SMART Exercise for PAD

Conditions

• Aging
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Walking, Difficulty

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Supervised Treadmill Exercise — BEHAVIORAL
  This is a 12 week intervention where participants will walk for exercise 3 times a week on a treadmill at a center while being supervised by healthcare personnel.
• Home-Based Exercise — BEHAVIORAL
  This is a 12 week intervention where participants will walk at home for exercise with guidance from a study coach. They will have 4 in person visits in the first four weeks and then have weekly phone calls in the last 8 weeks of the intervention with their coach.
• Nitrate-rich beetroot Juice — DIETARY_SUPPLEMENT
  Participants will drink one shot of nitrate rich beet-root juice twice daily for 12 weeks.

Study Details

Supervised exercise therapy (SET), consisting of treadmill exercise conducted three times weekly at a center while supervised by healthcare personnel, is first line therapy for people disabled by lower extremity peripheral artery disease (PAD). However, travelling three times/week to a center for SET is burdensome. Compared to SET, home-based exercise is more accessible and less burdensome. Yet, evidence-based guidelines recommend SET over home-based exercise for PAD. Walking exercise is first line therapy to improve walking distance for PAD, but it does not eliminate ischemic leg symptoms in most people with PAD. The investigators' work and that of others showed that nitrate-rich beetroot juice, which increases plasma nitrite, limb perfusion, and skeletal muscle function, significantly improved exercise tolerance and reduced non-response to exercise in people with and without PAD. The investigators will use a 2 x 2 factorial design to address two major barriers to achieving benefits from exercise therapy for PAD: First, guideline recommendations for supervised exercise therapy (SET) as first line therapy for PAD. Second, the inability of exercise therapy to eliminate PAD-related disability in most people with PAD. Participants will be randomized to one of four groups for 12 weeks: Supervised treadmill exercise + nitrate rich beetroot juice; supervised treadmill exercise + placebo, home-based walking exercise + nitrate rich beetroot juice, home-based walking exercise + placebo.

Key Dates

Start date

Sep 8, 2023

Status verified

Apr 2026

Primary completion

Nov 1, 2028

Completion

Mar 31, 2029

Study Design

Enrollment

210 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: Supervised treadmill exercise + nitrate rich beetroot juice
  This group will be participating in Supervised Treadmill Exercise and drinking nitrate rich beetroot juice for 12 weeks.
• Placebo Comparator: Supervised treadmill exercise + placebo
  This group will be participating in Supervised Treadmill Exercise and drinking placebo beetroot juice with nitrate removed for 12 weeks.
• Experimental: Home-based walking exercise + nitrate rich beetroot juice
  This group will be participating in Home-Based Exercise and drinking nitrate rich beetroot juice for 12 weeks.
• Placebo Comparator: Home-based walking exercise + placebo
  This group will be participating in Home-Based Exercise and drinking placebo beetroot juice with nitrated removed for 12 weeks.

Primary Outcome Measure

Six-Minute Walk Distance [ Time Frame: Measured at baseline and 12 week follow-up ]

Central Contacts

• Mary McDermott, MD
  312-503-6438
  [email protected]

Locations (3)

Find similar trials in Chicago, IL

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