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Exercise Training After an Acute Blood Clot (TRAIN ABC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01864447
First Posted: May 29, 2013
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Susan Lakoski, University of Vermont
  Purpose
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 Intervention
VTE Behavioral: VTE REHABILITATION: High-Caloric Expenditure Exercise Training (HCE) and The Dietary Behavioral Weight Loss Intervention (BWL)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Susan Lakoski, University of Vermont:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Maximal Exercise Capacity [ Time Frame: 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 [ Time Frame: 3 months ]
    Feasibility will be evaluated by assessing the rates of study eligibility, acceptance, and overall accrual.

  • Safety [ Time Frame: every 4 weeks, for up to 12 weeks ]
    Safety will be evaluated by the type and prevalence of adverse events during exercise-related assessments.


Enrollment: 20
Study Start Date: May 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 79 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864447


Locations
United States, Vermont
Flether Allen Healthcare
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Susan G Lakoski, MD University of Vermont
  More Information

Publications:

Responsible Party: Susan Lakoski, Assistant Professor, University of Vermont College of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT01864447     History of Changes
Other Study ID Numbers: CHRMS M13-219
First Submitted: May 17, 2013
First Posted: May 29, 2013
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Susan Lakoski, University of Vermont:
VTE
Exercise
Diet
Weight loss
DVT
PE