The Effects of Diet and Exercise Interventions in Peripheral Artery Disease
Recruiting now · Not applicable
Conditions studied: Claudication, Peripheral Artery Disease
In brief
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.
Key facts
- Study ID
- NCT03845036
- Run by
- University of Oklahoma
- People needed
- 150
- Starts
- 2024-09-16
- Expected to finish
- 2029-05-31
- Last updated by the study team
- 2026-04-17
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- History of claudication,
- Presence of PAD, defined by meeting at least one of the following criteria (ABI at rest < 0.90, or > 20% decrease in ABI following a heel-rise exercise test in patients with a normal ABI at rest (> 0.90), or history of peripheral revascularization.
You may not qualify if…
- absence of PAD, defined by meeting all of the following 3 criteria (ABI at rest > 0.90), < 20% decrease in ABI following a heel-rise exercise test, and no history of peripheral revascularization,
- non-compressible vessels (ABI > 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 indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
- peripheral revascularization within one month prior to investigation,
- active cancer,
- end stage renal disease defined as stage 5 chronic kidney disease,
- medical conditions that are contraindicative for exercise according to the American College of Sports Medicine,
- cognitive dysfunction (mini-mental state examination score < 24), and
- failure to complete the baseline tests within three weeks.
Where it is running
- O'Donoghue Research Building, University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
Full record on ClinicalTrials.gov
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