Progressive Exercise After Total Knee Arthroplasty (TKA)

March 4, 2013 updated by: Mirja Vuorenmaa, Jyväskylä Central Hospital

Progressive Exercise After Total Knee Arthroplasty: A Randomised Controlled Trial

Total knee arthroplasty (TKA) is performed more than 7.000 times a year in Finland most often for osteoarthritis (OA). While pain is predictably reduced, function does not typically ever reach that of age-matched, uninjured subjects. Quadriceps weakness has been implicated in the development and progression of knee OA and is a significant problem after TKA. Advance to return to normal daily activities is not sufficient to restore knee function or quadriceps strength after TKA.

The aim of this study is to assess the effectiveness of progressive exercise program restoring knee strength, mobility and improving the functional outcome after primary TKA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many studies have shown, that after TKA pain decreased significantly, but muscle strength of the operated knee did not recover and may stay under the preoperative level. To find out the effects of progressive exercise program the investigators will perform, 6 weeks after TKA, a randomized clinical trial of lower extremity strength training using two subgroups of people: traditional exercise group and progressive exercise group.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jyväskylä, Finland, FIN-40620
        • Ceneral Finland Health Care District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary unilateral TKA for knee osteoarthritis

Exclusion Criteria:

  • Rheumatoid arthritis
  • Fibromyalgia
  • Bilateral TKA
  • Heart or lung disease, which prevent training
  • Unstable serious disease (cancer)
  • Reduced cooperation (drug, alcohol abuse, mental illness)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exercise
progressive exercise, home-based exercise program, tree exercise sessions weekly, chec-up visits every third month
Other: Knee muscle exercises
Home exercises three times a week, control every three months
Active Comparator: Conventional treatment
Normal treatment, single guidance to home exercise
Other: Knee muscle exercises
Home exercises three times a week, control every three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional tests, pain
Time Frame: baseline , 6 weeks after operation (start of training), after 12 months training
Timed-Up and Go-test, Visual analogue scale (VAS)
baseline , 6 weeks after operation (start of training), after 12 months training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee muscle strength
Time Frame: baseline, 6 weeks after operation (start of training), after 12 months training
isometric strength of quadriceps and hamstrings
baseline, 6 weeks after operation (start of training), after 12 months training
Health related quality of life
Time Frame: baseline and 12 months
SF-36
baseline and 12 months
gait analysis
Time Frame: baseline, 6 weeks postoperatively, 12 months
baseline, 6 weeks postoperatively, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jyväskylä Central Hospital

Investigators

  • Study Director: Jari Ylinen, MD, PhD, Central Finland Health Care District
  • Study Chair: Arja Häkkinen, PhD, Professor, Central Finland Health Care District
  • Principal Investigator: Petri Salo, M.Sc., Central Finland Health Care District
  • Principal Investigator: Mirja Vuorenmaa, M.Sc., Central Finland Health Care District
  • Study Chair: Maija Pesola, MD, Central Finland Health Care District

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 16, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSSHP Dnro6/2007
  • KSSHP (Other Identifier: KSSHP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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