Descriptive Study of Strength Training Exercises to Activate the Muscles of the Operated Leg After Total Knee Replacement
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Six different strength training exercises
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Arthroplasty, Replacement, Knee, Electromyography, Resistance training, Physical Therapy Modalities
Eligibility 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 a special rehabilitation modality
- Alcohol and drug abuse
- Lack of wish to participate or unwillingness to sign an informed consent
Sites / Locations
- Clinical Research Centre, Copenhagen University Hospital, Hvidovre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Six different strength training exercises
Arm Description
Six different strength training exercises are investigated. Four repetitions of each exercise are performed with a relative loading of 10 RM.
Outcomes
Primary Outcome Measures
Normalized neuromuscular activity (EMG) of the quadriceps and hamstring muscles
Normalized electromyographic (EMG) activity (amplitude) during the different exercises. The EMG activity elicited during standardized, maximal contractions is used as a reference for normalization.
Secondary Outcome Measures
Full Information
NCT ID
NCT01708980
First Posted
October 16, 2012
Last Updated
October 22, 2013
Sponsor
Copenhagen University Hospital, Hvidovre
1. Study Identification
Unique Protocol Identification Number
NCT01708980
Brief Title
Descriptive Study of Strength Training Exercises to Activate the Muscles of the Operated Leg After Total Knee Replacement
Official Title
Neuromuscular Activity of the Operated Leg During Strength Training Performed in Machines and in More Simple Forms After Total Knee Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital, Hvidovre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background:
In the early phase after a total knee replacement (TKA), patients experience multi-level weakness in the operated leg, which is caused primarily by reduced central (CNS) activation failure of the muscles - especially the knee extensors. This considerable loss of muscle strength relates to reduced functional performance. The investigators recently reported that early-commenced physiotherapy, including progressive strength training performed in machines, seems feasible after TKA. The question is, if neuromuscular activity of the muscles in the operated leg, elicited during strength training in machines, can be reached during strength training in more simple forms? Many clinicians are faced with the problem of not having strength training equipment at their institution, or having to prescribe simple strength training exercises for home-based training.
Purpose and hypothesis:
The purpose of this study is to determine which strength training exercises that activate the muscles in the operated leg the most after TKA. The hypothesis is that strength training exercises performed in machines is more effective compared to strength training performed in more simple forms (using elastic bands or own body weight, etc.).
Participants and methods:
Twenty participants with a unilateral TKA, operated between 4 to 8 weeks prior to the first investigation, will be included. The participants are investigated twice. During the first investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a load that can be lifted exactly 10 times) will be determined for all the exercises. At least 72 hours later, the participants will undergo an electromyographic analysis, which determines the neuromuscular activity of the thigh muscles in the operated leg.
Ethical issues:
From a pilot study, the investigators found that strength training exercises commenced early after TKA seems feasible as the exercises did not increase knee joint swelling or knee pain. None of the financial supporters, or any of the authors, have any potential conflicts of interest with regard to the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Arthroplasty, Replacement, Knee, Electromyography, Resistance training, Physical Therapy Modalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Six different strength training exercises
Arm Type
Experimental
Arm Description
Six different strength training exercises are investigated. Four repetitions of each exercise are performed with a relative loading of 10 RM.
Intervention Type
Other
Intervention Name(s)
Six different strength training exercises
Other Intervention Name(s)
Resistance training
Intervention Description
Electromyographic (EMG) activity of the vastus medialis, vastus lateralis, semitendinosus and biceps femoris muscles of the operated leg will be recorded during 6 different strength training exercises. The six exercises performed unilaterally are: seated knee extensions and leg presses in machines (gold standard exercises), and the four other exercises are: sit-to-stands, squats, straight leg raises and seated knee extensions using an elastic band.
The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM of the 6 strength training exercises 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.
Primary Outcome Measure Information:
Title
Normalized neuromuscular activity (EMG) of the quadriceps and hamstring muscles
Description
Normalized electromyographic (EMG) activity (amplitude) during the different exercises. The EMG activity elicited during standardized, maximal contractions is used as a reference for normalization.
Time Frame
One time point, 4 to 8 weeks after TKA
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 a special rehabilitation modality
Alcohol and drug abuse
Lack of wish to participate or unwillingness to sign an informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bandholm, PhD
Organizational Affiliation
Clinical Research Center, Copenhagen University Hospital, Hvidovre, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Centre, Copenhagen University Hospital, Hvidovre
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
22084974
Citation
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.
Results Reference
background
PubMed Identifier
21044725
Citation
Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.
Results Reference
background
PubMed Identifier
31267365
Citation
Jakobsen TL, Jakobsen MD, Andersen LL, Husted H, Kehlet H, Bandholm T. Quadriceps muscle activity during commonly used strength training exercises shortly after total knee arthroplasty: implications for home-based exercise-selection. J Exp Orthop. 2019 Jul 2;6(1):29. doi: 10.1186/s40634-019-0193-5.
Results Reference
derived
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Descriptive Study of Strength Training Exercises to Activate the Muscles of the Operated Leg After Total Knee Replacement
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