Knee Stability Training for Knee Osteoarthritis (OA)

January 23, 2013 updated by: University of Pittsburgh

Knee Stability Training in Individuals With Knee Osteoarthritis

People with knee osteoarthritis (OA) frequently complain of knee instability. This study will test whether certain exercises can improve knee stability, reduce pain, and improve physical function in people with knee OA.

Study hypotheses: 1) Participants in the stability training group will demonstrate less pain and higher levels of physical function, based on self-report measures of pain and function (WOMAC, Lower Extremity Function Scale), and less time to complete the Get Up and Go test, a physical performance measure of function. 2) During walking and the step down task, participants in the stability training group will demonstrate greater knee motion during weight bearing, greater vertical ground reaction forces and loading rates, and reduced ratios of co-contraction between quadriceps/hamsting and tibialis anterior/gastrocnemius muscle pairs compared to the standard group. Participants in the stability group will also demonstrate greater step lengths, single limb support times, and average walking velocity compared to the standard group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Traditional exercise therapy for knee OA primarily focuses on lower limb strength and joint motion deficits. Recent evidence has suggested that changes in lower limb biomechanical factors during weight bearing activities may have substantial impact on physical function and disease progression in individuals with knee OA. The effectiveness of exercise therapy programs might be improved by incorporating balance and agility training techniques (knee stability training). The aim of this trial is to test the effectiveness of supplementing traditional exercise therapy with knee stability training techniques tailored for individuals with knee OA.

Participants will be randomly assigned to one of two groups. The first group will participate in a standard rehabilitation program of traditional exercise therapy for knee OA. The second group will participate in a standard rehabilitation program supplemented with a knee stability program. Study visits will occur at study entry, 2 months, 6 months, and 1 year. At each study visit, changes in pain, physical function, and biomechanical factors will be assessed. This study will last for one year.

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Phase 2

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

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis
  • Grade II or greater Kellgren and Lawrence radiographic changes

Exclusion Criteria:

  • History of two or more falls within the year prior to study entry
  • Unable to walk a distance of 100 feet without an assistive device or a rest period
  • Total knee arthroplasty
  • Uncontrolled hypertension
  • History of cardiovascular disease
  • History of neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy
  • Corticosteroid injection to the quadriceps or patellar tendon in the past month, or 3 or more within the past year
  • Quadriceps tendon rupture, patellar tendon rupture, or patellar fracture that could place them at risk of re-injury during quadriceps strength testing
  • Pregnancy

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Traditional exercise program supplemented with knee stability training activities
Other: Knee stability training
The addition of agility and perturbation training techniques to the traditional exercise program
Active Comparator: 2
Traditional exercise program
Other: Traditional exercise therapy for knee osteoarthritis
Exercises include stretching, strengthening, and aerobic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Western Ontario and McMaster OA index (WOMAC)
Time Frame: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Lower Extremity Function Scale
Time Frame: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Get Up and Go test (a physical performance measure of function)
Time Frame: Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months
Knee Outcome Survey - Activities of Daily Living Scale
Time Frame: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Cartilage morphology changes as measured by MRI
Time Frame: Measured at baseline, 1 year
Measured at baseline, 1 year
Physical Activity Scale for the Elderly
Time Frame: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Quadriceps strength and activation
Time Frame: Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months
Radiographic severity of OA
Time Frame: Measured at baseline, 1 year
Measured at baseline, 1 year
Fear Avoidance questionnaire for the knee
Time Frame: Measured at baseline, 2months, 6 months, 1 year
Measured at baseline, 2months, 6 months, 1 year
Beck Anxiety Index
Time Frame: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Center for Epidemiological Studies Depression Scale
Time Frame: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Motion analysis variables (knee motion, vertical ground reaction force, loading rates, knee adduction/abduction moment, and lower extremity muscle co-contractions during walking and a step-down task)
Time Frame: Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: G. Kelley Fitzgerald, PhD, PT, University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 3, 2004

First Submitted That Met QC Criteria

March 3, 2004

First Posted (Estimate)

March 4, 2004

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAMS-117
  • R01AR048760-01A2 (U.S. NIH Grant/Contract)

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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