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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have peripheral artery disease.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Peak Walking Time (PWT)

Secondary outcome measures

Adherence to Exercise

Change in Claudication Onset Time (COT)

Change in PADQOL Factor 1: Social Relationships and Interactions

+14 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,379 Previous Clinical Trials

1,588,462 Total Patients Enrolled

8 Trials studying Peripheral Arterial Disease

1,261 Patients Enrolled for Peripheral Arterial Disease

Ryan Mays, PhD, MPH, MSPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria to participate in this medical trial?

"This medical trial seeks 30 PAD patients between 40 and 90 years of age. To qualify, they must have had at least one limb revascularized; bilateral revascularization sufferers are also acceptable. Additionally, all applicants must be able to participate in an exercise regimen."

Answered by AI

Are people currently being recruited to participate in this experimental endeavor?

"Affirmative. The clinical trial's records on clinicaltrials.gov point to it being actively recruiting patients at the moment, with a post-date of April 8th 2022 and an update of May 10th 2022. In total, 30 individuals need to be registered from just one medical centre."

Answered by AI

How vast is the population sample of this clinical experiment?

"Affirmative. According to the info on clinicaltrials.gov, this research trial is actively recruiting participants since being posted on April 8th 2022 and last updated May 10th 2022. The study requires 30 individuals from a single site for enrolment."

Answered by AI

Does the protocol of this trial include those who have exceeded five decades in age?

"According to the parameters of this scientific experiment, candidates must be between 40 and 90 years old. Furthermore, there are 11 studies for those below 18 and 209 participants above age 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Community-based Exercise Following Revascularization for PAD

2022. "Community-based Exercise Following Revascularization for PAD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04252950.

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