Motivational Feedback Following Total or Unicompartmental Knee Arthroplasty

NCT06005623 | Active Not Recruiting

• 1 other identifier: OUH KneeActivity
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Physical activity; Motivational Feedback; Rehabilitation; Tele-Health

Outcome Measures

Primary Outcomes (1)

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

  PA will be evaluated by SENS Motion as described above. The primary outcome measure is the between-group change score of total daily PA (accelerometer counts) from baseline to 12 weeks following discharge. Accelerometer counts per day is a cumulative and validated variable based on raw accelerometer data in 3 planes and is a proxy for total daily PA

  Baseline and 12 weeks

Secondary Outcomes (6)

• Physical active minuts (Between-group change)

  Baseline and 12 weeks

• Physical activity (Between-group change)

  Baseline, 12 weeks and 12 months

• Patient satisfaction and patient reported outcome measures (Between-group change)

  Baseline, 12 weeks and 12 months

• Quality of Life (Between-group change)

  Baseline, 12 weeks and 12 months

• Return to work in day-surgery (Between-group change)

  12 weeks, 12 months

Other Outcomes (3)

• Activity types (Between-group change)

  Baseline and 12 weeks

• Post-OP pain (Between-group change)

  12 weeks

• Use of POST-op pain medication (Between-group change)

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Activity tracking and motivational feed-back by gamification.

Device: SENS Motion + Motivational Feedback

Care as usual

NO INTERVENTION

Activity tracking without motivational feed-back

Interventions

SENS Motion + Motivational Feedback DEVICE

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.

Intervention

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Do not own a smartphone

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator
• Gigtforeningen: collaborator
• Region of Southern Denmark: collaborator
• Vejle Hospital: collaborator

Study Sites (4)

Herlev Gentofte Hospital

Hellerup, Region Sjælland, 2900, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Odense University Hospital

Svendborg, Denmark

Location

Lillebaelt Hospital

Vejle, Denmark

Location

Related Publications (1)

• Skov CD, Lindberg-Larsen M, Wiil UK, Varnum C, Schmal H, Jensen CM, Holsgaard-Larsen A. 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). BMC Musculoskelet Disord. 2024 Oct 2;25(1):778. doi: 10.1186/s12891-024-07878-0.

  PMID: 39358699 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Cecilie D Skov, MD

  Odense University Hospital and Institute of Clinical Research, SDU

  PRINCIPAL INVESTIGATOR

• Anders Holsgaard-Larsen, Professor

  Odense University Hospital and Institute of Clinical Research, SDU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Data will be analyzed by the PhD student blinded towards group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: Multicenter randomized (1:1) parallel-group intervention study with blinded statistical analysis towards group allocation. Patients will be randomized to activity tracking and motivational feed-back by gamification for patient self-mobilization (INT) or 'care-as-usual' including activity tracking without motivational feed-back (CON).

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: September 15, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)