Clinical trial NCT01864447: Exercise Training After an Acute Blood Clot
Official title: An Exercise Training and Behavioral Weight Loss Program After an Acute Blood Clot: TRAIN ABC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: VTE
Keywords: VTE
Exercise
Diet
Weight loss
DVT
PE
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biomarkers of Obesity and VTE Recurrence
timeFrame: 3 months
Secondary outcomes:
measure: Maximal Exercise Capacity
timeFrame: 3 months
Other outcomes:
measure: Feasibility
timeFrame: 3 months
measure: Safety
timeFrame: every 4 weeks, for up to 12 weeks
Locations:
city: Burlington
country: United States
facility: Flether Allen Healthcare
state: Vermont
Study officials:
affiliation: University of Vermont
name: Susan G Lakoski, MD
role: PRINCIPAL_INVESTIGATOR
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