Please select the eligibility criteria that correspond to the clinical trial below.
Title: Increasing Activity in Peripheral Arterial Disease
Brief Summary: Lower extremity peripheral arterial disease (PAD) is a disease in which fatty build-up, or plaque, accumulates in the arteries of the legs. People with lower extremity PAD often experience leg pain while walking, which is caused by reduced blood flow to the legs. Regular walking has significant benefits for people with blood flow problems in their legs, but previous studies have shown that most men and women with PAD do not walk for exercise on a regular basis. A group home-based walking program may help people with PAD to walk more often and improve their lower extremity functioning. This study will evaluate the effectiveness of a home-based group mediated cognitive behavioral (GMCB) exercise program in helping people with lower extremity PAD to increase their walking frequency and improve their lower leg functioning.


Options:
A: Inclusion Criteria:

* Positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire
* Exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol
* Ankle/brachial index (ABI) less than 0.90 at rest, which decreases to less than 0.73 immediately following the treadmill exercise test

Exclusion Criteria:

* Absence of PAD (peripheral artery disease)
* Asymptomatic PAD (Fontaine stage I)
* Rest pain due to PAD (Fontaine stage III)
* Tissue loss due to PAD (Fontaine stage IV)
* Medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.)
* Cognitive dysfunction (mini-mental state examination score less than 24)
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:

1. Participants with an ankle brachial index (ABI) ≤ 0.90 will be eligible for participation.
2. Participants with an ABI \> 0.90 but ≤ 1.00 who experience a 20% drop in ankle pressure after the heel-rise exercise will be eligible.
3. Participants with an ABI \> 0.90 who have medical record evidence of prior lower extremity revascularization and experience a 20% drop in ankle pressure after the heel-rise exercise will be eligible for inclusion.
4. Participants with an ABI \> 0.90 who have medical record evidence of a non-invasive vascular laboratory test result consistent with PAD. Note that a screen-positive test from Lifeline Screening is not sufficient for inclusion in the study.

Exclusion Criteria:

The following exclusion criteria will be initially assessed by telephone:

1. Below or above-knee amputation.
2. Wheelchair confinement.
3. Use of a walking aid other than a cane (i.e. people using walkers).
4. Non-English speaking.
5. Significant hearing impairment.
6. Significant visual impairment.
7. Diagnosis of Parkinson's disease.
8. Inability to return to the medical center at the required visit frequency (three times per week).
9. \> Class II New York Heart Association heart failure or angina (symptoms at rest or with minimal exertion).
10. Any increase in angina pectoris symptoms during the previous 6 months or angina at rest.
11. Foot ulcer. (Participants with a foot ulcer will be excluded by telephone and/or during a baseline study visit).
12. Lower extremity revascularization in the last three months or major orthopedic surgery during the previous three months.
13. Myocardial infarction, stroke, or coronary artery bypass grafting during the previous 3 months.
14. Major medical illnesses including end stage renal disease requiring dialysis and chronic lung disease requiring oxygen, since these individuals may not be able to adhere to study requirements. Participants who only use oxygen at night may still qualify.
15. Potential participants who have received G-CSF, GM-CSF, or erythropoietin within the past year will be excluded because these interventions may influence study outcomes independently of the interventions.
16. Pre-menopausal women will be excluded because cyclic estrogen changes can influence progenitor cell levels.
17. Potential participants with diabetes and documented proliferative retinopathy will be excluded because GM-CSF may exacerbate this condition.
18. Potential participants with a history of myeloid malignancy will be excluded because GM-CSF may exacerbate these conditions.
19. Potential participants who have been treated for late stage cancer during the past three years, since GM-CSF may theoretically activate quiescent cancer cells.
20. Planned lower extremity revascularization within the next 6 months.
21. Current participation in another clinical trial. If a participant recently completed a clinical trial, at least three months must have passed before they can be considered for the PROPEL Trial. However, for a clinical trial of stem cell or gene therapy intervention, potential participants will be potentially eligible immediately after the final study visit of the stem cell or gene therapy clinical trial, so long as at least six months has passed since the participant received their final treatment in the stem cell or gene therapy intervention.
22. Walking for exercise at a level comparable to that targeted in our intervention.
23. Current participation in or completion of a cardiac rehabilitation program within the last six months.

    The following exclusion criteria will be assessed at the time of the study visit or later:
24. Severe aortic stenosis identified by physical exam at the study visit.
25. Critical limb ischemia identified by physical exam at the study visit.
26. Coronary ischemia during exercise, defined as ST segment depression \> 1 mm during the baseline exercise treadmill test, with or without associated chest discomfort, without a perfusion stress test demonstrating no reversible ischemia within the previous 3 months.
27. 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 previous 3 months.
28. Stopping during the treadmill stress test for shortness of breath, chest pain, hip pain, knee pain, or another symptom that may not represent ischemic leg pain.
29. Stopping during the six-minute walk test for symptoms other than ischemic leg symptoms.
30. Foot ulcer identified at the study visit.
31. Mini-Mental Status Examination (MMSE) score \< 23 or disabling psychiatric disease.
32. Failure to complete a study run-in period.
33. Walking impairment due to a cause other than PAD.

In addition to the exclusion criteria listed above, individuals thought to be poorly suited to the intervention (i.e. not a good fit) can be excluded at the discretion of the principal investigator.
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: D