Descriptive Study of Knee Joint Pain During Strength Training After Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Knee Joint Pain During Strength Training After Total Knee Arthroplasty: Effect of Loading and Repetitions to Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729520
• Other study ID #: BA-2012-BR
• Status: Completed
• Phase: N/A
• First received: November 14, 2012
• Last updated: June 24, 2013
• Start date: November 2012
• Est. completion date: April 2013

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2013
• Est. primary completion date: April 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

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Knee extension strength training
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

Locations

Country	Name	City	State
Denmark	Clinical Research Center (136), Copenhagen University Hospital, Hvidovre	Hvidovre	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No
Primary	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.	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.	No
Secondary	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.	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.	No
Secondary	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.	Before the strength training sets at a single day,1 to 2 weeks after surgery.	No