Status:
COMPLETED
Feasibility Study of Exercise in Patients With Leg Blood Clots
Lead Sponsor:
University of Oklahoma
Conditions:
Deep Vein Thrombosis
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
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 de...
Detailed Description
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 anticoagula...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00910364
Start Date
October 1 2008
End Date
December 1 2016
Last Update
April 13 2017
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104