Kakkos 2005.

Methods	Study design: RCT Method of randomization: blind, block "telephone" randomization procedure by means of computer
Participants	Country: UK Setting: vascular outpatient clinics No. of participants: Baseline: SET: n = 12; WA: n = 9 6 weeks: SET: n = 10; WA: n = 9 6 months: SET: n = 8; WA: n = 9 12 months: SET: n = 6; WA: n = 8 Age, years (SD): SET: 69 (11.8); WA: 66 (10.5) Sex, % male: SET: 92; WA: 89 PAD diagnosed by: Duplex ultrasonography or angiography Inclusion criteria: stable IC for > 6 months (San Diego claudication questionnaire) due to superficial femoral artery occlusion > 6 cm in length on ultrasonography and/or angiography Exclusion criteria: duration of symptoms < 6 months, previous angioplasty or arterial surgery to symptomatic leg, myocardial infarction within previous 6 months, inability to manage treadmill examination or training and any psychiatric illness or other reason making follow‐up difficult, ischemic rest pain, gangrene or ischemic ulceration, inability to attend SET program or severe peripheral neuropathy, ABI at enrollment > 0.9 or non‐compressible calf arteries precluding ABI measurement, iliac occlusions or stenoses amenable to surgery or angioplasty, femoral artery occlusion < 6 cm as shown on Duplex, suitable for angioplasty and limited exercise capacity caused by symptoms of angina, congestive heart failure, chronic obstructive pulmonary disease, disease of spinal column, venous disease, neurological disease, mental illness or arthritis; maximum claudication distance > 300 meters or < 50 meters; screening treadmill tests different by > 25% in terms of absolute claudication distance
Interventions	SET: advice to attend SET program 3 times per week for 6 months and exercise daily by walking as much as possible to near‐maximal pain; advice to stop smoking, antiplatelet therapy, and lipid‐lowering agents WA: advice to exercise daily by walking as much as possible to near‐maximal pain; advice to stop smoking, antiplatelet therapy, and lipid‐lowering agents Duration: 6 months Follow‐up period: 12 months
Outcomes	Treadmill test: constant load treadmill test (10% gradient, 3.5 km/h) Outcomes: ABI, initial claudication distance (ICD), absolute claudication distance (ACD), calf arterial inflow Participant‐reported outcomes: SF‐36, WIQ, intermittent claudication questionnaire Adherence: attendance rate of SET classes
Notes
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	Unclear risk	Insufficient information to permit judgement
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; 7 of 21 participants lost to follow‐up (SET: n = 6; WA: n = 1)
Selective reporting (reporting bias)	Low risk	WIQ outcomes reported incompletely; missing outcomes could be obtained from trial authors
Other bias	Unclear risk	Medians and IQRs of ICD, ACD, and SF‐36 reported; SDs calculated by dividing IQRs by 1.35