Step‐Monitored Home Exercise Improves Ambulation, Vascular Function, and Inflammation in Symptomatic Patients With Peripheral Artery Disease: A Randomized Controlled Trial

BACKGROUND: This prospective, randomized, controlled clinical trial compared changes in primary outcome measures of claudication onset time (COT) and peak walking time (PWT), and secondary outcomes of submaximal exercise performance, daily ambulatory activity, vascular function, inflammation, and calf muscle hemoglobin oxygen saturation (StO(2)) in patients with symptomatic peripheral artery disease (PAD) following new exercise training using a step watch (NEXT Step) home‐exercise program, a supervised exercise program, and an attention‐control group. METHODS AND RESULTS: One hundred eighty patients were randomized. The NEXT Step program and the supervised exercise program consisted of intermittent walking to mild‐to‐moderate claudication pain for 12 weeks, whereas the controls performed light resistance training. Change scores for COT (P<0.001), PWT (P<0.001), 6‐minute walk distance (P=0.028), daily average cadence (P=0.011), time to minimum calf muscle StO(2) during exercise (P=0.025), large‐artery elasticity index (LAEI) (P=0.012), and high‐sensitivity C‐reactive protein (hsCRP) (P=0.041) were significantly different among the 3 groups. Both the NEXT Step home program and the supervised exercise program demonstrated a significant increase from baseline in COT, PWT, 6‐minute walk distance, daily average cadence, and time to minimum calf StO(2). Only the NEXT Step home group had improvements from baseline in LAEI, and hsCRP (P<0.05). CONCLUSIONS: NEXT Step home exercise utilizing minimal staff supervision has low attrition, high adherence, and is efficacious in improving COT and PWT, as well as secondary outcomes of submaximal exercise performance, daily ambulatory activity, vascular function, inflammation, and calf muscle StO(2) in symptomatic patients with PAD. CLINICAL TRIAL REGISTRATION: URL: ClinicalTrials.gov. Unique Identifier: NCT00618670.