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NCT06032065 · ClinicalTrials.gov registry record · Phase 3
SMART Exercise for PAD
A Phase 3 study of Aging and Peripheral Arterial Disease, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 210
- Enrollment target
- 3
- Study locations
NCT06032065 is a Phase 3 study of Aging and Peripheral Arterial Disease that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 210 participants, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT06032065, a Phase 3 study of Aging and Peripheral Arterial Disease, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 210 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Supervised Treadmill Exercise
- BEHAVIORAL Home-Based Exercise
- DIETARY_SUPPLEMENT Nitrate-rich beetroot Juice
Study Locations (3)
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
- University of Chicago - Chicago
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2023-09-08 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06032065
The ClinicalTrials.gov registry entry for NCT06032065 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (90% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Aging appearing as the primary indexed condition, and to 3 interventions - of which Supervised Treadmill Exercise is the first listed.
NCT06032065 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Illinois, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06032065 about?
NCT06032065 is a clinical study titled "SMART Exercise for PAD". 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 SE...
What is the current status of trial NCT06032065?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2023-09-08. Estimated completion is 2029-03-31.
What conditions does trial NCT06032065 study?
This clinical trial studies the following conditions: Aging, Peripheral Arterial Disease, Peripheral Vascular Diseases, Walking, Difficulty.
What interventions are being tested in trial NCT06032065?
The interventions under investigation include: Supervised Treadmill Exercise (BEHAVIORAL), Home-Based Exercise (BEHAVIORAL), Nitrate-rich beetroot Juice (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06032065?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06032065 being conducted?
This trial has 3 study locations across Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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