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

April 11, 2017 updated by: Suman Rathbun, University of Oklahoma

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma city, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exercise testing
Feasibility study; all participants receive intervention
Other: Exercise
Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Villalta PTS score
Time Frame: at 26 weeks
at 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PTS, venous valvular reflux, VEINES, MOS SF-36, maximal treadmill test, 6-minute walk, and blood analysis
Time Frame: at 12 weeks
at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (ESTIMATE)

May 29, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14181
  • ORA #20081607 (OTHER: Office of Research Administration)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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