Knee Stability Training for Knee Osteoarthritis (OA) - Full Text View

Sponsor:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00078624

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Knee Stability Training in Individuals With Knee Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Joint Disorders Osteoarthritis

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

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 ]

Estimated Enrollment:	240
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
1: Experimental 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
2: Active Comparator 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

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

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

More Information

No publications provided

Responsible Party:	University of Pittsburgh ( G. Kelley Fitzgerald, PT, PhD; Associate Professor )
Study ID Numbers:	NIAMS-117, R01 AR048760-01A2
Study First Received:	March 3, 2004
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00078624 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Osteoarthritis
Knee Joint
Joint Stability
Motor Control
Exercise Therapy

Additional relevant MeSH terms:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Arthritis
Joint Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2009