Effect of Comprehensive Behavioral and Exercise Intervention on Physical Function and Activity Participation After Total Knee Replacement: A Pilot Randomized Study

Abstract

Objective: To test the feasibility of a comprehensive behavioral intervention (CBI) program that combines intense exercises with an education program, to be implemented at a later stage (3 months) following total knee replacement (TKR), and to get a first impression of the effects of the CBI as compared to a standard of care exercise (SCE) program on the outcomes of physical function and physical activity.

Methods: A total of 44 subjects participated in a 3-month program of either CBI or SCE, followed by 3 months of a home exercise program. Outcomes of physical function and physical activity were measured at baseline and at 6-month followup. Analysis of variance was used to compare statistical differences between groups, whereas responder analyses were used for clinically important differences.

Results: The CBI was found to be safe and well tolerated. As compared to the SCE group, the CBI group had less pain (P = 0.035) and better physical function based on the Short Form 36 health survey (P = 0.017) and the single-leg stance test (P = 0.037). The other outcome measures did not demonstrate statistically significant differences between the 2 groups. Results from the responder analysis demonstrated that the CBI group had a 36% higher rate of responders in physical function as compared to the SCE group. Also, the CBI group had 23% more responders in the combined domains of physical function and physical activity.

Conclusion: The CBI program is feasible and improves physical function and physical activity in patients several months after TKR. Larger pragmatic randomized trials are needed to confirm the results of this study.

Trial registration: ClinicalTrials.gov NCT01799772.

Conflict of interest statement

Financial interests of the authors do not create a potential or apparent conflict of interest regarding the work.

© 2017, American College of Rheumatology.

Figures

Figure 1. Study Flow Diagram

Figure 2. Responders in Physical Function and in the Combined Outcomes of Physical Function and Physical Activity in the Comprehensive Behavioral Intervention and Standard of Care Exercise Groups

* A responder to physical function is defined as a subject who improved in at least one patient-reported outcome and in one performance-based outcome above the MCII. A responder to physical function and physical activity is defined as a subject who is a responder to physical function and also improved in physical activity above the MCII.