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
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Joint Diseases
Other: Traditional exercise therapy for knee osteoarthritis
Other: Knee stability training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Knee Stability Training in Individuals With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 231
Study Start Date: April 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00078624

Locations
United States, Pennsylvania
University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: G. Kelley Fitzgerald, PhD, PT University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00078624     History of Changes
Other Study ID Numbers: NIAMS-117, R01AR048760-01A2, R01 AR048760-01A2
Study First Received: March 3, 2004
Last Updated: January 23, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Osteoarthritis
Knee Joint
Joint Stability
Motor Control
Exercise Therapy

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

ClinicalTrials.gov processed this record on August 28, 2014