NCT01729520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

November 14, 2012

Last Update Submit

June 24, 2013

Conditions

Keywords

Total knee arthroplastyTotal knee replacementStrength trainingResistance trainingPhysical therapy modalitiesFatigue

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Secondary Outcomes (2)

  • Change from baseline (pre strength training) in resting knee joint pain (numerical rating scale points).

    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

    Before the strength training sets at a single day,1 to 2 weeks after surgery.

Study Arms (1)

Knee extension strength training

EXPERIMENTAL
Other: Knee extension strength training

Interventions

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

Knee extension strength training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral primary TKA
  • Between the age of 18 to 80 years
  • Understand and speak Danish
  • Informed consent
  • to 2 weeks after TKA

You may not qualify if:

  • Disease/Musculoskeletal disorder, which requires special rehabilitation modality
  • Alcohol and drug abuse
  • Lack of wish to participate or unwillingness to sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center (136), Copenhagen University Hospital, Hvidovre

Hvidovre, Copenhagen, DK-2500, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, KneeFatigue

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Bandholm, PhD

    Clinical Research Center, Copenhagen University Hospital, Hvidovre, Copenhagen, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher, PhD

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 20, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations