Active — Not RecruitingNot Applicable

Motivational Feedback Following Total or Unicompartmental Knee Arthroplasty

Denmark152 participantsStarted 2023-09-15

Plain-language 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.

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age: 40-85 years
. patients scheduled for primary TKA or UKA
. understanding both verbal and written Danish language.

Exclusion criteria

. Difficulty adhering to the study protocol
. Refusal of standard care
. Known- or newly diagnosed malignancy or palliative care
. Participation in an interventional clinical trial during the last 3 months potentially interacting with the aims of the current study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Between-group change score of total daily PA (accelerometer counts)

Timeframe: Baseline and 12 weeks

Trial details

NCT IDNCT06005623

SponsorOdense University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01

View on ClinicalTrials.gov More Knee Arthropathy trials