Exercise Therapy after Revascularization for Peripheral Arterial Disease

Overseen By Courtney Farland-Johnson, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Pentoxifylline, Cilostazol

Disqualifiers: Amputation, Critical limb ischemia, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a specific exercise program can help people with peripheral artery disease (PAD) recover better after revascularization, a procedure that improves blood flow. Participants will receive either the usual revascularization treatment or both this treatment and a community-based structured exercise therapy (CB-SET). The trial seeks individuals who have undergone revascularization in at least one leg due to PAD and can participate in an exercise program. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding the benefits of exercise therapy in PAD recovery.

Will I have to stop taking my current medications?

The trial requires that you stop taking pentoxifylline or cilostazol for claudication at least 4 weeks before screening. Other medications are not specifically mentioned, so it's best to discuss with the study team.

What prior data suggests that this exercise therapy is safe for PAD patients?

Research shows that community-based structured exercise therapy (CB-SET) is generally safe for people with peripheral artery disease (PAD). Studies have found that various types of exercise can help these patients walk better. No strong evidence indicates major safety issues with CB-SET. In fact, exercise therapy is often recommended to improve health and quality of life for people with PAD.

Additionally, CB-SET has improved walking ability without significant side effects, indicating it is usually well-tolerated by patients. Potential participants should discuss these findings with their healthcare provider to ensure it suits their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the community-based structured exercise therapy (CB-SET) because it offers a new, holistic approach to managing Peripheral Arterial Disease (PAD) after revascularization. Unlike the standard treatment that focuses primarily on surgical interventions like revascularization, CB-SET emphasizes the role of tailored exercise regimens to improve blood flow and overall vascular health. This method could lead to better long-term outcomes by enhancing patients' mobility and quality of life without relying solely on medical or surgical interventions. Additionally, this community-based approach makes it more accessible and sustainable for patients, potentially leading to broader health benefits beyond just the treatment of PAD.

What evidence suggests that this trial's treatments could be effective for peripheral artery disease?

Research shows that structured exercise programs can greatly improve walking ability and overall quality of life for people with peripheral artery disease (PAD). One study found that community exercise programs helped African American patients with PAD walk better. Additionally, exercising at home increased both the distance patients could walk without pain and their maximum walking distance. In this trial, participants in the CB-SET Treatment arm will receive community-based structured exercise therapy (CB-SET) alongside standard revascularization therapy. These findings suggest that adding structured exercise to standard treatments could enhance recovery and improve heart health. ^{1 4 6 7 8}

Who Is on the Research Team?

Ryan Mays, PhD, MPH, MS

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had surgery to restore blood flow to both sides of my body.

You are able to take part in an exercise program.

I have peripheral artery disease.

Exclusion Criteria

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

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

Your diabetes is not well controlled, which means your blood sugar levels are very high.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants in the intervention group receive supervised exercise training in the exercise physiology laboratory for one week following revascularization

1 week

3 visits (in-person)

Community-based Structured Exercise Therapy (CB-SET)

Participants receive 11 weeks of community-based structured exercise therapy with training, monitoring, and coaching

11 weeks

3 visits (in-person, community-based)

Monitoring

Participants are monitored with a piezoelectric accelerometer to determine total volume of activity

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CB-SET
• Revascularization

Trial Overview 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.

How Is the Trial Designed?

Group I: CB-SET Treatment Experimental Treatment 2 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: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a study of 63 patients with peripheral artery disease (PAD) undergoing a 6-month supervised exercise therapy (SET) program, an increase in walking speed of 0.03 m/s or greater was identified as the minimal clinically important difference (MCID), indicating meaningful improvement in walking ability.

The study established specific thresholds for small and substantial improvements in walking speed, which can help clinicians set realistic goals and assess progress in claudicating patients with PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Claudicating patients with peripheral artery disease have meaningful improvement in walking speed after supervised exercise therapy. Rahman, H., Pipinos, II., Johanning, JM., et al.[2022]

Supervised exercise therapy (SET) is highly recommended for patients with symptomatic peripheral artery disease (PAD) and is reimbursable by most insurances, highlighting its efficacy in improving walking performance.

Despite its benefits, referral and participation rates in SET are low, indicating that many patients are not receiving this valuable treatment, which suggests a need for improved referral practices and awareness among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised Exercise Therapy for Symptomatic Peripheral Artery Disease: A REVIEW OF CURRENT EXPERIENCE AND PRACTICE-BASED RECOMMENDATIONS. Ehrman, JK., Gardner, AW., Salisbury, D., et al.[2023]

In a study of 20 patients with peripheral artery disease (PAD) participating in a 12-week community-based structured exercise training program, non-exercise walking (NEW) activity was found to have a moderate positive correlation with improvements in peak walking time (PWT), suggesting that everyday walking can enhance exercise performance.

The results indicate that increasing walking activity outside of formal exercise sessions may be beneficial for PAD patients, highlighting the importance of overall physical activity in managing their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of non-exercise walking activity with exercise performance in patients with peripheral artery disease: NEW activity for PAD. Mays, RJ., Kahnke, R., Schorr, EN., et al.[2023]

A supervised exercise therapy (SET) program for patients with intermittent claudication showed a 20% improvement in walking distance, increasing from an average of 298.5 meters to 360 meters, based on a study involving 155 patients over nearly two years.

