Supervised Exercise May Become Standard PAD Treatment

Building on decades of research, a group of experts from the University of Minnesota has developed a cost-effective way to better treat peripheral artery disease (PAD), a life-threatening condition that affects more than 8 million people in the United States.

Unlike current standards of care that use expensive drugs and invasive procedures, like angioplasty, stent placement or surgery, this treatment is founded on a novel tenet: supervised exercise in a cardiac rehabilitation program. Research shows it may be the most effective, safe and cost-effective treatment for many patients – and it may soon be covered & approved by CMS.


Peripheral artery disease occurs when plaque clogs arteries that deliver oxygenated blood to the legs. A key symptom of PAD is called “claudication”, when a person experiences leg muscle fatigue, discomfort or pain during exercise, which subsides with rest. It decreases mobility, independence and quality of life, and is also a major short-term risk factor for heart attack and stroke.

“If you ask nearly anyone, including many health professionals, ‘have you heard of PAD and do you know its risks?’ they often won’t know very much about it,” said Alan T. Hirsch, MD, Professor at the University of Minnesota Medical School. “But PAD is seven-fold more common than HIV, and is responsible for more than 1,300 lost limbs per year in Minnesota alone.”

Typically, physicians treat PAD with medications to reduce discomfort, stents to improve blood flow, or artery-opening surgeries to open blockages.

These expensive procedures have long been covered by insurance, making them an attractive option for patients and providers alike. But research shows that exercise with guidance from an experienced health professional is often a more effective option.

Treating PAD

Hirsch and colleagues set out to examine the benefits of a supervised exercise program and how it compares to other treatments. They started the national CLEVER trial study, which ran from 2008 to 2014, and proved that the approach was successful.

That data provided the key foundation for Hirsch to work with the University of Minnesota School of Nursing and Fairview rehabilitation services to develop a similar program that could be offered to all patients with PAD at University of Minnesota Health locations.

Over the course of nearly two years, the majority of patients saw significant improvement in walking distance and fewer physical symptoms. The American Association of Cardiovascular and Pulmonary Rehabilitation recently provided its 2016 Innovation Award to recognize the program for its creativity and effectiveness.

“Stenting and medications will continue to be a common way to treat claudication and these approaches may be preferred by some patients,” Hirsch said. “But now we have a program that offers all patients more therapeutic choice. Supervised exercise is extremely effective to improve leg symptoms and lower heart disease risk for PAD patients and should be available to all who need it.”

Change Is Ahead

With decades worth of data, with the success of our University program, and with support from fellow researchers, Hirsch helped lead a request in September 2016 to the Centers for Medicare and Medicaid. On behalf of the American Heart Association, Hirsch is seeking a new National Coverage Determination that would include supervised exercise therapy as a benefit for Medicare beneficiaries with PAD.

The decision will likely be favorable, Hirsch says. The establishment of this new PAD standard of treatment across the U.S. could yield similar benefits to what has already been seen at the University.

“New CMS coverage of supervised exercise programs could markedly improve national access to claudication treatment,” Hirsch said. “Either in conjunction with stenting, or on its own, this approach could improve – or even cure – PAD symptoms at a fraction of the cost. This would be a major advancement in treating the disease.”