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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01713140
Other study ID # EA2012_2013
Secondary ID
Status Completed
Phase N/A
First received October 18, 2012
Last updated June 24, 2013
Start date October 2012
Est. completion date March 2013

Study information

Verified date June 2013
Source Copenhagen University Hospital, Hvidovre
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
1 strength training set performed until contraction failure
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.

Locations

Country Name City State
Denmark Clinical Reaserch Center, Copenhagen University Hospital, Hvidovre Copenhagen Hvidovre

Sponsors (2)

Lead Sponsor Collaborator
Copenhagen University Hospital, Hvidovre University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View Citation

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.0b013e318239c38 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline (pre strength training) in perceived exertion (Borg CR 10 scale points) The rate of perceived exertion scale (Borg CR 10) is used to monitor the subjects self-reported experience of exertion. From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery. No
Primary 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. 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. No
Primary 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. 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. No
Secondary 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. From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery. No
Secondary 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). From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery. No
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