Knee Stability Training for Knee Osteoarthritis (OA)

NCT ID: NCT00078624

Last Updated: 2013-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis Joint Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Traditional exercise program supplemented with knee stability training activities

Group Type EXPERIMENTAL

Knee stability training

Intervention Type OTHER

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

2

Traditional exercise program

Group Type ACTIVE_COMPARATOR

Traditional exercise therapy for knee osteoarthritis

Intervention Type OTHER

Exercises include stretching, strengthening, and aerobic exercise

Interventions

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Traditional exercise therapy for knee osteoarthritis

Exercises include stretching, strengthening, and aerobic exercise

Intervention Type OTHER

Knee stability training

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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G. Kelley Fitzgerald, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22674892 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22003157 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21330451 (View on PubMed)

Other Identifiers

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R01AR048760-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAMS-117

Identifier Type: -

Identifier Source: org_study_id

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