Table 2.
Domain | Data source | Measure/instrument | Time points (week) |
Demographic characteristics | Research assessment | Age, height, weight | 0 0,13,26 |
Comorbidities and medications | Research assessment | Comorbidities, current medications | 0 0,13,26 |
Radiographic evaluation | Research assessment | Bilateral knee radiographs: PA semiflexed weight bearing and skyline views37 scored for Kellgren and Lawrence grades and using the Nottingham line drawing atlas38 | 0 |
Knee pain | Self-report | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)39 | 0,13,26 |
Self-report | Analgesic and NSAID consumption | 0,13,26 | |
Research assessment | Quantitative sensory testing* including pressure pain detection threshold, temporal summation and conditioned pain modulation | 0,13,26 | |
Physical activity | Self-report | International Physical Activity Questionnaire (IPAQ)40 | 0,13,26 |
Function | Self-report | WOMAC function subscale39 | 0,13,26 |
Research assessment | Timed Up and Go (TUG) test41 30 s chair stand test42 |
0,13,26 | |
Muscle function | Research assessment | Isometric and isokinetic quadriceps strength* | 0,13,26 |
Quality of life | Self-report | The Short Form-36 Health Survey V243 EQ-5D-5L44 |
0,13, 26 |
Psychological wellness | Self-report | Hospital Anxiety and Depression Scale (HADS)45 | 0,13,26 |
Healthcare use | Self-report | Service use questionnaire to assess use of NHS or private healthcare, prescription and over-the-counter medicines related to knee pain outside of the study | 0,13,26 |
Participant engagement in treatment | Nurse-completed questionnaire | Pittsburgh Rehabilitation Participation Scale (PRPS)46 | 13/26† |
Exercise adherence | Self-report | Adherence to Exercise Scale for Older Patients (AESOP)47 | 13/26‡ |
Acceptability of intervention | Self-report | Participant satisfaction with treatment | 13,26 |
Blood markers | Research assessment | Non-fasting serum cholesterol, HbA1c and C-reactive protein§ | 0,13,26 |
Safety | Case report form | Adverse events | 26 |
*Further description included in detail in online supplementary additional files 3 and 4.
†This will be completed by the nurse after each of the non-pharmacological sessions.
‡This will be completed by the participant at the end of non-pharmacological arm.
EQ-5D-5L, 5-level version of EuroQol-5 Dimension; NHS, National Health Service; NSAID, non-steroidal anti-inflammatory drug; PA, physical activity.