Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

University of Virginia

Status: Terminated

Conditions: Peripheral Arterial Disease

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02388685

IRB-HSR# 16084

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Home exercise

Experimental group

Description:

Patients will undergo home exercise therapy under the supervision of the exercise laboratory

Treatment:

Other: Exercise

No exercise

No Intervention group

Description:

Patients will continue with usual care