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

Christman 2003.

Methods Study design: RCT
Method of randomization: NA
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
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
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
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