Improving Mobility After Revascularization in Peripheral Artery Disease

Launched by NORTHWESTERN UNIVERSITY · Nov 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying ways to help people with Peripheral Artery Disease (PAD) improve their walking ability after a procedure called revascularization, which helps restore blood flow to the legs. The researchers want to find out if doing exercises at home, along with revascularization, can help patients walk better compared to just having the procedure alone. They are also testing if drinking beetroot juice, which is high in a substance that helps improve blood flow, can further enhance walking performance after the procedure.

To participate in this trial, you must be between the ages of 65 and 74 and have had successful revascularization for disabling PAD within the last three months. You should not have any serious health issues or conditions that could interfere with the study. If you join the trial, you can expect to be randomly assigned to one of two groups: one group will do home exercises, while the other will not, and both groups will drink either beetroot juice or a placebo (a drink with no active ingredients). The trial aims to see how these different approaches can help improve your walking over a six-month period.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Successful lower extremity revascularization for disabling PAD performed at least 30 days before baseline testing and between 30 and 100 days before randomization.
• Exclusion Criteria:
• • 1. History of leg amputation, not including toe and partial foot amputation
• • 2. Active gangrene
• • 3. Active limb threatening ischemia
• • 4. Already exercising at a level consistent with exercise intervention, using investigator discretion.
• • 5. Unstable angina
• • 6. Unwilling to drink study beverages
• • 7. Unwilling to adhere to the interventions and complete follow-up testing
• • 8. Currently taking sildenafil, tadalafil, or related drugs.
• • 9. Unwilling to accept randomization into either group (home-based exercise or attention control)
• • 10. Currently consuming beetroot juice, oral nitrate or nitrite, or a beetroot supplement and/or unwilling to avoid beetroot juice during the study. Participants will be asked to discontinue these items for 30 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from taking these items, they will not be eligible for the clinical trial.
• • 11. History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial.
• • 12. Baseline blood pressure \<100/45.
• • 13. Wheelchair confinement or requiring a walker to ambulate
• • 14. Walking is limited by a condition other than PAD
• • 15. Current foot ulcer
• • 16. Planned major surgery, coronary revascularization, or lower extremity revascularization during the next 12 months
• • 17. Major medical illness including lung disease requiring oxygen, Parkinson's disease, or a life-threatening illness with life expectancy less than six months.
• • 18. Allergy to beetroot juice
• • 19. Currently consuming one cup or more of beets daily. Participants will be asked to decrease beet consumption to less than one cup of beets per day for 14 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from daily beet consumption of one cup or more for 30 days before the trial and during the trial, they will not be eligible for the clinical trial.
• • 20. Participation in or completion of a clinical trial in the previous three months, using investigator discretion for trials that may not impact study participation or outcome measures of the IMPACT PAD Trial.
• • 21. Visual impairment that limits walking ability.
• • 22. Unable to communicate in English, unless the participant communicates in Spanish and is enrolled at a site that can deliver the intervention in Spanish. All sites with a Spanish speaking coordinator and interventionist will be able to enroll Spanish-speaking participants. While investigators aim to be as inclusive as possible, resources are not available to allow inclusion of people speaking languages that are not Spanish or English.
• • 23. Using a mouthwash containing chlorhexidine or cetylpyridinium chloride or a mouthwash determined to be bactericidal and unwilling to discontinue.
• • 24. Planning to begin a supervised treadmill exercise program in the next 12 months.
• • 25. Heart attack or stroke in previous three months prior to baseline testing.
• • 26. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.