Table 1
Study activity/assessment plan for the ERASE Trial based on the Standard Protocol Items: Recommendations for Interventional Trials
| Activity/assessment | Staff member | Approx. time to complete | T-1 | T0 | T1 | T2 | T3 | F1 | F2 |
| Screening/ consent | Baseline assessment/ randomisation | Start intervention | End intervention | Postintervention assessment | 6-month follow-up | 1-year follow-up | |||
| Enrolment | |||||||||
| Eligibility screen | Study coordinator | 5 min | X | ||||||
| Informed consent | Study coordinator | 5 min | X | ||||||
| Randomisation | Study coordinator | 5 min | X | ||||||
| Interventions | |||||||||
| Exercise training | CEPs | 30 min per session |
| ||||||
| Usual care | N/A | N/A |
| ||||||
| Assessments | |||||||||
| Demographic/ behavioural/ medical variables | Study coordinator | 5 min | X | ||||||
| Primary outcome | |||||||||
| Cardiorespiratory fitness | CEPs | 20 min | X | X | |||||
| Secondary outcomes | |||||||||
| Physical function/ anthropometrics | CEPs | 20 min | X | X | |||||
| Blood biomarkers | Lab technicians | 3-4 hour | X | X | |||||
| PSA | Lab technicians | 15 min | X | X | X | X | |||
| Patient-reported outcomes | Study coordinator | 30 min | X | X | X | X | |||
| Exploratory outcomes | |||||||||
| Clinical events | Study coordinator | 5 min | X | X | X | X |
CEP, clinical exercise physiologist; PSA, prostate specific antigen.