The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• history of claudication assessed by the Walking Impairment Questionnaire,
• ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol,
• an ABI \<= 0.90 at rest or \> 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test.
• age \>= 60 years.
Locations
United States
Oklahoma
O'Donoghue Research Building, University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Contact Information
Primary
Andrew W. Gardner, Ph.D.
andrew-gardner@ouhsc.edu
405-271-4742
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 100
Treatments
Experimental: Non-Ischemic Exercise (NICE) exercise program
Patients will perform supervised treadmill walking for 3 months. Patients randomized to the NICE program will walk intermittently at a slow speed of approximately 1.4 mph for only 2-3 minute bouts that do not elicit claudication pain.
Active_comparator: Standard exercise program
Patients will perform supervised treadmill walking for 3 months. Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA), Case Western Reserve University
Leads: University of Oklahoma