Improving Exercise Rehabilitation Efficacy Outcomes Veterans Peripheral Artery Disease
Peripheral Artery Disease (D058729), Oxidative Stress (D018384), Inflammation (D007249)
About this trial
This is an interventional treatment trial for Peripheral Artery Disease (D058729) focused on measuring inflammation (D007249), Skeletal muscle (D018482), Antioxidants (D000975)
Eligibility Criteria
Inclusion Criteria: Age 40 and older with clinically diagnosed femoropopliteal PAD (ankle-brachial index < 0.9) Must understand the study requirements and be willing and able to sign an informed consent document Patients with mild cognitive impairment (i.e., montreal cognitive assessment (MOCA) <26) will be included but must have a responsible caregiver or spouse present during the informed consent Women that are not pregnant, breastfeeding, or likely to become pregnant within the next 6 months Exclusion Criteria: Patients with a bleeding disorder that would contraindicate the performance of a muscle biopsy, such as a history of clinically significant bleeding diathesis (i.e., Hemophilia A or B, Von Willebrand's Disease, or congenital Factor VII deficiency) Patients with a complex atherosclerotic lesion such that withholding medication creates disproportionate risk Women currently taking hormone replacement therapy Any other condition or event considered exclusionary by the PI and faculty physician
Sites / Locations
- University of Utah Dept of Vascular Surgery
- VA Salt Lake City Health Care System, Salt Lake City, UTRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Exercise Rehabilitation+PB125
Exercise Rehabilitation with Placebo
Participants will be assigned to the Exercise+Placebo or Exercise+PB125 rehabilitation interventions using block randomization.
Participants will be assigned to the Exercise+Placebo rehabilitation interventions using block randomization.