Preoperative Strength Training in Patients With Total Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01647243
First received: July 13, 2012
Last updated: July 20, 2012
Last verified: July 2012

July 13, 2012
July 20, 2012
January 2012
October 2013   (final data collection date for primary outcome measure)
Primary outcome: Sit-to-stand test [ Time Frame: Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative ] [ Designated as safety issue: No ]
Ability of function test
Same as current
Complete list of historical versions of study NCT01647243 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    Muscle strength test in dynamometer
  • 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 ] [ Designated as safety issue: No ]
    Muscle strength test in dynamometer
  • 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 ] [ Designated as safety issue: No ]
    Muscle strength test in dynamometer
  • 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 ] [ Designated as safety issue: No ]
    Muscle strength test in dynamometer
  • 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 ] [ Designated as safety issue: No ]
    Muscle test in dynamometer
  • 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 ] [ Designated as safety issue: No ]
    Ability of function test
  • 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 ] [ Designated as safety issue: No ]
    Ability of function test
  • 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 ] [ Designated as safety issue: No ]
    Ability of function test
  • 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 ] [ Designated as safety issue: No ]
    Disease-specific questionnaire
  • Oxford Knee Score (OKS) [ Time Frame: 6 weeks before the operation and 6 weeks after ] [ Designated as safety issue: No ]
    Disease-specific questionnaire
  • 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 ] [ Designated as safety issue: No ]
    Generic questionnaire for self-rated health
  • Short-Form Health Survey (SF 12) [ Time Frame: 6 weeks before the operation and 1 year after ] [ Designated as safety issue: No ]
    Generic questionnaire for self-rated health
  • 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 ] [ Designated as safety issue: No ]
    Questionnaire about pain, medicine use, alcohol intake, smoking, education, job
  • 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 ] [ Designated as safety issue: No ]
    Extension of the knee Flexion of the knee
  • 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 ] [ Designated as safety issue: No ]
    Weight/height2
Same as current
Not Provided
Not Provided
 
Preoperative Strength Training in Patients With Total Knee Arthroplasty
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis, Knee
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
  • 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
    Intervention: Other: Preoperative strength training
  • No Intervention: Living as usual
    The patients are living as usual the last 4 weeks before operation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Birgit Sørensen Skoffer, MPH +45 50 42 28 30 BSkoffer@dadlnet.dk
Denmark
 
NCT01647243
M-20110181
Yes
University of Aarhus
University of Aarhus
Not Provided
Study Chair: Kjeld Soeballe, Professor Aarhus University Hospital, Department of orthopaedic, Tage Hansensgade 2, 8000 Aarhus C
University of Aarhus
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP