Experimental Study of Strength Training to Activate the Quadriceps Muscle After Total Knee Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Elin Andersson, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT01713140
First received: October 18, 2012
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
Other: 1 strength training set performed until contraction failure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Central (CNS) Activation of the Quadriceps Muscle During Strength Training With Repetitions to Contraction Failure After Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital, Hvidovre:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    The rate of perceived exertion scale (Borg CR 10) is used to monitor the subjects self-reported experience of exertion.


Enrollment: 20
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.
Other Name: Resistance training.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713140

Locations
Denmark
Clinical Reaserch Center, Copenhagen University Hospital, Hvidovre
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
University of Southern Denmark
Investigators
Study Director: Thomas Bandholm, PhD Clinical Research Center, Copenhagen University Hospital, Hvidovre, Denmark
  More Information

Publications:
Responsible Party: Elin Andersson, Physiotherapist, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT01713140     History of Changes
Other Study ID Numbers: EA2012_2013
Study First Received: October 18, 2012
Last Updated: June 24, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Copenhagen University Hospital, Hvidovre:
strength training
resistance training
fatigue
knee extension
total knee arthroplasty
total knee replacement
electromyography
physical therapy modalities

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014