Knee Stability Training for Knee Osteoarthritis (OA)

NCT00078624 | Completed Phase 2

• 2 other identifiers: NIAMS-117R01AR048760-01A2
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Joint Diseases

Keywords

Osteoarthritis; Knee Joint; Joint Stability; Motor Control; Exercise Therapy

Outcome Measures

Primary Outcomes (4)

• Western Ontario and McMaster OA index (WOMAC)

  Measured at baseline, 2 months, 6 months, 1 year

• Lower Extremity Function Scale

  Measured at baseline, 2 months, 6 months, 1 year

• Get Up and Go test (a physical performance measure of function)

  Measured at baseline, 2 months, 6 months

• Knee Outcome Survey - Activities of Daily Living Scale

  Measured at baseline, 2 months, 6 months, 1 year

Secondary Outcomes (8)

• Cartilage morphology changes as measured by MRI

  Measured at baseline, 1 year

• Physical Activity Scale for the Elderly

  Measured at baseline, 2 months, 6 months, 1 year

• Quadriceps strength and activation

  Measured at baseline, 2 months, 6 months

• Radiographic severity of OA

  Measured at baseline, 1 year

• Fear Avoidance questionnaire for the knee

  Measured at baseline, 2months, 6 months, 1 year

Study Arms (2)

1

EXPERIMENTAL

Traditional exercise program supplemented with knee stability training activities

Other: Knee stability training

2

ACTIVE COMPARATOR

Traditional exercise program

Other: Traditional exercise therapy for knee osteoarthritis

Interventions

Traditional exercise therapy for knee osteoarthritis OTHER

Exercises include stretching, strengthening, and aerobic exercise

2

Knee stability training OTHER

The addition of agility and perturbation training techniques to the traditional exercise program

1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis
• Grade II or greater Kellgren and Lawrence radiographic changes

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (3)

• 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.

  PMID: 22674892 DERIVED

• 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.

  PMID: 22003157 DERIVED

• 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.

  PMID: 21330451 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• G. Kelley Fitzgerald, PhD, PT

  University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2004
• First Posted: March 4, 2004
• Study Start: April 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)