Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty

Knee arthrosis has a high prevalence. Non-surgical treatment, such as exercise, is the first choice of treatment. However, most patients end up having a surgical procedure such as total knee arthroplasty. Following surgery with total knee replacement as much as 20% of patients report to not be satisfied with the results. It is noteworthy that this level of dissatisfaction has persisted over the last decades despite formidable progress in surgical methods and technology. Leg strength prior to surgery is associated with faster recovery post operatively, which may influence satisfaction. The investigators aim is to implement a period of strength training prior to surgery to evaluate if training prior to surgery may reduce the level of dissatisfaction post operatively.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Prehabilitation
• Intervention / Treatment: Behavioral: Maximal strength training

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Berg; Phone Number: +47 71 19 57 71; Email: olbe@himolde.no

Study Locations

• Norway
  • Møre Og Romsdal
    • Molde, Møre Og Romsdal, Norway, 6410
      • Recruiting
      • Molde University College
      • Contact: Ole Kristian Berg, Dr.; Phone Number: +47 71 19 57 71; Email: olbe@himolde.no

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Knee artrosis, refered to surgery

Exclusion Criteria:

• Kognitive disability
• Inflamatory disease in muscles
• varus/ valgus and extension deficit >15 degrees
• Neurological disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maximal strength training; eight weeks of leg press strength training prior to knee surgery	Behavioral: Maximal strength training; 3 sessions/ week. leg press at ~85% of one repetition maximum for 8 weeks
No Intervention: Control; treatment as usual prior to knee surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Leg press strength	The maximal weight that can be lifted once	Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Group differences in Patient satisfaction	Satisfied with the results of knee surgery: yes/no	Change from 3 week post-surgery, 12 months post-surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Voluntary activation	Force production of thigh muscle during contraction with superimposed electrical stimulation	Baseline, 1 week pre-surgery, 3week post-surgery.
Change in Self reported knee function	The Knee Injury and Osteoarthritis Outcome Score - Physical Function - Short Form	Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Change in Walking speed	10 meter walking test	Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Change in Chair rising ability	30 second sit to stand test	Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Change in Balance	unipedal stance test, postural sway	Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.

Collaborators and Investigators

• Sponsor: Molde University College
• Investigators: Principal Investigator: Berg, Molde UC

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 522685

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