Abstract
BackgroundThere 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.MethodsThis 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.DiscussionThe 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 registrationThe trial is registered in the Dutch Trial Register (www.trialregister.nl, NTR 5109) (March 22, 2015).
Highlights
There is consistent evidence that supervised programs are not superior to home-based programs after total knee arthroplasty (TKA), especially in patients without complications
To increase the adherence and thereby improve recovery after TKA we aim to study the effect of the additional use of such an activity coaching system alongside a home-based exercise program
The secondary objectives are to determine the additive effect of a digital activity coaching system alongside a homebased exercise program on 1) adherence to the activity level; 2) physical functioning measured with the 2-Minute Walk Test (2MWT) and self-reported physical function (Knee Osteoarthritis Outcome Score [KOOS]) at two and six weeks, three months and one year; 3) quality of life (SF-36) at two and six weeks, three months and one year; 4) healthcare use for one year after TKA and 5) cost-effectiveness
Summary
Baseline characteristics of participants collected preoperatively are: age (years), gender, BMI, activity level (activity diary), coping style (PAM), walking pattern (GALN), physical status (TUG, 2MWT, KOOS) and quality of life (SF-36) This is shown in the flow chart (Fig. 1). Healthcare use Healthcare use includes all kinds of healthcare consumed by the patient in relation to TKA surgery beginning at the start of the home-based exercise program up to one year postoperatively It includes physical therapy, hospital visits, visits of the general practitioner and medication use. According to the formula described by Twisk [48] for longitudinal studies with repeated measures the required sample size is calculated assuming a mean effect of 10% difference for the TUG scores between the groups over time and a standard deviation of 4.2 These parameter values are based on a study by Kennedy et al on the clinimetric properties of the TUG in patients with knee and hip arthroplasty [35]. These data will be used to generate possible hypotheses on mediating factors which can be tested using the quantitative data [52]
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