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

June 24, 2013 updated by: Thomas Bandholm, Hvidovre University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Hvidovre, Copenhagen, Denmark, DK-2500
        • Clinical Research Center (136), Copenhagen University Hospital, Hvidovre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Knee extension strength training
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Load experiment: Difference (in numerical rating scale points) between 20 RM, 14 RM, and 8 RM loadings, in knee joint pain during knee extensions.
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.
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.
Failure experiment: Change (in numerical rating scale points) from 10% contraction failure in knee joint pain during knee extensions.
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline (pre strength training) in resting knee joint pain (numerical rating scale points).
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.
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.
Knee joint pain (in numerical rating scale points) during activities of daily living
Time Frame: Before the strength training sets at a single day,1 to 2 weeks after surgery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Study Director: Thomas Bandholm, PhD, Clinical Research Center, Copenhagen University Hospital, Hvidovre, Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Estimate)

June 25, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA-2012-BR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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