Clinical Research Centre, Copenhagen University Hospital, Hvidovre
Hvidovre, 2650, Denmark
NCT Number: NCT01351831
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Hvidovre, 2650, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint) .
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.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
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.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
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.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
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.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
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
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Knee joint ROM of the operated leg is assessed using a large universal goniometer.
Further assessments: 1 month and 6 months.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
The self-reported function is assessed using Knee injury and Osteoarthritis Outcome Score (KOOS).
Further assessments: 1 month and 6 months.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Self-reported function is assessed using Oxford Knee Score (OKS). Further assessments: 1 month and 6 months.
Time frame: Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Self-reported quality of life is assessed using EuroQol questionnaire (EQ-5D). Further assessments: 1 month and 6 months.
Copenhagen University Hospital, Hvidovre
Other
The Difference Between Rehabilitation With or Without Progressive Strength Training After Fast-track Total Knee Arthroplasty: A Randomized Controlled Trial
Acronym: TKA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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