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Early Progressive Strength Training to Patients With Unicompartmental Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345825
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : May 14, 2015
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

The purpose and Study hypotheses:

The purpose of the study is to investigate the effect of progressive resistance training in the early postoperative phase on patients who has had unicompartmental knee replacement. The hypotheses are that this group compared to a control group will achieve greater muscle strength and functional ability in terms of gait and working capacity.

Study design:

The subjects will be randomized into two groups; intervention and control. Intervention group: strength training two times a week supervised by a physiotherapist.

Control group: Training at home, following extradited guidelines.


Primary endpoint is two months postoperative. The following test will be used: muscle power test (by a Power Rig), instrumented gait analysis using a combined accelerometer and gyro-sensor in; 6 min. walk test, stair climbing test, 20 meter walking test and block step test.

Furthermore, the questionnaire KOOS will be used for monitoring every 2 weeks.

Sample size:

The power calculation is based on an expected improvement in muscle power by 25%. The risk of a type 1 error is set to 5 %, and the power is set to 80%. The calculations showed that 24 patients are needed in both groups, but 30 patient will be included in both groups to account for dropouts.


This study is, to our knowledge, the first study to investigate the effect of strength training after unicompartmental knee replacement. Moreover it has , to our knowledge not been. At the moment no guidelines for rehabilitation exist, and research showed that this group of patients has a decreased function in their daily living compared with the background population. If, as expected, cases have an overall increased function compared to controls, this study can provide a basis for future rehabilitation.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Resistance training Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial: The Effectiveness of 8-weeks Progressive Strength Training to Patients With Unicompartmental Knee Replacement, Initiated Within the First Postoperative Week
Study Start Date : March 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: resistance training Other: Resistance training
Week 1: 2 sets x 12 repetitions at 12 RM Week 2: 3 sets of 12 repetitions with 12 RM Week 3: 3 sets of 10 repetitions with 10 RM Week 4-5: 3 sets of 10 repetitions with 10 RM Week 6: 3 sets of 8 repetitions with 8 RM Week 7: 4 sets of 8 repetitions with 8 RM Week 8: 4 sets of 8 repetitions with 8 RM

Primary Outcome Measures :
  1. Muscle power test (by a power rig) [ Time Frame: prior to operation (baseline), 9 weeks post operativ and 1 year post operative ]

Secondary Outcome Measures :
  1. Gait quality [ Time Frame: prior to operation (baseline), 9 weeks post operativ and 1 year post operative ]
    Instrumentet gait analysis using a combined gyro-sensor and accelerometer - inertia measurement unit(IMU).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • medial osteoarthrosis in knee assigned to unicompartmental knee replacement
  • 18+ years.

Exclusion Criteria:

  • rheumatoid arthritis
  • neuro muscular conditions
  • alcohol or drug abuse
  • cognitive problems
  • patients not fluid in the Danish language
  • walking disability caused by other than in condition in question

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01345825

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Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
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Principal Investigator: Kjeld Søballe Orthopaedic Surgery Research Unit, Aarhus
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Responsible Party: University of Aarhus Identifier: NCT01345825    
Other Study ID Numbers: M-20100185
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015
Keywords provided by University of Aarhus:
unicompartmental knee replacement
resistance training
Muscle power
gait analysis
Gyro sensor
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases