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

Sandercock 2007.

Methods Study design: RCT
Method of randomization: random number tables
Participants Country: UK
Setting: vascular outpatient clinic
No. of participants:
Baseline: SET: n = 14; HBET: n = 15; WA: n = 15
6 weeks: SET: n = 14; HBET: n = 15; WA: n = 15
3 months: SET: n = 14; HBET: n = 15; WA: n = 15
Age, years (SD): SET: 66 (8); HBET: 62 (14); WA: 67 (6)
Sex, % male: SET: 71; HBET: 80; WA: 67
PAD diagnosed by: ABI
Inclusion criteria: ABI < 0.94 at rest; symptomatic IC during walking
Exclusion criteria: inability to perform familiarization test, poorly controlled hypertension, poorly controlled diabetes, severe coronary artery disease, valvular heart disease, limb ischemia, and debilitating pulmonary disease
Interventions SET: twice a week, 30 minutes of treadmill walking; exercise diary; instructed to undertake 1 additional 30‐minute walking session per week
HBET: exercise diary; instructed to undertake three 30‐minute walking sessions per week at rating of perceived effort (RPE) of 12 to 14; contacted weekly by telephone and given support and encouragement in adhering to protocol
WA: verbal information regarding safety and efficacy of walking exercise but no specific instructions regarding exercise duration, intensity, or frequency
Duration: 3 months
Follow‐up period: 3 months
Outcomes Treadmill test: graded treadmill test; initial speed of 2 miles/h for 2 minutes; gradient then increased by 2% every 2 minutes until test termination
Outcomes: maximal walking time, peak oxygen uptake, respiratory exchange ratio, heart rate variability measures
Participant‐reported outcomes: RPE, pain rating
Adherence: NA
Notes When data were missing, most recent recorded values were carried forward.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Referring to random number table
Allocation concealment (selection bias) Low risk Central allocation
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 High risk No blinding
Incomplete outcome data (attrition bias) 
 All outcomes High risk Missing data imputed via potentially inappropriate methods; when data were missing, most recent recorded values were carried forward
ITT analysis described; 3 of 44 participants lost to follow‐up (SET: n = 2; HBET: n = 1; WA: n = 0)
Selective reporting (reporting bias) Low risk Published reports included all expected outcomes
Other bias Low risk Study appears to be free of other sources of bias