Osteoarthritis, KneeNCT01713140
Experimental Study of Strength Training to Activate the Quadriceps Muscle After Total Knee Arthroplasty
A study testing 1 strength training set performed until contraction failure in people with Osteoarthritis, Knee, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
Background: Progressive strength training is a training modality used in rehabilitation after total knee arthroplasty (TKA). Strength deficits up to 80% in the quadriceps muscle is shown to be present in the operated leg after TKA, which relates to reduced central nervous system (CNS) activation of the muscle. 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?
- 1 strength training set performed until contraction failure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral primary TKA
- Between the age of 18 to 80 years
- Understand and speak Danish
- Informed consent
- 4 to 8 weeks after TKA
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 Reaserch Center, Copenhagen University Hospital, Hvidovre
Copenhagen, Hvidovre, 2650
About this study
Official title: Central (CNS) Activation of the Quadriceps Muscle During Strength Training With Repetitions to Contraction Failure After Total Knee Arthroplasty
Background:
Progressive strength training is a training modality used in rehabilitation after total knee arthroplasty (TKA). Strength deficits up to 80% in the quadriceps muscle is shown to be present in the operated leg after TKA, which relates to reduced central nervous system (CNS) activation of the muscle. As increased CNS activation occurs during strength training when muscular fatigue is approaching in healthy subjects, it is relevant to investigate if this also is the case after TKA. The clinical implication is that repetitions performed to contraction failure during strength training, may help reduce CNS activation deficits of the quadriceps muscle after TKA.
Read more
Purpose:
The aim of this study is to investigate CNS activation of the quadriceps muscle during strength training performed with repetitions to contraction failure after TKA.
Method:
Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL), semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions performed in a knee extension machine until contraction failure. The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a minimum of 3 days before the day where the EMG-data are recorded. The primary outcomes will be normalized EMG amplitude and median power frequency for each 10th (10%, 20%, 30% failure, etc.) of the set to failure.
Hypothesis:
Based on previous findings in healthy subjects, we hypothesize that in patients with a TKA, the EMG amplitude will increase while the median power frequency will decrease during a strength training set performed to contraction failure after TKA.
- Conditions
- Osteoarthritis, Knee
- Being tested
- 1 strength training set performed until contraction failure
- Keywords
- strength training, resistance training, fatigue, knee extension, total knee arthroplasty, total knee replacement, electromyography, physical therapy modalities
- Medical subject headings
- Osteoarthritis, Knee, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 strength training set performed until contraction failureOther
Also called Resistance training.
Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL), semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions performed in a knee extension machine in a single set performed until contraction failure. The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a minimum of 3 days before the day where the EMG-data are recorded. Range of motion and time under tension for each repetition will be controlled for.
| Study group | Role | What they receive |
|---|---|---|
| 1 strength training set performed until contraction failure | Experimental | Knee extensions until contraction failure will be performed, using a relative loading of 10 repetition maximum (RM). Receives: Other: 1 strength training set performed until contraction failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from 10% contraction failure in normalized EMG amplitude (%EMGmax).
EMG amplitude-data from the set performed until contraction failure will be reduced to time points corresponding to 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100% contraction failure.
Measured: 10% to 100% contraction failure in a single set performed until contraction failure. The set is performed at a single day, 4 to 8 weeks after surgery.
Change from 10% contraction failure in median power frequency (Hz)
Median power frequency-data from the set performed until contraction failure will be reduced to time points corresponding to 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100% contraction failure.
Measured: 10% to 100% contraction failure in a single set performed until contraction failure. The set is performed at a single day, 4 to 8 weeks after surgery.
Secondary outcomes (2)
Change from baseline (pre strength training) in Nm/kg body mass
Maximal isometric knee-extension force will be measured, using a fixated hand-held dynamometer, and expressed as the maximal voluntary torque per kilo body mass, using the external lever arm and body weight of each subject.
Measured: From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.
Change from baseline (pre strength training) in knee pain (VAS-mm)
Knee pain is scored by each subject at rest and during strength training, using a standard VAS-ruler with endpoints of "no pain" (0 mm) and "worst pain imaginable" (100 mm).
Measured: From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Elin Andersson, Copenhagen University Hospital, Hvidovre
- Investigators
- Thomas Bandholm, PhD, Study director, Clinical Research Center, Copenhagen University Hospital, Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713140
- Sponsor's protocol ID
- EA2012_2013
- Status last verified
- Jun 2013
- First submitted
- 18 Oct 2012
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thomas AC, Stevens-Lapsley JE. Importance of attenuating quadriceps activation deficits after total knee arthroplasty. Exerc Sport Sci Rev. 2012 Apr;40(2):95-101. doi: 10.1097/JES.0b013e31824a732b.
PubMed 22249398Jakobsen TL, Husted H, Kehlet H, Bandholm T. Progressive strength training (10 RM) commenced immediately after fast-track total knee arthroplasty: is it feasible? Disabil Rehabil. 2012;34(12):1034-40. doi: 10.3109/09638288.2011.629019. Epub 2011 Nov 15.
PubMed 22084974Sundstrup E, Jakobsen MD, Andersen CH, Zebis MK, Mortensen OS, Andersen LL. Muscle activation strategies during strength training with heavy loading vs. repetitions to failure. J Strength Cond Res. 2012 Jul;26(7):1897-903. doi: 10.1519/JSC.0b013e318239c38e.
