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Exercise Therapy after Revascularization for Peripheral Arterial Disease

N/A

Recruiting

Led By Ryan Mays, PhD, MPH, MS

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with focal and/or diffuse peripheral artery disease

Patients receiving Revascularization for aorto-iliac and/or femoral-popliteal disease in at least one limb

Must not have

Lower extremity amputation(s) which interfere(s) with walking on the treadmill

Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether an easily accessible and disseminated exercise therapy intervention can improve the function and cardiovascular health of peripheral artery disease patients undergoing revascularization.

Who is the study for?

This trial is for PAD patients who've had revascularization in one or both legs and can exercise. It's not for those with recent heart attacks, major surgeries, uncontrolled health issues like hypertension or diabetes, or non-atherosclerotic PAD. Participants must speak English and be stable enough to safely do the exercises.

What is being tested?

The study tests if a community-based structured exercise program (CB-SET) after revascularization surgery improves function and heart health in PAD patients. The goal is to see if this accessible program provides additional benefits beyond the surgical procedure alone.

What are the potential side effects?

While specific side effects are not listed for CB-SET, general risks may include muscle soreness, fatigue, and potential exacerbation of underlying conditions during physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have peripheral artery disease.

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I am undergoing or have undergone a procedure to improve blood flow in my leg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had leg amputations that prevent me from walking on a treadmill.

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I have severe leg pain at rest or sores due to poor blood flow.

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I have not had major heart surgery or other big operations in the last 6 months.

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My ability to walk is mainly limited by lung or heart problems.

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My blood pressure is not higher than 180/100.

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My PAD is not caused by hardening of the arteries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Peak Walking Time (PWT)

Secondary study objectives

Adherence to Exercise

Change in Claudication Onset Time (COT)

Change in PADQOL Factor 1: Social Relationships and Interactions

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CB-SET TreatmentExperimental Treatment2 Interventions

Participants randomized to this group will receive a community-based structured exercise therapy (CB-SET) along with the standard of care (revascularization)

Group II: ControlActive Control1 Intervention

Participants randomized to this group will receive standard of care (revascularization)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Revascularization

2021

N/A

~700

0 / 8Eligibility criteria met