Osteoarthritis, KneePhase 2TKANCT01351831
The Difference Between Rehabilitation With or Without Strength Training After Total Knee Replacement
A Phase 2 study testing Rehabilitation with strength training and Rehabilitation without strength training in people with Osteoarthritis, Knee, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
Background and purpose: In the early phase after a total knee replacement (TKA), patients experience a decrease in leg muscle strength with up to about 80%. This considerable loss of muscle strength is related to reduced functional performance at this point in time. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Rehabilitation with strength training and Rehabilitation without strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with a primary unilateral total knee arthroplasty.
- Age between 18 and 80 years.
- Participants must understand and speak Danish.
- Participants undergo surgery at Copenhagen University Hospital, Hvidovre, and live in the counties of Copenhagen, Brøndby or Hvidovre.
Who cannot join
- Disease/Musculoskeletal disorder, which requires special rehabilitation modality.
- Alcohol and drug abuse.
- Lack of wish to participate or unwillingness to sign an informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Clinical Research Centre, Copenhagen University Hospital, Hvidovre
Hvidovre, 2650
About this study
Official title: The Difference Between Rehabilitation With or Without Progressive Strength Training After Fast-track Total Knee Arthroplasty: A Randomized Controlled Trial
Background and purpose:
In the early phase after a total knee replacement (TKA), patients experience a decrease in leg muscle strength with up to about 80%. This considerable loss of muscle strength is related to reduced functional performance at this point in time. As the loss of muscle strength and functional performance is most pronounced early after TKA, rehabilitation including strength training initiated early after TKA seems a logical choice. However, tradition and fear of symptom exacerbation, such as increased knee joint swelling, knee pain and slow recovery of knee joint range of motion, have typically precluded strength training early after TKA.
Read more
Hypothesis:
Our hypothesis is that the effect of early rehabilitation including strength training will be greater than rehabilitation without strength training. If the hypothesis is confirmed, strength training early after TKA could be implemented directly into clinical rehabilitation practice.
Participants and methods:
Seventy participants with a unilateral TKA, between the age of 18 to 80 years, who understand and speak Danish, have given informed consent, will be included in this study.The study is a single-blinded randomized controlled study, where the participants receive supervised 1) rehabilitation with or 2) rehabilitation without strength training in 7 weeks. All components of the rehabilitation program (balance-, and mobility training etc.) are the same in both groups except the strength training exercises. Instead of the strength training exercises, the group without strength training spend more time on warm-up exercises, mobility- and balance exercises. The rehabilitation program lasts 1 hour per session, and will be performed twice per week. The participants perform a test battery 4 times from before to 6 months after the TKA. The test battery assesses the participants' walking ability, leg strength, knee pain, knee joint swelling- and range of motion, and self-reported function and quality of life.
Ethical issues:
From a pilot study conducted in the beginning of 2010, the investigators found, that strength training initiated early after TKA seems feasible, and does not increase knee joint swelling and knee pain. None of the financial supporters, or any of the authors, have any potential conflicts of interest with regard to the study.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Rehabilitation with strength training, Rehabilitation without strength training
- Keywords
- Arthroplasty, Replacement, Knee, Resistance training, Physical Therapy Modalities, Randomized Controlled Trial
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation with strength trainingOther
The rehabilitation programme lasts 1 hour per session, and is performed twice per week for 7 weeks. The rehabilitation program consists of balance-, mobility- and functional training exercises etc. In addition, the participants perform unilateral (operated leg) knee-extensions and leg presses in 2 sets for each strength training exercise, using relative loads of 12 RM (week 1), 10 RM (weeks 2-5), and 8 RM (week 6-7). All sets are performed to failure.
Rehabilitation without strength trainingOther
The rehabilitation programme lasts 1 hour per session, and is performed twice per week for 7 weeks. The rehabilitation program consists of the same balance-, mobility- and functional training exercises etc. as used in the other experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation with strength training | Experimental | Not described Receives: Other: Rehabilitation with strength training |
| Rehabilitation without strength training | Active comparator | Not described Receives: Other: Rehabilitation without strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the maximal distance (in meters) walked in 6 minutes at 2 months after surgery.
