT. Despite standard
care, 25% to 50% of patients with DVT progress to the chronic post-thrombotic syndrome (PTS)
resulting in significant disability, loss of productivity, and healthcare costs. The
investigators postulate that a supervised exercise program in patients with acute DVT could
increase lower extremity venous flow, accelerate thrombus resolution, and thereby decrease
the risk of PTS. If the patient is unable to perform exercises, NMES (neuromuscular
electrical stimulation) will be used to induce contraction of the muscles of the lower
extremities.
Aim 1 will test whether a 3-month exercise program has long-term clinical benefits in acute
DVT. The primary outcome measures will be Villalta score for PTS and VEINS-QOL score (Venous
Insufficiency Epidemiological and Economic Study-QOL) for venous quality of life at 2 years
of follow-up. Aim 2 will evaluate whether exercise therapy in patients with acute DVT
enhances thrombus resolution. Aim 3 will assess the relationship between PTS, venous
hemodynamics and exercise capacity.
short term focus on preventing pulmonary embolism (PE) and recurrent DVT. Despite standard
care, 25% to 50% of patients with DVT progress to the chronic post-thrombotic syndrome (PTS)
resulting in significant disability, loss of productivity, and healthcare costs. The
investigators postulate that a supervised exercise program in patients with acute DVT could
increase lower extremity venous flow, accelerate thrombus resolution, and thereby decrease
the risk of PTS. If the patient is unable to perform exercises, NMES (neuromuscular
electrical stimulation) will be used to induce contraction of the muscles of the lower
extremities.
Aim 1 will test whether a 3-month exercise program has long-term clinical benefits in acute
DVT. The primary outcome measures will be Villalta score for PTS and VEINS-QOL score (Venous
Insufficiency Epidemiological and Economic Study-QOL) for venous quality of life at 2 years
of follow-up. Aim 2 will evaluate whether exercise therapy in patients with acute DVT
enhances thrombus resolution. Aim 3 will assess the relationship between PTS, venous
hemodynamics and exercise capacity.
Inclusion Criteria:
- Acute Lower Extremity DVT
- Documented by ultrasound, CT/MR venogram, or conventional venogram
- Documented within 4 weeks of onset of symptoms
- Age 18 years
Exclusion Criteria:
- Peripheral arterial disease (disabling claudication, rest pain, tissue loss) with
ABI<0.5
- Immediate need for thrombolysis/thrombectomy
- DVT involving the 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
We found this trial at
1
site
Baltimore, Maryland 21201
Principal Investigator: Brajesh K Lal, MD
Phone: 410-605-7000
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