We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative Strength Training in Patients With Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01647243
Recruitment Status : Unknown
Verified July 2012 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : July 23, 2012
Last Update Posted : July 23, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment
Osteoarthritis, Knee Other: Preoperative strength training

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Preoperative Strength Training on Postoperative Quadriceps Strength and Ability of Function in Patients With Total Knee Arthroplasty in Fast Track Regi
Study Start Date : January 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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

  7. 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

  8. 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

  9. 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

  10. Oxford Knee Score (OKS) [ Time Frame: 6 weeks before the operation and 6 weeks after ]
    Disease-specific questionnaire

  11. 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

  12. Short-Form Health Survey (SF 12) [ Time Frame: 6 weeks before the operation and 1 year after ]
    Generic questionnaire for self-rated health

  13. 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

  14. 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

  15. 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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647243


Contacts
Contact: Birgit Sørensen Skoffer, MPH +45 50 42 28 30 BSkoffer@dadlnet.dk

Locations
Denmark
Aarhus University hospital Recruiting
Aarhus, Denmark, 8000
Contact: Birgit Sørensen Skoffer, MPH    +45 50 42 28 30    BSkoffer@dadlnet.dk   
Principal Investigator: Birgit Sørensen Skoffer, MPH         
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Kjeld Soeballe, Professor Aarhus University Hospital, Department of orthopaedic, Tage Hansensgade 2, 8000 Aarhus C
More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01647243     History of Changes
Other Study ID Numbers: M-20110181
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: July 23, 2012
Last Verified: July 2012

Keywords provided by University of Aarhus:
Knee osteoarthritis
Total knee arthroplasty
Preoperative training
Strength training

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases