Sandercock 2007.
Methods | Study design: RCT Method of randomization: random number tables |
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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 |
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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 |
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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 |
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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 |