Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Aging and Peripheral Arterial Disease, sponsored by Northwestern University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in six-minute walk distance
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 |
What NCT06032065 shows while recruiting
NCT06032065 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Aging
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06032065's enrollment target sits among peer trials
210 48th of 262 higher than 215 of 262 other Aging trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aging trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics
ACTIVE NOT RECRUITING · Phase 3
-
ACHIEVE Brain Health Follow-Up Study
ACTIVE NOT RECRUITING · Phase 3
-
Combination Gerotherapeutic Interventions for Healthspan Improvement
ACTIVE NOT RECRUITING · Phase 3
-
SeniorWISE: Improving Everyday Memory in At-Risk Elderly
COMPLETED · Phase 3
-
Exercise, Executive Processes and the Aging Brain
COMPLETED · Phase 3
-
Ketone Ester And Salt (KEAS) in Older Adults
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02665923 · 210 participants
Gastric Emptying in Neonates and Infants After Formula Feeding
- NCT03322891 · 210 participants · NA
Improving Health Literacy in African-American Prostate Cancer Patients
- NCT03544489 · 210 participants · Phase 2
Effectiveness of Exercise After an ICD
- NCT04408430 · 210 participants · NA
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI