Exercise Therapy after Revascularization for Peripheral Arterial Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Minnesota
Must not be taking: Pentoxifylline, Cilostazol
Disqualifiers: Amputation, Critical limb ischemia, COPD, others
No Placebo Group
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.
12345Is 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.
12367How 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.
23789Eligibility 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.
+1 more
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.
+10 more
Trial 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
Participant Groups
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.
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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
Loading ...
Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Claudicating patients with peripheral artery disease have meaningful improvement in walking speed after supervised exercise therapy. [2022]Supervised exercise therapy (SET) is a first-line treatment for patients with peripheral artery disease (PAD). The efficacy of SET is most commonly expressed by significant statistical improvement of parameters that do not clarify how each individual patient will benefit from SET. This study examined the minimal clinically important difference (MCID) in walking speed in claudicating patients with PAD after SET.
Relation of non-exercise walking activity with exercise performance in patients with peripheral artery disease: NEW activity for PAD. [2023]Community-based structured exercise training (CB-SET) programs are beneficial for patients with peripheral artery disease (PAD). However, the impact of lower levels of walking activity accumulated separately from formal exercise is unclear. The aim of this study was to determine the relation of non-exercise walking (NEW) activity with exercise performance in PAD.
Implementation of a supervised exercise therapy programme. [2020]Guidelines for peripheral vascular disease state that supervised exercise therapy (SET) programmes improve walking distance and quality of life in patients with intermittent claudication. This paper outlines the steps needed to implement a successful SET programme and discusses some of the challenges.
Supervised exercise therapy in the management of peripheral arterial disease - an assessment of compliance. [2017]Supervised exercise therapy (SET) is an effective option in the management of peripheral arterial disease (PAD). Unfortunately, poor compliance remains prevalent. This study aimed to assess patient exercise compliance and to identify factors influencing symptomatic improvement and SET participation.
When is supervised exercise therapy considered useful in peripheral arterial occlusive disease? A nationwide survey among vascular surgeons. [2018]Although international guidelines state that supervised exercise therapy (SET) should be offered to all patients with intermittent claudication (IC), SET appears to be underutilised in clinical practice. The aim of this study was to document current opinions of Dutch vascular surgeons on SET as treatment option for peripheral arterial occlusive disease (PAOD).
Supervised Exercise Therapy for Symptomatic Peripheral Artery Disease: A REVIEW OF CURRENT EXPERIENCE AND PRACTICE-BASED RECOMMENDATIONS. [2023]This review encompasses several practical components of supervised exercise therapy (SET) for patients with claudication including referral, exercise training, and billing issues. Real-life SET session examples are also provided. SET was approved for reimbursement by the Centers for Medicare & Medicaid Services (CMS) in 2017, and there is continual growth of programs offering SET and in participation. The purpose of this review is to provide useful information for the clinical exercise professionals working with these patients.
Rationale and design of a smartphone-enabled, home-based exercise program in patients with symptomatic peripheral arterial disease: The smart step randomized trial. [2023]Supervised exercise therapy (SET) is recommended in patients with symptomatic peripheral arterial disease (PAD) as first-line therapy, although patient adoption remains low. Home-based exercise therapy (HBET) delivered through smartphones may expand access. The feasibility of such programs, especially in low-resource settings, remains unknown.
Clinical Effectiveness of a Supervised Exercise Therapy Program for Treatment of Peripheral Artery Disease: A Translational Study. [2023]National guidelines for the treatment and management of symptomatic peripheral artery disease (PAD) recommend supervised exercise therapy (SET) as a first line of therapy. However, it is unknown how these expert opinion-based SET guidelines work in clinical practice as SET programs become established following the 2017 Centers for Medicare & Medicaid Services coverage announcement. The purpose of this prospective, nonrandomized translational study was to evaluate the clinical effectiveness of a SET program and specifically walking exercise modalities that did not incorporate a treadmill (TM).
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]Supervised exercise therapy (SET) is the cornerstone of medical therapy for symptomatic peripheral artery disease (PAD). Despite the efficacy of SET, initial reports following the 2017 Centers for Medicare and Medicaid Services (CMS) reimbursement decision indicate low SET uptake, referral, and completion. Vascular medicine specialists are key to the success of such programs. We examined rates of SET referral, completion, and outcomes in a health system with a robust SET program during the first 5 years of CMS reimbursement.