Table 1

Outcome measures

Characteristics and confoundersDescription and instrumentData sourceSampleCollection points
Patient’s characteristicsDate 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, IDBIG, COt0, t3, t6, t12, t24
Primary outcome measureClinical outcomes
PainWOMAC Index 3.1 German (11-box NRS): subscale painSAQIG, COt0, t3
FunctionWOMAC Index 3.1 German (11-box NRS): subscale physical functioningSAQIG, COt0, t3
Secondary outcome measuresClinical outcomesIG, CO
Stiffness, disease specific impairmentWOMAC Index 3.1 German (11-box NRS): subscale stiffness, overall scoreSAQIG, COt0, t3, t6, t12, t24
Pain, physical functionWOMAC Index 3.1 German (11-box NRS): subscale pain, subscale physical functionSAQIG, COt6, t12, t24
Health-related quality of lifeVR-12 including VR-6D utility index (4-week time slot)SAQIG, COt0, t3, t6, t12, t24
General self-efficacyGeneral Self-Efficacy ScaleSAQIG, COt0, t3, t6, t12, t24
Response to exerciseOMERACT-OARSI set of responder criteria: composite score with minimum absolute and relative change levels for pain or pain and functionSAQIG, COt0, t3, t6, t12, t24
Physical activity statusHabitual physical and sports activity statusSAQIG, COt0, t3, t6, t12, t24
Time to surgeryEndpoint ‘elective joint replacement’IDBIG, COt0, t3, t6, t12, t24
Patient satisfaction
Patient satisfactionModified version of the ZUF-8 Questionnaire to assess patient satisfactionSAQIGt3, 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.PPTIGt0, t3, t6
Economic data
Unspecific and specific (OA related) healthcare costsOutpatient costs, hospital costs, costs related to drugs, adjuvants and physical modalities, rehabilitation costs, sick payIDBIG, COtm24, tm18, tm12, tm6
t0, t3, t6, t12, t24
Unspecific/specific (OA related) periods of disabilityDays of disability (overall and related to OA)IDBIG, COtm24, tm18, tm12, tm6
t0, t3, t6, t12, t24
Intervention-related costsCosts for human and physical resources/sessionIDBIGt3, t6, t12, t24
Adherence to exercise
Training adherenceSummarised number of attended training sessions according to training logSAQIGt3
Safety evaluation
Adverse events and side effectsSummarised number and details of adverse events and side effects according to training logSAQIGt3
  • 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.