VTE
Conditions
Keywords
VTE, Exercise, Diet, Weight loss, DVT, PE
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.
Interventions
BEHAVIORALVTE REHABILITATION: High-Caloric Expenditure Exercise Training (HCE) and The Dietary Behavioral Weight Loss Intervention (BWL)
Sponsors
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 79 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers of Obesity and VTE Recurrence | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximal Exercise Capacity | 3 months | Maximal exercise capacity will be assessed on the treadmill with measurement of peak oxygen uptake, duration of treadmill exercise and maximal exercise intensity in METS. A continuous modified-Balke protocol will be used, with exercise increasing gradually at 1 MET increments at 2 minute intervals. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 3 months | Feasibility will be evaluated by assessing the rates of study eligibility, acceptance, and overall accrual. |
| Safety | every 4 weeks, for up to 12 weeks | Safety will be evaluated by the type and prevalence of adverse events during exercise-related assessments. |
Countries
United States
Outcome results
None listed