Helping people walk better after leg revascularization for peripheral artery disease

IMProving Mobility After revasCularizaTion in Peripheral Artery Disease: The IMPACT PAD Trial

This project will see if adding a home-based walking program or taking nitrate-rich beetroot juice after leg revascularization helps people with peripheral artery disease walk farther and faster.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 386 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Locations: 7 sites (Tucson, Arizona and 6 other locations)
• Trial ID: NCT06686121 on ClinicalTrials.gov

What this trial studies

This phase 3 randomized study enrolls people who had successful lower extremity revascularization for disabling PAD 30 to 100 days before randomization and tests two interventions against controls. One intervention is a structured home-based exercise program compared with an attention control, and the other compares nitrate-rich beetroot juice to a nitrate-free placebo. The main outcome is walking performance measured after revascularization, with follow-up testing at study visits. The design responds to evidence that supervised exercise plus revascularization improves walking but is often inaccessible, and to preclinical and early clinical evidence that inorganic nitrate may improve vascular and muscle recovery.

Who should consider this trial

Good fit: Adults who had successful lower extremity revascularization for disabling PAD 30–100 days before randomization, who are not already exercising at the study level, can attend follow-up visits, and are willing to drink the study beverages.

Not a fit: Patients with active limb‑threatening ischemia, a history of major leg amputation, unstable angina or other unstable cardiac conditions, or those who cannot stop contraindicated medications or drink the study beverages are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the interventions could help patients regain better walking distance and daily function after revascularization using a more accessible home exercise program or a simple dietary supplement.

How similar studies have performed: Previous research shows supervised exercise plus revascularization improves walking, while nitrate therapies have strong preclinical support and some clinical signals but are not yet well established in this setting.

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.

Where this trial is running

Tucson, Arizona and 6 other locations

• University of Arizona — Tucson, Arizona, United States (Not_yet_recruiting)
• Rancho Research Institute — Downey, California, United States (Recruiting)
• Emory University School of Medicine — Atlanta, Georgia, United States (Not_yet_recruiting)
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (Recruiting)
• University of Chicago — Chicago, Illinois, United States (Recruiting)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (Not_yet_recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Mary M McDermott, MD

Conditions Peripheral Artery Disease; Intermittent Claudication; Peripheral Vascular Disease; Mobility Limitation; Revascularization; Behavior Change; Patient Reported Outcome Measures; Mobility