Knee Stability Training for Knee Osteoarthritis (OA)

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT00078624
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
231
1
2
56
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Traditional exercise therapy for knee osteoarthritis
  • Other: Knee stability training
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
231 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Knee Stability Training in Individuals With Knee Osteoarthritis
Study Start Date :
Apr 1, 2004
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Western Ontario and McMaster OA index (WOMAC) [Measured at baseline, 2 months, 6 months, 1 year]

  2. Lower Extremity Function Scale [Measured at baseline, 2 months, 6 months, 1 year]

  3. Get Up and Go test (a physical performance measure of function) [Measured at baseline, 2 months, 6 months]

  4. Knee Outcome Survey - Activities of Daily Living Scale [Measured at baseline, 2 months, 6 months, 1 year]

Secondary Outcome Measures

  1. Cartilage morphology changes as measured by MRI [Measured at baseline, 1 year]

  2. Physical Activity Scale for the Elderly [Measured at baseline, 2 months, 6 months, 1 year]

  3. Quadriceps strength and activation [Measured at baseline, 2 months, 6 months]

  4. Radiographic severity of OA [Measured at baseline, 1 year]

  5. Fear Avoidance questionnaire for the knee [Measured at baseline, 2months, 6 months, 1 year]

  6. Beck Anxiety Index [Measured at baseline, 2 months, 6 months, 1 year]

  7. Center for Epidemiological Studies Depression Scale [Measured at baseline, 2 months, 6 months, 1 year]

  8. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences Pittsburgh Pennsylvania United States 15260

Sponsors and Collaborators

  • University of Pittsburgh
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00078624
Other Study ID Numbers:
  • NIAMS-117
  • R01AR048760-01A2
First Posted:
Mar 4, 2004
Last Update Posted:
Jan 24, 2013
Last Verified:
Jan 1, 2013
Keywords provided by University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2013