Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

NCT02388685 | Terminated

• 1 other identifier: IRB-HSR# 16084
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial disease; exercise; perfusion; energetics; magnetic resonance imaging; magnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Calf muscle capillary density

  Change from baseline at 12 weeks

• Treadmill testing

  Change from baseline at 12 weeks

• 6-minute walk test

  Change from baseline at 12 weeks

Study Arms (2)

Home exercise

EXPERIMENTAL

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

Other: Exercise

No exercise

NO INTERVENTION

Patients will continue with usual care

Interventions

Exercise OTHER

Home exercise therapy

Home exercise

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented ABI 0.5-0.9
• Ability to walk on treadmill

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christopher M Kramer, MD

  University of Virginia Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 17, 2015
• Study Start: July 1, 2014
• Primary Completion: June 1, 2020
• Study Completion: November 22, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

US (1)