An Exercise Training and Behavioral Weight Loss Program After an Acute Blood Clot: TRAIN ABC
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Vermont
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Biomarkers of Obesity and VTE Recurrence
Study Overview
Brief Summary
Patients after an acute blood clot in the veins are at risk for leg-related complications such as pain, swelling, and immobility. In addition, the occurrence of blood clots can have major implications for personal health including weight gain, blood clot recurrence and impairment in cardiovascular functioning. The goal of this study is to determine whether aerobic exercise training is a therapeutic strategy to offset risk factors for recurrent blood clots or leg complications.
Detailed Description
Cardiac rehabilitation (CR), a formalized exercise and behavioral modification program, is the cornerstone of secondary prevention for heart disease. Implementation of CR early after an acute myocardial infarction (MI) is associated with improved cardiac function and survival. As such, CR is now standard of care for a majority of hospital-based discharge programs following coronary events. In stark contrast, no similar program exists following an acute venous thromboembolism (VTE or blood clot), despite a high rate of limb and respiratory disability after VTE, shared risk factors with heart disease, and known beneficial impact of exercise training on VTE complications (e.g. post-thrombotic syndrome, PTS).
Body weight is a key modifiable risk factor driving risk of incident and recurrent VTE. Obese patients with prior VTE have a 2-fold higher risk of a second VTE compared to normal weight patients.(1) Importantly, VTE recurrence risk escalates if weight control is not established. Weight gain after acute DVT is common, with a mean 7% increase over 6 months.(2) To date, however, there is limited evidence regarding whether early initiation of exercise training following acute DVT is safe and feasible and mitigates weight gain associated with a VTE diagnosis. Previously, a significant decrease in body weight and fat mass loss was demonstrated utilizing high-caloric expenditure exercise in the CR setting.(3) Delineating the impact of high-caloric expenditure exercise to induce weight loss and reduce VTE complications and recurrence is a critical first step toward evaluating the role of early post-VTE rehabilitation in the clinical setting.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 79 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of acute unprovoked proximal or distal DVT >= 6 weeks
- •On anticoagulation therapy
- •Patient self-report of ability to walk 10 minutes without interruption or pain
- •Age >=16 and <80
- •Willingness to participate in exercise rehabilitation program at Tilley Drive South Burlington
Exclusion Criteria
- •Symptomatic PE, defined as 1) right heart strain as assessed by computed tomography or echocardiogram, 2) resting hypoxia - resting oxygen saturation <92%
- •Provoked VTE: major surgery, trauma, or pregnancy
- •Medical condition that alters ability to walk for exercise
Outcomes
Primary Outcomes
Biomarkers of Obesity and VTE Recurrence
Time Frame: 3 months
Blood work will be taken at baseline and 3 months. Measures will include adiponectin, leptin, resistin, visfatin, CRP, IL-6, PAI-1, endogenous thrombin potential, and D-dimer.Samples will be processed in the clinic with attention to issues related to coagulation activation, and plasma and serum will be stored at -80 degrees C in our laboratory.
Secondary Outcomes
- Maximal Exercise Capacity(3 months)
Investigators
Susan Lakoski
Assistant Professor, University of Vermont College of Medicine
University of Vermont