Christman 2003.
Methods | Study design: RCT Method of randomization: NA |
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Participants | Country: USA Setting: several large vascular surgery offices No. of participants: Baseline: HBET: n = 21; WA: n = 17 3 months: HBET: n = 14; WA: n = 14 6 months: HBET: n = 10; WA: n = 12 Age, years (SD): HBET: 66.14 (4.91); WA: 67.69 (2.94) Sex, % male: HBET: 71.4; WA: 68.8 PAD diagnosed by: ABI Inclusion criteria: ABI < 0.9 and/or decrease in ankle pressure ≥ 15 mmHg after standard exercise protocol; between ages of 40 and 75 with arterial claudication symptoms, not exercising; in precontemplation, contemplation, or preparation stage of change for exercise and smoking Exclusion criteria: lack of interest or inability to walk on treadmill, cardiologist did not want participation in unsupervised exercise program, already in action or maintenance stages of exercise; not meeting hemodynamic criteria or ischemic rest pain or tissue loss; inability to tolerate exercise as result of comorbid illness such as arthritis or chronic obstructive pulmonary disease |
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Interventions | HBET: 12‐week education intervention consisting of one 1‐hour class per week and personalized home‐based exercise prescription (3 times/week); smoking cessation manual; exercise diary; contacted by telephone every 2 weeks for encouragement WA: admonition to begin exercising and quit smoking with no additional follow‐up Duration: 3 months Follow‐up period: 6 months |
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Outcomes | Treadmill test: graded, progressive treadmill exercise test initiated at 1 mph with grade of 5%, increasing in speed and grade at 5‐minute intervals through 4 stages to 2.5 mph at 10% grade Outcomes: claudication pain time, maximal walking time, smoking cessation rate Participant‐reported outcomes: stage of change for exercise and smoking cessation, decisional balance for exercise and smoking, exercise self‐efficacy Adherence: NA |
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Notes | Dissertation | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information about sequence generation process to permit judgement |
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 | High risk | Reasons for missing outcome data likely to be related to true outcome, with imbalance in numbers and reasons (health problems) for missing data across intervention groups ITT analysis not described; 16 of 38 participants lost to follow‐up (HBET: n = 11; WA: n = 5) |
Selective reporting (reporting bias) | Low risk | Published reports included all expected outcomes |
Other bias | Unclear risk | Dissertation Funding: National Institute of Nursing Research grant, Society of Vascular Nursing grant, and Sigma Theta Tau grant |