Non-painful exercise program for patients with Peripheral Artery Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a novel Non-Ischemic Exercise (NICE) program designed to improve walking ability and quality of life in patients with Peripheral Artery Disease (PAD). Over three months, 100 participants will be randomly assigned to either the NICE program or a standard painful exercise regimen, with outcomes measured in terms of ambulation, health-related quality of life, and vascular function. The study aims to demonstrate that the NICE program can enhance microvascular mechanisms without causing leg ischemia, leading to better overall results compared to traditional methods.

Why it matters

Who can join: the full rules

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.

Where it's running

• O'Donoghue Research Building, University of Oklahoma Health Sciences Center
  Oklahoma City, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Andrew W. Gardner, Ph.D — Professor, Department of Medicine, Cardiology
• Study coordinator: Andrew W. Gardner, Ph.D.
• Email: andrew-gardner@ouhsc.edu
• Phone: 405-271-4742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.