Preoperative Strength Training in Patients With Total Knee Arthroplasty

July 20, 2012 updated by: University of Aarhus

Effect of Preoperative Strength Training on Postoperative Quadriceps Strength and Ability of Function in Patients With Total Knee Arthroplasty in Fast Track Regi

The purpose of this study is to investigate if preoperative strength training will result in faster recovery and higher level of function six weeks after total knee arthroplasty (TKA).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Reduced strength of the quadriceps muscle is a common clinical finding in patients with Knee Osteoarthritis and this seems to play a central role in the development of the disease. The strength of the quadriceps muscle have been shown to be reduced by 20-40% as compared to age-matched healthy controls and this decrease in muscle strength have been closely associated with a reduced level of function and increase of pain. Furthermore, it has been demonstrated that the preoperative strength of the quadriceps muscle in patients undergoing TKA, is associated with the level of function one year after surgery. Compared to the level before the operation, an additional operation-induced reduction of the strength of the quadriceps muscle up to 60% as has been demonstrated. Presumably, an optimizing of the strength of the quadriceps muscle could counteract the impact of the expected postoperative loss of muscle strength to such an extent that the loss will be of less clinical significance. It is hypothesized that an optimizing of the strength of the quadriceps muscle may have a favorable effect on the postoperative rehabilitation program and shorten the period of convalescence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Recruiting
        • Aarhus University Hospital
        • Contact:
        • Principal Investigator:
          • Birgit Sørensen Skoffer, MPH

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Planned TKA at the Aarhus University Hospital or Region Hospital Silkeborg,
  • Living in Aarhus Municipality,
  • Primary knee osteoarthritis or secondary osteoarthritis after meniscectomy or ligament injury

Exclusion Criteria:

  • Unstable blood pressure,
  • Neuromuscular or neurodegenerative disease,
  • Comprehension or dementia problems

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Preoperative strength training
Progressive strength training on group basis four weeks before the operation and progressive strength training on group basis four weeks after the operation
Other: Preoperative strength training
Progressive strength training on group basis (not more than 3 subjects) 3 sessions weekly starting 4 weeks before the operation, in total 12 sessions Strength training 3 sessions weekly 4 weeks postsurgery
Other Names:
  • Strength training
  • Preoperative training
NO_INTERVENTION: Living as usual
The patients are living as usual the last 4 weeks before operation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary outcome: Sit-to-stand test
Time Frame: Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative
Ability of function test
Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Isokinetic: Quadriceps 60 gr./sek
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Muscle strength test in dynamometer
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Isokinetic: Hamstrings 60 gr./sek
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks 12 weeks and 1 year after the operation
Muscle strength test in dynamometer
6 weeks and 1 week before the operation, 1 week, 6 weeks 12 weeks and 1 year after the operation
Isometric: Quadriceps (70 gr. flexion)
Time Frame: 6 weeks and 1 week before the operation and 11 week, 6 weeks, 12 weeks and 1 year after the operation
Muscle strength test in dynamometer
6 weeks and 1 week before the operation and 11 week, 6 weeks, 12 weeks and 1 year after the operation
Isometric: Hamstrings (20 gr. flexion)
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Muscle strength test in dynamometer
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Rate of force development (flexion and extension)
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Muscle test in dynamometer
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Timed Up and Go
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Ability of function test
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
10 meter walk test
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Ability of function test
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
6 minute walk test
Time Frame: 6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Ability of function test
6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Disease-specific questionnaire
6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Oxford Knee Score (OKS)
Time Frame: 6 weeks before the operation and 6 weeks after
Disease-specific questionnaire
6 weeks before the operation and 6 weeks after
EuroQol-5 dimensions (EQ-5D)
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Generic questionnaire for self-rated health
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Short-Form Health Survey (SF 12)
Time Frame: 6 weeks before the operation and 1 year after
Generic questionnaire for self-rated health
6 weeks before the operation and 1 year after
Background data questionnaire
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Questionnaire about pain, medicine use, alcohol intake, smoking, education, job
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Range of motion of the knee
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Extension of the knee Flexion of the knee
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Body mass index
Time Frame: 6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation
Weight/height2
6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Kjeld Soeballe, Professor, Aarhus University Hospital, Department of orthopaedic, Tage Hansensgade 2, 8000 Aarhus C

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M-20110181

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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