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. 2020 Oct 1;10(10):e034376. doi: 10.1136/bmjopen-2019-034376

Table 4.

Outcome measures to be collected

Outcome measures Data collection instrument Time points of assessment
Primary outcome
 Sit-to-stand function 30 s chair stand test B, S, 3 and 12 months
Secondary outcomes
 Ambulatory capacity Timed up and go B, S, 3 and 12 months
 Gait speed 4x10 m walk test B, S, 3 and 12 months
 1RM leg press strength Leg press machine B, S, 3 and 12 months
 1RM knee extension strength Knee extension machine B, S, 3 and 12 months
 Isometric knee extensor muscle strength Handheld Dynamometer B, S, 3 and 12 months
 Isometric knee flexion muscle strength Handheld Dynamometer B, S, 3 and 12 months
 Myofiber morphology Muscle Biopsies B, S, 3 months
 Myogenic stem cell content Muscle Biopsies B, S, 3 months
 Pain KOOS B, S, 6 weeks, 3 and 12 months
 Symptoms KOOS B, S, 6 weeks, 3 and 12 months
 Activities of daily living KOOS B, S, 6 weeks, 3 and 12 months
 Sports and recreation KOOS B, S, 6 weeks, 3 and 12 months
 Quality of life KOOS B, S, 6 weeks, 3 and 12 months
 Socioeconomic costs EQ-5D B, S, 6 weeks, 3 and 12 months
 Adverse events Questionnaire and medical records 3 months
 Exercise compliance and progression Physiotherapist records BFRE
 Pain during visits NRS for pain B, BFRE, S, 3 and 12 months
 Declining to be operated Questionnaire 3 months
 Postoperative supervised physiotherapy Questionnaire 6 weeks, 3 and 12 months
 Knee joint range of motion Goniometer B, S, 3 and 12 months
Patient characteristics and related Questionnaire B
Measurements Questionnaire B
 Gender Tape measure B
 Age Electronic body mass scale B
 Height Questionnaire B
 Body mass Questionnaire B
 Civil status Questionnaire B
 Educational level Questionnaire B
 Employment status Questionnaire B
 Substance use (alcohol, smoking) Questionnaire B
 Duration of knee symptoms Questionnaire B
 Pain medication during the last week Questionnaire B
 Comorbidities Questionnaire B

B, baseline; BFRE, low-load blood flow restricted exercise; D, during surgery; EQ-5D, EuroQol Group 5-dimension; KOOS, knee disability and osteoarthritis outcome score; 12 months, 12 months after TKR; 3 months, 3 months after TKR; NRS, Numeric Rating Scale; RM, repetition maximum; S, 0–2 days before surgery.