Descriptive Study of Knee Joint Pain During Strength Training After Total Knee Arthroplasty
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Knee extension strength training
Sponsored by
About this trial
This is an interventional basic science trial for Knee Osteoarthritis focused on measuring Total knee arthroplasty, Total knee replacement, Strength training, Resistance training, Physical therapy modalities, Fatigue
Eligibility Criteria
Inclusion Criteria:
- Unilateral primary TKA
- Between the age of 18 to 80 years
- Understand and speak Danish
- Informed consent
- 1 to 2 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
Sites / Locations
- Clinical Research Center (136), Copenhagen University Hospital, Hvidovre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Knee extension strength training
Arm Description
Outcomes
Primary Outcome Measures
Load experiment: Difference (in numerical rating scale points) between 20 RM, 14 RM, and 8 RM loadings, in knee joint pain during knee extensions.
A 0-10 numerical rating scale is used to rate knee joint pain during every repetition.
Failure experiment: Change (in numerical rating scale points) from 10% contraction failure in knee joint pain during knee extensions.
A 0-10 numerical rating scale is used to rate knee joint pain during every repetition.
Secondary Outcome Measures
Change from baseline (pre strength training) in resting knee joint pain (numerical rating scale points).
A 0-10 numerical rating scale is used to rate knee joint pain at rest.
Knee joint pain (in numerical rating scale points) during activities of daily living
Knee joint pain is rated during standing and walking, using a 0-10 numerical rating scale.
Full Information
NCT ID
NCT01729520
First Posted
November 14, 2012
Last Updated
June 24, 2013
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01729520
Brief Title
Descriptive Study of Knee Joint Pain During Strength Training After Total Knee Arthroplasty
Official Title
Knee Joint Pain During Strength Training After Total Knee Arthroplasty: Effect of Loading and Repetitions to Failure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background:
In the early phase after a total knee arthroplasty (TKA), patients experience multi-level weakness in the operated leg, which is caused primarily by reduced central nervous system (CNS) activation failure of the muscles - especially the knee extensors. This considerable loss of muscle strength relates to reduced functional performance. Early-commenced, progressive strength training of the knee extensors of the operated leg therefore seems rational. However, the concern is that this type of early-commenced, intense physical rehabilitation exacerbates post-operative symptoms, such as knee joint pain.
The investigators have recently reported that early-commenced physical rehabilitation, including progressive strength training of the knee extensors of the operated leg seems feasible after TKA. The classic exercise-physiology literature emphasizes loading and repetitions performed to contraction failure - among others - as important variables for muscle hypertrophy and strength gains. It is currently not known how loading and repetitions performed to contraction failure during knee extensions with the operated leg, influences post-operative knee joint pain in patients with TKA.
Purpose and hypothesis:
The purpose of this study is to investigate how loading and repetitions to contraction failure influence knee joint pain during knee extensions with the operated leg early after TKA.
The hypothesis is that knee pain increases with increasing loading and fatigue.
Methods:
Fifteen patients with a unilateral TKA, operated between 1 to 2 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 unilateral (operated leg) knee extension. At the second investigation, at least 72 hours later, the patients will perform 1 set of 4 repetitions with a relative loading of 8, 14, and 20 RM each, in a randomized order, estimated from their 10 RM test at the first investigation. Time under tension (contraction velocity) and range of knee joint motion for each repetition will be controlled for. During the concentric phase of each repetition, the patients rate their knee joint pain verbally, using a numerical rating scale placed 1 meter in front of them. After a short break, the patients perform 1 set of knee extension with a relative loading of 10 RM until of contraction failure. As for the loading effect described above, they rate their knee joint pain during the concentric phase of each repetition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total knee arthroplasty, Total knee replacement, Strength training, Resistance training, Physical therapy modalities, Fatigue
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Knee extension strength training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Knee extension strength training
Intervention Description
Load experiment: Four knee extensions will be performed with the operated leg at 20, 14, and 8 RM loadings each, in a randomized order. Range of knee joint motion and time under tension for each repetition will be controlled for
Failure experiment: One strength training set of knee extensions will be performed with the operated leg at 10 RM loading until contraction failure. Range of knee joint motion and time under tension for each repetition will be controlled for
Primary Outcome Measure Information:
Title
Load experiment: Difference (in numerical rating scale points) between 20 RM, 14 RM, and 8 RM loadings, in knee joint pain during knee extensions.
Description
A 0-10 numerical rating scale is used to rate knee joint pain during every repetition.
Time Frame
Four repetitions at 20 RM, 14 RM, and 8 RM loadings. The strength training sets are performed at a single day, 1 to 2 weeks after surgery.
Title
Failure experiment: Change (in numerical rating scale points) from 10% contraction failure in knee joint pain during knee extensions.
Description
A 0-10 numerical rating scale is used to rate knee joint pain during every repetition.
Time Frame
10% to 100% contraction failure in a single strength training set performed until contraction failure. The strength training set is performed at a single day, 1 to 2 weeks after surgery.
Secondary Outcome Measure Information:
Title
Change from baseline (pre strength training) in resting knee joint pain (numerical rating scale points).
Description
A 0-10 numerical rating scale is used to rate knee joint pain at rest.
Time Frame
From baseline (pre strength training) to after the strength training sets. The strength training sets are performed at a single day,1 to 2 weeks after surgery.
Title
Knee joint pain (in numerical rating scale points) during activities of daily living
Description
Knee joint pain is rated during standing and walking, using a 0-10 numerical rating scale.
Time Frame
Before the strength training sets at a single day,1 to 2 weeks after surgery.
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
1 to 2 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bandholm, PhD
Organizational Affiliation
Clinical Research Center, Copenhagen University Hospital, Hvidovre, Copenhagen, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center (136), Copenhagen University Hospital, Hvidovre
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
DK-2500
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
24614574
Citation
Bandholm T, Thorborg K, Lunn TH, Kehlet H, Jakobsen TL. Knee pain during strength training shortly following fast-track total knee arthroplasty: a cross-sectional study. PLoS One. 2014 Mar 10;9(3):e91107. doi: 10.1371/journal.pone.0091107. eCollection 2014.
Results Reference
derived
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Descriptive Study of Knee Joint Pain During Strength Training After Total Knee Arthroplasty
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