The 6-minute walk test (6MWT) measures the maximal distance a participant is able to walk in 6 minutes between 2 cones placed 29 meters apart from each other.
Further assessments: 1 month and 6 months.
Measured: Pre-surgery (baseline) and 2 months after surgery (primary endpoint) .
Secondary outcomes (8)
Change from baseline in maximum isometric knee-extension and knee-flexion strength at 2 months after surgery.
Maximum isometric knee-extension and knee-flexion strength of the operated leg are assessed using a computerized strength chair (Good Strength Chair, Metitur Oy, Jyvasklya, Finland.
Further assessments: 1 month and 6 months.
Measured: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in maximum concentric leg press power at 2 months after surgery.
Maximum concentric leg press power of the operated leg is assessed using a leg extensor power rig (Medical Engineering Unit, University of Nottingham - Medical School, Nottingham, UK).
Further assessments: 1 month and 6 months.
Measured: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in knee pain during activity and rest at 2 months after surgery.
Knee pain during activity, and rest before and after examination, are assessed using a 100-mm mechanical Visual Analogue Scale (VAS).
Further assessments: 1 month and 6 months.
Measured: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in knee joint swelling at 2 months after surgery.
Knee joint swelling of the operated leg is assessed by measuring the knee joint circumference with a tape measure.
Further assessments: 1 month and 6 months
Measured: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in knee joint range of motion (ROM) at 2 months after surgery.
Knee joint ROM of the operated leg is assessed using a large universal goniometer.
Further assessments: 1 month and 6 months.
Measured: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in self-reported function at 2 months after surgery.
The self-reported function is assessed using Knee injury and Osteoarthritis Outcome Score (KOOS).
Further assessments: 1 month and 6 months.
Measured: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in self-reported function at 2 months after surgery.
Self-reported function is assessed using Oxford Knee Score (OKS). Further assessments: 1 month and 6 months.
Measured: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in self-reported quality of life at 2 month after surgery.
Self-reported quality of life is assessed using EuroQol questionnaire (EQ-5D). Further assessments: 1 month and 6 months.
Measured: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Linding Jakobsen, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351831
- Sponsor's protocol ID
- H-3-2010-106
- Acronym
- TKA
- Status last verified
- Sep 2013
- First submitted
- 28 Apr 2011
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Langkilde A, Jakobsen TL, Bandholm TQ, Eugen-Olsen J, Blauenfeldt T, Petersen J, Andersen O. Inflammation and post-operative recovery in patients undergoing total knee arthroplasty-secondary analysis of a randomized controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1265-1273. doi: 10.1016/j.joca.2017.03.008. Epub 2017 Mar 16.
PubMed 28323139Jakobsen TL, Kehlet H, Husted H, Petersen J, Bandholm T. Early progressive strength training to enhance recovery after fast-track total knee arthroplasty: a randomized controlled trial. Arthritis Care Res (Hoboken). 2014 Dec;66(12):1856-66. doi: 10.1002/acr.22405.
PubMed 25074397
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference Between Rehabilitation With or Without Progressive Strength Training After Fast-track Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01351831
- Acronym / sponsor ID
- TKA / H-3-2010-106
- Conditions
- Osteoarthritis, Knee
- Keywords
- Arthroplasty, Replacement, Knee, Resistance training, Physical Therapy Modalities, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 May 2011 (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.
Background and purpose:
In the early phase after a total knee replacement (TKA), patients experience a decrease in leg muscle strength with up to about 80%. This considerable loss of muscle strength is related to reduced functional performance at this point in time. As the loss of muscle strength and functional performance is most pronounced early after TKA, rehabilitation including strength training initiated early after TKA seems a logical choice. However, tradition and fear of symptom exacerbation, such as increased knee joint swelling, knee pain and slow recovery of knee joint range of motion, have typically precluded strength training early after TKA.
Hypothesis:
Our hypothesis is that the effect of early rehabilitation including strength training will be greater than rehabilitation without strength training. If the hypothesis is confirmed, strength training early after TKA could be implemented directly into clinical rehabilitation practice.
