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. 2018 Apr 6;2018(4):CD005263. doi: 10.1002/14651858.CD005263.pub4

Collins 2011.

Methods Study design: RCT
Method of randomization: permutated blocks with randomized block sizes
Participants Country: USA
Setting: clinics and communities; referred by physicians or self‐referred from flyers distributed at health fairs, community centers, and churches; media advertisements; word of mouth; postcards
No. of participants:
Baseline: HBET: n = 72; WA: n = 73
6 months: HBET: n = 61; WA: n = 65
Age, years (SD): HBET: 66.2 (10.2); WA: 66.8 (10.1)
Sex, % male: HBET: 65; WA: 73
PAD diagnosed by: ABI
Inclusion criteria: resting or postexercise ABI < 0.90, toe‐brachial index < 0.7, or prior surgery for PAD with continued exertional leg symptoms not including joint pain; men and women aged 40 years and older with diagnosis of PAD; diagnosis of diabetes mellitus type 1 or 2; leg symptoms at enrollment
Exclusion criteria: no intention to start exercising in next 6 months; no available phone, foot or lower leg amputation, critical leg ischemia, or lower extremity revascularization within 6 months before enrollment; myocardial infarction within preceding 3 months; evidence of significant coronary ischemia at low workload; systolic blood pressure > 180 mmHg or diastolic pressure > 110 mmHg; diagnosis of life‐threatening malignancy within previous year; exercise tolerance limited by leg pain of non‐vascular origin or other factors
Interventions HBET: 7‐minute educational video about PAD and strategies for disease and risk factor management (aerobic activity); one‐on‐one interaction with research coordinator at baseline; walking training (3 days per week) and weekly group walking classes with instructor; biweekly telephone calls for 6 months
WA: 7‐minute educational video about PAD and strategies for disease and risk factor management (aerobic activity); twice‐monthly phone calls with research coordinator
Duration: 6 months
Follow‐up period: 6 months
Outcomes Treadmill test: Gardner‐Skinner graded exercise treadmill test
Outcomes: maximum pain distance, onset of pain distance
Participant‐reported outcomes: WIQ, SF‐36, Geriatric Depression Score, self‐efficacy, Exercise Behaviors Questionnaire
Adherence: NA
Notes People with diabetes only
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Use of computer random number generator
Allocation concealment (selection bias) Unclear risk Method of concealment not described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding; inherent to study design
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Missing outcome date balanced in numbers across intervention groups, with similar reasons for missing data across groups
ITT analysis described; 19 of 145 participants lost to follow‐up (HBET: n = 11; WA: n = 8)
Selective reporting (reporting bias) Low risk Published reports included all expected outcomes
Other bias High risk Patients self‐referred from flyers distributed at health fairs, community centers, and churches; media advertisements; word of mouth; postcards
People with diabetes only
Six months' follow‐up: SDs of SF‐36 and WIQ imputed with baseline SDs; means and SDs of PCS and MCS of SF‐36 calculated
Funding: American Diabetes Association