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

NCT02148029 | Completed Results DMC

• 1 other identifier: F0995-R
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Deep Vein Thrombosis

Keywords

Deep vein thrombosis; Post thrombotic syndrome; Thrombus resolution

Outcome Measures

Primary Outcomes (2)

• 2-year Change in Villalta Score

  The Villalta score quantifies severity of symptoms and can be used to diagnose Post-Thrombotic Syndrome (PTS). The Villalta score quantifies severity of symptoms and can be used to diagnose Post-Thrombotic Syndrome (PTS). Higher Villalta scores denote more severe symptoms and greater likelihood of PTS. The outcome measure is not the score itself, but change in scores over time, calculated by subtracting the baseline score from the score at the 2-year follow-up. The range of the Villalta score is 0-33, so the minimum possible change is -33 and the maximum possible change is 33, with 0 indicating no change in Villalta scores (same score at baseline and at 2-year follow-up). An increase (positive change) in Villalta score indicates worsening symptoms, while a decrease (negative change) indicates improving symptoms.

  Change from baseline to 2-year follow-up

• 2-year Change in VEINES-QOL Summary Score

  The VEINES-QOL summary score is calculated from the Venous Insufficiency Epidemiological and Economic Study (VEINES) Quality of Life (QOL) questionnaire, and it provides an estimate of the overall impact of deep venous thrombosis (DVT) on the patient's quality of life. A higher VEINES-QOL score indicates better quality of life. The outcome measure is not the score itself, but change in scores over time, calculated by subtracting the baseline score from the score at the 2-year visit. The range of the VEINES-QOL summary score is 25-117, so the minimum possible change is -92 and the maximum possible change is 92, with 0 indicating no change in VEINES-QOL scores (same score at baseline and at 2-year follow-up). An increase (positive change) in VEINES-QOL score indicates an improvement in quality of life, and a decrease (negative change) indicates worsening quality of life.

  Change from baseline to 2-year follow-up

Secondary Outcomes (2)

• 2-year Change in SF-36 Domain Scores

  Change from baseline to 2-year follow-up

• 3-month Percent-change in Thrombus Volume

  Change from baseline to 3-month follow-up

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard care: anticoagulation, compression, and ad-lib ambulation

Other: Standard Care

Exercise

EXPERIMENTAL

Standard care + Interventional Exercise therapy

Other: Exercise; Other: Standard Care

Interventions

Exercise OTHER

Upper and Lower extremity exercise

Exercise

Standard Care OTHER

anticoagulation, compression, and ad-lib ambulation

Control; Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute Lower Extremity DVT
• DVT documented by ultrasound, CT/Magnetic Resonance imaging (MR) venogram, or conventional venogram
• Enrolled within 4 weeks of onset of symptoms
• Age 18 years or older

You may not qualify if:

• Peripheral arterial disease (disabling claudication, rest pain, tissue loss) with ankle brachial index (ABI)\<0.5
• Immediate need for thrombolysis/thrombectomy
• DVT involving the inferior vena cava (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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Maryland: collaborator

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome

Interventions

Exercise; Standard of Care

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Brajesh K. Lal
• Organization: Veterans Administration of Baltimore Maryland

blal@som.umaryland.edu

410-328-5840

Study Officials

• Brajesh K Lal, MD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 28, 2014
• Study Start: September 15, 2014
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)