Home exercise and beetroot juice to help walking after leg artery procedures
Tests home exercise and beetroot juice in people with peripheral artery disease after revascularization.
Key facts
- Who runs it
- Northwestern University
- Where
- Atlanta, Chicago, Detroit, Downey, Lebanon, Tampa, and Tucson, United StatesSee the 8 sites
- Trial code
- Registry title
- Improving Mobility After Revascularization in Peripheral Artery Disease
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 386 people, planned
- Started
- 4 Aug 2025
- Expected to end
- 1 Aug 2032
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Home Based Exercise
- Nitrate Rich Beetroot Juice
- Attention Control
- Placebo Beetroot Juice Without Nitrate
- Record updated
- 5 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with peripheral artery disease (PAD) who recently had a successful procedure to restore blood flow in the leg. It tests home exercise and nitrate-rich beetroot juice.
- Age
- 18 years and older
- Sex
- All sexes can join
- Disease stage
- Disabling PAD without active limb-threatening loss of blood flow.
- Earlier treatment
- A successful leg blood-flow procedure (revascularization) for disabling PAD, done at least 30 days before baseline testing and 30 to 100 days before randomization. People taking sildenafil, tadalafil or related drugs, or beetroot juice, oral nitrate or nitrite, cannot join unless they stop.
- Biomarker or test result
- Blood pressure not below 100/45. eGFR not below 30 and potassium not above 5.0.
Main reasons for not taking part
- Leg amputation (toe and partial foot amputation allowed), active gangrene or a current foot ulcer
- Unstable angina, or heart attack or stroke in the previous three months
- Using a wheelchair or walker, or walking limited by something other than PAD
- Planned major surgery or another blood-flow procedure in the next 12 months
- Kidney stones needing low oxalate intake, or allergy to beetroot juice
The registry criteria, word for word
Show all 28 criteriaShow less
Who can take part
- Successful lower extremity revascularization for disabling PAD performed at least 30 days before baseline testing and between 30 and 100 days before randomization
Who cannot take part
- Currently taking sildenafil, tadalafil, or related drugs
- 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
- Planned major surgery, coronary revascularization, or lower extremity revascularization during the next 12 months
- 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
- 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
- Heart attack or stroke in previous three months prior to baseline testing
- History of leg amputation, not including toe and partial foot amputation
- Unstable angina
- History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial
- Walking is limited by a condition other than PAD
- Current foot ulcer
- 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
- Visual impairment that limits walking ability
- An eGFR value <30 or potassium >5.0
- Active gangrene
- Active limb threatening ischemia
- Already exercising at a level consistent with exercise intervention, using investigator discretion
- Unwilling to drink study beverages
- Unwilling to adhere to the interventions and complete follow-up testing
- Unwilling to accept randomization into either group (home-based exercise or attention control)
- Baseline blood pressure <100/45
- Wheelchair confinement or requiring a walker to ambulate
- 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
- Using a mouthwash containing chlorhexidine or cetylpyridinium chloride or a mouthwash determined to be bactericidal and unwilling to discontinue
- 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
Where in United States
- Emory University School of MedicineAtlanta, United StatesContact: Olamide Alabi, MDTaking people
- Northwestern University Feinberg School of MedicineChicago, United StatesContact: Kathryn Domanchuk, BSTaking people
- University of ChicagoChicago, United StatesContact: Tamar Polonsky, MDTaking people
- Henry Ford HealthDetroit, United StatesContact: Jonathan Ehrman, PhDTaking people
- Rancho Research InstituteDowney, United StatesContact: Tze-Woei Tan, MDTaking people
- Dartmouth Hitchcock Medical CenterLebanon, United StatesContact: Philip P Goodney, MDTaking people
- University of South FloridaTampa, United StatesContact: Ulka Sachdev, MDTaking people
- University of ArizonaTucson, United StatesContact: Wei Zhou, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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 inflammation, neointimal hyperplasia, thrombosis, and vascular smooth muscle cell migration at sites of revascularization. NO increases angiogenesis and perfusion, repairs skeletal muscle damaged by ischemia, and stimulates mitochondrial activity.
In a randomized clinical trial with a 2 x 2 factorial design, the trial will test the following two primary hypotheses in 386 patients randomized within three months of a successful lower extremity revascularization for disabling PAD: First, that home-based exercise combined with lower extremity revascularization will improve six-minute walk distance more than revascularization alone at 6-month follow-up (Primary Aim #1). Second, that nitrate-rich beetroot juice combined with lower extremity revascularization will improve six-minute walk, compared to placebo combined with revascularization at 6-month follow-up (Primary Aim #2).
The 4 groups in the trial
- Home based exercise + nitrate rich beetroot juiceTreatment being tested
This group will be participating in home based exercise and drinking nitrate rich beetroot juice for six months.
Treatment: Home Based Exercise and Nitrate Rich Beetroot Juice
- Home-based exercise + placeboPlacebo, for comparison
This group will be participating in home based exercise and drinking placebo beetroot juice with nitrate removed for six months.
Treatment: Home Based Exercise and Placebo Beetroot Juice Without Nitrate
- Attention control + nitrate-rich beetroot juiceTreatment being tested
This group will be participating in attention control and drinking nitrate rich beetroot juice for six months.
Treatment: Nitrate Rich Beetroot Juice and Attention Control
- Attention control + placeboPlacebo, for comparison
This group will be participating in attention control and drinking placebo beetroot juice with nitrate removed for six months.
Treatment: Attention Control and Placebo Beetroot Juice Without Nitrate
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- IMProving Mobility After revasCularizaTion in Peripheral Artery Disease: The IMPACT PAD Trial
- Plain-language title
- Home exercise and beetroot juice to help walking after leg artery proceduresGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 5 October 2026