Non-painful exercise program for patients with Peripheral Artery Disease

The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease

This study is testing a new exercise program that doesn’t cause pain to see if it can help people with Peripheral Artery Disease walk better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: University of Oklahoma (Academic / other)
• Locations: 1 site (Oklahoma City, Oklahoma)
• Trial ID: NCT05712395 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 and older with a history of claudication and confirmed Peripheral Artery Disease.

Not a fit: Patients with asymptomatic PAD, rest pain, or tissue loss due to PAD will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve walking ability and quality of life for patients suffering from Peripheral Artery Disease.

How similar studies have performed: While similar approaches have been explored, this specific non-ischemic exercise intervention is novel and has not been extensively tested in prior studies.

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 \>= 60 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 this trial is running

Oklahoma City, Oklahoma

• 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.

Conditions Claudication; Peripheral Artery Disease