PubMed 21986694Mikkelsen EK, Jakobsen TL, Holsgaard-Larsen A, Andersen LL, Bandholm T. Strength Training to Contraction Failure Increases Voluntary Activation of the Quadriceps Muscle Shortly After Total Knee Arthroplasty: A Cross-sectional Study. Am J Phys Med Rehabil. 2016 Mar;95(3):194-203. doi: 10.1097/PHM.0000000000000361.
PubMed 26339729
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central (CNS) Activation of the Quadriceps Muscle During Strength Training With Repetitions to Contraction Failure After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01713140
- Acronym / sponsor ID
- EA2012_2013
- Conditions
- Osteoarthritis, Knee
- Keywords
- strength training, resistance training, fatigue, knee extension, total knee arthroplasty, total knee replacement, electromyography, physical therapy modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 Oct 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.
Background:
Progressive strength training is a training modality used in rehabilitation after total knee arthroplasty (TKA). Strength deficits up to 80% in the quadriceps muscle is shown to be present in the operated leg after TKA, which relates to reduced central nervous system (CNS) activation of the muscle. As increased CNS activation occurs during strength training when muscular fatigue is approaching in healthy subjects, it is relevant to investigate if this also is the case after TKA. The clinical implication is that repetitions performed to contraction failure during strength training, may help reduce CNS activation deficits of the quadriceps muscle after TKA.
Purpose:
The aim of this study is to investigate CNS activation of the quadriceps muscle during strength training performed with repetitions to contraction failure after TKA.
Method:
Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL), semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions performed in a knee extension machine until contraction failure. The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a minimum of 3 days before the day where the EMG-data are recorded. The primary outcomes will be normalized EMG amplitude and median power frequency for each 10th (10%, 20%, 30% failure, etc.) of the set to failure.
Hypothesis:
Based on previous findings in healthy subjects, we hypothesize that in patients with a TKA, the EMG amplitude will increase while the median power frequency will decrease during a strength training set performed to contraction failure after TKA.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 strength training set performed until contraction failure | Experimental | Other: 1 strength training set performed until contraction failureKnee extensions until contraction failure will be performed, using a relative loading of 10 repetition maximum (RM). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral primary TKA
- Between the age of 18 to 80 years
- Understand and speak Danish
- Informed consent
- 4 to 8 weeks after TKA
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 |
|---|---|---|
| 1 strength training set performed until contraction failureAlso: Resistance training.Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL), semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions performed in a knee extension machine in a single set performed until contraction failure. The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a minimum of 3 days before the day where the EMG-data are recorded. Range of motion and time under tension for each repetition will be controlled for. | Other | 1 strength training set performed until contraction failure |
Primary outcome
Change from 10% contraction failure in normalized EMG amplitude (%EMGmax).
Time frame: 10% to 100% contraction failure in a single set performed until contraction failure. The set is performed at a single day, 4 to 8 weeks after surgery.
EMG amplitude-data from the set performed until contraction failure will be reduced to time points corresponding to 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100% contraction failure.
Change from 10% contraction failure in median power frequency (Hz)
Time frame: 10% to 100% contraction failure in a single set performed until contraction failure. The set is performed at a single day, 4 to 8 weeks after surgery.
Median power frequency-data from the set performed until contraction failure will be reduced to time points corresponding to 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100% contraction failure.
2 secondary outcomes
Change from baseline (pre strength training) in Nm/kg body mass
Time frame: From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.
Change from baseline (pre strength training) in knee pain (VAS-mm)
Time frame: From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.
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 25 Jun 2013.
- Background: PubMed 22249398Thomas AC, Stevens-Lapsley JE. Importance of attenuating quadriceps activation deficits after total knee arthroplasty. Exerc Sport Sci Rev. 2012 Apr;40(2):95-101. doi: 10.1097/JES.0b013e31824a732b.
- Results publication: PubMed 22084974Jakobsen TL, Husted H, Kehlet H, Bandholm T. Progressive strength training (10 RM) commenced immediately after fast-track total knee arthroplasty: is it feasible? Disabil Rehabil. 2012;34(12):1034-40. doi: 10.3109/09638288.2011.629019. Epub 2011 Nov 15.
- Results publication: PubMed 21986694Sundstrup E, Jakobsen MD, Andersen CH, Zebis MK, Mortensen OS, Andersen LL. Muscle activation strategies during strength training with heavy loading vs. repetitions to failure. J Strength Cond Res. 2012 Jul;26(7):1897-903. doi: 10.1519/JSC.0b013e318239c38e.
- Derived from this study: PubMed 26339729Mikkelsen EK, Jakobsen TL, Holsgaard-Larsen A, Andersen LL, Bandholm T. Strength Training to Contraction Failure Increases Voluntary Activation of the Quadriceps Muscle Shortly After Total Knee Arthroplasty: A Cross-sectional Study. Am J Phys Med Rehabil. 2016 Mar;95(3):194-203. doi: 10.1097/PHM.0000000000000361.
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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.
Thomas Bandholm, PhD study director
Clinical Research Center, Copenhagen University Hospital, Hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 strength training set performed until contraction failure 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 5 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 25 Jun 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.
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 10% contraction failure in normalized EMG amplitude (%EMGmax). (time frame: 10% to 100% contraction failure in a single set performed until contraction failure. The set is performed at a single day, 4 to 8 weeks after surgery.). The study lists 2 primary outcomes in all. 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 NCT01713140, which also lists 4 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 25 Jun 2013.