Back to resultsPrehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
Primary Purpose
Prehabilitation, Knee Osteoarthritis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Maximal strength training
Sponsored by
About this trial
This is an interventional prevention trial for Prehabilitation
Eligibility Criteria
Inclusion Criteria: Knee artrosis, refered to surgery Exclusion Criteria: Kognitive disability Inflamatory disease in muscles varus/ valgus and extension deficit >15 degrees Neurological disorders
Sites / Locations
- Molde University College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Maximal strength training
Control
Arm Description
eight weeks of leg press strength training prior to knee surgery
treatment as usual prior to knee surgery
Outcomes
Primary Outcome Measures
Change in Leg press strength
The maximal weight that can be lifted once
Group differences in Patient satisfaction
Satisfied with the results of knee surgery: yes/no
Secondary Outcome Measures
Change in Voluntary activation
Force production of thigh muscle during contraction with superimposed electrical stimulation
Change in Self reported knee function
The Knee Injury and Osteoarthritis Outcome Score - Physical Function - Short Form
Change in Walking speed
6 minute walking test
Change in Chair rising ability
30 second sit to stand test
Change in Balance
unipedal stance test, postural sway
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05892133
Brief Title
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
Official Title
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molde University College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehabilitation, Knee Osteoarthritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maximal strength training
Arm Type
Experimental
Arm Description
eight weeks of leg press strength training prior to knee surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
treatment as usual prior to knee surgery
Intervention Type
Behavioral
Intervention Name(s)
Maximal strength training
Intervention Description
3 sessions/ week. leg press at ~85% of one repetition maximum for 8 weeks
Primary Outcome Measure Information:
Title
Change in Leg press strength
Description
The maximal weight that can be lifted once
Time Frame
Baseline, 1 week pre-surgery, 1week post-surgery, 12 months post-surgery.
Title
Group differences in Patient satisfaction
Description
Satisfied with the results of knee surgery: yes/no
Time Frame
Change from 1 week post-surgery, 12 months post-surgery.
Secondary Outcome Measure Information:
Title
Change in Voluntary activation
Description
Force production of thigh muscle during contraction with superimposed electrical stimulation
Time Frame
Baseline, 1 week pre-surgery, 1week post-surgery.
Title
Change in Self reported knee function
Description
The Knee Injury and Osteoarthritis Outcome Score - Physical Function - Short Form
Time Frame
Baseline, 1 week pre-surgery, 1week post-surgery, 12 months post-surgery.
Title
Change in Walking speed
Description
6 minute walking test
Time Frame
Baseline, 1 week pre-surgery, 1week post-surgery, 12 months post-surgery.
Title
Change in Chair rising ability
Description
30 second sit to stand test
Time Frame
Baseline, 1 week pre-surgery, 1week post-surgery, 12 months post-surgery.
Title
Change in Balance
Description
unipedal stance test, postural sway
Time Frame
Baseline, 1 week pre-surgery, 1week post-surgery, 12 months post-surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Knee artrosis, refered to surgery
Exclusion Criteria:
Kognitive disability
Inflamatory disease in muscles
varus/ valgus and extension deficit >15 degrees
Neurological disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berg
Phone
+47 71 19 57 71
Email
olbe@himolde.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berg
Organizational Affiliation
Molde UC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Molde University College
City
Molde
State/Province
Møre Og Romsdal
ZIP/Postal Code
6410
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ole Kristian Berg, Dr.
Phone
+47 71 19 57 71
Email
olbe@himolde.no
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
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