OBJECTIVE: To investigate whether knee osteoarthritis (OA) related pain and function can be improved by offering enhanced physical therapist-led exercise interventions. DESIGNS: Three-arm prospectively designed pragmatic randomized controlled trial. SETTINGS: General practices and National Health Service physical therapy services in England. PARTICIPANTS: 514 adults (252 men, 262 women) aged >= 45 years with a clinical diagnosis of knee osteoarthritis (n = 514). Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at baseline were 8.4 for pain and 28.1 for function. INTERVENTIONS: Participants were individually randomized (1:1:1 allocation) to usual physical therapy care (UC control: up to 4 sessions of advice and exercise over 12 weeks), individually tailored exercise (ITE: individualized, supervised, and progressed lower limb exercises, 6 to 8 sessions over 12 weeks), or targeted exercise adherence (TEA: transitioning from lower limb exercise to general physical activity, 8 to 10 contacts over 6 months). MAIN OUTCOME MEASURES: Primary outcomes were pain and physical function measured by the WOMAC at 6 months. Secondary outcomes were measured at 3, 6, 9, 18, and 36 months. RESULTS: Participants receiving UC, ITE, and TEA all experienced moderate improvement in pain and function. There were no significant differences between groups at 6 months (adjusted mean differences (95% confidence intervals): pain UC versus ITE, -0.3 (-1.0 to 0.4), UC versus TEA, -0.3 (-1.0 to 0.4); function UC versus ITE, 0.5 (-1.9 to 2.9), UC versus TEA, -0.9 (-3.3 to 1.5)), or any other time-point. CONCLUSIONS: Patients receiving UC experienced moderate improvement in pain and function; however, ITE and TEA did not lead to superior outcomes. Other strategies for patients with knee osteoarthritis to enhance the benefits of exercise-based physical therapy are needed.

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