Nicolai 2010.

Methods	Study design: RCT Method of randomization: computer‐generated block randomization list stratified by center
Participants	Country: Netherlands Setting: outpatient vascular surgery clinics No. of participants: Baseline: SET: n = 202; WA: n = 102 3 months: SET: n = 177; WA: n = 88 6 months: SET: n = 169; WA: n = 83 9 months: SET: n = 169; WA: n = 83 12 months: SET: n = 169; WA: n = 83 Age, years (SD): SET: 65.9 (9.7); WA: 66.9 (8.6) Sex, % male: SET: 66.8; WA: 55.9 PAD diagnosed by: ABI Inclusion criteria: ABI < 0.9; Stage II PAD according to Fontaine and absolute claudication distance (ACD) < 500 meters as assessed with standardized treadmill test Exclusion criteria: prior SET program for IC, previous peripheral vascular intervention, insufficient command of Dutch language, serious cardiopulmonary limitations, previous lower limb amputation, psychiatric instability, and any other serious comorbidity that might hinder physical training
Interventions	SET: supervised program by local community‐based physical therapists with frequency of 2 to 3 sessions of 30 minutes weekly; verbal walking advice and brochure; cardiovascular risk management, cholesterol‐lowering medication, antiplatelet therapy, advice to stop smoking, and modification of other atherosclerotic risk factors; 93 of 202 participants received accelerometer to provide daily feedback on physical activity WA: verbal walking advice and brochure; cardiovascular risk management, cholesterol‐lowering medication, antiplatelet therapy, advice to stop smoking, and modification of other atherosclerotic risk factors Duration: 12 months Follow‐up period: 12 months
Outcomes	Treadmill test: standardized progressive treadmill test with constant speed of 3.2 km/h, starting with 0% inclination, increasing every 2 minutes by 2% (Gardner‐Skinner protocol) Outcomes: ACD, functional claudication distance (FCD) Participant‐reported outcomes: WIQ, SF‐36 Adherence: NA
Notes	SET and SET with feedback groups were combined into single group. FWD outcomes were analyzed as PFWD outcomes.
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)	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	Low risk	Blinding of outcome assessment ensured
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups ITT analysis described; 52 of 304 participants lost to follow‐up (SET: n = 33; WA: n = 19)
Selective reporting (reporting bias)	Low risk	WIQ and SF‐36 outcomes reported incompletely; missing outcomes could be obtained from trial authors
Other bias	Unclear risk	SET and SET with feedback groups combined into single group FWD outcomes analyzed as PFWD outcomes Medians and IQRs of ACD and FCD reported; SDs calculated by dividing IQRs by 1.35 Funding: Netherlands Organisation for Health Research and Development grant