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
  Purpose

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).


Condition Intervention
Deep Vein Thrombosis
Other: Exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: EXPERT Trial: Exercise to Prevent Post-thrombotic Syndrome Elicited by Recent Thrombosis

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Villalta PTS score [ Time Frame: at 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
Study Start Date: October 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Exercise
    Exercise
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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910364

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma city, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Suman W. Rathbun, M.D. Oklahoma University Health Sciences Center
  More Information

No publications provided

Responsible Party: Suman Rathbun, Professor of Medicine, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00910364     History of Changes
Other Study ID Numbers: 14181, ORA #20081607
Study First Received: May 28, 2009
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Lower extremity DVT
Clot
leg clot
Deep vein thrombosis
Thrombosis
Warfarin

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014