NCT05712395 The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
| NCT ID | NCT05712395 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oklahoma |
| Condition | Claudication |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2029-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-09-09 with a primary completion date of 2029-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. history of claudication assessed by the Walking Impairment Questionnaire, 2. 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, 3. 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. 4. age \>= 40 years. Exclusion Criteria: 1. absence of PAD (ABI \> 0.90 at rest and ankle systolic blood pressure \< 20% decrease after exercise, 2. inability to obtain an ABI measure due to non-compressible vessels (ABI \> 1.40), 3. asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test, 4. rest pain due to PAD (Fontaine stage III) 5. tissue loss due to PAD (Fontaine stage IV) 6. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation, 7. peripheral revascularization within one month prior to investigation, or peripheral revascularization performed during the study, 8. exercise tolerance limited by any disease process other than PAD, 9. active cancer, 10. kidney failure defined as stage 5 chronic kidney disease, 11. a calf skin fold measurement \> 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue, 12. pulse arterial oxygen saturation of the index finger \< 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and 13. failure to complete the baseline run-in phase within three weeks.
Contact & Investigator
Andrew W. Gardner, Ph.D
PRINCIPAL INVESTIGATOR
Professor, Department of Medicine, Cardiology
Frequently Asked Questions
Who can join the NCT05712395 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Claudication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05712395 currently recruiting?
Yes, NCT05712395 is actively recruiting participants. Contact the research team at andrew-gardner@ouhsc.edu for enrollment information.
Where is the NCT05712395 trial being conducted?
This trial is being conducted at Oklahoma City, United States.
Who is sponsoring the NCT05712395 clinical trial?
NCT05712395 is sponsored by University of Oklahoma. The principal investigator is Andrew W. Gardner, Ph.D at Professor, Department of Medicine, Cardiology. The trial plans to enroll 100 participants.