Feasibility Study of Exercise in Patients With Leg Blood Clots
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 3/29/2017 |
| Start Date: | October 2008 |
| End Date: | December 2016 |
EXPERT Trial: Exercise to Prevent Post-thrombotic Syndrome Elicited by Recent Thrombosis
The purpose of this pilot study is to assess the feasibility of determining the effects of a
structured exercise program started two to four weeks after diagnosis of a first episode
lower-extremity deep vein thrombosis (DVT) for a period of 12 weeks in reducing the
incidence of post-thrombotic syndrome (PTS).
structured exercise program started two to four weeks after diagnosis of a first episode
lower-extremity deep vein thrombosis (DVT) for a period of 12 weeks in reducing the
incidence of post-thrombotic syndrome (PTS).
Deep Vein Thrombosis (DVT) affects nearly 300,000 people in the U.S. each year. DVT of the
leg results in PTS in up to 65% of patients,despite receiving appropriate medical management
with anticoagulant therapy.
PTS, caused by persistent venous outflow obstruction and venous valvular dysfunction, may
result in symptoms of leg pain, swelling, heaviness and cramping especially with prolonged
standing.
All eligible patients with documented first-episode DVT interested in participating will
undergo medical screening and a screening treadmill test prior to enrollment between two and
four weeks post DVT diagnosis. All patients will be provided and asked to wear class II (30
to 40mmHg) knee length compression hose daily during the entire trial.
The formal exercise training includes both a supervised walking program and a home-based
walking program for 12 weeks with follow-up at 26 weeks. Blood tests will be taken to
measure levels of indicators of inflammation at baseline, week 4, week 12, and week 26. The
primary outcomes will be the feasibility of the exercise program and the incidence of
post-thrombotic syndrome at 26 weeks.
leg results in PTS in up to 65% of patients,despite receiving appropriate medical management
with anticoagulant therapy.
PTS, caused by persistent venous outflow obstruction and venous valvular dysfunction, may
result in symptoms of leg pain, swelling, heaviness and cramping especially with prolonged
standing.
All eligible patients with documented first-episode DVT interested in participating will
undergo medical screening and a screening treadmill test prior to enrollment between two and
four weeks post DVT diagnosis. All patients will be provided and asked to wear class II (30
to 40mmHg) knee length compression hose daily during the entire trial.
The formal exercise training includes both a supervised walking program and a home-based
walking program for 12 weeks with follow-up at 26 weeks. Blood tests will be taken to
measure levels of indicators of inflammation at baseline, week 4, week 12, and week 26. The
primary outcomes will be the feasibility of the exercise program and the incidence of
post-thrombotic syndrome at 26 weeks.
Inclusion Criteria:
- First episode lower extremity DVT (proximal or distal) documented by ultrasound, CT
angiogram or venogram within last 4 weeks.
- Treatment with LMWH, or unfractionated heparin (UFH) followed by warfarin adjusted to
keep INR 2 to 3 for at least 3 months, or LMWH given in therapeutic doses as sole
therapy.
- Age 21 to 75 years old.
Exclusion Criteria:
- Recurrent DVT.
- Treatment of DVT with systemic or catheter-directed thrombolysis Contraindications to
exercise training according to the American College of Sports Medicine (e.g., acute
myocardial infarction, unstable angina, etc.,).
- Life expectancy < 1 year.
- Pregnancy.
- Geographic inaccessibility.
- Screening (pre-randomization) exercise stress test demonstrating contraindication to
exercise training (see exclusion #2).
- Cognitive dysfunction assessed by mini-mental status exam (score < 24).
- Inability to walk.
We found this trial at
1
site
940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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