Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty

• Sponsor: Molde University College (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05892133
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 89
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prehabilitation; Knee Osteoarthritis	Behavioral: Maximal strength training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2030

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Leg press strength [Baseline, 1 week pre-surgery, 1week post-surgery, 12 months post-surgery.]

   The maximal weight that can be lifted once

2. Group differences in Patient satisfaction [Change from 1 week post-surgery, 12 months post-surgery.]

   Satisfied with the results of knee surgery: yes/no

Secondary Outcome Measures

1. Change in Voluntary activation [Baseline, 1 week pre-surgery, 1week post-surgery.]

   Force production of thigh muscle during contraction with superimposed electrical stimulation

2. Change in Self reported knee function [Baseline, 1 week pre-surgery, 1week post-surgery, 12 months post-surgery.]

   The Knee Injury and Osteoarthritis Outcome Score - Physical Function - Short Form

3. Change in Walking speed [Baseline, 1 week pre-surgery, 1week post-surgery, 12 months post-surgery.]

   6 minute walking test

4. Change in Chair rising ability [Baseline, 1 week pre-surgery, 1week post-surgery, 12 months post-surgery.]

   30 second sit to stand test

5. Change in Balance [Baseline, 1 week pre-surgery, 1week post-surgery, 12 months post-surgery.]

   unipedal stance test, postural sway

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Knee artrosis, refered to surgery

Exclusion Criteria:

• Kognitive disability

• Inflamatory disease in muscles

• varus/ valgus and extension deficit >15 degrees

• Neurological disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Molde University College	Molde	Møre Og Romsdal	Norway	6410

Sponsors and Collaborators

• Molde University College

Investigators

• Principal Investigator: Berg, Molde UC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Molde University College
• ClinicalTrials.gov Identifier: NCT05892133
• Other Study ID Numbers: 522685
• First Posted: Jun 7, 2023
• Last Update Posted: Jun 7, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Jun 7, 2023