- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00078624
Knee Stability Training for Knee Osteoarthritis (OA)
Knee Stability Training in Individuals With Knee Osteoarthritis
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15260
- University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 1
Traditional exercise program supplemented with knee stability training activities
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The addition of agility and perturbation training techniques to the traditional exercise program
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|
Comparador activo: 2
Traditional exercise program
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Exercises include stretching, strengthening, and aerobic exercise
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Western Ontario and McMaster OA index (WOMAC)
Periodo de tiempo: Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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Lower Extremity Function Scale
Periodo de tiempo: Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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Get Up and Go test (a physical performance measure of function)
Periodo de tiempo: Measured at baseline, 2 months, 6 months
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Measured at baseline, 2 months, 6 months
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Knee Outcome Survey - Activities of Daily Living Scale
Periodo de tiempo: Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Cartilage morphology changes as measured by MRI
Periodo de tiempo: Measured at baseline, 1 year
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Measured at baseline, 1 year
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Physical Activity Scale for the Elderly
Periodo de tiempo: Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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Quadriceps strength and activation
Periodo de tiempo: Measured at baseline, 2 months, 6 months
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Measured at baseline, 2 months, 6 months
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Radiographic severity of OA
Periodo de tiempo: Measured at baseline, 1 year
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Measured at baseline, 1 year
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Fear Avoidance questionnaire for the knee
Periodo de tiempo: Measured at baseline, 2months, 6 months, 1 year
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Measured at baseline, 2months, 6 months, 1 year
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Beck Anxiety Index
Periodo de tiempo: Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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Center for Epidemiological Studies Depression Scale
Periodo de tiempo: Measured at baseline, 2 months, 6 months, 1 year
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Measured at baseline, 2 months, 6 months, 1 year
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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)
Periodo de tiempo: Measured at baseline, 2 months, 6 months
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Measured at baseline, 2 months, 6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: G. Kelley Fitzgerald, PhD, PT, University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NIAMS-117
- R01AR048760-01A2 (Subvención/contrato del NIH de EE. UU.)
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