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

Hodges 2008.

Methods Study design: RCT
Method of randomization: computerized random numbers table
Participants Country: UK
Setting: vascular outpatient clinic
No. of participants:
Baseline: SET: n = 14; WA: n = 14
6 weeks: SET: n = 14; WA: n = 14
3 months: SET: n = 14; WA: n = 14
Age, years (SD): 68 (8)
Sex, % male: NA
PAD diagnosed by: ABI
Inclusion criteria: PAD (ABI < 0.9 at rest) and symptomatic IC (Edinburgh Walking Questionnaire)
Exclusion criteria: inability to complete familiarization test, poorly controlled hypertension, poorly controlled diabetes, severe coronary artery disease, valvular heart disease, and debilitating pulmonary disease
Interventions SET: 12 weeks of supervised exercise twice weekly; treadmill walking until Stage III or IV on PAD pain scale; further exercise session at home
WA: walking as often as possible, but no exercise regimen to follow
Duration: 3 months
Follow‐up period: 3 months
Outcomes Treadmill test: graded progressive treadmill exercise test with initial speed of 3.2 km/h and 0% gradient for 2 minutes; gradient increased by 2% every 2 minutes, and speed remaining constant (Gardner‐Skinner protocol)
Outcomes: maximal walking time, peak oxygen uptake, maximal heart rate, respiratory exchange ratio, rate of perceived exertion, pain, mean arterial pressure, cardiac output, cardiac power output
Participant‐reported outcomes: NA
Adherence: NA
Notes  
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) 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 Unclear risk Insufficient reporting of attrition to permit judgement
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