Motivational Feedback Following Total or Unicompartmental Knee Arthroplasty

Summary

The goal of this randomized controlled trial (RCT) nested in a prospective cohort study is to investigate whether physical activity (PA) following total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA) can be optimized by the use of an activity tracking device including motivational feedback in comparison with activity tracking without feedback. Furthermore, the project will investigate the predictive value of PA level prior to TKA/UKA for the length of stay, return to work, and quality of life.

The main hypothese of the study are:

RCT study:

* Using an activity tracking device, including motivational feed-back on PA show a superior short-term effect on increased PA (Total counts; primary outcome measure), physical functioning, return to work, and quality of life in comparison with no motivational feed-back from the activity tracker, defined as 'care as usual', in TKA and UKA patients
* Using an activity tracking device, including motivational feedback, will have a superior effect on step counts, activity types and pain compared to the standard care, in TKA and UKA patients

Prospective cohort:

* PA prior to TKA or UKA can work as a predictive measure for function and quality of life following surgery
* PA prior to TKA or UKA can work as a predictive measure for the length of hospital stay and return to work

Patients will be randomized to activity tracking and motivational feed-back by gamification for patient self-mobilization (Intervention-group) or 'care-as-usual' including activity tracking without motivational feed-back (Control-group). Patients not eligible and/or willing to participate in the RCT study, will be offered to participate in a prospective non-interventional cohort study.

Conditions

• Knee Arthropathy

Interventions

DEVICE

SENS Motion + Motivational Feedback

To weeks prior to surgery and in a 12-week period following discharge after TKA/UKA patients will be equipped with a discrete patch and built-in accelerometer (SENS Motion, Denmark, Copenhagen) attached on the thigh of the leg not undergoing surgery. Following discharge after TKA/UKA patients randomized to the intervention-group will receive the app ("SENS motion"). On their provided app, patients will be able to choose between two tabs. Tab 1 will allow patients to view predefined goals, all of which are locations in a self-selected city. The sensor will measure the physical activity and daily rhythm of the patient, and accelerometer counts will be converted into daily steps, which will be visible to the patients. In Tab 2, patients will be able to see graphical representations of their daily activity as well as their history during the period in which they have worn the accelerometer. The graphical representations include: Daily steps, physical active minutes, and type of activity.

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Gigtforeningen

  collaborator OTHER

• Region of Southern Denmark

  collaborator OTHER

• Vejle Hospital

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Cecilie D Skov, MD · Odense University Hospital and Institute of Clinical Research, SDU

• Anders Holsgaard-Larsen, Professor · Odense University Hospital and Institute of Clinical Research, SDU

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-15

Primary Completion

2025-04-01

Completion

2026-05-01

Countries

• Denmark

Study Locations