Leicht 2011.
Methods | Study design: RCT Method of randomisation: (info from study author) Consecutive IC patients were randomly allocated to each group via sealed envelopes that were developed by a researcher not associated with the study. Exclusions post randomisation: nil stated Losses to follow‐up: described in detail in CONSORT chart (Leicht 2011) |
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Participants | Country: Australia Setting: local hospital and university centre No. of participants: 25 PAD, 24 healthy age‐matched controls Age: 66.9 years (± 8 years) Sex: 14 male (56%) Inclusion criteria: PAD was confirmed based on absence of lower limb peripheral pulses, lower limb artery stenosis, or occlusion on duplex or computed tomographic angiography, and ankle brachial index (ABI) < 0.94. Exclusion criteria: inability to attend potential regular supervised exercise (n = 48), selected for surgical or endovascular intervention (n = 30), declined (n = 20), other medical condition influencing gait (n = 20), exhibited significant ectopy at rest (n = 3) |
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Interventions | • Conservative medical treatment (n = 13) • Supervised exercise (n = 12) consisted of treadmill walking 3 days per week for 25 to 40 minutes per day at a workload that induced intense to maximal claudication pain. Control: healthy age‐matched controls (n = 24) Duration: 12 months |
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Outcomes | Primary: to compare heart rate variability (HRV) in patients with IC and in age‐matched healthy adults Secondary: to examine the influence of an intense long‐term (12‐month) exercise programme on HRV in patients with IC PFWD, MWD, ABI |
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Notes | Treadmill test: 3.2 km/h and incline of 0%. The incline increased by 2% every 2 minutes until voluntary exhaustion or a maximum time of 25 minutes. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised, consecutive IC patients were randomly allocated to each group via sealed envelopes that were developed by a researcher not associated with the study. |
Allocation concealment (selection bias) | Low risk | Consecutive IC patients were randomly allocated to each group via sealed envelopes that were developed by a researcher not associated with the study. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcome data reported |
Selective reporting (reporting bias) | Low risk | All outcome data reported |
Other bias | Unclear risk | Small numbers |