- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01713140
Experimental Study of Strength Training to Activate the Quadriceps Muscle After Total Knee Arthroplasty
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hvidovre
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Copenhagen, Hvidovre, Denmark, 2650
- Clinical Reaserch Center, Copenhagen University Hospital, Hvidovre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Unilateral primary TKA
- Between the age of 18 to 80 years
- Understand and speak Danish
- Informed consent
- 4 to 8 weeks after TKA
Exclusion Criteria:
- Disease/Musculoskeletal disorder, which requires special rehabilitation modality
- Alcohol and drug abuse
- Lack of wish to participate or unwillingness to sign an informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 strength training set performed until contraction failure
Knee extensions until contraction failure will be performed, using a relative loading of 10 repetition maximum (RM).
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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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.
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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.
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.
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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.
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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).
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From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline (pre strength training) in perceived exertion (Borg CR 10 scale points)
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.
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The rate of perceived exertion scale (Borg CR 10) is used to monitor the subjects self-reported experience of exertion.
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From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Thomas Bandholm, PhD, Clinical Research Center, Copenhagen University Hospital, Hvidovre, Denmark
Publications and helpful links
General 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.
- Jakobsen 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.
- Sundstrup 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.
- Mikkelsen 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA2012_2013
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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