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Randomized Controlled Trial
. 2014 Sep 18;3(5):e001107.
doi: 10.1161/JAHA.114.001107.

Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial

Andrew W Gardner  1 , Donald E Parker  2 , Polly S Montgomery  3 , Steve M Blevins  4
Affiliations
Randomized Controlled Trial

Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial

Andrew W Gardner et al. J Am Heart Assoc. .

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.

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 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.

Clinical trial registration url: ClinicalTrials.gov. Unique Identifier: NCT00618670.

Keywords: claudication; exercise; peripheral vascular disease.

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Figures

Figure 1.
Figure 1.
Consolidated standards of reporting trials (CONSORT) flow diagram of patients through the trial. ITT indicates intent‐to‐treat.
See this image and copyright information in PMC

References

    1. Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013; 382:1329-1340. - PubMed
    1. Hirsch AT, Hartman L, Town RJ, Virnig BA. National health care costs of peripheral arterial disease in the Medicare population. Vasc Med. 2008; 13:209-215. - PubMed
    1. Criqui MH, Langer RD, Fronek A, Feigelson HS, Klauber MR, McCann TJ, Browner D. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992; 326:381-386. - PubMed
    1. Gardner AW, Skinner JS, Cantwell BW, Smith LK. Progressive vs single‐stage treadmill tests for evaluation of claudication. Med Sci Sports Exerc. 1991; 23:402-408. - PubMed
    1. McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, Chan C, Celic L, Pearce WH, Schneider JR, Sharma L, Clark E, Gibson D, Martin GJ. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. 2001; 286:1599-1606. - PubMed

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