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:

1. community-dwelling older adults aged 60 years and older as defined according to the United Nations standard numerical criterion (World Health Organization, 2016);
2. previously sedentary (i.e. engaged in less than 20 minutes per week of regular physical activity for the past month and \< 125 minutes/week of moderate intensity physical activity) (Stevens et al., 1998). Moderate intensity activity that is noticeable accelerates the heart rate and is equal to approximately 3-6 metabolic equivalents (METs) (American College of Sports Medicine, 2013);
3. at risk of feeling socially isolated or lonely (indicated by a score of 6 or higher out of 9) on the 3-item loneliness scale for the phone screening by Hughes et al. (2004) (Appendix 1 - Phone-based eligibility screening form);
4. physically mobile as measured using the Short Physical Performance Battery (SPPB) (Guralnik et al., 1994) with a score ≥ 9 out of 12 (Pahor et al., 2014);
5. healthy or having one or more common chronic diseases but ambulatory;
6. without a cognitive disability as assessed by the Montreal Cognitive Assessment (MOCA) (Nasreddine et al., 2005) with a score ≥ 22 out of 30 (Freitas et al., 2013);
7. able to give written informed consent;
8. English speaking and able to complete paper and pencil questionnaires.

Exclusion Criteria:

1. not community-dwelling older adults 60 years or over;
2. not previously sedentary;
3. currently taking part in another physical activity intervention;
4. not at risk for feeling socially isolated or lonely (i.e. score of less than 6 (out of 9) on the 3-item loneliness scale for the phone screening by Hughes et al., (2004);
5. moderate to severe cognitive disability or clinical diagnosis of dementia;
6. physical disability (i.e. SPPB score less than 9);
7. severe frailty or any chronic health condition that precludes participation in the physical activity intervention and significantly limits the physical mobility of the participant (i.e. hospital settings/ non-ambulatory regime);
8. cognitive disability (i.e. less than 14 points on MOCA);
9. not able to give written informed consent;
10. not English speaking that precludes taking pen and paper tests.
B: 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
C: Inclusion Criteria:

* insulin resistance, impaired glucose tolerance or type 2-diabetes, including two or more of the following factors: Blood pressure ≥ 140/90 mm Hg, Triglycerides Fasting ≥ 1,7 mmol/l, and/or low HDL-cholesterol (≤ 0,9 mmol/l in men, ≤ 1,0 mmol/l in women)
* Obesity, Waist-hip ratio ≥ 0,9 in men, ≥ 0,85 in women or BMI (body mass index) ≥ 30 kg/m2
* Microalbuminuria (albumin secretion ≥ 20 mg/l or 20 - 200 g per minute)

Exclusion Criteria:

-
D: Inclusion Criteria:

* Sedentary (exercises fewer than two times per week)
* Overweight or mildly obese (body mass index \[BMI\] of 25 to 35 kg/m2) with mild to moderate lipid abnormalities (either LDL cholesterol 130 to 190 mg/dl or HDL cholesterol less than 40 mg/dl for men or 5 less than 45 mg/dl for women)

Exclusion Criteria:

* Diabetes
* Hypertension
* Other metabolic or musculoskeletal diseases
* Current use of or intent to diet
* Use of confounding medication
* Overt presence of coronary heart disease
* Unwilling to be randomized to any group

Answer: B