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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Rehabilitation with strength training
Rehabilitation without strength training
Sponsored by
Copenhagen University Hospital, Hvidovre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Arthroplasty, Replacement, Knee, Resistance training, Physical Therapy Modalities, Randomized Controlled Trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Research Centre, Copenhagen University Hospital, Hvidovre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rehabilitation with strength training

Rehabilitation without strength training

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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
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.
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.
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.
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.

Full Information

First Posted
April 28, 2011
Last Updated
September 10, 2013
Sponsor
Copenhagen University Hospital, Hvidovre
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1. Study Identification

Unique Protocol Identification Number
NCT01351831
Brief Title
The Difference Between Rehabilitation With or Without Strength Training After Total Knee Replacement
Acronym
TKA
Official Title
The Difference Between Rehabilitation With or Without Progressive Strength Training After Fast-track Total Knee Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital, Hvidovre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Arthroplasty, Replacement, Knee, Resistance training, Physical Therapy Modalities, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation with strength training
Arm Type
Experimental
Arm Title
Rehabilitation without strength training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Rehabilitation with strength training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Rehabilitation without strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in the maximal distance (in meters) walked in 6 minutes at 2 months after surgery.
Description
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) .
Secondary Outcome Measure Information:
Title
Change from baseline in maximum isometric knee-extension and knee-flexion strength at 2 months after surgery.
Description
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).
Title
Change from baseline in maximum concentric leg press power at 2 months after surgery.
Description
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).
Title
Change from baseline in knee pain during activity and rest at 2 months after surgery.
Description
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).
Title
Change from baseline in knee joint swelling at 2 months after surgery.
Description
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).
Title
Change from baseline in knee joint range of motion (ROM) at 2 months after surgery.
Description
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).
Title
Change from baseline in self-reported function at 2 months after surgery.
Description
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).
Title
Change from baseline in self-reported function at 2 months after surgery.
Description
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).
Title
Change from baseline in self-reported quality of life at 2 month after surgery.
Description
Self-reported quality of life is assessed using EuroQol questionnaire (EQ-5D). Further assessments: 1 month and 6 months.
Time Frame
Pre-surgery (baseline) and 2 months after surgery (primary endpoint).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Clinical Research Centre, Copenhagen University Hospital, Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28323139
Citation
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.
Results Reference
derived
PubMed Identifier
25074397
Citation
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.
Results Reference
derived

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

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