Actively Recruiting
Community-based Exercise to Improve Physical Functioning and Cardiovascular Health Following Revascularization for Peripheral Artery Disease
Led by University of Minnesota · Updated on 2025-09-19
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a community-based structured exercise therapy (CB-SET) can provide additional benefits for patients with peripheral artery disease (PAD) who have undergone revascularization (REVASC). The study aims to improve participants' physical function and cardiovascular health by comparing the CB-SET program to standard care. This trial is interventional and focuses on accessible exercise options that can be easily spread within communities. Participants in the intervention group will first receive supervised exercise sessions in a laboratory setting for one week immediately after revascularization, followed by 11 weeks of community-based structured exercise therapy with ongoing training, monitoring, and coaching. The control group will receive verbal advice to exercise and continue with standard care without supervised training. Both groups will be monitored using accelerometers to track physical activity, and intervention participants will also use pedometers and receive coaching calls to encourage adherence and address barriers. Throughout the 12-week study, participants will have their physical activity measured continuously, and staff will conduct monthly visits and phone calls to monitor progress and collect data. Assessments include peak walking time, claudication onset time, VO2max, exercise volume and adherence, and quality of life questionnaires. Safety and health measures such as heart rate and blood pressure will also be tracked. The total participation duration covers baseline evaluations and follow-up assessments at 12 weeks to determine the effect of the exercise interventions.
CONDITIONS
Brief Title
Community-based Exercise Following Revascularization for PAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 are also included
- Ability to participate in an exercise program
You will not qualify if you...
- Lower extremity amputation(s) interfering with walking on the treadmill
- Critical limb ischemia with rest pain or ulcers/gangrene on lower limbs
- Peripheral artery disease of non-atherosclerotic nature (e.g., fibromuscular dysplasia)
- Coronary artery bypass or major surgery within 6 months before screening
- Walking limited mainly by chronic obstructive pulmonary disease, angina, or heart failure
- Myocardial infarction within 3 months before screening
- Transient ischemic attack or stroke within 3 months before screening
- Uncontrolled hypertension with systolic 65180 or diastolic 65100 mmHg at rest
- Treatment with pentoxifylline or cilostazol within 4 weeks before screening
- Poorly controlled diabetes with glycated hemoglobin over 12%
- Abnormal blood work that would make exercise unsafe
- Inability to speak English
- Other unstable or confounding medical conditions as judged by the study team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants undergo revascularization and either receive supervised structured exercise therapy in the laboratory for one week followed by 11 weeks of community-based structured exercise therapy with training, monitoring, and coaching, or receive standard care with verbal advice to exercise without structured training.
3 community visits (in-person) and weekly phone calls (telehealth) for intervention group; monthly phone calls for control group
Duration - 12 weeks
Participants are monitored for physical activity using piezoelectric accelerometers worn continuously during waking hours over 12 weeks, with device data downloaded at community visits or by mail. Participants also use a smartphone app to log activity locations and details.
Continuous device use with data downloads monthly
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
C
Courtney Farland-Johnson, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here