Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home exercise<br>Patients will undergo home exercise therapy under the supervision of the exercise laboratory | Other: Exercise<br>* Home exercise therapy<br>|
| No Intervention: No exercise<br>Patients will continue with usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise calf muscle perfusion | Arterial spin labeling MRI at peak exercise | Change from baseline at 12 weeks | 
| Exercise calf muscle energetics | Phosphocreatine recovery kinetics by MR spectroscopy at end exercise | Change from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calf muscle capillary density | Biopsy sample of calf muscle for capillary density | Change from baseline at 12 weeks | 
| Treadmill testing | Treadmill testing with peak VO2 measures | Change from baseline at 12 weeks | 
| 6-minute walk test | 6-minute walk test | Change from baseline at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral arterial disease, exercise, perfusion, energetics, magnetic resonance imaging, magnetic resonance spectroscopy