Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

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 Overview

• Status: Terminated
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home exercise; Patients will undergo home exercise therapy under the supervision of the exercise laboratory	Other: Exercise; Home exercise therapy
No Intervention: No exercise; Patients will continue with usual care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Christopher M Kramer, MD, University of Virginia Health System

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): November 22, 2023

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimated): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; exercise; magnetic resonance spectroscopy; perfusion; peripheral arterial disease; energetics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: IRB-HSR# 16084