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| ID | Type | Description | Link |
|---|---|---|---|
| ORA #20081607 | Other Identifier | Office of Research Administration |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise testing | Experimental | Feasibility study; all participants receive intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| Villalta PTS score | at 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PTS, venous valvular reflux, VEINES, MOS SF-36, maximal treadmill test, 6-minute walk, and blood analysis | at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suman W. Rathbun, M.D. | Oklahoma University Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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