Table 1. Schedule of participant enrolment, intervention and assessment.
| Milestones | Activity | Screen | Baseline (preintervention) | Postintervention | Follow-up | ||
| Week | 0 | 1 | 8 | 34 | |||
| Visit (timepoint) | 1 | 2 | 3 | 4 | 5 | 6 | |
| Recruitment | Patient identification | X | |||||
| Prescreen checklist for eligibility | X | ||||||
| Enrolment and screening | Consent | X | |||||
| Confirm eligibility | X | ||||||
| Demographics and health history | X | ||||||
| Familiarisation with 6MWT | X | ||||||
| Randomisation | Stratification and randomisation | X | |||||
| Intervention | Usual care plus community-based CR programme (weeks 2 to 7) |
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| Control | Usual care (weeks 2 to 7) |
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| Primary outcome | 6MWT | X | X | X | |||
| Secondary outcomes | Treadmill walking test and cardiorespiratory fitness test with ECG* | X | X | ||||
| Quality of life (WIQ, ICQ) | X | X | X | ||||
| Physical activity levels (7 day accelerometer, physical activity survey) | X | X | X | ||||
| Exploratory outcomes | Ankle-to-brachial systolic blood pressure index | X | X | X | |||
| Brachial artery flow-mediated dilation assessment | X | X | X | ||||
| Arterial stiffness assessments (AIx, carotid-femoral artery PWV) | X | X | X | ||||
| Markers of CVD (total cholesterol, LDL, HDL triglycerides, HbA1c) | X | X | |||||
Note: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 programprogramme (intervention) or a usual care group (control) for 6-weeks 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 post-intervention assessments at weeks 8 and 34, the assessment window may be extended by up to 7 days days to accommodate unforeseen circumstances (eg, participant illness).
AIx, augmentation index; CR, cardiovascular rehabilitation; CVD, cardiovascular disease; HbA1c, haemoglobin A1cHDL, high-density lipoprotein; ICQ, intermittent claudication questionnaire; LDL, low-density lipoprotein; 6MWTsix-minute walk testPWV, pulse wave velocity; WIQ, Walking Impairment Questionnaire