Clinical trial NCT00910364: Feasibility Study of Exercise in Patients With Leg Blood Clots
Official title: EXPERT Trial: Exercise to Prevent Post-thrombotic Syndrome Elicited by Recent Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis
Keywords: Lower extremity DVT
Clot
leg clot
Deep vein thrombosis
Thrombosis
Warfarin
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-05-29
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 deep vein thrombosis (DVT) for a period of 12 weeks in reducing the incidence of post-thrombotic syndrome (PTS).

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Villalta PTS score
timeFrame: at 26 weeks
Secondary outcomes:
measure: PTS, venous valvular reflux, VEINES, MOS SF-36, maximal treadmill test, 6-minute walk, and blood analysis
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Oklahoma city
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: Oklahoma University Health Sciences Center
name: Suman W. Rathbun, M.D.
role: PRINCIPAL_INVESTIGATOR
References: