Maximal and Self-selected Walkingspeed After Knee Arthroplasty - a Prospective Cohort Study (LOVKNEE)

MAXIMAL and SELF-SELECTED WALKING SPEED AFTER KNEE ARTHROPLASTY

The purpose of this prospective study is to explore whether maximal and self-selected walking speed in individuals with knee arthroplasty is a useful and applicable clinical measure that can provide new insights into physical function after prosthetic surgery. We will examine the progression of walking speed and other measures of physical function, and investigate if walking speed can predict postoperative function. Individuals over 55 years, scheduled for knee arthroplasty will be invited to participate. Standardized functional tests such as walking speed, sit to stand and one legged stance along with patient reported outcomes will be assessed preoperatively, three months and 12 months after surgery. The study may provide useful knowledge that can be aplied clinically in the assessment and follow-up of this patient group.

Study Overview

• Status: Recruiting
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Other: Physical function

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Brita Stanghelle, PhD; Phone Number: +47 97514751; Email: brita.stanghelle@oslomet.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Lovisenberg Diaconal Hospital
    • Contact: Brita Stanghelle, PhD; Phone Number: +47 97514751; Email: brita.stanghelle@lds.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Persons with knee osteoarthritis scheduled for knee arthroplasty at Lovisenberg Diaconal Hospital who meet the eligibility criteria

Description

Inclusion Criteria: age 55 +, living in or near the city of Oslo (up to appox 2 hours commute), sceduled for primary knee arthroplasty, able to walk independently with or without walking aids, understand and speak Norwegian sufficently to take instructions and respond to questionnaires

Exclusion Criteria:

Other reasons than osteoarthritis for knee arthroplasty, revision due to infection or failure, arthroplasty in the same or other limb during the 12 months time period, severe neurological or ohter types of disease that affects walking (e.g MS; parkinsonism, hemiplegiea)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Persons scheduled for knee arthroplasty; Age 55 or over, scheduled for primary uni or total knee arthroplasty, able to walk indepentdently with or without walkingaids, living in the eastern part of Norway within 1-2 hours commute from Oslo, able understand Norwegian for instructions and filling out forms,	Other: Physical function; Observe walking speed, both maximal and self-selected, over a 12-months period after knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to 3 and 12 months in means in maximal and self-selected walking speed walikgn	Walking speed will be measured by 10 meter self-selected and maximal walking speed, respectively. Participant will perform two repetitions of self-selected walking speed, followed by two repetitions of maximal walking speed. Mean, measured by meters per seconds, will be calculated onboth of the two different walking speeds.	Baseline, 3 months and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sit-to-stand	Lower extremity strength will be measured by 30 sec sit to stand. Number of standing up in 30 seconds will be counted and recorded	Baseline, 3 months and 12 months after surgery
One legged stance	Balance will be measured by one legged stance. The participant will perform the test by standing on one leg and the other in 90 degrees flexion of the hip and knee, hands on hips. The test will be performed twice, with the non-affected leg to be tested first. The best of the two scores for each leg will be recorded.	Baseline, 3 months and 12 months after surgery
Knee specific function and pain	Pain and function in the knee will be measured by the patient reported form KOOS which includes 42 questions evaluating pain and function in different activities in daily life the last week.	Baseline and 12 months
EQ5D- Health-related quality of life	Measures self-reported health-related quality of life.	Baseline and 12 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	To measure physical activity UCLA activity score will be applied. UCLA is a simple scale from 1 to 10 where the participant mark the level that suits their level of activity best. 1 is the lowest, 10 the highest score.	Baseline and 12 months after surgery

Collaborators and Investigators

• Sponsor: Lovisenberg Diakonale Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 764176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No