Domain | Data collection instrument | Time points | ||||
---|---|---|---|---|---|---|
Baseline | After 1st treatment session | 12 weeks | 6 M | 12 M | ||
Descriptive data | ||||||
Age, gender, weight, height, body mass index | X | |||||
Duration of knee OA symptoms | X | |||||
Educational level, postcode | X | |||||
Treatment and medication use in past month | X | X | X | X | ||
Problems in other joints | X | |||||
Co-morbidities | Functional Co-morbidity Index | X | ||||
Primary outcome measures | ||||||
Physical activity level | Average daily step count via wrist-worn accelerometry | X | X | X | X | |
OA knee symptoms in past 48 h | WOMAC Total score (includes pain, physical function, stiffness subscales) | X | X | X | X | |
Secondary outcome measures | ||||||
Average knee pain past week | 11-point NRS | X | X | X | X | |
Average knee pain during walking past week | 11-point NRS | X | X | X | X | |
Physical activity level | Daily minutes of sedentary, light, moderate, vigorous activity via wrist-worn accelerometry | X | X | X | X | |
Knee pain past 48 h | WOMAC pain subscale | X | X | X | X | |
Knee function past 48 h | WOMAC function subscale | X | X | X | X | |
Depression past week | 4-item PROMIS depression subscale | X | X | X | X | |
Anxiety past week | 4-item PROMIS anxiety subscale | X | X | X | X | |
Stress past month | 4-item PSS | X | X | X | X | |
Fear of movement | Brief FOM questionnaire | X | X | X | X | |
Pain catastrophising | PCS | X | X | X | X | |
Health related quality of life | EQ-5D-5L | X | X | X | X | |
Knee perception | FREKAQ | X | X | X | X | |
Global rating of change | 7 point ordinal scale | X | X | X | ||
Mediators | ||||||
OA/activity Conceptualisation | Osteoarthritis and Physical Activity Conceptualisation Scale | X | X | X | X | |
Pain self-efficacy | PSEQ | X | X | X | X | |
Exploratory: Implicit movement bias | Implicit association task | X | X | |||
Exploratory: Implicit environmental bias | Distance estimation task Hill steepness estimation task | X | X | |||
Exploratory: Pain sensitivity to activity | Pain pre−/post- 6 min walk task | X | X | |||
Exploratory objective factors and questionnaires (potential modulators/moderators) | ||||||
Implicit motor imagery | Left/right judgement task | X | X | |||
Tactile acuity at the knee | Two point discrimination task | X | X | |||
OA pain conceptualisation | OA pain drawing task | X | X | |||
Self-regulated learning ability | Items from the Motivated Strategies for Learning and Regulation of Learning questionnaires | X | X | X | X | |
Resource use | ||||||
Health care usea | Resource use associated with the delivery of the intervention. Self-reported use of health services and co-interventions; MBS; and hospital admissions and emergency department presentations from administrative datasets | X | X | X | X | |
Medication usea | Self-reported medication use and PBS data from administrative datasets | X | X | X | X | |
Additional outcomes | ||||||
Expectation of treatment outcome | 5 point ordinal scale | X | ||||
Treatment credibility | Modified Treatment Credibility/Expectancy Questionnaire | X | ||||
Intention to exercise | 7 point ordinal scales (commitment, motivation, determination to exercise) | X | X | X | X | |
COVID-19 impact on physical activity | 7-point ordinal scale | X | X | X | X | |
Adherence | Self-rated adherence to walking and strengthening program, 11-point NRS and number of days in past week exercise performed | X | X | X | ||
Number of in-person sessions attended | X | X | X | |||
Number of telehealth sessions attended | X | |||||
Review of patient diary | X | |||||
Harms | Adverse events | X | X | X | ||
Blinding | Participant blinding assessed via allocation guesses (and reasons); then forced choice | X | ||||
Outcome assessor blinding (same method) | X | |||||
Therapist blinding (same method) | Xb | |||||
Therapist related factors | Beliefs about exercise; self-rated via Therapist Beliefs about Exercise Questionnaire | X | Xc | |||
Beliefs about pain; self-rated via Pain Attitudes and Beliefs Scale for Physiotherapists | X | Xc | ||||
Pain knowledge; assessed via rNPQ | X | Xc | ||||
Perceived intervention credibility; assessed via modified intervention credibility and expectancy questionnaire | X | Xd | Xd | |||
Perceived connection with participant; self-rated via 101-point NRS Connectedness Scale | X |