Peripheral Arterial Disease
Conditions
Keywords
peripheral arterial disease, exercise, perfusion, energetics, magnetic resonance imaging, magnetic resonance spectroscopy
Brief 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).
Detailed description
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.
Interventions
OTHERExercise
Home exercise therapy
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise calf muscle perfusion | Change from baseline at 12 weeks | Arterial spin labeling MRI at peak exercise |
| Exercise calf muscle energetics | Change from baseline at 12 weeks | Phosphocreatine recovery kinetics by MR spectroscopy at end exercise |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calf muscle capillary density | Change from baseline at 12 weeks | Biopsy sample of calf muscle for capillary density |
| Treadmill testing | Change from baseline at 12 weeks | Treadmill testing with peak VO2 measures |
| 6-minute walk test | Change from baseline at 12 weeks | 6-minute walk test |
Countries
United States
Outcome results
None listed