Outcomes
claudication pain, AWD
DISEASE, INTERMITTENT CLAUDICATION
The primary outcome measure was AWD at 3 months using the standardized Gardner–Skinner treadmill test; beginning at 3.2 km/h at a 0 per cent incline with the incline increasing by 2 per cent every 2 minutes, for a total of 15 minutes. Patients indicated when they first experienced claudication pain (ICD) and the test would finish when this prevented continuation (AWD). To prevent bias, patients were blinded to the AWD.Secondary outcomes included ICD, compliance to interventions, QoL and haemodynamic changes. ICD was assessed by the Gardner–Skinner treadmill test at randomization, 3, 6 and 12 months. Device compliance during the treatment period was assessed by self-report patient diaries, cross-checked with voltage/current data loggers. Patients were able to continue to use the device following the 3-month treatment period.The generic EuroQoL Five Dimensions Five-Level (EQ-5D-5L), the Medical Outcomes Study 36-Item Short-Form (SF-36) Health Survey and the disease e-specific Intermittent Claudication Questionnaire (ICQ) (Due to the COVID-19 pandemic, study sites replaced on-site visits with telephone calls (A health economic analysis was prespecified in the trial protocol, but the results are not reported in the current article.