- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01647243
Preoperative Strength Training in Patients With Total Knee Arthroplasty
July 20, 2012 updated by: University of Aarhus
Effect of Preoperative Strength Training on Postoperative Quadriceps Strength and Ability of Function in Patients With Total Knee Arthroplasty in Fast Track Regi
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Aarhus, Denmark, 8000
- Recruiting
- Aarhus University Hospital
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Contact:
- Birgit Sørensen Skoffer, MPH
- Phone Number: +45 50 42 28 30
- Email: BSkoffer@dadlnet.dk
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Principal Investigator:
- Birgit Sørensen Skoffer, MPH
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Preoperative strength training
Progressive strength training on group basis four weeks before the operation and progressive strength training on group basis four weeks after the operation
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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
Other Names:
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NO_INTERVENTION: Living as usual
The patients are living as usual the last 4 weeks before operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary outcome: Sit-to-stand test
Time Frame: Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative
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Ability of function test
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Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isokinetic: Quadriceps 60 gr./sek
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
|
Muscle strength test in dynamometer
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6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
|
|
Isokinetic: Hamstrings 60 gr./sek
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks 12 weeks and 1 year after the operation
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Muscle strength test in dynamometer
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6 weeks and 1 week before the operation, 1 week, 6 weeks 12 weeks and 1 year after the operation
|
|
Isometric: Quadriceps (70 gr. flexion)
Time Frame: 6 weeks and 1 week before the operation and 11 week, 6 weeks, 12 weeks and 1 year after the operation
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Muscle strength test in dynamometer
|
6 weeks and 1 week before the operation and 11 week, 6 weeks, 12 weeks and 1 year after the operation
|
|
Isometric: Hamstrings (20 gr. flexion)
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Muscle strength test in dynamometer
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6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
|
|
Rate of force development (flexion and extension)
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Muscle test in dynamometer
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6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
|
|
Timed Up and Go
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Ability of function test
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6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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10 meter walk test
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Ability of function test
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6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
|
|
6 minute walk test
Time Frame: 6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Ability of function test
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6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
|
|
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Disease-specific questionnaire
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6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
|
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Oxford Knee Score (OKS)
Time Frame: 6 weeks before the operation and 6 weeks after
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Disease-specific questionnaire
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6 weeks before the operation and 6 weeks after
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EuroQol-5 dimensions (EQ-5D)
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Generic questionnaire for self-rated health
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6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Short-Form Health Survey (SF 12)
Time Frame: 6 weeks before the operation and 1 year after
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Generic questionnaire for self-rated health
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6 weeks before the operation and 1 year after
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Background data questionnaire
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Questionnaire about pain, medicine use, alcohol intake, smoking, education, job
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6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Range of motion 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
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Extension of the knee Flexion of the knee
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6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
|
|
Body mass index
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Weight/height2
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6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kjeld Soeballe, Professor, Aarhus University Hospital, Department of orthopaedic, Tage Hansensgade 2, 8000 Aarhus C
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (ANTICIPATED)
October 1, 2013
Study Completion (ANTICIPATED)
December 1, 2013
Study Registration Dates
First Submitted
July 13, 2012
First Submitted That Met QC Criteria
July 20, 2012
First Posted (ESTIMATE)
July 23, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
July 23, 2012
Last Update Submitted That Met QC Criteria
July 20, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-20110181
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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