Knee Stability Training for Knee Osteoarthritis (OA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00078624
First received: March 3, 2004
Last updated: January 23, 2013
Last verified: January 2013

March 3, 2004
January 23, 2013
April 2004
December 2008   (final data collection date for primary outcome measure)
  • Western Ontario and McMaster OA index (WOMAC) [ Time Frame: Measured at baseline, 2 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Lower Extremity Function Scale [ Time Frame: Measured at baseline, 2 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Get Up and Go test (a physical performance measure of function) [ Time Frame: Measured at baseline, 2 months, 6 months ] [ Designated as safety issue: No ]
  • Knee Outcome Survey - Activities of Daily Living Scale [ Time Frame: Measured at baseline, 2 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster OA index (WOMAC)
  • Lower Extremity Function Scale
  • Get Up and Go test (a physical performance measure of function)
Complete list of historical versions of study NCT00078624 on ClinicalTrials.gov Archive Site
  • Cartilage morphology changes as measured by MRI [ Time Frame: Measured at baseline, 1 year ] [ Designated as safety issue: No ]
  • Physical Activity Scale for the Elderly [ Time Frame: Measured at baseline, 2 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Quadriceps strength and activation [ Time Frame: Measured at baseline, 2 months, 6 months ] [ Designated as safety issue: No ]
  • Radiographic severity of OA [ Time Frame: Measured at baseline, 1 year ] [ Designated as safety issue: Yes ]
  • Fear Avoidance questionnaire for the knee [ Time Frame: Measured at baseline, 2months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Beck Anxiety Index [ Time Frame: Measured at baseline, 2 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Center for Epidemiological Studies Depression Scale [ Time Frame: Measured at baseline, 2 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Knee Stability Training for Knee Osteoarthritis (OA)
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis
  • Joint Diseases
  • Other: Traditional exercise therapy for knee osteoarthritis
    Exercises include stretching, strengthening, and aerobic exercise
  • Other: Knee stability training
    The addition of agility and perturbation training techniques to the traditional exercise program
  • Experimental: 1
    Traditional exercise program supplemented with knee stability training activities
    Intervention: Other: Knee stability training
  • Active Comparator: 2
    Traditional exercise program
    Intervention: Other: Traditional exercise therapy for knee osteoarthritis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
231
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00078624
NIAMS-117, R01AR048760-01A2, R01 AR048760-01A2
No
University of Pittsburgh
University of Pittsburgh
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: G. Kelley Fitzgerald, PhD, PT University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
University of Pittsburgh
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP