NCT00605124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

2.9 years

First QC Date

January 16, 2008

Last Update Submit

March 4, 2013

Conditions

Keywords

osteoarthritiskneetotal knee arthroplastyexercise

Outcome Measures

Primary Outcomes (1)

  • Functional tests, pain

    Timed-Up and Go-test, Visual analogue scale (VAS)

    baseline , 6 weeks after operation (start of training), after 12 months training

Secondary Outcomes (3)

  • Knee muscle strength

    baseline, 6 weeks after operation (start of training), after 12 months training

  • Health related quality of life

    baseline and 12 months

  • gait analysis

    baseline, 6 weeks postoperatively, 12 months

Study Arms (2)

exercise

EXPERIMENTAL

progressive exercise, home-based exercise program, tree exercise sessions weekly, chec-up visits every third month

Other: Knee muscle exercises

Conventional treatment

ACTIVE COMPARATOR

Normal treatment, single guidance to home exercise

Other: Knee muscle exercises

Interventions

Home exercises three times a week, control every three months

Conventional treatmentexercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary unilateral TKA for knee osteoarthritis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ceneral Finland Health Care District

Jyväskylä, FIN-40620, Finland

Location

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Jari Ylinen, MD, PhD

    Central Finland Health Care District

    STUDY DIRECTOR
  • Arja Häkkinen, PhD, Professor

    Central Finland Health Care District

    STUDY CHAIR
  • Petri Salo, M.Sc.

    Central Finland Health Care District

    PRINCIPAL INVESTIGATOR
  • Mirja Vuorenmaa, M.Sc.

    Central Finland Health Care District

    PRINCIPAL INVESTIGATOR
  • Maija Pesola, MD

    Central Finland Health Care District

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 30, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2012

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations