Community-based exercise program for patients after revascularization for PAD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a community-based structured exercise therapy (CB-SET) for patients with peripheral artery disease (PAD) who have undergone revascularization. Participants will be divided into two groups: one receiving supervised exercise training for one week followed by 11 weeks of community-based exercise, and the other receiving only verbal advice to exercise. The study will monitor participants' activity levels using accelerometers to assess compliance and outcomes related to cardiovascular health and functional improvement. The goal is to determine if the structured exercise program provides additional benefits compared to standard advice.

Why it matters

Who can join: the full rules

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 it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Ryan Mays, PhD, MPH, MS — University of Minnesota
• Study coordinator: Ryan Mays, PhD, MPH, MS
• Email: rjmays@umn.edu
• Phone: 612-625-0430

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Antiplatelet-Only versus Antiplatelet plus Low-Dose Rivaroxaban after Heart Events

  In adults 65 or older with prior heart events and certain arterial diseases, this study tests whether continuing clopidogrel alone is no worse than adding low-dose rivaroxaban to aspirin-based therapy.

  Recruiting Phase 4 Seoul National University Bundang Hospital · Seongnam-si, Gyeonggi-do · NCT07796217

• Home-based Pedal Exerise Therapy for Moderate-to-Severe PAD

  This pilot study tests whether a 12-week home-based pedal exerciser program, guided remotely, can help adults with moderate-to-severe PAD improve walking and function.

  Recruiting Laval University · Lévis, Quebec · NCT07655206

• Super-resolution ultrasound imaging for peripheral artery disease

  This project will test whether super-resolution contrast ultrasound can reveal small-vessel problems in adults with or without peripheral artery disease.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07374601

• Obstructive sleep apnea prevalence in people with peripheral artery disease

  This project will test how common obstructive sleep apnea is in adults with peripheral artery disease by using sleep polygraphy during routine care.

  Recruiting Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Toulon, Var · NCT07283289

• Using wearable activity trackers and a mobile app to help people with peripheral artery disease walk better

  This project will test whether a personalized home walking program guided by wearable activity trackers and automatic feedback can help people with peripheral artery disease walk as well as supervised exercise sessions.

  Recruiting at 2 sites Chinese University of Hong Kong · Hong Kong, Hong Kong and 1 other locations · NCT07012070

• Evaluating a Paclitaxel Coated Balloon for Treating Atherosclerosis in Leg Arteries

  This study is testing a special balloon treatment to see if it can safely improve blood flow and reduce symptoms in people with blocked leg arteries due to peripheral artery disease.

  Recruiting at 2 sites Balton Sp.zo.o. · Chrzanów, Malopolska and 2 other locations · NCT06734221

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.