TRAIN ABC: Exercise Training After an Acute Blood Clot

Sponsor

University of Vermont (Other)

Overall Status

Completed

CT.gov ID

NCT01864447

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
VTE	Behavioral: VTE REHABILITATION: High-Caloric Expenditure Exercise Training (HCE) and The Dietary Behavioral Weight Loss Intervention (BWL)	N/A

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

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Exercise Training and Behavioral Weight Loss Program After an Acute Blood Clot: TRAIN ABC

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VTE REHABILITATION The exercise prescription emphasizes gradual progression to longer duration (45-60 minutes per session), lower intensity (60-70% peak heart rate (PHR) exercise. Subjects have an exercise expenditure goal of >3000 kcal/wk, attained after 2 to 4 weeks of gradually lengthening exercise bouts. All exercise sessions will be performed onsite for the first two weeks, after which subjects will perform 2 additional sessions a week in the home environment. Exercise logs will be reviewed weekly. The Dietary Behavioral Weight Loss Intervention(BWL) intervention consists primarily of 12 small group sessions led by a dietician emphasizing dietary records, itemization of food, and caloric content. Subjects will be given individualized daily caloric goals 500 kcal less than predicted maintenance calories based on their baseline body weight.	Behavioral: VTE REHABILITATION: High-Caloric Expenditure Exercise Training (HCE) and The Dietary Behavioral Weight Loss Intervention (BWL)
No Intervention: CONTROL The 12-week program will consist of monthly phone contacts to check-in to capture physical activity done outside of the intervention setting.

Arm

Intervention/Treatment

Experimental: VTE REHABILITATION

The exercise prescription emphasizes gradual progression to longer duration (45-60 minutes per session), lower intensity (60-70% peak heart rate (PHR) exercise. Subjects have an exercise expenditure goal of >3000 kcal/wk, attained after 2 to 4 weeks of gradually lengthening exercise bouts. All exercise sessions will be performed onsite for the first two weeks, after which subjects will perform 2 additional sessions a week in the home environment. Exercise logs will be reviewed weekly. The Dietary Behavioral Weight Loss Intervention(BWL) intervention consists primarily of 12 small group sessions led by a dietician emphasizing dietary records, itemization of food, and caloric content. Subjects will be given individualized daily caloric goals 500 kcal less than predicted maintenance calories based on their baseline body weight.

Behavioral: VTE REHABILITATION: High-Caloric Expenditure Exercise Training (HCE) and The Dietary Behavioral Weight Loss Intervention (BWL)

No Intervention: CONTROL

The 12-week program will consist of monthly phone contacts to check-in to capture physical activity done outside of the intervention setting.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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