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

Acute Deep Vein Thrombosis Clinical Trial

— EFFORT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148029
• Other study ID #: F0995-R
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Deep Vein Thrombosis
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Exercise
Upper and Lower extremity exercise
• Control
Standard care: anticoagulation, compression & ad-lib ambulation

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Maryland, College Park

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Thrombotic Syndrome (Villalta Score)	Post Thrombotic Syndrome (Villalta Score)	2 years
Primary	Quality of LIfe (SF 36, VEINS-QOL)	Quality of LIfe (SF 36, VEINS-QOL)	2 years