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The Difference Between Rehabilitation With or Without Strength Training After Total Knee Replacement (TKA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thomas Linding Jakobsen, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT01351831
First received: April 28, 2011
Last updated: September 25, 2012
Last verified: August 2012
History of Changes
  Purpose

Background and purpose:

In the early phase after a total knee replacement (TKA), patients experience a decrease in leg muscle strength with up to about 80%. This considerable loss of muscle strength is related to reduced functional performance at this point in time. As the loss of muscle strength and functional performance is most pronounced early after TKA, rehabilitation including strength training initiated early after TKA seems a logical choice. However, tradition and fear of symptom exacerbation, such as increased knee joint swelling, knee pain and slow recovery of knee joint range of motion, have typically precluded strength training early after TKA.

Hypothesis:

Our hypothesis is that the effect of early rehabilitation including strength training will be greater than rehabilitation without strength training. If the hypothesis is confirmed, strength training early after TKA could be implemented directly into clinical rehabilitation practice.

Participants and methods:

Seventy participants with a unilateral TKA, between the age of 18 to 80 years, who understand and speak Danish, have given informed consent, will be included in this study.The study is a single-blinded randomized controlled study, where the participants receive supervised 1) rehabilitation with or 2) rehabilitation without strength training in 7 weeks. All components of the rehabilitation program (balance-, and mobility training etc.) are the same in both groups except the strength training exercises. Instead of the strength training exercises, the group without strength training spend more time on warm-up exercises, mobility- and balance exercises. The rehabilitation program lasts 1 hour per session, and will be performed twice per week. The participants perform a test battery 4 times from before to 6 months after the TKA. The test battery assesses the participants' walking ability, leg strength, knee pain, knee joint swelling- and range of motion, and self-reported function and quality of life.

Ethical issues:

From a pilot study conducted in the beginning of 2010, the investigators found, that strength training initiated early after TKA seems feasible, and does not increase knee joint swelling and knee pain. None of the financial supporters, or any of the authors, have any potential conflicts of interest with regard to the study.


Condition Intervention Phase
Osteoarthritis, Knee
 Other: Rehabilitation with strength training
Other: Rehabilitation without strength training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Difference Between Rehabilitation With or Without Progressive Strength Training After Fast-track Total Knee Arthroplasty: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Copenhagen University Hospital, Hvidovre:

Primary Outcome Measures:
  • Change from baseline in the maximal distance (in meters) walked in 6 minutes at 2 months after surgery. [ Time Frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint) . ] [ Designated as safety issue: No ]

    The 6-minute walk test (6MWT) measures the maximal distance a participant is able to walk in 6 minutes between 2 cones placed 29 meters apart from each other.

    Further assessments: 1 month and 6 months.



Secondary Outcome Measures:
  • Change from baseline in maximum isometric knee-extension and knee-flexion strength at 2 months after surgery. [ Time Frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint). ] [ Designated as safety issue: No ]

    Maximum isometric knee-extension and knee-flexion strength of the operated leg are assessed using a computerized strength chair (Good Strength Chair, Metitur Oy, Jyvasklya, Finland.

    Further assessments: 1 month and 6 months.


  • Change from baseline in maximum concentric leg press power at 2 months after surgery. [ Time Frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint). ] [ Designated as safety issue: No ]

    Maximum concentric leg press power of the operated leg is assessed using a leg extensor power rig (Medical Engineering Unit, University of Nottingham - Medical School, Nottingham, UK).

    Further assessments: 1 month and 6 months.


  • Change from baseline in knee pain during activity and rest at 2 months after surgery. [ Time Frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint). ] [ Designated as safety issue: No ]

    Knee pain during activity, and rest before and after examination, are assessed using a 100-mm mechanical Visual Analogue Scale (VAS).

    Further assessments: 1 month and 6 months.


  • Change from baseline in knee joint swelling at 2 months after surgery. [ Time Frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint). ] [ Designated as safety issue: No ]

    Knee joint swelling of the operated leg is assessed by measuring the knee joint circumference with a tape measure.

    Further assessments: 1 month and 6 months


  • Change from baseline in knee joint range of motion (ROM) at 2 months after surgery. [ Time Frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint). ] [ Designated as safety issue: No ]

    Knee joint ROM of the operated leg is assessed using a large universal goniometer.

    Further assessments: 1 month and 6 months.


  • Change from baseline in self-reported function at 2 months after surgery. [ Time Frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint). ] [ Designated as safety issue: No ]

    The self-reported function is assessed using Knee injury and Osteoarthritis Outcome Score (KOOS).

    Further assessments: 1 month and 6 months.


  • Change from baseline in self-reported function at 2 months after surgery. [ Time Frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint). ] [ Designated as safety issue: No ]
    Self-reported function is assessed using Oxford Knee Score (OKS). Further assessments: 1 month and 6 months.

  • Change from baseline in self-reported quality of life at 2 month after surgery. [ Time Frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint). ] [ Designated as safety issue: No ]
    Self-reported quality of life is assessed using EuroQol questionnaire (EQ-5D). Further assessments: 1 month and 6 months.


Estimated Enrollment: 70
Study Start Date: January 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rehabilitation with strength training Other: Rehabilitation with strength training
The rehabilitation programme lasts 1 hour per session, and is performed twice per week for 7 weeks. The rehabilitation program consists of balance-, mobility- and functional training exercises etc. In addition, the participants perform unilateral (operated leg) knee-extensions and leg presses in 2 sets for each strength training exercise, using relative loads of 12 RM (week 1), 10 RM (weeks 2-5), and 8 RM (week 6-7). All sets are performed to failure.
Active Comparator: Rehabilitation without strength training Other: Rehabilitation without strength training
The rehabilitation programme lasts 1 hour per session, and is performed twice per week for 7 weeks. The rehabilitation program consists of the same balance-, mobility- and functional training exercises etc. as used in the other experimental arm.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with a primary unilateral total knee arthroplasty.
  • Age between 18 and 80 years.
  • Participants must understand and speak Danish.
  • Participants undergo surgery at Copenhagen University Hospital, Hvidovre, and live in the counties of Copenhagen, Brøndby or Hvidovre.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351831

Locations
Denmark
Clinical Research Centre, Copenhagen University Hospital, Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
  More Information

No publications provided

Responsible Party: Thomas Linding Jakobsen, Research Physiotherapist, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT01351831     History of Changes
Other Study ID Numbers: H-3-2010-106
Study First Received: April 28, 2011
Last Updated: September 25, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Copenhagen University Hospital, Hvidovre:
Arthroplasty, Replacement, Knee
Resistance training
Physical Therapy Modalities
Randomized Controlled Trial

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

ClinicalTrials.gov processed this record on June 17, 2013