Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Progressive Exercise After Total Knee Arthroplasty (TKA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mirja Vuorenmaa, Jyväskylä Central Hospital
ClinicalTrials.gov Identifier:
NCT00605124
First received: January 16, 2008
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Osteoarthritis
 Other: Knee muscle exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Progressive Exercise After Total Knee Arthroplasty: A Randomised Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jyväskylä Central Hospital:

Primary Outcome Measures:
  • Functional tests, pain [ Time Frame: baseline , 6 weeks after operation (start of training), after 12 months training ] [ Designated as safety issue: Yes ]
    Timed-Up and Go-test, Visual analogue scale (VAS)


Secondary Outcome Measures:
  • Knee muscle strength [ Time Frame: baseline, 6 weeks after operation (start of training), after 12 months training ] [ Designated as safety issue: Yes ]
    isometric strength of quadriceps and hamstrings

  • Health related quality of life [ Time Frame: baseline and 12 months ] [ Designated as safety issue: Yes ]
    SF-36

  • gait analysis [ Time Frame: baseline, 6 weeks postoperatively, 12 months ] [ Designated as safety issue: Yes ]
Enrollment: 120
Study Start Date: January 2008
Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mirja Vuorenmaa, physiotherapist, Jyväskylä Central Hospital
ClinicalTrials.gov Identifier: NCT00605124     History of Changes
Other Study ID Numbers: KSSHP Dnro6/2007, KSSHP
Study First Received: January 16, 2008
Last Updated: March 4, 2013
Health Authority: Finland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on February 27, 2015