title: Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial.
abstract: 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 (StO2) 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.
  
  
  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 StO2 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 StO2. 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 StO2 in symptomatic patients with PAD.
  
  
  BACKGROUND
  ClinicalTrials.gov. Unique Identifier: NCT00618670.
authors.affiliation: Reynolds Oklahoma Center on Aging, Donald W. Reynolds Department of Geriatric Medicine, University of Oklahoma Health Sciences Center (OUHSC), Oklahoma City, OK (A.W.G., P.S.M.) Veterans Affairs Medical Center, Oklahoma City, OK (A.W.G.).
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Gardner
authors.affiliation: Department of Biostatistics and Epidemiology, OUHSC, Oklahoma City, OK (D.E.P.).
authors.forename: Donald E
authors.initials: DE
authors.lastname: Parker
authors.affiliation: Reynolds Oklahoma Center on Aging, Donald W. Reynolds Department of Geriatric Medicine, University of Oklahoma Health Sciences Center (OUHSC), Oklahoma City, OK (A.W.G., P.S.M.).
authors.forename: Polly S
authors.initials: PS
authors.lastname: Montgomery
authors.affiliation: General Internal Medicine Section, Department of Medicine, OUHSC, Oklahoma City, OK (S.M.B.).
authors.forename: Steve M
authors.initials: SM
authors.lastname: Blevins
mesh_terms: D000367:Age Factors; D000368:Aged; D000704:Analysis of Variance; D015992:Body Mass Index; D015444:Exercise / Q000502:physiology*; D005081:Exercise Therapy / Q000379:methods*; D017079:Exercise Tolerance / Q000502:physiology*; D005260:Female; D006699:Home Care Services; D006801:Humans; D007249:Inflammation / Q000503:physiopathology / Q000534:rehabilitation; D007383:Intermittent Claudication / Q000175:diagnosis / Q000534:rehabilitation*; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D053580:Muscle Strength / Q000502:physiology; D010101:Oxygen Consumption / Q000502:physiology; D010349:Patient Compliance / Q000706:statistics & numerical data; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000534:rehabilitation*; D011446:Prospective Studies; D011788:Quality of Life; D012016:Reference Values; D012720:Severity of Illness Index; D012737:Sex Factors; D016896:Treatment Outcome; D014654:Vascular Patency / Q000502:physiology; D016138:Walking / Q000502:physiology*
keywords: claudication; exercise; peripheral vascular disease