Study measures to be collected
| Baseline measures and outcomes | Description and instrument | Data source | Collection points |
| Patient’s characteristics | Date of birth, gender, BMI (height, weight) social and living status, leisure activities, level of physical activity, smoking, medicine, sleep, comorbidities, anxiety and depression, catastrophising, life satisfaction, kinesiophobia | SAQ | t0 |
| Primary outcome measure | Clinical outcomes | ||
| Pain | KOOS: subscale pain | SAQ | t0, t2, t4, t6, t8, t10, t12, t26, t52 |
| Other symptoms | KOOS: subscale other symptoms | SAQ | t0, t2, t4, t6, t8, t10, t12, t26, t52 |
| Function | KOOS: subscale physical functioning | SAQ | t0, t2, t4, t6, t8, t10, t12, t26, t52 |
| Sport, recreation | KOOS: subscale sport and recreation | SAQ | t0, t2, t4, t6, t8, t10, t12, t26, t52 |
| Secondary outcome measures | Clinical outcomes | ||
| VAS (100 mm scale): pain | SAQ | t0, t2, t4, t6, t8, t10, t12, t26, t52 | |
| VAS (100 mm scale): knee pain not loading | SAQ | t0, t2, t4, t6, t8, t10, t12, t26, t52 | |
| VAS (100 mm scale): pain at weight bearing | SAQ | t0, t2, t4, t6, t8, t10, t12, t26, t52 | |
| VAS (100 mm scale): knee pain at night | SAQ | t0, t2, t4, t6, t8, t10, t12, t26, t52 | |
| Physical functioning | |||
| 20 m walk test | PT | t0, t12 | |
| Chair stand test | PT | t0, t12 | |
| Unilateral knee bending | PT | t0, t12 | |
| Pain threshold and tolerance | |||
| Pain matcher | PainMatcher apparatus | t0, t12 | |
| Quality of life | |||
| (EQ-5D-5L) | SAQ | t0, t12, t26, t52 | |
| (SF-36) | SAQ | t0, t12, t26, t52 | |
| Life satisfaction | |||
| LISAT | SAQ | t0, t12, t26, t52 | |
| Psychological outcomes | |||
| Anxiety and depression (HAD Scale), | SAQ | t0, t12, t26, t52 | |
| Catastrophising (PCS) | SAQ | t0, t12, t26, t52 | |
| Kinesiophobia (TSK) | SAQ | t0, t12, t26, t52 | |
| Beliefs and attitude towards exercise | |||
| SEE Scale | SAQ | t0, t12, t26, t52 | |
| OEE Scale | SAQ | t0, t12, t26, t52 |
Data source: Self-administered questionnaire (SAQ), physical testing (PT).
Collection points: t0=inclusion, t1–t12=measurement every second week during the 12-week intervention period, t1=2 weeks, t2=4 weeks, t3=6 weeks, t4=8 weeks, t5=10 weeks, t6=12 weeks (end of inclusion), t26=6 months follow-up, t52=12 months follow-up.
BMI, body mass index; EQ-5D-5L, EuroQol-5D-5L; HAD, Hospital Anxiety and Depression; KOOS, Knee Injury and Osteoarthritis Outcome Score; LISAT, Life Satisfaction Questionnaire; OEE, Outcome Expectancy for Exercise; PCS, Pain Catastrophising Scale; SEE, Self-Efficacy for Exercise; SF-36, Short Form Health Survey; TSK, Tampa Scale of Kinesiophobia; VAS, Visual Analogue Scale.