- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02075931
Collaborative-care Intervention to Promote Physical Activity After Total Knee Arthroplasty
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
More than 650,000 total knee arthroplasties (TKAs) are performed annually to alleviate pain and disability associated with osteoarthritis (OA); a chronic, degenerative condition that compromises the quality of life of 37% of adults over age 60. With the aging of the population, an estimated 3.5 million TKAs will be performed annually by 2030. Despite improvements in pain and self-reported function, physical activity after TKA remains at pre-operative, sedentary levels (<5,000 steps/day). Physical activity in TKA confers powerful protective effects against common post-surgical sequelae including increased weight gain (mean=6.4 kg, 2 years post TKA), decreased functional performance, increased risk/progression of co-morbid conditions (e.g. type 2 diabetes mellitus, cardiovascular disease), and progression of knee and hip osteoarthritis which may necessitate additional joint replacement in the contralateral limb. An intervention aimed at improved self-management of physical activity may aid patients in overcoming habitual lifestyle patterns of low physical activity secondary to knee pain prior to TKA.
Recent investigations on the effects of real-time, user-friendly, electronic physical activity feedback (PAF) systems and face-to-face (FTF) patient group meetings aimed to promote self-management of physical activity suggest that such interventions can successfully increase physical activity. Therefore, the investigators propose a randomized, controlled trial to assess efficacy and feasibility of a physical activity intervention combined with FTF group meetings (PAF+FTF) initiated within one month of patients' discharge from outpatient rehabilitation for TKA compared to a control group receiving standard care (CON). This type of intervention is surprisingly novel to this patient population and is not common practice in rehabilitation following TKA.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado School of Medicine
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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:
- undergone unilateral total knee arthroplasty
Exclusion Criteria:
- severe contralateral leg osteoarthritis (>4/10 with stair climbing)
- unstable orthopaedic condition that limits function
- neurological conditions that affect muscle function
- vascular or cardiac conditions that limit function
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Physical Activity Feedback
The physical activity feedback intervention will involve real-time physical activity monitoring using a device to provide activity feedback directly to patients in combination with patient group meetings held monthly during the 12 week intervention for the purposes of mutual support in attaining physical activity goals.
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Physical activity feedback
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Comparador activo: Control
The control represents the current standard of care post total knee arthroplasty.
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Sin intervención
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Physical activity
Periodo de tiempo: Change from baseline to immediately post-12 week intervention
|
Daily step and activity counts
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Change from baseline to immediately post-12 week intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Functional performance
Periodo de tiempo: Change from baseline to immediately post-12 week intervention
|
Six-minute walk test, timed up-and-go, 10 meter walk test
|
Change from baseline to immediately post-12 week intervention
|
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Change in Self-reported physical function
Periodo de tiempo: Change from baseline to immediately post-12 week intervention
|
Knee injury and Osteoarthritis Outcome Score, Physical Activity Scale for the Elderly
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Change from baseline to immediately post-12 week intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jennifer Stevens-Lapsley, MPT, PhD, Associate professor
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13-2568
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