Charlottesville, Virginia 22908


Purpose:

The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control).


Study summary:

The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control). Patients will be studied before and after program completion with MRI/MRS, calf muscle biopsy for capillary density, and exercise performance measures. Arterial spin labeling peak exercise calf muscle perfusion will be used as the primary endpoint in the most symptomatic leg. All will undergo ASL, peak exercise PCr recovery kinetics, calf muscle biopsy, and functional measures including treadmill exercise, VO2 testing, and 6-minute walk. Correlations will be examined between changes in perfusion and energetics with changes in capillary density, peak VO2, and functional capacity from before to after completion of home exercise therapy.


Criteria:

Inclusion Criteria: - Documented ABI 0.5-0.9 - Ability to walk on treadmill Exclusion Criteria: - Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment - Critical limb ischemia - Known or suspected peripheral neuropathy, heel cord contracture and foot deformity - Other conditions that limit walking, e.g. lung disease or arthritis - Active coronary artery disease such as unstable angina, significant left main disease or three vessel coronary artery disease (>70% stenosis, unprotected by grafts) or recent (<2 months) myocardial infarction, - BMI > 40, - Known contraindication to MRI (intracardiac pacer, defibrillator, certain intracranial aneurysm clips, intraocular or cochlear implants, claustrophobia, etc.) - Allergy to lidocaine or xylocaine (local anesthetic)


NCT ID:

NCT02388685


Primary Contact:

Principal Investigator
Christopher M Kramer, MD
University of Virginia Health System

Christopher M Kramer, MD
Phone: 4342430736
Email: ckramer@virginia.edu


Backup Contact:

N/A


Location Contact:

Charlottesville, Virginia 22908
United States

Christopher M Kramer, MD
Phone: 434-243-0736
Email: ckramer@virginia.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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