Preoperative Strength Training in Patients With Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Preoperative strength training
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee osteoarthritis, Total knee arthroplasty, Preoperative training, Strength training
Eligibility Criteria
Inclusion Criteria:
- Planned TKA at the Aarhus University Hospital or Region Hospital Silkeborg,
- Living in Aarhus Municipality,
- Primary knee osteoarthritis or secondary osteoarthritis after meniscectomy or ligament injury
Exclusion Criteria:
- Unstable blood pressure,
- Neuromuscular or neurodegenerative disease,
- Comprehension or dementia problems
Sites / Locations
- Aarhus University hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Preoperative strength training
Living as usual
Arm Description
Progressive strength training on group basis four weeks before the operation and progressive strength training on group basis four weeks after the operation
The patients are living as usual the last 4 weeks before operation
Outcomes
Primary Outcome Measures
Primary outcome: Sit-to-stand test
Ability of function test
Secondary Outcome Measures
Isokinetic: Quadriceps 60 gr./sek
Muscle strength test in dynamometer
Isokinetic: Hamstrings 60 gr./sek
Muscle strength test in dynamometer
Isometric: Quadriceps (70 gr. flexion)
Muscle strength test in dynamometer
Isometric: Hamstrings (20 gr. flexion)
Muscle strength test in dynamometer
Rate of force development (flexion and extension)
Muscle test in dynamometer
Timed Up and Go
Ability of function test
10 meter walk test
Ability of function test
6 minute walk test
Ability of function test
Knee injury and Osteoarthritis Outcome Score (KOOS)
Disease-specific questionnaire
Oxford Knee Score (OKS)
Disease-specific questionnaire
EuroQol-5 dimensions (EQ-5D)
Generic questionnaire for self-rated health
Short-Form Health Survey (SF 12)
Generic questionnaire for self-rated health
Background data questionnaire
Questionnaire about pain, medicine use, alcohol intake, smoking, education, job
Range of motion of the knee
Extension of the knee Flexion of the knee
Body mass index
Weight/height2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01647243
Brief Title
Preoperative Strength Training in Patients With Total Knee Arthroplasty
Official Title
Effect of Preoperative Strength Training on Postoperative Quadriceps Strength and Ability of Function in Patients With Total Knee Arthroplasty in Fast Track Regi
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate if preoperative strength training will result in faster recovery and higher level of function six weeks after total knee arthroplasty (TKA).
Detailed Description
Reduced strength of the quadriceps muscle is a common clinical finding in patients with Knee Osteoarthritis and this seems to play a central role in the development of the disease. The strength of the quadriceps muscle have been shown to be reduced by 20-40% as compared to age-matched healthy controls and this decrease in muscle strength have been closely associated with a reduced level of function and increase of pain. Furthermore, it has been demonstrated that the preoperative strength of the quadriceps muscle in patients undergoing TKA, is associated with the level of function one year after surgery. Compared to the level before the operation, an additional operation-induced reduction of the strength of the quadriceps muscle up to 60% as has been demonstrated. Presumably, an optimizing of the strength of the quadriceps muscle could counteract the impact of the expected postoperative loss of muscle strength to such an extent that the loss will be of less clinical significance. It is hypothesized that an optimizing of the strength of the quadriceps muscle may have a favorable effect on the postoperative rehabilitation program and shorten the period of convalescence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Knee osteoarthritis, Total knee arthroplasty, Preoperative training, Strength training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative strength training
Arm Type
Experimental
Arm Description
Progressive strength training on group basis four weeks before the operation and progressive strength training on group basis four weeks after the operation
Arm Title
Living as usual
Arm Type
No Intervention
Arm Description
The patients are living as usual the last 4 weeks before operation
Intervention Type
Other
Intervention Name(s)
Preoperative strength training
Other Intervention Name(s)
Strength training, Preoperative training
