Progressive Exercise After Total Knee Arthroplasty (TKA) - Full Text View

Sponsor:	Jyväskylä Central Hospital
Information provided by (Responsible Party):	Mirja Vuorenmaa, Jyväskylä Central Hospital
ClinicalTrials.gov Identifier:	NCT00605124

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:

MedlinePlus related topics: Exercise and Physical Fitness Knee Replacement Osteoarthritis

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 analoque 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 ]

Estimated Enrollment:	120
Study Start Date:	January 2008
Estimated Study Completion Date:	April 2012
Primary Completion Date:	April 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605124

Contacts

Contact: Jari Ylinen, MD, Phd

358 14 2691145

jari.ylinen@ksshp.fi

Locations

Finland
Ceneral Finland Health Care District	Recruiting
Jyväskylä, Finland, FIN-40620
Contact: Jari Ylinen, MD, PhD 358 14 2691145 jari.ylinen@ksshp.fi

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:	February 13, 2012
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 13, 2012