The effectiveness of the use of a digital activity coaching system in addition to a two-week home-based exercise program in patients after total knee arthroplasty: study protocol for a randomized controlled trial

BACKGROUND: There is consistent evidence that supervised programs are not superior to home-based programs after total knee arthroplasty (TKA), especially in patients without complications. Home-based exercise programs are effective, but we hypothesize that their effectiveness can be improved by increasing the adherence to physical therapy advice to reach an adequate exercise level during the program and thereafter. Our hypothesis is that an activity coaching system (accelerometer-based activity sensor), alongside a home-based exercise program, will increase adherence to exercises and the activity level, thereby improving physical functioning and recovery. The objective of this study is to determine the effectiveness of an activity coaching system in addition to a home-based exercise program after a TKA compared to only the home-based exercise program with physical functioning as outcome. METHODS: This study is a single-blind randomized controlled trial. Both the intervention (n = 55) and the control group (n = 55) receive a two-week home-based exercise program, and the intervention group receives an additional activity coaching system. This is a hand-held electronic device together with an app on a smartphone providing information and advice on exercise behavior during the day. The primary outcome is physical functioning, measured with the Timed Up and Go test (TUG) after two weeks, six weeks and three months. Secondary outcomes are 1) adherence to the activity level (activity diary); 2) physical functioning, measured with the 2-Minute Walk Test (2MWT) and the Knee Osteoarthritis Outcome Score; 3) quality of life (SF-36); 4) healthcare use up to one year postoperatively and 5) cost-effectiveness. Data are collected preoperatively, three days, two and six weeks, three months and one year postoperatively. DISCUSSION: The strengths of the study are the use of both performance-based tests and self-reported questionnaires and the personalized tailored program after TKA given by specialized physical therapists. Its weakness is the lack of blinding of the participants to treatment allocation. Outcomes are generalizable to uncomplicated patients as defined in the inclusion criteria. TRIAL REGISTRATION: The trial is registered in the Dutch Trial Register (www.trialregister.nl, NTR 5109) (March 22, 2015).