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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02388685
Other study ID # IRB-HSR# 16084
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date November 22, 2023

Study information

Verified date November 2023
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date November 22, 2023
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 35 Years to 85 Years
Eligibility 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 Design


Intervention

Other:
Exercise
Home exercise therapy

Locations

Country Name City State
United States University of Virginia Health System Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exercise calf muscle perfusion Arterial spin labeling MRI at peak exercise Change from baseline at 12 weeks
Primary Exercise calf muscle energetics Phosphocreatine recovery kinetics by MR spectroscopy at end exercise Change from baseline at 12 weeks
Secondary Calf muscle capillary density Biopsy sample of calf muscle for capillary density Change from baseline at 12 weeks
Secondary Treadmill testing Treadmill testing with peak VO2 measures Change from baseline at 12 weeks
Secondary 6-minute walk test 6-minute walk test Change from baseline at 12 weeks
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