Feasibility Study of Exercise in Patients With Leg Blood Clots

Deep Vein Thrombosis Clinical Trial

— EXPERT  

Official title:

EXPERT Trial: Exercise to Prevent Post-thrombotic Syndrome Elicited by Recent Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910364
• Other study ID #: 14181
• Secondary ID: ORA #20081607
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: April 11, 2017
• Start date: October 2008
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2016
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Postthrombotic Syndrome
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Exercise
Exercise

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma city	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Villalta PTS score		at 26 weeks
Secondary	PTS, venous valvular reflux, VEINES, MOS SF-36, maximal treadmill test, 6-minute walk, and blood analysis		at 12 weeks