Table 1

PEP-TALK trial objectives, outcome measures and measurement time points

ObjectivesOutcome measuresTime 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 ScaleBaseline; 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 ScaleBaseline; 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 ScoreBaseline; 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 PainBaseline; 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 ScaleBaseline; 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 KinesiophobiaBaseline; 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 ScaleBaseline; 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 forms6 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 questionnaire6 months; 12 months