Table 1.
PEP-TALK trial objectives, outcome measures and measurement time points
| Objectives | Outcome measures | Time points |
| Primary objective | ||
| To compare physical activity participation at 12 months post randomisation between people who receive a group exercise and behaviour change intervention versus group exercise alone following THR or TKR. | University of California, Los Angeles Activity Scale | Baseline; 6 months; 12 months (primary time point) |
| Secondary objectives | ||
| To compare the functional outcome between people who receive a group exercise and behaviour-change intervention versus group exercise alone following THR or TKR. | Lower Extremity Functional Scale | Baseline; 6 months; 12 months |
| To compare the disease-specific pain and function between people who receive a group exercise and behaviour-change intervention versus group exercise alone following THR or TKR. | Oxford Hip Score36 or Oxford Knee Score | Baseline; 6 months; 12 months |
| To compare the perceived level of pain between people who receive a group exercise and behaviour-change intervention versus group exercise alone following THR or TKR. | Numerical Rating Scale for Pain | Baseline; 6 months; 12 months |
| To compare participant’s self-efficacy between those who receive a group exercise and behaviour-change intervention versus group exercise alone following THR or TKR. | Generalised Self-Efficacy Scale | Baseline; 6 months; 12 months |
| To compare participant’s fear avoidance to movement between those who receive a group exercise and behaviour-change intervention versus group exercise alone following THR or TKR. | The Tampa Scale for Kinesiophobia | Baseline; 6 months; 12 months |
| To compare participant’s psychological distress (anxiety and depression) between those who receive a group exercise and behaviour-change intervention versus group exercise alone following THR or TKR. | Hospital Anxiety and Depression Scale | Baseline; 6 months; 12 months |
| To compare participant’s complications and adverse events between those who receive a group exercise and behaviour-change intervention versus group exercise alone following THR or TKR. | Complications or adverse events recorded in the case report forms | 6 months; 12 months |
| To collect cost-effectiveness data (health resource utilisation; direct and indirect costs) of a group exercise and a behaviour-change intervention versus group exercise alone following THR or TKR. | EQ-5D-5L; Bespoke healthcare resource self-reported questionnaire | 6 months; 12 months |