Exercise Training After an Acute Blood Clot

NCT01864447 | Completed DMC

• 1 other identifier: CHRMS M13-219
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

VTE

Keywords

VTE; Exercise; Diet; Weight loss; DVT; PE

Outcome Measures

Primary Outcomes (1)

• Biomarkers of Obesity and VTE Recurrence

  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.

  3 months

Secondary Outcomes (1)

• Maximal Exercise Capacity

  3 months

Other Outcomes (2)

• Feasibility

  3 months

• Safety

  every 4 weeks, for up to 12 weeks

Study Arms (2)

VTE REHABILITATION

EXPERIMENTAL

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)

CONTROL

NO INTERVENTION

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

Interventions

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

VTE REHABILITATION

Eligibility Criteria

• Age: 16 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

Flether Allen Healthcare

Burlington, Vermont, 05401, United States

Location

Related Publications (38)

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MeSH Terms

Conditions

Motor Activity; Weight Loss

Interventions

HCE

Condition Hierarchy (Ancestors)

Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan G Lakoski, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, University of Vermont College of Medicine

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 29, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

US (1)