Improving Mobility After Revascularization in Peripheral Artery Disease

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Northwestern University
Study ID
NCT06686121
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Home Based Exercise — BEHAVIORAL
    This is a six month intervention where participants will walk at home for exercise with guidance from a study coach. They will attend two to four weekly meetings with the coach at the clinical site in the first 4 weeks following randomization, followed by once weekly telephone coaching calls for the remainder of the six-month intervention
  • Nitrate Rich Beetroot Juice — DRUG
    Participants will drink one shot of nitrate rich beet-root juice twice daily for six months.
  • Attention Control — BEHAVIORAL
    Participants will be asked to participate in weekly meetings with the coach in the attention control group for weeks 1-26. A staff member will present a topic from the National Institute on Aging "age pages" relevant to health, such as cancer screening or blood pressure treatment. Calls will last approximately 5-15 minutes and will focus on educational topics such as diabetes, healthy eating, and Medicare Part D.
  • Placebo Beetroot Juice Without Nitrate — DRUG
    Participants will drink one shot of placebo beetroot without nitrate juice twice daily for six months.

Study Details

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 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).

Key Dates

Start date
Aug 4, 2025
Status verified
Aug 2025
Primary completion
Feb 1, 2032
Completion
Aug 1, 2032

Study Design

Enrollment
386 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Home based exercise + nitrate rich beetroot juice
    This group will be participating in home based exercise and drinking nitrate rich beetroot juice for six months.
  • Placebo Comparator: Home-based exercise + placebo
    This group will be participating in home based exercise and drinking placebo beetroot juice with nitrate removed for six months.
  • Experimental: Attention control + nitrate-rich beetroot juice
    This group will be participating in attention control and drinking nitrate rich beetroot juice for six months.
  • Placebo Comparator: Attention control + placebo
    This group will be participating in attention control and drinking placebo beetroot juice with nitrate removed for six months.

Primary Outcome Measure

Six-Minute Walk Distance 6-month change [ Time Frame: Baseline to 6-month follow-up ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724
Wei Zhou, MD
Rancho Research InstituteDowneyCalifornia90242
Tze-Woei Tan, MD
Emory University School of MedicineAtlantaGeorgia30307
Olamide Alabi, MD
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Kathryn Domanchuk, BS
[email protected]
312-503-6438
Mary M McDermott, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Tamar Polonsky, MD
773-702-6153
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03766
Philip P Goodney, MD
University of PittsburghPittsburghPennsylvania15213
Ulka Sachdev, MD

Find similar trials in Tucson, AZ

By condition
Peripheral artery disease
By specialty
CardiologyVascular medicine
By research site
University of Arizona· Tucson, AZRancho Research Institute· Downey, CAEmory University School of Medicine· Atlanta, GANorthwestern University Feinberg School of Medicine· Chicago, ILUniversity of Chicago· Chicago, ILDartmouth Hitchcock Medical Center· Lebanon, NH

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