Actively Recruiting
The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
Led by University of Oklahoma · Updated on 2025-06-12
100
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
Sponsors
U
University of Oklahoma
Lead Sponsor
C
Case Western Reserve University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of claudication assessed by the Walking Impairment Questionnaire
- Leg pain with walking consistent with intermittent claudication confirmed by a graded treadmill test
- Ankle-brachial index (ABI) of 0.90 or less at rest, or more than 20% decrease in ankle systolic blood pressure after exercise
- Age 60 years or older
You will not qualify if you...
- No peripheral artery disease (ABI greater than 0.90 at rest and less than 20% decrease after exercise)
- Inability to measure ABI due to non-compressible vessels (ABI greater than 1.40)
- Asymptomatic PAD (Fontaine Stage I)
- Rest pain from PAD (Fontaine Stage III)
- Tissue loss from PAD (Fontaine Stage IV)
- Use of cilostazol or pentoxifylline started within 3 months prior
- Peripheral revascularization within 1 month prior or during study
- Exercise limitations from other diseases
- Active cancer
- Stage 5 chronic kidney disease
- Calf skin fold measurement greater than 25 mm
- Pulse oxygen saturation of the finger less than 95%
- Failure to complete baseline run-in phase within 3 weeks
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
O'Donoghue Research Building, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117
Actively Recruiting
Research Team
A
Andrew W. Gardner, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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