Improving Mobility After Revascularization in Peripheral Artery Disease
- Registration Number
- NCT06686121
- Lead Sponsor
- Northwestern University
- Brief 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. We hypothesize that home-based exercise combined with lower extremity rev...
- Detailed Description
More than 300,000 surgical or endovascular lower extremity revascularization procedures are performed annually for Medicare beneficiaries who have lower extremity peripheral artery disease (PAD) without limb threatening ischemia, and rates of these procedures are increasing. In these patients, revascularization typically improves, but does not eliminate, PAD...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 386
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Lower extremity revascularization for disabling PAD (endovascular or surgical revascularization and either femoropopliteal or aortoiliac revascularization) performed at least one month before baseline testing and less than 3 months before randomization.
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Successful revascularization (assessed one month after revascularization), adjudicated by committee. A successful revascularization will be defined as:
- Considered successful based on the surgical note and subsequent clinical visits (as relevant)
- History of leg amputation, not including toe and partial foot amputation.
- History of gangrene.
- History of critical limb ischemia.
- Already exercising at a level consistent with exercise intervention, using investigator discretion.
- Planning to engage in new exercise consistent with exercise intervention outside of the study.
- Unstable angina.
- Abnormal baseline stress test without subsequent clearance for exercise by physician.
- Failure to complete study run-in.
- Unwilling to adhere to the interventions and complete follow-up testing.
- Mini-Mental Status Examination (MMSE) score < 23. If the MMSE is < 23 and the Principal Investigator evaluation determines that the lower score is related to language barriers or education level, the Principal Investigator has discretion to allow a participant with MMSE < 23 to participate, as appropriate.
- Dementia and psychiatric illness with sufficient impairment to prevent full engagement in all aspects of the trial will be an exclusion per the investigator's discretion.
- Currently taking sildenafil, tadalafil, or related drugs.
- Unwilling to accept randomization into either group (home-based exercise or attention control).
- 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.
- History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial.
- Baseline blood pressure <100/45.
- Wheelchair confinement or requiring a walker to ambulate.
- Walking is limited by a condition other than PAD.
- Current foot ulcer on bottom of foot.
- Planned major surgery during the next six months.
- Major medical illness including lung disease requiring oxygen, Parkinson's disease, or a life-threatening illness with life expectancy less than six months.
- Allergy to beetroot juice.
- Currently consuming one cup or more of beets daily. Participants will be asked to discontinue beet ingestion of one cup or more of beets for 30 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.
- Participation in or completion of a clinical trial in the previous three months, using investigator discretion for trials that may not impact on study participation.
- Visual impairment that limits walking ability.
- Unable to communicate in English.
- Planning to begin a supervised treadmill exercise program in the next 12 months.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Home based exercise + nitrate rich beetroot juice Home Based Exercise This group will be participating in home based exercise and drinking nitrate rich beetroot juice for six months. Home based exercise + nitrate rich beetroot juice Nitrate Rich Beetroot Juice This group will be participating in home based exercise and drinking nitrate rich beetroot juice for six months. Home-based exercise + placebo Home Based Exercise This group will be participating in home based exercise and drinking placebo beetroot juice with nitrate removed for six months. Home-based exercise + placebo Placebo Beetroot Juice Without Nitrate This group will be participating in home based exercise and drinking placebo beetroot juice with nitrate removed for six months. Attention control + nitrate-rich beetroot juice Nitrate Rich Beetroot Juice This group will be participating in attention control and drinking nitrate rich beetroot juice for six months. Attention control + nitrate-rich beetroot juice Attention Control This group will be participating in attention control and drinking nitrate rich beetroot juice for six months. Attention control + placebo Attention Control This group will be participating in attention control and drinking placebo beetroot juice with nitrate removed for six months. Attention control + placebo Placebo Beetroot Juice Without Nitrate This group will be participating in attention control and drinking placebo beetroot juice with nitrate removed for six months.
- Primary Outcome Measures
Name Time Method Six-Minute Walk Distance at baseline Baseline to 6-month follow-up Distance walked in six minutes
Six-Minute Walk Distance 6-month change Baseline to 6-month follow-up Distance walked in six minutes
- Secondary Outcome Measures
Name Time Method Walking Impairment Questionnaire (WIQ) Distance Score 12-month change Baseline to 12-month follow-up Patient reported ability to walk long distances. Score Range 0-100, 100 is best.
PROMIS Mobility Questionnaire Score 6-month change Baseline to 6-month follow-up Patient report of mobility in daily living. Score range is from zero to infinity and a higher score means a better outcome.
Walking Impairment Questionnaire (WIQ) Distance Score 6-month change Baseline to 6-month follow-up. Patient reported ability to walk long distances. Score Range 0-100, 100 is best.
PROMIS Mobility Questionnaire Score 12-month change Baseline to 12-month follow-up. Patient report of mobility in daily living. Score range is from zero to infinity and a higher score means a better outcome.
Prevention of Hemodynamic Failure of The Revascularized Vessel Baseline to 12 month follow-up Hemodynamic failure consists of loss of patency of the revascularized vessel. The outcome will be adjudicated as a categorical outcome. Medical records between randomization and final follow-up will be obtained and reviewed by the IMPACT PAD adjudication committee, consisting of field center investigators and an interventional cardiologist. Participants who ...
Trial Locations
- Locations (8)
University of Arizona
🇺🇸Tucson, Arizona, United States
Rancho Research Institute
🇺🇸Downey, California, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Harvard University
🇺🇸Boston, Massachusetts, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States