Hodges 2008.
Methods | Study design: RCT Method of randomization: computerized random numbers table |
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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 |
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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 |
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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 |
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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 |