Actively Recruiting
IMProving Mobility After revasCularizaTion in Peripheral Artery Disease: The IMPACT PAD Trial
Led by Northwestern University · Updated on 2025-08-26
386
Participants Needed
7
Research Sites
26 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
R
Rancho Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating ways to improve walking ability in people with peripheral artery disease (PAD) who have undergone lower extremity revascularization for disabling symptoms. The study evaluates whether adding home-based exercise or drinking nitrate-rich beetroot juice can help improve walking distance more than revascularization alone. This randomized clinical trial has a two-by-two design and aims to test these interventions in 386 patients within three months after successful revascularization. Participants will be assigned to one of four groups: home-based exercise plus nitrate-rich beetroot juice, home-based exercise plus placebo beetroot juice, attention control plus nitrate-rich beetroot juice, or attention control plus placebo beetroot juice. The home-based exercise involves walking at home with coaching support over six months, starting with 2-4 weekly meetings followed by weekly phone calls. Beetroot juice or placebo shots are taken twice daily for six months. The attention control group attends weekly educational sessions on health topics during the same period. During the study, patients will undergo baseline and follow-up assessments including a six-minute walk test to measure walking distance. Additional questionnaires will evaluate walking impairment and mobility. Researchers will monitor blood flow in the treated vessels and measure nitric oxide levels in the blood. The main outcomes are measured at six and twelve months after starting the interventions. Safety, adherence, and quality of life will be tracked throughout the study, which plans to follow participants up to eight years after enrollment.
CONDITIONS
Brief Title
Improving Mobility After Revascularization in Peripheral Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Successful lower extremity revascularization for disabling PAD performed at least 30 days before baseline testing and between 30 and 100 days before randomization
- Age 18 years or older
- Able and willing to adhere to study interventions and complete follow-up testing
- Willing to drink study beverages as assigned
- Able to accept randomization into either home-based exercise or attention control group
You will not qualify if you...
- History of leg amputation beyond toe or partial foot amputation
- Active gangrene or limb threatening ischemia
- Currently exercising at level consistent with study exercise intervention
- Unstable angina
- Taking sildenafil, tadalafil, or similar drugs
- Currently consuming beetroot juice, oral nitrate, nitrite, or beetroot supplements and unwilling to stop
- History of kidney stones requiring low oxalate intake
- Baseline blood pressure less than 100/45
- Wheelchair confinement or requiring a walker to walk
- Walking limitation caused by condition other than PAD
- Current foot ulcer
- Planned major surgery or coronary/lower extremity revascularization in next 12 months
- Major illness with life expectancy under six months
- Allergy to beetroot juice
- Consuming one cup or more of beets daily and unwilling to reduce intake
- Participation in another clinical trial within past three months
- Visual impairment limiting walking
- Unable to communicate in English or Spanish at sites without Spanish-speaking staff
- Using bactericidal mouthwash and unwilling to discontinue
- Planning to start supervised treadmill exercise in next 12 months
- Heart attack or stroke within past three months
- Investigator discretion for safety or fit concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive lower extremity revascularization followed by randomization to one of four groups combining home-based exercise or attention control with nitrate-rich beetroot juice or placebo. Home-based exercise includes walking at home with coaching calls and in-person meetings. Participants drink a shot of beetroot juice or placebo twice daily for six months.
2 to 4 weekly in-person meetings with a coach for the first 4 weeks, then weekly telephone coaching calls for the remainder of 6 months
Duration - Up to 6 months after treatment ends (12 months total from baseline)
Participants are monitored for walking performance and vascular health up to 12 months after baseline to assess the durability of treatment effects.
Visits at 6-month and 12-month follow-ups
Trial Site Locations
Total: 7 locations
1
University of Arizona
Tucson, Arizona, United States, 85724
Not Yet Recruiting
2
Rancho Research Institute
Downey, California, United States, 90242
Actively Recruiting
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30307
Not Yet Recruiting
4
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
5
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Not Yet Recruiting
7
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
Research Team
M
Mary M McDermott, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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