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

The Difference Between Rehabilitation With or Without Progressive Strength Training After Fast-track Total Knee Arthroplasty: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Rehabilitation with strength training; Other: Rehabilitation without strength training

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Clinical Research Centre, Copenhagen University Hospital, Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the maximal distance (in meters) walked in 6 minutes at 2 months after surgery.	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.	Pre-surgery (baseline) and 2 months after surgery (primary endpoint) .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in maximum isometric knee-extension and knee-flexion strength at 2 months after surgery.	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.	Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in maximum concentric leg press power at 2 months after surgery.	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.	Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in knee pain during activity and rest at 2 months after surgery.	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.	Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in knee joint swelling at 2 months after surgery.	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	Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in knee joint range of motion (ROM) at 2 months after surgery.	Knee joint ROM of the operated leg is assessed using a large universal goniometer. Further assessments: 1 month and 6 months.	Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in self-reported function at 2 months after surgery.	The self-reported function is assessed using Knee injury and Osteoarthritis Outcome Score (KOOS). Further assessments: 1 month and 6 months.	Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in self-reported function at 2 months after surgery.	Self-reported function is assessed using Oxford Knee Score (OKS). Further assessments: 1 month and 6 months.	Pre-surgery (baseline) and 2 months after surgery (primary endpoint).
Change from baseline in self-reported quality of life at 2 month after surgery.	Self-reported quality of life is assessed using EuroQol questionnaire (EQ-5D). Further assessments: 1 month and 6 months.	Pre-surgery (baseline) and 2 months after surgery (primary endpoint).

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre

Publications and helpful links

General Publications

• Langkilde A, Jakobsen TL, Bandholm TQ, Eugen-Olsen J, Blauenfeldt T, Petersen J, Andersen O. Inflammation and post-operative recovery in patients undergoing total knee arthroplasty-secondary analysis of a randomized controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1265-1273. doi: 10.1016/j.joca.2017.03.008. Epub 2017 Mar 16.
• Jakobsen TL, Kehlet H, Husted H, Petersen J, Bandholm T. Early progressive strength training to enhance recovery after fast-track total knee arthroplasty: a randomized controlled trial. Arthritis Care Res (Hoboken). 2014 Dec;66(12):1856-66. doi: 10.1002/acr.22405.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Estimate): September 11, 2013
• Last Update Submitted That Met QC Criteria: September 10, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Physical Therapy Modalities; Resistance training; Arthroplasty, Replacement, Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: H-3-2010-106