What Is the Research About?
Peripheral artery disease (PAD) is a form of cardiovascular disease that affects the arteries supplying blood flow to the legs. The prevalence of PAD is increasing rapidly in the United States. When PAD is severe, it can cause pain with movement and limit a person’s ability to walk or perform their normal daily activities. With severe PAD, a procedure is often performed in which an artery is held open with a small tube called a stent.
Programs of exercise-based rehabilitation have been shown to greatly help these patients in terms of the pain they experience with walking, their ability to perform daily activities or those required by work, and improved quality of life. There is also a newer form of therapy, called prehabilitation, which has been shown to have important benefits for patients with PAD. Prehabilitation involves four to six weeks of exercise therapy and lifestyle recommendations before undergoing a stent procedure. Prehabilitation helps patients improve exercise tolerance and make lifestyle changes that improve risk factors before the procedure. Those who participate in prehabilitation programs have fewer complications with the stent procedure, spend fewer days in the hospital, and have a better ability to exercise and return to work more quickly.
Although the benefits of prehabilitation and rehabilitation are well established, most doctors neglect to recommend these treatments to their patients who undergo a stent procedure for PAD. The research team will study the impact of prehabilitation, rehabilitation or both forms of therapy. The results will likely encourage more doctors to recommend the best option for their patients, and possibly to recommend both prehabilitation and rehabilitation among patients who are having a stent procedure.
What Are the Study Aims?
The primary aim of the study is to compare the effectiveness of a six-week preoperative program of exercise therapy (prehabilitation) versus a six-week program of rehabilitation (postoperative) and a group that undergoes both prehabilitation and rehabilitation. To assess whether there are any longer-term effects of these programs, measurements of exercise tolerance, vascular health and quality of life will also be studied 14 weeks after the procedure.
Who Can This Research Help?
This research is intended to help patients who have PAD, particularly those whose condition has advanced to the point that they have difficulty walking and performing their normal daily activities.
What Is the Research Team Doing?
The research team is enrolling patients with PAD who have a stent procedure already scheduled. Participants in the study will be enrolled by chance into one of three groups: (1) prehabilitation, (2) rehabilitation, or (3) prehabilitation and rehabilitation. The prehabilitation and rehabilitation programs will each last for six weeks, during which time a health professional will guide patients through an individualized exercise program and help them to make lifestyle changes that optimize their cardiovascular health.
What Things Will be Measured?
At the beginning of the study and at intervals of six weeks, 14 weeks, and 22 weeks, measurements of exercise tolerance on a treadmill, walking time to the beginning of leg pain and a measure of the health of the blood vessels will be measured. Quality of life will also be determined using questionnaires designed for PAD patients, along with factors in the blood that indirectly indicate the health of the blood vessels.
Who Will be Able to Use This Information?
Doctors who treat patients with PAD will be better able to recommend programs of prehabilitation, rehabilitation or both to patients with PAD who are appropriate for a stent procedure. Patients with PAD who experience severe symptoms will be better able to understand why lifestyle changes are important for the treatment of their condition, and which option may be best for them.
What Is the Role of Other Stakeholders?
In addition to the research team, stakeholders include patients and their families, doctors, other researchers, patient advocacy groups, and industry. The research team has formulated a panel of stakeholders that will be engaged in all phases of the project. They will help to guide the study so that its results will best inform doctors and help patients with PAD make the best decisions for their health so that the information is used in the most positive way for patients with PAD.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.