The program is cost-effective compared to traditional physiotherapy and is designed to be accessible, with efforts made to increase participation through additional classes and venues, demonstrating the potential for successful implementation of community-based health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a supervised exercise therapy programme. Murgitroyd, E., Fraser, S., Hebson, A., et al.[2020]

A survey of 91 Dutch vascular surgeons revealed that 75.4% would refer newly diagnosed patients with intermittent claudication for supervised exercise therapy (SET), indicating a strong belief in its importance as a treatment for peripheral arterial occlusive disease (PAOD).

Surgeons expressed that SET should be combined with lifestyle management and emphasized that despite its recognized benefits, SET is underutilized in clinical practice, particularly for patients with co-morbidities or significant artery stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When is supervised exercise therapy considered useful in peripheral arterial occlusive disease? A nationwide survey among vascular surgeons. Lauret, GJ., van Dalen, HC., Hendriks, HJ., et al.[2018]

The Smart Step pilot trial is exploring the feasibility of smartphone-enabled home-based exercise therapy (HBET) for patients with symptomatic peripheral arterial disease (PAD), with a focus on improving walking distance over 12 weeks.

With 15 participants enrolled so far, the study aims to demonstrate that HBET can increase accessibility to exercise rehabilitation, potentially offering a more convenient alternative to traditional supervised exercise therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of a smartphone-enabled, home-based exercise program in patients with symptomatic peripheral arterial disease: The smart step randomized trial. Harzand, A., Vakili, AA., Alrohaibani, A., et al.[2023]

In a study of 98 patients with peripheral arterial disease (PAD), those who attended more supervised exercise therapy (SET) sessions showed significant improvements in their symptoms, highlighting the importance of exercise compliance for better health outcomes.

Factors such as educational level, smoking history, and pre-existing conditions like hypertension and hypercholesterolemia influenced both exercise compliance and symptomatic improvement, suggesting that tailored patient education and exercise plans could enhance participation in SET.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised exercise therapy in the management of peripheral arterial disease - an assessment of compliance. Aherne, TM., Kheirelseid, EAH., Boland, M., et al.[2017]

A 12-week supervised exercise therapy (SET) program for patients with mild to moderate peripheral artery disease (PAD) significantly improved walking capacity, as evidenced by a 32.1 meter increase in the 6-minute walk test among 93 participants.

The study suggests that non-treadmill walking modalities, such as total body recumbent stepping, can be effectively incorporated into SET programs, although no significant differences in outcomes were found between different exercise modalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of a Supervised Exercise Therapy Program for Treatment of Peripheral Artery Disease: A Translational Study. Salisbury, DL., Brown, R., Elgersma, K., et al.[2023]

In a study of 5320 patients with peripheral artery disease (PAD), only 773 were referred to supervised exercise therapy (SET), and just 415 enrolled, highlighting low referral and completion rates despite SET's proven effectiveness.

Patients who completed SET showed statistically significant improvements in functional capacity and quality of life, indicating that while SET is beneficial, more efforts are needed to increase its availability and referral rates among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake and outcomes of supervised exercise therapy for peripheral artery disease: The importance of vascular medicine specialists at a large midwestern health care system during the first 5 years of CMS reimbursement. Whipple, MO., Burt, MA., Pergolski, AL., et al.[2023]

Citations

1. acc.org acc.org/Latest-in-Cardiology/Articles/2025/04/02/13/44/Exercise-Therapy-in-Symptomatic-Peripheral-Artery-Disease

Exercise Therapy in Symptomatic Peripheral Artery Disease Structured exercise programs have been shown to improve walking performance, functional status, and QOL in patients with symptomatic PAD.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30768192/

Efficacy of Community-Based Exercise Therapy Among ... Efficacy of Community-Based Exercise Therapy Among African American Patients With Peripheral Artery Disease: A Randomized Clinical Trial.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04252950?term=AREA%5BBasicSearch%5D(desirudin)&rank=7

Community-based Exercise Following Revascularization ... The primary goal of this clinical trial is to evaluate whether a community-based structured exercise therapy (CB-SET) intervention, which could be ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11749748/

Effectiveness of home-based walking exercise for patients ... Home-based exercise interventions for patients with PAD and IC were beneficial in improving pain-free walking distance and maximal walking distance.

5. heart.org heart.org/-/media/Files/Health-Topics/Peripheral-Artery-Disease/PAD-Webinars/Webinar-3-Exercise-in-PAD-slides.pdf?sc_lang=en

Supervised Exercise Therapy for Peripheral Artery Disease ... IIa. A. In patients with PAD, a structured community- or home- based exercise program with behavioral change techniques can be beneficial to improve walking ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10562863/

Exercise Therapy in the Management of Peripheral Arterial ... A systemic review of multiple modes of ET revealed that most modes and intensities of exercise resulted in significantly improved walking capability. Mortality.

7. withpower.com withpower.com/trial/phase-peripheral-arterial-disease-11-2021-cbd05

Exercise Therapy after Revascularization for Peripheral ... Research shows that community-based structured exercise training (CB-SET) programs are beneficial for patients with peripheral artery disease (PAD), improving ...

8. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=287

NCA - Supervised Exercise Therapy (SET) for Symptomatic ... Outcomes assessed were walking parameters, claudication parameters, patient-reported outcomes (from SF-36, peripheral artery questionnaire, and WIQ).