Methods | Assessor‐blinded, 3‐arm randomised controlled trial. | |
Participants |
Inclusion criteria: aged > 50 years, knee OA fulfilling ACR criteria, and at least moderate difficulty with daily activities (WOMAC). Exclusion criteria: "systemic arthritic conditions such as rheumatoid arthritis; medical condition precluding safe exercise such as uncontrolled hypertension or heart condition; self‐reported history of serious mental illness, such as schizophrenia, or self‐reported diagnosis of current clinical depression; neurological condition such as Parkinson's disease, multiple sclerosis or stroke; knee surgery including arthroscopy within the past 6 months or total joint replacement; awaiting or planning any back or lower limb surgery within the next 12 months; current or past (within 3 months) oral or intra‐articular corticosteroid use; physiotherapy, chiropractic or acupuncture treatment or exercises specifically for the knee within the past 6 months; walking exercise for >30 minutes continuously daily; participating in a regular (more than twice a week) structured or supervised (or both) exercise programme such as attending exercise classes in a gym or use of a personal trainer; participating in or previous participation in a formal PCST programme; inability to walk unaided; inadequate written and spoken English; inability to comply with the study protocol such as inability to attend physical therapy sessions or attend assessment appointments at the University." Sample size: 222. Exercise group: 75; mean age: 62.7 years (SD 7.9); 44 women; median symptom duration 6 years. Education group: 74; mean age: 63.0 years (SD 7.9); 45 women; median symptom duration 5.5 years. Combined intervention: 73; mean age 64.6 years (SD 8.3); 44 women; median symptom duration 5.5 years. Country: Australia. |
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Interventions |
Providers: physical therapists, with 11 therapists delivering education and education/exercise treatments and 11 therapists delivering exercise treatments. Training: yes. Setting: private practice. Content: CG: education only (pain education and cognitive and behavioural pain coping skills; exercise only group: 6 exercises to strengthen quadriceps, hamstrings, and hip abductor muscles; exercise + education group. Length/intensity: 10 treatments over 12 weeks + home programme. |
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Outcomes | Outcomes at 12, 32 and 52 weeks: Primary outcomes:
Secondary outcomes:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers table used for allocations, which were sealed in an envelope by an independent person. |
Allocation concealment (selection bias) | Low risk | Envelopes opened by another independent person who emailed the therapist shortly before the next participant attended. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Therapists not blinded. Participants blinded to study hypotheses but not to intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up from 222 participants: 21 at 12 weeks (9.5%), 41 (27.9%) at 32 weeks and 36 (44.1%) at 52 weeks. |
Selective reporting (reporting bias) | Low risk | Results reported for all variables. |
Other bias | Low risk |