Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05892133
• Other study ID #: 522685
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: December 31, 2030

Study information

• Verified date: June 2023
• Source: Molde University College
• Contact: Berg
• Phone: +47 71 19 57 71
• Email: olbe[@]himolde.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Knee artrosis, refered to surgery

Exclusion Criteria:

• Kognitive disability

• Inflamatory disease in muscles

• varus/ valgus and extension deficit >15 degrees

• Neurological disorders

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Prehabilitation

Intervention

Behavioral:
• Maximal strength training
3 sessions/ week. leg press at ~85% of one repetition maximum for 8 weeks

Locations

Country	Name	City	State
Norway	Molde University College	Molde	Møre Og Romsdal

Sponsors (1)

Lead Sponsor	Collaborator
Molde University College

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change in Voluntary activation	Force production of thigh muscle during contraction with superimposed electrical stimulation	Baseline, 1 week pre-surgery, 3week post-surgery.
Secondary	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.
Secondary	Change in Walking speed	10 meter walking test	Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Secondary	Change in Chair rising ability	30 second sit to stand test	Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.
Secondary	Change in Balance	unipedal stance test, postural sway	Baseline, 1 week pre-surgery, 3week post-surgery, 12 months post-surgery.