Early Progressive Strength Training to Patients With Unicompartmental Knee Replacement

Phase 3

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Resistance training

• Registration Number: NCT01345825
• Lead Sponsor: 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.

Endpoint:

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.

Perspectives:

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Primary Completion: 2013-06
• Study Completion: 2014-07
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resistance training	Resistance training	-

Primary Outcome Measures

Name	Time	Method
Muscle power test (by a power rig)	prior to operation (baseline), 9 weeks post operativ and 1 year post operative

Secondary Outcome Measures

Name	Time	Method
Gait quality	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).

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark