Collins 2011.
Methods | Study design: RCT Method of randomization: permutated blocks with randomized block sizes |
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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 |
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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 |
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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 |
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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 |