Please select the eligibility criteria that correspond to the clinical trial below.
Title: HOme-based moNitORed Exercise for PAD: The HONOR Study
Brief Summary: The purpose of this study is to determine the effects of a home-based exercise intervention on walking ability in people with peripheral artery disease. In 200 patients with peripheral artery disease (PAD), the investigators are conducting a randomized controlled trial to determine whether a patient-centered home-based exercise program improves walking ability, physical activity, mobility, pain, and social functioning, compared to a usual care group.


Options:
A: Inclusion Criteria:

All participants will have PAD. PAD will be defined as follows. First, an ABI \< or = 0.90 at the baseline study visit is a well-accepted standard for the diagnosis of PAD and will be an inclusion criterion. Second, people with an ABI of \>0.90 and \< or = 1.00 who experience a 20% ankle systolic pressure drop after the heel-rise test will also be included. Third, potential participants with an ABI \> 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD who have ischemic symptoms during the six-minute walk and/or treadmill exercise stress test will be eligible. In addition to meeting a criterion for PAD, all participants must be symptomatic, defined by one of the following criteria:; a) ischemic leg symptoms (primarily assessed with the San Diego Claudication Questionnaire); b) report ischemic leg symptoms at the end of the six-minute walk; c) report ischemic leg symptoms at the end of the baseline treadmill stress test; d) walking impairment questionnaire results, e) interview with the potential participant about the presence and nature of leg symptoms during walking activity.

Exclusion Criteria:

1. Above or below knee amputation, critical limb ischemia, wheelchair confinement, or foot ulcer.
2. Individuals whose walking is limited by a condition other than PAD.
3. \> Class II NYHA heart failure or angina. Increase in angina, angina at rest, or abnormal baseline treadmill stress test.
4. Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next twelve months.
5. Major medical illness including renal disease requiring dialysis, lung disease requiring oxygen other than at night, or cancer (other than non-melanoma skin cancer) requiring treatment in the prior three years. Potential participants may still qualify if they have had treatment for early stage cancer in the previous three years and the prognosis is excellent.
6. Mini-mental status examination score \<23, dementia, or psychiatric illness including severe depression or anxiety. Investigator discretion may be used to allow some people with an MMSE below 23 to participate if the investigator determines there is another reason for their lower score, including lack of sufficient familiarity with the English language or lack of sufficient education to achieve a score of 23 or higher.
7. Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention.
8. Current or recent (within 3 months) participation in another clinical trial or cardiac rehabilitation. For a clinical trial of a stem cell or gene therapy intervention, potential participants will be potentially eligible immediately after the final study visit for the clinical trial, so long as long as at least six months has passed since the participant received their final treatment in the stem cell or gene therapy intervention. For a clinical trial involving open-label therapy in which the treatment is not related to functional performance and will not change during the LITE Trial, participants may still qualify for the LITE Trial based on investigator discretion.
9. Individuals with PAD who have a history of lower extremity revascularization and have a normal ABI.
10. Individuals who are not able to walk for exercise at a sufficiently slow pace to avoid ischemic leg symptoms.
B: Inclusion Criteria:

1. PAD with IC (Fontaine II ou Rutherford 1-3) due to atherosclerotic disease;
2. ABI below 0.9 at rest or below 0.73 after exercise (20% decrease);
3. Age range between 50 and 80;
4. MWD in treadmill test between 50 and 500 meters;

Exclusion Criteria:

1. Asymptomatic PAD;
2. Critical Ischemia (Fontaine III/IV or Rutherford 4-6);
3. Previous lower extremity vascular surgery, angioplasty, or lumbar sympathectomy;
4. Any condition other than PAD that limits walking;
5. Miocardial Infarction or Unstable Angina in the last 6 months;
6. Inability to obtain ABI measure because of non-compressible vessels;
7. Use of cilostazol and pentoxifylline initiated within 3 months before the investigation;
8. Active cancer, renal disease, or liver disease;
9. Severe chronic obstructive pulmonary disease (GOLD stage III/IV);
10. Severe congestive heart failure (NYHA class III/IV);
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 for PAD will be eligible
4. Participants with an ABI \> 0.90 who have medical record evidence of PAD based on non-invasive vascular laboratory testing or based on angiographic findings will be eligible. Non-invasive vascular laboratory evidence of PAD must be obtained from a vascular laboratory.

Exclusion Criteria:

1. Above or below knee amputation, critical limb ischemia, wheelchair confinement, foot ulcer, non-English speaking, significant visual impairment that interferes with walking activity, hearing impairment that interferes with full study participation, unable to return to the medical center or fitness center at the expected visit frequency, or unwilling to use technology required for the intervention.
2. Individuals whose walking is limited by a condition other than PAD.
3. Greater than class II NYHA heart failure or angina. Increase in angina, angina at rest, abnormal baseline stress test.
4. Major surgery including lower extremity revascularization or orthopedic surgery during the prior three months or anticipated in the next nine months.
5. Major medical illness including lung disease requiring oxygen, Parkinson's disease that impairs walking ability, or cancer requiring treatment in the prior two years (potential participants may still qualify if they were diagnosed with non-melanoma skin cancer in the past two years or if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent).
6. Heart attack, stroke, or coronary artery bypass surgery in the last 3 months.
7. Mini-mental status examination score \< 23, dementia, or psychiatric illness.
8. Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
9. Currently enrolled in another clinical trial, exercise trial, or in cardiac rehabilitation. Currently enrolled in a clinical trial or current participation in cardiac rehabilitation or a trial of a therapeutic intervention within the past three months. For a clinical trial of a stem cell or gene therapy intervention, potential participants will be potentially eligible immediately after the final study visit for the clinical trial, so long as s at least six months has passed since the participant received their final treatment in the stem cell or gene therapy study .
10. Deemed a poor candidate for the study or poorly suited for the intervention (at PI discretion).
D: Inclusion Criteria:

* PHQ-9 score 10 or higher
* Has an e-mail account, computer, and broadband access to the Internet
* Familiarity with mobile phones and is within a cellular network range the majority of the day.
* Is able to speak and read English.
* Is at least 19 years of age.

Exclusion Criteria:

* Hearing or voice impairment preventing participation in psychotherapy.
* Visual impairment that would prevent use of the website, mobile phone application, and assessment materials.
* Has any psychiatric condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders, bipolar disorders, dissociative disorders, etc.).
* Planning to be out of town or unavailable for intervention for 1 or more weeks during the scheduled study participation.
* Exhibits severe suicidality, including ideation, plan, and intent.

Answer: C