BACKGROUND: Current practice guidelines emphasize the use of physical activity as the first-line treatment of knee osteoarthritis; however, up to 90% of people with osteoarthritis are inactive. OBJECTIVE: We aimed to assess the efficacy of a technology-enabled counseling intervention for improving physical activity in people with either a physician-confirmed diagnosis of knee osteoarthritis or having passed two validated criteria for early osteoarthritis. METHODS: We conducted a proof-of-concept randomized controlled trial. The immediate group received a brief education session by a physical therapist, a Fitbit Flex, and four biweekly phone calls for activity counseling. The delayed group received the same intervention 2 months later. Participants were assessed at baseline (T0) and at the end of 2 months (T1), 4 months (T2), and 6 months (T3). Outcomes included (1) mean time on moderate-to-vigorous physical activity (MVPA >= 3 metabolic equivalents (METs), primary outcome), (2) mean time on MVPA >= 4 METs, (3) mean daily steps, (4) mean time on sedentary activities, (5) Knee Injury and Osteoarthritis Outcome Score (KOOS), and (6) Partners in Health scale. Mixed-effects repeated measures analysis of variance was used to assess five planned contrasts of changes in outcome measures over measurement periods. The five contrasts were (1) immediate T1 minus T0 versus delayed T1 minus T0, (2) delayed T2 minus T1 versus delayed T1 minus T0, (3) mean of contrast 1 and contrast 2, (4) immediate T1 minus T0 versus delayed T2 minus T1, and (5) mean of immediate T2 minus T1 and delayed T3 minus T2. The first three contrasts estimate the between-group effects. The latter two contrasts estimate the effect of the 2-month intervention delay on outcomes. RESULTS: We recruited 61 participants (immediate n = 30; delayed n = 31). Both groups were similar in age (immediate mean 61.3, SD 9.4 years; delayed mean 62.1, SD 8.5 years) and body mass index (immediate: mean 29.2, SD 5.5 kg/m2; delayed mean 29.2, SD 4.8 kg/m2). Contrast analyses revealed significant between-group effects in MVPA >= 3 METs (contrast 1 coefficient 26.6, 95% CI 4.0 to 49.1, p = 0.02; contrast 3 coefficient 26.0, 95% CI 3.1 to 49.0, p = 0.03), daily steps (contrast 1 coefficient 1,699.2, 95% CI 349.0 to 3,049.4, p = 0.02; contrast 2 coefficient 1,601.8, 95% CI 38.7 to 3,164.9, p = 0.045; contrast 3 coefficient 1,650.5, 95% CI 332.3 to 2,968.7; p = 0.02), KOOS activity of daily living subscale (contrast 1 coefficient 6.9, 95% CI 0.1 to 13.7, p = 0.047; contrast 3 coefficient 7.2, 95% CI 0.8 to 13.6, p = 0.03), and KOOS quality of life subscale (contrast 1 coefficient: 7.4, 95% CI 0.0 to 14.7, p = 0.049; contrast 3 coefficient 7.3, 95% CI 0.1 to 14.6, p = 0.048). We found no significant effect in any outcome measures due to the 2-month delay of the intervention. CONCLUSIONS: Our counseling program improved MVPA >= 3 METs, daily steps, activity of daily living, and quality of life in people with knee osteoarthritis. These findings are important because an active lifestyle is an important component of successful self-management. TRIAL REGISTRATION: ClinicalTrials.gov NCT02315664; https://ClinicalTrials.gov/ct2/show/NCT02315664.

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