The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention 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 Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).
Key facts
- Study ID
- NCT05712395
- Run by
- University of Oklahoma
- People needed
- 100
- Starts
- 2024-09-09
- Expected to finish
- 2029-07-31
- Last updated by the study team
- 2026-05-29
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 >= 40 years.
You may not qualify if…
- absence of PAD (ABI > 0.90 at rest and ankle systolic blood pressure < 20% decrease after exercise,
- inability to obtain an ABI measure due to non-compressible vessels (ABI > 1.40),
- asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,
- rest pain due to PAD (Fontaine stage III)
- tissue loss due to PAD (Fontaine stage IV)
- 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, or peripheral revascularization performed during the study,
- exercise tolerance limited by any disease process other than PAD,
- active cancer,
- kidney failure defined as stage 5 chronic kidney disease,
- a calf skin fold measurement > 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue,
- pulse arterial oxygen saturation of the index finger < 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and
- failure to complete the baseline run-in phase 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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