Improving Mobility After Revascularization in Peripheral Artery Disease
Lower extremity revascularization combined with supervised exercise significantly improves walking performance compared to revascularization alone in people who have PAD without limb threatening ischemia. However, supervised exercise is inaccessible or burdensome for most PAD patients. Investigators hypothesize that ho
| Condition(s) | Peripheral Artery Disease, Intermittent Claudication, Peripheral Vascular Disease, Mobility Limitation, Revascularization |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Lower extremity revascularization combined with supervised exercise significantly improves walking performance compared to revascularization alone in people who have PAD without limb threatening ischemia. However, supervised exercise is inaccessible or burdensome for most PAD patients. Investigators hypothesize that home-based exercise combined with lower extremity revascularization will significantly improve walking performance compared to revascularization alone in patients with PAD undergoing revascularization for disabling PAD. Investigators further hypothesize that inorganic nitrate, a major source of nitric oxide (NO) abundant in beetroot juice, will improve walking performance after lower extremity revascularization, compared to placebo. In preclinical models, NO inhibits inflammati |
| Who can participate | 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 b |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Northwestern University |
| Locations | Tucson, Arizona, United States; Downey, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Chicago, Illinois, United States; Lebanon, New Hampshire, United States (+1 more sites) |
| Start date | 2025-08-04 |
| NCT ID | NCT06686121 |
| Official listing | https://clinicaltrials.gov/study/NCT06686121 |