Feasibility Study of Exercise in Patients With Leg Blood Clots (EXPERT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Suman Rathbun, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00910364
First received: May 28, 2009
Last updated: October 30, 2013
Last verified: October 2013

May 28, 2009
October 30, 2013
October 2008
December 2012   (final data collection date for primary outcome measure)
Villalta PTS score [ Time Frame: at 26 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00910364 on ClinicalTrials.gov Archive Site
PTS, venous valvular reflux, VEINES, MOS SF-36, maximal treadmill test, 6-minute walk, and blood analysis [ Time Frame: at 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Feasibility Study of Exercise in Patients With Leg Blood Clots
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).

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Deep Vein Thrombosis
Other: Exercise
Exercise
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
December 2014
December 2012   (final data collection date for primary outcome measure)

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.
Both
21 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00910364
14181, ORA #20081607
Yes
Suman Rathbun, University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Suman W. Rathbun, M.D. Oklahoma University Health Sciences Center
University of Oklahoma
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP