Actively Recruiting
The Effects of Diet and Exercise Interventions in Peripheral Artery Disease
Led by University of Oklahoma · Updated on 2026-04-17
150
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
Sponsors
U
University of Oklahoma
Lead Sponsor
M
Milton S. Hershey Medical Center
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 DASH dietary program combined with a home-based exercise program, quantified by a step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.
CONDITIONS
Official Title
The Effects of Diet and Exercise Interventions in Peripheral Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of claudication
- Presence of peripheral artery disease, defined by one or more of the following: resting ankle-brachial index (ABI) less than 0.90, more than 20% decrease in ABI after heel-rise exercise if resting ABI is above 0.90, or previous peripheral revascularization
You will not qualify if you...
- No peripheral artery disease, defined by resting ABI greater than 0.90, less than 20% decrease in ABI after heel-rise exercise, and no history of peripheral revascularization
- Non-compressible vessels (ABI greater than 1.40)
- Rest pain due to PAD (Fontaine stage III; Rutherford Grade II)
- Tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III)
- Use of medications for intermittent claudication (cilostazol or pentoxifylline) started within three months before the study
- Peripheral revascularization within one month before the study
- Active cancer
- End stage renal disease (stage 5 chronic kidney disease)
- Medical conditions that contraindicate exercise as per the American College of Sports Medicine
- Cognitive dysfunction with mini-mental state examination score below 24
- Failure to complete baseline tests within three weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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 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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