Clinical trial NCT00078624: Knee Stability Training for Knee Osteoarthritis (OA)
Official title: Knee Stability Training in Individuals With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Joint Diseases
Keywords: Osteoarthritis
Knee Joint
Joint Stability
Motor Control
Exercise Therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2004-03-04
Enrollment: 231
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Western Ontario and McMaster OA index (WOMAC)
timeFrame: Measured at baseline, 2 months, 6 months, 1 year
measure: Lower Extremity Function Scale
timeFrame: Measured at baseline, 2 months, 6 months, 1 year
measure: Get Up and Go test (a physical performance measure of function)
timeFrame: Measured at baseline, 2 months, 6 months
measure: Knee Outcome Survey - Activities of Daily Living Scale
timeFrame: Measured at baseline, 2 months, 6 months, 1 year
Secondary outcomes:
measure: Cartilage morphology changes as measured by MRI
timeFrame: Measured at baseline, 1 year
measure: Physical Activity Scale for the Elderly
timeFrame: Measured at baseline, 2 months, 6 months, 1 year
measure: Quadriceps strength and activation
timeFrame: Measured at baseline, 2 months, 6 months
measure: Radiographic severity of OA
timeFrame: Measured at baseline, 1 year
measure: Fear Avoidance questionnaire for the knee
timeFrame: Measured at baseline, 2months, 6 months, 1 year
measure: Beck Anxiety Index
timeFrame: Measured at baseline, 2 months, 6 months, 1 year
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Measured at baseline, 2 months, 6 months, 1 year
measure: 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)
timeFrame: Measured at baseline, 2 months, 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
name: G. Kelley Fitzgerald, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fitzgerald GK, White DK, Piva SR. Associations for change in physical and psychological factors and treatment response following exercise in knee osteoarthritis: an exploratory study. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1673-80. doi: 10.1002/acr.21751.
citation: Teixeira PE, Piva SR, Fitzgerald GK. Effects of impairment-based exercise on performance of specific self-reported functional tasks in individuals with knee osteoarthritis. Phys Ther. 2011 Dec;91(12):1752-65. doi: 10.2522/ptj.20100269. Epub 2011 Oct 14.
citation: Fitzgerald GK, Piva SR, Gil AB, Wisniewski SR, Oddis CV, Irrgang JJ. Agility and perturbation training techniques in exercise therapy for reducing pain and improving function in people with knee osteoarthritis: a randomized clinical trial. Phys Ther. 2011 Apr;91(4):452-69. doi: 10.2522/ptj.20100188. Epub 2011 Feb 17.