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

Trial Summary

What is the purpose of this trial?

The primary goal of this clinical trial is to evaluate whether a community-based structured exercise therapy (CB-SET) intervention, which could be accessible and easily disseminated, adds benefit to peripheral artery disease (PAD) patients undergoing revascularization (REVASC) to improve their function and cardiovascular health.

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 data supports the effectiveness of the treatment CB-SET for Peripheral Arterial Disease?

Research shows that community-based structured exercise training (CB-SET) programs are beneficial for patients with peripheral artery disease (PAD), improving their exercise performance. Additionally, supervised exercise therapy (SET), a component of CB-SET, is known to improve walking distance and quality of life in these patients. ^{1 2 3 4 5}

Is exercise therapy safe for people after revascularization for peripheral arterial disease?

The available research on supervised exercise therapy (SET) for peripheral artery disease (PAD) does not specifically address safety concerns, but SET is widely recommended and approved for use, suggesting it is generally considered safe for patients with PAD. ^{1 2 3 6 7}

How is the treatment CB-SET different from other treatments for peripheral arterial disease?

CB-SET (Community-based Structured Exercise Therapy) is unique because it focuses on structured exercise programs that can be done in the community, potentially increasing accessibility for patients who may not have access to traditional supervised exercise therapy (SET) programs. This approach may help improve exercise performance and quality of life for patients with peripheral arterial disease by incorporating regular walking activities outside of formal exercise sessions. ^{2 3 7 8 9}

Research Team

Ryan Mays, PhD, MPH, MS

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Claudicating patients with peripheral artery disease have meaningful improvement in walking speed after supervised exercise therapy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Relation of non-exercise walking activity with exercise performance in patients with peripheral artery disease: NEW activity for PAD. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Implementation of a supervised exercise therapy programme. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Supervised exercise therapy in the management of peripheral arterial disease - an assessment of compliance. [2017]

5. England pubmed.ncbi.nlm.nih.gov

When is supervised exercise therapy considered useful in peripheral arterial occlusive disease? A nationwide survey among vascular surgeons. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Supervised Exercise Therapy for Symptomatic Peripheral Artery Disease: A REVIEW OF CURRENT EXPERIENCE AND PRACTICE-BASED RECOMMENDATIONS. [2023]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical Effectiveness of a Supervised Exercise Therapy Program for Treatment of Peripheral Artery Disease: A Translational Study. [2023]

9. England 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. [2023]