Participants and methods:
Seventy participants with a unilateral TKA, between the age of 18 to 80 years, who understand and speak Danish, have given informed consent, will be included in this study.The study is a single-blinded randomized controlled study, where the participants receive supervised 1) rehabilitation with or 2) rehabilitation without strength training in 7 weeks. All components of the rehabilitation program (balance-, and mobility training etc.) are the same in both groups except the strength training exercises. Instead of the strength training exercises, the group without strength training spend more time on warm-up exercises, mobility- and balance exercises. The rehabilitation program lasts 1 hour per session, and will be performed twice per week. The participants perform a test battery 4 times from before to 6 months after the TKA. The test battery assesses the participants' walking ability, leg strength, knee pain, knee joint swelling- and range of motion, and self-reported function and quality of life.
Ethical issues:
From a pilot study conducted in the beginning of 2010, the investigators found, that strength training initiated early after TKA seems feasible, and does not increase knee joint swelling and knee pain. None of the financial supporters, or any of the authors, have any potential conflicts of interest with regard to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation with strength training | Experimental | Other: Rehabilitation with strength training |
| Rehabilitation without strength training | Active comparator | Other: Rehabilitation without strength training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with a primary unilateral total knee arthroplasty.
- Age between 18 and 80 years.
- Participants must understand and speak Danish.
- Participants undergo surgery at Copenhagen University Hospital, Hvidovre, and live in the counties of Copenhagen, Brøndby or Hvidovre.
Key exclusion criteria (3 listed)
- Disease/Musculoskeletal disorder, which requires special rehabilitation modality.
- Alcohol and drug abuse.
- Lack of wish to participate or unwillingness to sign an informed consent.
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 |
|---|---|---|
| Rehabilitation with strength trainingThe rehabilitation programme lasts 1 hour per session, and is performed twice per week for 7 weeks. The rehabilitation program consists of balance-, mobility- and functional training exercises etc. In addition, the participants perform unilateral (operated leg) knee-extensions and leg presses in 2 sets for each strength training exercise, using relative loads of 12 RM (week 1), 10 RM (weeks 2-5), and 8 RM (week 6-7). All sets are performed to failure. | Other | Rehabilitation with strength training |
| Rehabilitation without strength trainingThe rehabilitation programme lasts 1 hour per session, and is performed twice per week for 7 weeks. The rehabilitation program consists of the same balance-, mobility- and functional training exercises etc. as used in the other experimental arm. | Other | Rehabilitation without strength training |
Primary outcome
Change from baseline in the maximal distance (in meters) walked in 6 minutes at 2 months after surgery.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint) .
The 6-minute walk test (6MWT) measures the maximal distance a participant is able to walk in 6 minutes between 2 cones placed 29 meters apart from each other. Further assessments: 1 month and 6 months.
8 secondary outcomes
Change from baseline in maximum isometric knee-extension and knee-flexion strength at 2 months after surgery.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in maximum concentric leg press power at 2 months after surgery.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in knee pain during activity and rest at 2 months after surgery.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in knee joint swelling at 2 months after surgery.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in knee joint range of motion (ROM) at 2 months after surgery.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in self-reported function at 2 months after surgery.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in self-reported function at 2 months after surgery.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in self-reported quality of life at 2 month after surgery.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
- Derived from this study: PubMed 28323139Langkilde A, Jakobsen TL, Bandholm TQ, Eugen-Olsen J, Blauenfeldt T, Petersen J, Andersen O. Inflammation and post-operative recovery in patients undergoing total knee arthroplasty-secondary analysis of a randomized controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1265-1273. doi: 10.1016/j.joca.2017.03.008. Epub 2017 Mar 16.
- Derived from this study: PubMed 25074397Jakobsen TL, Kehlet H, Husted H, Petersen J, Bandholm T. Early progressive strength training to enhance recovery after fast-track total knee arthroplasty: a randomized controlled trial. Arthritis Care Res (Hoboken). 2014 Dec;66(12):1856-66. doi: 10.1002/acr.22405.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rehabilitation with strength training and Rehabilitation without strength training in people with Osteoarthritis, Knee, run by Copenhagen University Hospital, Hvidovre 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 4 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: finished, as of the sponsor's last update on 11 Sep 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the maximal distance (in meters) walked in 6 minutes at 2 months after surgery. (time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint) .). 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 NCT01351831, 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 11 Sep 2013; AzTrials last refreshed its copy on 31 Oct 2026.