Role of a Novel Exercise Program to Prevent Post-thrombotic Syndrome (EFFORT2)

Despite standard care, 25%-50% of patients with clots in the deep veins of the arms and legs progress to chronic post-clot problems resulting in significant disability, loss of productivity, and healthcare costs. Reverse flow in the veins from an organizing clot is the primary cause of post-clot problems. Veins with early clot breakdown have a lower incidence of reverse flow. The investigators have observed that clot breakdown is enhanced by increased blood flow and that moderate arm and leg exercise result in increased venous blood flow. Hence, the investigators predict that a supervised exercise program in patients with deep vein clots could increase leg vein blood flow, accelerate clot breakdown, and decrease the risk of post clot problems. The primary hypothesis is that increased blood flow across the clot (induced by supervised exercise) will increase clot breakdown and decrease severity of post clot problems. The investigators are conducting a randomized clinical trial of standard therapy compared to progressive exercise training in patients with leg deep vein clots.

Study Overview

• Status: Completed
• Conditions: Acute Deep Vein Thrombosis
• Intervention / Treatment: Other: Control; Other: Exercise

Detailed Description

Standard anticoagulation therapy for acute deep vein thrombosis (DVT) reflects the current short term focus on preventing pulmonary embolism (PE) and recurrent DVT. Despite standard care, 25% to 50% of patients with DVT progress to the chronic post-thrombotic syndrome (PTS) resulting in significant disability, loss of productivity, and healthcare costs. The investigators postulate that a supervised exercise program in patients with acute DVT could increase lower extremity venous flow, accelerate thrombus resolution, and thereby decrease the risk of PTS. If the patient is unable to perform exercises, NMES (neuromuscular electrical stimulation) will be used to induce contraction of the muscles of the lower extremities.

Aim 1 will test whether a 3-month exercise program has long-term clinical benefits in acute DVT. The primary outcome measures will be Villalta score for PTS and VEINS-QOL score (Venous Insufficiency Epidemiological and Economic Study-QOL) for venous quality of life at 2 years of follow-up. Aim 2 will evaluate whether exercise therapy in patients with acute DVT enhances thrombus resolution. Aim 3 will assess the relationship between PTS, venous hemodynamics and exercise capacity.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Acute Lower Extremity DVT
• Documented by ultrasound, CT/MR venogram, or conventional venogram
• Documented within 4 weeks of onset of symptoms
• Age 18 years

Exclusion Criteria:

• Peripheral arterial disease (disabling claudication, rest pain, tissue loss) with ABI<0.5
• Immediate need for thrombolysis/thrombectomy
• DVT involving the IVC
• Contraindication to anticoagulation
• Contraindications to exercise training
• Medical illness interfering with evaluation/follow-up
• Life expectancy <2 years
• Pregnancy
• Inability to walk
• Hemodynamically significant PE

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control; Standard care: anticoagulation, compression & ad-lib ambulation	Other: Control; Standard care: anticoagulation, compression & ad-lib ambulation
EXPERIMENTAL: Exercise; Standard care + Interventional Exercise therapy	Other: Control; Standard care: anticoagulation, compression & ad-lib ambulation; Other: Exercise; Upper and Lower extremity exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Thrombotic Syndrome (Villalta Score)	Post Thrombotic Syndrome (Villalta Score)	2 years
Quality of LIfe (SF 36, VEINS-QOL)	Quality of LIfe (SF 36, VEINS-QOL)	2 years

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Maryland, College Park
• Investigators: Principal Investigator: Brajesh K Lal, MD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2014
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (ESTIMATE): May 28, 2014

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Post thrombotic syndrome; Deep vein thrombosis; Thrombus resolution
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: F0995-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No