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Knee Stability Training for Knee Osteoarthritis (OA)

Primary Purpose

Osteoarthritis, Joint Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Traditional exercise therapy for knee osteoarthritis
Knee stability training
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Knee Joint, Joint Stability, Motor Control, Exercise Therapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Traditional exercise program supplemented with knee stability training activities

Traditional exercise program

Outcomes

Primary Outcome Measures

Western Ontario and McMaster OA index (WOMAC)
Lower Extremity Function Scale
Get Up and Go test (a physical performance measure of function)
Knee Outcome Survey - Activities of Daily Living Scale

Secondary Outcome Measures

Cartilage morphology changes as measured by MRI
Physical Activity Scale for the Elderly
Quadriceps strength and activation
Radiographic severity of OA
Fear Avoidance questionnaire for the knee
Beck Anxiety Index
Center for Epidemiological Studies Depression Scale
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)

Full Information

First Posted
March 3, 2004
Last Updated
January 23, 2013
Sponsor
University of Pittsburgh
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00078624
Brief Title
Knee Stability Training for Knee Osteoarthritis (OA)
Official Title
Knee Stability Training in Individuals With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Joint Diseases
Keywords
Osteoarthritis, Knee Joint, Joint Stability, Motor Control, Exercise Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Traditional exercise program supplemented with knee stability training activities
Arm Title
2
Arm Type
Active Comparator
Arm Description
Traditional exercise program
Intervention Type
Other
Intervention Name(s)
Traditional exercise therapy for knee osteoarthritis
Intervention Description
Exercises include stretching, strengthening, and aerobic exercise
Intervention Type
Other
Intervention Name(s)
Knee stability training
Intervention Description
The addition of agility and perturbation training techniques to the traditional exercise program
Primary Outcome Measure Information:
Title
Western Ontario and McMaster OA index (WOMAC)
Time Frame
Measured at baseline, 2 months, 6 months, 1 year
Title
Lower Extremity Function Scale
Time Frame
Measured at baseline, 2 months, 6 months, 1 year
Title
Get Up and Go test (a physical performance measure of function)
Time Frame
Measured at baseline, 2 months, 6 months
Title
Knee Outcome Survey - Activities of Daily Living Scale
Time Frame
Measured at baseline, 2 months, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Cartilage morphology changes as measured by MRI
Time Frame
Measured at baseline, 1 year
Title
Physical Activity Scale for the Elderly
Time Frame
Measured at baseline, 2 months, 6 months, 1 year
Title
Quadriceps strength and activation
Time Frame
Measured at baseline, 2 months, 6 months
Title
Radiographic severity of OA
Time Frame
Measured at baseline, 1 year
Title
Fear Avoidance questionnaire for the knee
Time Frame
Measured at baseline, 2months, 6 months, 1 year
Title
Beck Anxiety Index
Time Frame
Measured at baseline, 2 months, 6 months, 1 year
Title
Center for Epidemiological Studies Depression Scale
Time Frame
Measured at baseline, 2 months, 6 months, 1 year
Title
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)
Time Frame
Measured at baseline, 2 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Kelley Fitzgerald, PhD, PT
Organizational Affiliation
University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22674892
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.
Results Reference
derived
PubMed Identifier
22003157
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.
Results Reference
derived
PubMed Identifier
21330451
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.
Results Reference
derived

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Knee Stability Training for Knee Osteoarthritis (OA)

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