Knee Stability Training for Knee Osteoarthritis (OA)

Osteoarthritis Clinical Trial

Official title:

Knee Stability Training in Individuals With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078624
• Other study ID #: NIAMS-117
• Secondary ID: R01AR048760-01A2
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2004
• Last updated: January 23, 2013
• Start date: April 2004
• Est. completion date: December 2008

Study information

• Verified date: January 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Traditional exercise therapy for knee osteoarthritis
Exercises include stretching, strengthening, and aerobic exercise
• Knee stability training
The addition of agility and perturbation training techniques to the traditional exercise program

Locations

Country	Name	City	State
United States	University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster OA index (WOMAC)		Measured at baseline, 2 months, 6 months, 1 year	No
Primary	Lower Extremity Function Scale		Measured at baseline, 2 months, 6 months, 1 year	No
Primary	Get Up and Go test (a physical performance measure of function)		Measured at baseline, 2 months, 6 months	No
Primary	Knee Outcome Survey - Activities of Daily Living Scale		Measured at baseline, 2 months, 6 months, 1 year	No
Secondary	Cartilage morphology changes as measured by MRI		Measured at baseline, 1 year	No
Secondary	Physical Activity Scale for the Elderly		Measured at baseline, 2 months, 6 months, 1 year	No
Secondary	Quadriceps strength and activation		Measured at baseline, 2 months, 6 months	No
Secondary	Radiographic severity of OA		Measured at baseline, 1 year	Yes
Secondary	Fear Avoidance questionnaire for the knee		Measured at baseline, 2months, 6 months, 1 year	No
Secondary	Beck Anxiety Index		Measured at baseline, 2 months, 6 months, 1 year	No
Secondary	Center for Epidemiological Studies Depression Scale		Measured at baseline, 2 months, 6 months, 1 year	No
Secondary	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)		Measured at baseline, 2 months, 6 months	No