Osteoarthritis, KneeNCT01647243
Preoperative Strength Training in Patients With Total Knee Arthroplasty
A study testing Preoperative strength training in people with Osteoarthritis, Knee, run by University of Aarhus at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Preoperative strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unstable blood pressure,
- Neuromuscular or neurodegenerative disease,
- Comprehension or dementia problems
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University hospital
Aarhus, 8000
Birgit Sørensen Skoffer, MPH, +45 50 42 28 30, BSkoffer@dadlnet.dk
Birgit Sørensen Skoffer, MPH
About this study
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
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).
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Preoperative strength training
- Keywords
- Knee osteoarthritis, Total knee arthroplasty, Preoperative training, Strength training
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative strength trainingOther
Also called Strength training, Preoperative training
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
| Study group | Role | What they receive |
|---|---|---|
| Preoperative strength training | Experimental | Progressive strength training on group basis four weeks before the operation and progressive strength training on group basis four weeks after the operation Receives: Other: Preoperative strength training |
| Living as usual | No intervention | The patients are living as usual the last 4 weeks before operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Sit-to-stand test
Ability of function test
Measured: Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative
Secondary outcomes (15)
Isokinetic: Quadriceps 60 gr./sek
Muscle strength test in dynamometer
Measured: 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
Muscle strength test in dynamometer
Measured: 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)
Muscle strength test in dynamometer
Measured: 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)
Muscle strength test in dynamometer
Measured: 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)
Muscle test in dynamometer
Measured: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Timed Up and Go
Ability of function test
Measured: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
10 meter walk test
Ability of function test
Measured: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
6 minute walk test
Ability of function test
Measured: 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)
Disease-specific questionnaire
Measured: 6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Oxford Knee Score (OKS)
Disease-specific questionnaire
Measured: 6 weeks before the operation and 6 weeks after
EuroQol-5 dimensions (EQ-5D)
Generic questionnaire for self-rated health
Measured: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Short-Form Health Survey (SF 12)
Generic questionnaire for self-rated health
Measured: 6 weeks before the operation and 1 year after
Background data questionnaire
Questionnaire about pain, medicine use, alcohol intake, smoking, education, job
Measured: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Range of motion of the knee
Extension of the knee Flexion of the knee
Measured: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Body mass index
Weight/height2
Measured: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kjeld Soeballe, Professor, Study chair, Aarhus University Hospital, Department of orthopaedic, Tage Hansensgade 2, 8000 Aarhus C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647243
- Sponsor's protocol ID
- M-20110181
- Status last verified
- Jul 2012
- First submitted
- 13 Jul 2012
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 29129608Skoffer 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.
PubMed 26713665
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01647243
- Acronym / sponsor ID
- M-20110181
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee osteoarthritis, Total knee arthroplasty, Preoperative training, Strength training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative strength training | Experimental | Other: Preoperative strength trainingProgressive strength training on group basis four weeks before the operation and progressive strength training on group basis four weeks after the operation |
| Living as usual | No intervention | –The patients are living as usual the last 4 weeks before operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Unstable blood pressure,
- Neuromuscular or neurodegenerative disease,
- Comprehension or dementia problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative strength trainingAlso: Strength training, Preoperative trainingProgressive 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 | Preoperative strength training |
Primary outcome
Primary outcome: Sit-to-stand test
Time frame: Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative
Ability of function test
15 secondary outcomes
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
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
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
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
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
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
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
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
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
Oxford Knee Score (OKS)
Time frame: 6 weeks before the operation and 6 weeks after
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
Short-Form Health Survey (SF 12)
Time frame: 6 weeks before the operation and 1 year after
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
- Derived from this study: PubMed 29129608Skoffer 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.
- Derived from this study: PubMed 26713665Skoffer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjeld Soeballe, Professor study chair
Aarhus University Hospital, Department of orthopaedic, Tage Hansensgade 2, 8000 Aarhus C
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative strength training in people with Osteoarthritis, Knee, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgit Sørensen Skoffer, MPH (+45 50 42 28 30, BSkoffer@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Sit-to-stand test (time frame: Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647243, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2012.