Intervention Description
Progressive strength training on group basis (not more than 3 subjects) 3 sessions weekly starting 4 weeks before the operation, in total 12 sessions Strength training 3 sessions weekly 4 weeks postsurgery
Primary Outcome Measure Information:
Title
Primary outcome: Sit-to-stand test
Description
Ability of function test
Time Frame
Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative
Secondary Outcome Measure Information:
Title
Isokinetic: Quadriceps 60 gr./sek
Description
Muscle strength test in dynamometer
Time Frame
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Title
Isokinetic: Hamstrings 60 gr./sek
Description
Muscle strength test in dynamometer
Time Frame
6 weeks and 1 week before the operation, 1 week, 6 weeks 12 weeks and 1 year after the operation
Title
Isometric: Quadriceps (70 gr. flexion)
Description
Muscle strength test in dynamometer
Time Frame
6 weeks and 1 week before the operation and 11 week, 6 weeks, 12 weeks and 1 year after the operation
Title
Isometric: Hamstrings (20 gr. flexion)
Description
Muscle strength test in dynamometer
Time Frame
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Title
Rate of force development (flexion and extension)
Description
Muscle test in dynamometer
Time Frame
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Title
Timed Up and Go
Description
Ability of function test
Time Frame
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Title
10 meter walk test
Description
Ability of function test
Time Frame
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Title
6 minute walk test
Description
Ability of function test
Time Frame
6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Title
Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
Disease-specific questionnaire
Time Frame
6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Title
Oxford Knee Score (OKS)
Description
Disease-specific questionnaire
Time Frame
6 weeks before the operation and 6 weeks after
Title
EuroQol-5 dimensions (EQ-5D)
Description
Generic questionnaire for self-rated health
Time Frame
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Title
Short-Form Health Survey (SF 12)
Description
Generic questionnaire for self-rated health
Time Frame
6 weeks before the operation and 1 year after
Title
Background data questionnaire
Description
Questionnaire about pain, medicine use, alcohol intake, smoking, education, job
Time Frame
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Title
Range of motion of the knee
Description
Extension of the knee Flexion of the knee
Time Frame
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Title
Body mass index
Description
Weight/height2
Time Frame
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Planned TKA at the Aarhus University Hospital or Region Hospital Silkeborg,
Living in Aarhus Municipality,
Primary knee osteoarthritis or secondary osteoarthritis after meniscectomy or ligament injury
Exclusion Criteria:
Unstable blood pressure,
Neuromuscular or neurodegenerative disease,
Comprehension or dementia problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgit Sørensen Skoffer, MPH
Phone
+45 50 42 28 30
Email
BSkoffer@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Soeballe, Professor
Organizational Affiliation
Aarhus University Hospital, Department of orthopaedic, Tage Hansensgade 2, 8000 Aarhus C
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgit Sørensen Skoffer, MPH
Phone
+45 50 42 28 30
Email
BSkoffer@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Birgit Sørensen Skoffer, MPH
12. IPD Sharing Statement
Citations:
PubMed Identifier
29129608
Citation
Skoffer B, Dalgas U, Maribo T, Soballe K, Mechlenburg I. No Exacerbation of Knee Joint Pain and Effusion Following Preoperative Progressive Resistance Training in Patients Scheduled for Total Knee Arthroplasty: Secondary Analyses From a Randomized Controlled Trial. PM R. 2018 Jul;10(7):687-692. doi: 10.1016/j.pmrj.2017.11.002. Epub 2017 Nov 9.
Results Reference
derived
PubMed Identifier
26713665
Citation
Skoffer B, Maribo T, Mechlenburg I, Hansen PM, Soballe K, Dalgas U. Efficacy of Preoperative Progressive Resistance Training on Postoperative Outcomes in Patients Undergoing Total Knee Arthroplasty. Arthritis Care Res (Hoboken). 2016 Sep;68(9):1239-51. doi: 10.1002/acr.22825. Epub 2016 Jul 28.
Results Reference
derived
Learn more about this trial
Preoperative Strength Training in Patients With Total Knee Arthroplasty
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