Table 1

Schedule of participant enrolment, intervention and assessment

MilestonesActivityScreenBaseline (preintervention)PostinterventionFollow-up
Week 0 1 8 34
Visit (timepoint)123456
Recruitment Patient identificationX
Prescreen checklist for eligibilityX
Enrolment and screening ConsentX
Confirm eligibilityX
Demographics and health historyX
Familiarisation with 6MWTX
Randomisation Stratification and randomisation X
Intervention Usual care plus community-based CR programme (weeks 2 to 7) Graphic
Control Usual care (weeks 2 to 7) Graphic
Primary outcome 6MWT X X X
Secondary outcomes Treadmill walking test and cardiorespiratory fitness test with ECG*XX
Quality of life (WIQ, ICQ)XXX
Physical activity levels (7 day accelerometer, physical activity survey)XXX
Exploratory outcomes Ankle-to-brachial systolic blood pressure indexXXX
Brachial artery flow-mediated dilation assessmentXXX
Arterial stiffness assessments (AIx, carotid-femoral artery PWV)XXX
Markers of CVD (total cholesterol, LDL, HDL triglycerides, HbA1c)XX
  • All participants will continue to receive usual care and medical advice from their general practitioner (local doctor) and vascular surgeon, and they will be randomly allocation to a community-based cardiovascular rehabilitation programme (intervention) or a usual care group (control) for 6 weeks. Prior to randomisation, participants will be stratified to account for type of procedure (eg, open surgical vs endovascular procedure) and time since procedure (< 12 weeks vs >12 weeks). Outcome measures will be assessed at baseline (week 1), at the end of the intervention/usual care period (week 8) and again at 6-month follow-up (week 34).

  • *As the treadmill walking test and the cardiorespiratory fitness test are secondary outcomes, participants will be given the option to opt out of performing those assessments. For the postintervention assessments at weeks 8 and 34, the assessment window may be extended by up to 7 days to accommodate unforeseen circumstances (eg, participant illness).

  • AIx, augmentation index; CR, cardiovascular rehabilitation; CVD, cardiovascular disease; HbA1c, haemoglobin A1c; HDL, high-density lipoprotein; ICQ, intermittent claudication questionnaire; LDL, low-density lipoprotein; 6MWT, six-minute walk test; PWV, pulse wave velocity; WIQ, Walking Impairment Questionnaire.