NCT02075502.

Trial name or title	Community walking exercise for patients with peripheral artery disease (GAIT)
Methods	Study type: ‐Interventional Study design: ‐Allocation: randomized ‐Intervention model: parallel assignment ‐Masking: single blind (investigator) ‐Primary purpose: treatment
Participants	134 patients with peripheral artery disease (PAD) Inclusion criteria: ‐Men and women with diagnosis of atherosclerotic PAD ‐≥ 40 years of age ‐Abnormal ankle‐brachial index (ABI) ≤ 0.90 ‐ABI > 0.90 and < 1.00, post‐exercise ABI drop ≥ 15% compared with resting ABI ‐Patients receiving lower extremity exercise therapy (ET) or peripheral open intervention ‐Patients not receiving lower extremity ET or peripheral open intervention but present with stable claudication and an abnormal ABI Exclusion criteria: ‐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 lower extremities ‐PAD of non‐atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis) ‐Coronary artery bypass grafts or major surgical procedures within 6 months before 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 ≥ 2 mph for ≥ 1 minute ‐Individuals who have had a myocardial infarction within 3 months before 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 before screening ‐Individuals with left bundle branch block or sustained ventricular tachycardia (> 0 seconds) during screening ‐Individuals with uncontrolled hypertension (≥ 180 systolic or ≥ 100 diastolic resting blood pressure) during screening ‐Treatment with pentoxifylline or cilostazol for claudication 4 weeks before 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/L) ‐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/dL for women and < 10 g/dL for men) ‐For patients who have not received peripheral revascularization, ABI > 0.90 ‐For patients with equivocal resting ABIs (0.91 to 0.99), a drop < 15% in the postexercise 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 results of the study
Interventions	Community‐based walking exercise program with detailed training, monitoring, and coaching (TMC) exercise components vs standard of care (exercise advice)
Outcomes	Primary outcome measure: ‐Change in peak walking time (PWT) Secondary outcome measures: ‐Change in claudication onset time (COT) ‐Change in patient‐reported outcomes ‐Change in peak oxygen uptake ‐Change in functional ability ‐Evaluation of total volume of activity ‐Evaluation of exercise adherence
Starting date	February 2014
Contact information	Ryan J. Mays, PhD, MPH, MS 406‐327‐1731; ryan.mays@providence.org
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