Impact of motivational feedback on levels of physical activity and quality of life by activity monitoring following knee arthroplasty surgery-protocol for a randomized controlled trial nested in a prospective cohort (Knee-Activity).

BACKGROUND

Evidence on how to improve daily physical activity (PA) levels following total knee arthroplasty (TKA) or medial uni-compartmental knee arthroplasty (mUKA) by motivational feedback is lacking. Moreover, it is unknown whether a focus on increased PA after discharge from the hospital improves rehabilitation, physical function, and quality of life. The aim of this randomized controlled trial (RCT) nested in a prospective cohort is (a) to investigate whether PA, physical function, and quality of life following knee replacement can be increased using an activity monitoring device including motivational feedback via a patient app in comparison with activity monitoring without feedback (care-as-usual), and (b) to investigate the potential predictive value of PA level prior to knee replacement for the length of stay, return to work, and quality of life.

METHODS

The study is designed as a multicenter, parallel-group, superiority RCT with balanced randomization (1:1) and blinded outcome assessments. One hundred and fifty patients scheduled for knee replacement (TKA or mUKA) will be recruited through Odense University Hospital, Denmark, Vejle Hospital, Denmark and Herlev/Gentofte Sygehus, Denmark. Patients will be randomized to either 12 weeks of activity monitoring and motivational feedback via a patient app by gamification or 'care-as-usual,' including activity monitoring without motivational feedback. The primary outcome is the between-group change score from baseline to 12-week follow-up of cumulative daily accelerometer counts, which is a valid proxy for average objectively assessed daily PA.

DISCUSSION

Improving PA through motivational feedback following knee replacement surgery might improve post-surgical function, health-related quality of life, and participation in everyday life.

TRIAL REGISTRATION

ClinicalTrials.gov, ID: NCT06005623. Registered on 2023-08-22.

TRIAL STATUS

Recruiting.