Supervised exercise was shown to be more effective than stenting or medication for improved walking ability in patients with peripheral artery disease. The findings from a national study were reported today at the 2011 American Heart Association Scientific Sessions meeting. Rhode Island Hospital is one of hospitals participating in the national CLEVER study.

Peripheral artery disease (PAD) is a condition in which plaque builds up in the arteries and impacts blood flow, especially to the legs. It is estimated that between 10 and 12 million people suffer from PAD in the United States. One symptom of PAD is known as claudication, a painful cramping of the leg muscles that limits the patient’s ability to walk. It affects nearly 2 million people who suffer from PAD, and results in a sedentary lifestyle and poor quality of life.

Current guidelines for the treatment of claudication include pharmacotherapy, supervised exercise rehabilitation and lower extremity revascularization using stents. Timothy Murphy, M.D., a radiologist who heads the vascular disease research center at Rhode Island Hospital, was the principal investigator for the Rhode Island Hospital arm of the CLEVER (Claudication: Exercise Versus. Endoluminal Revascularizaton) Study, a multi-center study sponsored by grants from the National Heart Lung and Blood Institute. It is the first multi-center clinical trial to compare the treatment strategies. He is also the lead author of the paper published in the November issue of the journal Circulation.

The research group reported that of 111 patients studied in the randomized trial, the most effective treatment proved to be supervised exercise based on the results of a treadmill test taken at baseline and again at six months. Patients who were in the supervised exercise group improved by a mean of 4.6 minutes in the treadmill test, while the group who received stents improved by a mean of 2.5 minutes. The researchers also found, however, that self-reported quality of life measurements proved to be higher in the group who received stents, even though their ability to walk did not improve as greatly as the group who received supervised exercise rehabilitation.

Murphy says, “This study demonstrates that for patients with claudication that supervised exercise provides a superior improvement in treadmill walking performance compared to both primary aortoiliac stenting and optimal medical care. This benefit is associated with an improvement in self-reported walking distance, an increase in HDL and a decrease of fibrinogen.” He adds, however, “Secondary measures of treatment efficacy such as self-reported physical function measures and pedometer measures of community walking favored primary stenting over supervised exercise.”

Alan T. Hirsch, M.D., of the Lillehei Heart Institute at the University of Minnesota Medical School, presented the findings today. Hirsch comments, “At a time when health care costs are appropriately in sharp public focus, this study provides an avenue by which we could - if we choose - achieve a major positive set of health outcomes at low risk and at lower cost.”

Murphy and the researchers believe that more studies are necessary, but also believe that supervised exercise may be an effective recommended treatment for PAD patients with claudication. Murphy comments, “The CLEVER team will be reporting further outcomes from this study based on an 18-month review.”

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The CLEVER study is funded through grants from the National Heart Lung and Blood Institute, as well as support from Cordis/Johnson & Johnson and Boston Scientific. Murphy collaborated with the presenter at the AHA meeting, Alan T.Hirsch, M.D., of the University of Minnesota Medical School, and other CLEVER Study investigators throughout the country.

Murphy’s principal affiliation is Rhode Island Hospital, a member hospital of the Lifespan health system in Rhode Island, and direct financial and infrastructure support for this project was received through the Lifespan Office of Research Administration. The researcher also has an academic appointment at The Warren Alpert Medical School of Brown University. Murphy’s lab is fully supported by Rhode Island Hospital and the Lifespan health system.

About Rhode Island Hospital:

Founded in 1863, Rhode Island Hospital in Providence, R.I., is a private, not-for-profit hospital and is the largest teaching hospital of The Warren Alpert Medical School of Brown University. A major trauma center for southeastern New England, the hospital is dedicated to being on the cutting edge of medicine and research. Rhode Island Hospital receives nearly $50 million each year in external research funding.

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Nancy Cawley Jean
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Lifespan