NCT04252950 · University of Minnesota
Community-based Exercise Following Revascularization for PAD
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
CB-SET
Community-based structured exercise therapy (CB-SET) programs for PAD have potential merit as an alternative to hospital-based SET, as they may provide similar benefit to hospital-based programs but in a convenient location for the exercise to be completed
PROCEDURE
Revascularization
Endovascular revascularization is a primary treatment option for patients with PAD
Primary outcome measures
Change in Peak Walking Time (PWT)
Time frame: Baseline, 12 weeks
Participants will perform graded exercise tests conducted on a treadmill with continuous electrocardiogram monitoring. Participants will run at a constant speed of 2.0 miles/hour, starting at 0% grade. Every 2 min the grade is increased 2% until maximal claudication limits exercise. PWT (reported in minutes) will be recorded as the maximal time a participant can walk on the treadmill before having to stop due to severe claudication (assessed using the Claudication Symptom Rating Scale which ranges from 1-5 with 1=no pain, 2=onset claudication, 3=mild, 4=moderate, and 5=severe).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients receiving Revascularization for aorto-iliac and/or femoral-popliteal disease in at least one limb
- Patients with focal and/or diffuse peripheral artery disease
- Bilateral Revascularization patients will also be included
- Ability to participate in an exercise program
Exclusion criteria
- 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
- PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis).
- Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening
- Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure
- Individuals who have had a myocardial infarction within 3 months prior to screening
- Individuals who have had a transient ischemic attack or stroke 3 months prior to screening
- Individuals with uncontrolled hypertension (≥180 systolic or ≥100 diastolic resting blood pressure) during screening
- Treatment with pentoxifylline or cilostazol for the treatment of claudication 4 weeks prior to screening. Patients can be reconsidered for study inclusion following a 1-month washout period
- Poorly controlled diabetes defined as glycated hemoglobin \>12%
- Abnormal results of blood work not conducive to safely participate in an exercise trial (e.g., anemic, electrolyte abnormalities)
- Inability to speak English
- Other clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 19, 2025 · Source of record for eligibility and locations