BACKGROUND: Foot-ankle exercises could improve pain and function of individuals with KOA and need to be tested. OBJECTIVE: To investigate whether an 8-week foot-ankle muscle strengthening program is effective for individuals with KOA to reduce pain and improve function. METHODS: In this randomized controlled trial, individuals diagnosed with clinical and radiographic KOA were randomized into the intervention (supervised foot-ankle strengthening exercise program three times a week for 8 weeks) or control (usual care and recommendations of the healthcare team) group. Effectiveness was assessed by changes in clinical and functional outcomes between baseline and 8 weeks with pain as the primary outcome. ANCOVA tests using the intervention group as a reference and sex, body mass index, and baseline values as covariates assessed between-group differences. RESULTS: The intervention group showed lower pain scores (-4.4 units; 95% CI -7.5 to -1.1), better function (-7.1 units; 95% CI -12.7 to -1.4), higher total functional score (-11.9 units; 95% CI -20.7 to -3.1), with confidence intervals indicating a potential for the differences to be clinically meaningful, and better scores for the 30-s chair stand test (2.7 repetitions; 95% CI 1.1 to 4.1), with a confidence interval indicating a moderate clinically meaningful difference, compared to the controls. CONCLUSION: The 8-week foot-ankle exercise program showed positive, and potentially clinically meaningful, effects on knee pain and physical function among individuals with KOA, when compared to usual care. TRIAL REGISTRATION: NCT04154059. https://clinicaltrials.gov/ct2/show/NCT04154059.

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