Please select the eligibility criteria that correspond to the clinical trial below.
Title: Self-Managed Walking Improves Function in Patients With Diabetes Mellitus and Peripheral Arterial Disease
Brief Summary: We are conducting a clinical research trial to determine the role of self-managed walking therapy to improve walking ability in patients with diabetes mellitus and peripheral arterial disease (PAD). PAD, commonly referred to as poor circulation in the legs, is a very common disease in patients with diabetes mellitus. For patients with PAD, there is a significant risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy but the traditional methods for the delivery of this treatment have required frequent visits to a university or hospital-based site. We will address the role of self-managed walking program, to be conducted at or near the home, to improve limb function.


Options:
A: Inclusion Criteria:

* 150 peripheral arterial disease patients with and without IC

Exclusion Criteria:

* Below or above-knee amputation
* Wheelchair confinement
* Inability to walk on a treadmill or inability to perform progressive resistance training
* Inability to return to the medical center three times weekly for 6 months
* Walking impairment due to a cause other than PAD
* Class II New York Heart Association (NYHA) heart failure or angina (heart failure or angina occurring at rest or with minimal exertion)
* Planned lower extremity revascularization or any other major surgery within 12 months
* Any increase in anginal symptoms during the previous 6 months or angina at rest
* Subjects with silent coronary ischemia, defined as ST segment depression greater than or equal to 1 mm during baseline exercise treadmill test without associated chest discomfort, unless they have had a normal perfusion stress test during the previous 6 months
* Subjects with left-bundle branch block or significant ST-T wave changes on their baseline ECG who do not have a perfusion stress test demonstrating absence of reversible ischemia within the previous 6 months
* Lower extremity revascularization, major orthopedic surgery, or other major surgery during the previous 3 months
* Myocardial infarction or coronary artery bypass grafting during the previous 3 months
* Major medical illnesses that may interfere with subject's ability to complete the interventions and/or follow-up testing
* Current foot ulcer
* ABI greater than 0.95
* Life expectancy less than 12 months
* Does not speak English
* Patient is currently involved in another clinical trial
* Dementia
* Poorly controlled blood pressure
* Current significant exercise, defined as exercising three times weekly for 30 minutes with sufficient exertion to produce a sweat or other exercise that is comparable to the exercise interventions offered in our protocol
* Treatment for cancer (other than non-melanoma skin cancer) during the past 12 months (including radiation therapy, chemotherapy, or surgery)
B: Inclusion Criteria:

* ankle-brachial pressure index \<0.9 on one or both legs
* presence of leg artery disease with exertional leg symptoms (claudication)
* age 18-90 years

Exclusion Criteria:

* inability to provide written, informed consent
* medical conditions that make exercise testing unsafe (e.g. unstable angina)
* comorbidities that limit walking performance to a greater extent than claudication symptoms
* unable to complete the tests involved in the study
C: Inclusion Criteria:

* Age 40 years and older
* Diabetes mellitus
* Peripheral arterial disease
* Leg symptoms

Exclusion Criteria:

* Myocardial infarction within 3 months of enrollment
* Inability to walk for exercise secondary to chest pain, dyspnea, or poor balance
* Prior major amputation
D: Inclusion Criteria:

* Have PAD
* Potential participants with a resting ABI greater than or equal to 0.91 and less than or equal to 1.00 at their baseline visit will be eligible if their ABI drops by at least 20% after the heel-rise test. Potential participants with a resting baseline ABI greater than 0.91 who do not meet criteria for inclusion based on the heel-rise test can be eligible if they have data from a certified non-invasive vascular laboratory that demonstrates presence of lower extremity ischemia. However, more evidence than an abnormal PVR from the non-invasive vascular laboratory is required (for example, a toe brachial index pressure less than 0.60). Finally, potential participants who do not meet the above criteria for inclusion will be eligible if they have an angiogram demonstrating greater than 50% stenosis on one or more lower extremity arterial vessels.

Exclusion Criteria:

* Below or above knee amputation
* Wheelchair confinement
* Uses a walking aid other than a cane (e.g., walker)
* Unable to return to the medical center at the required visit frequency
* Greater than Class II New York Heart Association heart failure or angina (symptoms at rest or with minimal exertion)
* Any increase in angina pectoris symptoms during the 6 months before study entry or angina at rest
* Presence of a foot ulcer
* Lower extremity revascularization or major orthopedic surgery during the 3 months before study entry
* Heart attack or coronary artery bypass grafting during the 3 months before study entry
* Major medical illnesses, including treatment for cancer (except non-melanoma skin cancer) during the 12 months before study entry
* Planned lower extremity revascularization within the 12 months after study entry
* Current participation in another clinical trial
* Walking for exercise at a level comparable to that targeted in the study's intervention
* Completion of a cardiac rehabilitation program within 3 months before study entry
* Coronary ischemia during exercise, defined as ST segment depression greater than 1 mm during the baseline exercise treadmill test, with or without associated chest discomfort
* Left-bundle branch block or significant ST-T wave changes on the baseline ECG without a perfusion stress test, demonstrating no reversible ischemia within the 3 months before study entry
* Stopping during the treadmill exercise stress test because of chest pain, shortness of breath, hip or knee arthritis. These individuals will be interviewed by the principal investigator and will be excluded only if it is determined that their walking performance (based in part on the treadmill test) is limited by a comorbidity other than leg ischemia.
* Unable to walk at least 50 feet without stopping during the 6-minute walk test
* Stopping during the 6-minute walk test for symptoms other than ischemic leg symptoms
* Mini-Mental Status Examination (MMSE) score of less than 23 or psychiatric illness
* Failure to complete a study run-in period
* Parkinson's disease
* Requires oxygen with exertion.

Answer: C