Community Walking Exercise for Patients With Peripheral Artery Disease

Completed · Not applicable

Conditions studied: Peripheral Artery Disease

In brief

The primary aim of the study is to determine the effect of a community-based walking exercise program with detailed training, monitoring, and coaching (TMC) exercise components enhanced by community-based participatory research (CBPR) practices (TMC+) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).

Key facts

Study ID: NCT02075502
Run by: University of Minnesota
People needed: 70
Starts: 2014-02-01
Expected to finish: 2020-02-12
Last updated by the study team: 2020-04-22

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women diagnosed with atherosclerotic PAD
≥40 years of age
An abnormal ankle-brachial index (ABI) of ≤.90
For patients with an ABI >.90 and <1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI
Patients receiving lower extremity ET or peripheral open intervention
Patients not receiving lower extremity ET or peripheral open intervention but present with stable claudication and an abnormal ABI

You may not qualify if…

Lower extremity amputation(s), including a toe amputation, 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 are unable to walk on the treadmill at a speed of at least 2 mph for at least 1 minute
Individuals who have had a myocardial infarction within 3 months prior to screening
Individuals who demonstrate symptoms consistent with acute coronary syndrome
Individuals who exhibit ischemia as documented on the 12-lead electrocardiogram including horizontal or down-sloping ST-segment depression ≥0.5 mm at rest and >1 mm with exercise in 2 contiguous leads, relative to the PR-segment (ST-segment measured 0.08 seconds after the J point, ST-segment elevation ≥1 mm)
Individuals who have had a transient ischemic attack or stroke 3 months prior to screening
Individuals with left bundle branch block or sustained ventricular tachycardia (>30 sec) during 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 from these medications
Electrolyte abnormalities (e.g., potassium <3.3 mmol∙Lˉ1 )
Pregnancy, fertility without protection against pregnancy (for women of childbearing potential, a serum pregnancy test will be performed at screening)
Incarcerated individuals
Individuals acutely impaired by alcohol or other illicit drugs
Poorly controlled diabetes defined as glycated hemoglobin >12%
Severely anemic patients (Hgb <11 g∙dLˉ1 for women and <10 g∙dLˉ1 for men)
For patients who have not received peripheral revascularization, an ABI of >0.90
For patients with equivocal resting ABIs (0.91-0.99), a drop of <15% in the post-exercise ABI
For individuals with non-compressible vessels (ABI >1.39) who have a toe- brachial index (TBI) >0.70
Inability to speak English
Other clinically significant disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study

Where it is running

International Heart Institute of Montana Foundation — Missoula, Montana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.