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. 2017 Dec 26;2017(12):CD000990. doi: 10.1002/14651858.CD000990.pub4

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)
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)
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
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
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