Characteristics and confounders | Description and instrument | Data source | Sample | Collection points |
Patient’s characteristics | Date of birth, gender, ethnicity, BMI (height, weight), site (s) of OA diagnosis, date of first OA diagnosis, labour situation (working, retired, unemployed, in rehabilitation status) | SAQ, IDB | IG, CO | t0, t3, t6, t12, t24 |
Primary outcome measure | Clinical outcomes | |||
Pain | WOMAC Index 3.1 German (11-box NRS): subscale pain | SAQ | IG, CO | t0, t3 |
Function | WOMAC Index 3.1 German (11-box NRS): subscale physical functioning | SAQ | IG, CO | t0, t3 |
Secondary outcome measures | Clinical outcomes | IG, CO | ||
Stiffness, disease specific impairment | WOMAC Index 3.1 German (11-box NRS): subscale stiffness, overall score | SAQ | IG, CO | t0, t3, t6, t12, t24 |
Pain, physical function | WOMAC Index 3.1 German (11-box NRS): subscale pain, subscale physical function | SAQ | IG, CO | t6, t12, t24 |
Health-related quality of life | VR-12 including VR-6D utility index (4-week time slot) | SAQ | IG, CO | t0, t3, t6, t12, t24 |
General self-efficacy | General Self-Efficacy Scale | SAQ | IG, CO | t0, t3, t6, t12, t24 |
Response to exercise | OMERACT-OARSI set of responder criteria: composite score with minimum absolute and relative change levels for pain or pain and function | SAQ | IG, CO | t0, t3, t6, t12, t24 |
Physical activity status | Habitual physical and sports activity status | SAQ | IG, CO | t0, t3, t6, t12, t24 |
Time to surgery | Endpoint ‘elective joint replacement’ | IDB | IG, CO | t0, t3, t6, t12, t24 |
Patient satisfaction | ||||
Patient satisfaction | Modified version of the ZUF-8 Questionnaire to assess patient satisfaction | SAQ | IG | t3, t6 |
Functional performance measures | ||||
Knee extension/flexion Hip abduction/adduction Trunk flexion/extension Closed kinetic chain leg extension | Isometric peak torque (1 RPM) using weight machines. | PPT | IG | t0, t3, t6 |
Economic data | ||||
Unspecific and specific (OA related) healthcare costs | Outpatient costs, hospital costs, costs related to drugs, adjuvants and physical modalities, rehabilitation costs, sick pay | IDB | IG, CO | tm24, tm18, tm12, tm6 t0, t3, t6, t12, t24 |
Unspecific/specific (OA related) periods of disability | Days of disability (overall and related to OA) | IDB | IG, CO | tm24, tm18, tm12, tm6 t0, t3, t6, t12, t24 |
Intervention-related costs | Costs for human and physical resources/session | IDB | IG | t3, t6, t12, t24 |
Adherence to exercise | ||||
Training adherence | Summarised number of attended training sessions according to training log | SAQ | IG | t3 |
Safety evaluation | ||||
Adverse events and side effects | Summarised number and details of adverse events and side effects according to training log | SAQ | IG | t3 |
Data source: self-administered questionnaire via mail (SAQ), physical performance test at study site (PPT) and insurance database (IDB). Sample: participants (IG), matched pairs control (CO).
BMI, body mass index; OA, osteoarthritis; OARSI, Osteoarthritis Research Society International; OMERACT, Outcome Measures in Rheumatoid Arthritis Clinical Trials; VR-12, Veterans RAND 12 Item Health Survey; WOMAC Index, Western Ontario McMaster Universities Osteoarthritis Index.