Background: The definitive treatment for knee osteoarthritis is a total knee replacement, which results in a clinically meaningful improvement in pain and physical function. However, evidence suggests that physical activity (PA) remains unchanged after total knee replacement (TKR).
Objective: The objective of this study is to investigate the efficacy, fidelity, and safety of a physical therapist-administered PA intervention for people after TKR.
Design: This study will be a randomized controlled trial.
Setting: The setting is an outpatient physical therapy clinic.
Participants: The participants are 125 individuals who are over the age of 45 and are seeking outpatient physical therapy following a unilateral TKR.
Intervention: In addition to standardized physical therapy after TKR, the intervention group will receive, during physical therapy, a weekly PA intervention that includes a wearable activity tracking device, individualized step goals, and face-to-face feedback provided by a physical therapist.
Control: The control group will receive standardized physical therapy alone after TKR.
Measurements: The efficacy of the intervention will be measured as minutes per week spent in moderate to vigorous PA at enrollment, at discharge, and at 6 months and 12 months after discharge from physical therapy. The fidelity and safety of the intervention will be assessed throughout the study.
Limitations: Participants will not be masked, PA data will be collected after randomization, and the trial will be conducted at a single site.
Conclusions: The goal of this randomized controlled trial is to increase PA after TKR. A protocol for investigating the efficacy, fidelity, and safety of a physical therapist-administered PA intervention for people after TKR is presented. The findings will be used to support a large multisite clinical trial to test the effectiveness, implementation, and cost of this intervention.
Trial registration: ClinicalTrials.gov NCT03228719.