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Progressive Exercise After Total Knee Arthroplasty (TKA)

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ClinicalTrials.gov Identifier: NCT00605124
Recruitment Status : Completed
First Posted : January 30, 2008
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Mirja Vuorenmaa, Jyväskylä Central Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Osteoarthritis Other: Knee muscle exercises

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Progressive Exercise After Total Knee Arthroplasty: A Randomised Controlled Trial
Study Start Date : January 2008
Primary Completion Date : December 2010
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Knee muscle strength [ Time Frame: baseline, 6 weeks after operation (start of training), after 12 months training ]
    isometric strength of quadriceps and hamstrings

  2. Health related quality of life [ Time Frame: baseline and 12 months ]
    SF-36

  3. gait analysis [ Time Frame: baseline, 6 weeks postoperatively, 12 months ]


Information from the National Library of Medicine

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

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)

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 ClinicalTrials.gov identifier (NCT number): NCT00605124


Locations
Finland
Ceneral Finland Health Care District
Jyväskylä, Finland, FIN-40620
Sponsors and Collaborators
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

Responsible Party: Mirja Vuorenmaa, physiotherapist, Jyväskylä Central Hospital
ClinicalTrials.gov Identifier: NCT00605124     History of Changes
Other Study ID Numbers: KSSHP Dnro6/2007
KSSHP ( Other Identifier: KSSHP )
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by Mirja Vuorenmaa, Jyväskylä Central Hospital:
osteoarthritis
knee
total knee arthroplasty
exercise

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases