- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00289458
Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis
The Effect of Aquatic Exercise and Aquatic Exercise Combined With Education and Efficacy Enhancement on Improving Indices of Fall Risk in Older Adults With Hip Osteoarthritis: a Randomized Controlled Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Older adults with hip osteoarthritis (OA) often experience pain and loss of mobility that significantly impairs their ability to walk, climb stairs, shop or participate in exercise programs. This can result in social isolation, depression and loss of confidence in their ability to manage independently in the community. A decline in physical and psycho-social function leads to increased risk of falling. It is crucial to identify high-risk fallers as well as the best interventions to decrease that risk; hip fractures from falls are devastating, resulting in death or admission to long-term care for the majority who sustain them.
Exercise programs designed to improve balance, strength and mobility can help to improve function and decrease risk of falling. However, individuals with hip OA may have difficulty participating in these programs due to pain. Aquatic exercise offers an activity alternative to improve mobility, strength and decrease fall risk. As well, the addition of a group program designed to enhance confidence in movement may further reduce the risk of falls by improving independence to be more active at home and in the community.
This project will evaluate the effect of aquatic exercise and aquatic exercise combined with a group educational program on decreasing fall risk in older adults with hip OA. Determining optimal fall prevention programs may avert death and loss of quality of life for older adults, clearly an important contribution to preventative health care.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7N 5B2
- College of Kinesiology
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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:
- over age 65
- clinical diagnosis of hip osteoarthritis
Exclusion Criteria:
- medical condition tha significantly decreases functional ability such that not safe to exercise in a community program
- already exercising in a moderate exercise program 2/week or more
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Control
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no exercise
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Experimental: Aquatic Education
Exercise combined with education
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Same as 1 with the addition of a 1/week educational group program to improve confidence in movement, learn about fall risk and fall prevention and the rationale for the exercises to decrease fall risk.
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Experimental: Aquatic
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A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Balance
Periodo de tiempo: baseline and 11 weeks
|
Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)
|
baseline and 11 weeks
|
Change in Chair Stands
Periodo de tiempo: baseline and 11 weeks
|
change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)
|
baseline and 11 weeks
|
Change in Walking
Periodo de tiempo: baseline and 11 weeks
|
change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks
|
baseline and 11 weeks
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Change in Falls-Efficacy
Periodo de tiempo: baseline and 11 weeks
|
change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)
|
baseline and 11 weeks
|
Change in Dual Task Function
Periodo de tiempo: baseline and 11 weeks
|
change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)
|
baseline and 11 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Physical Activity
Periodo de tiempo: baseline and 11 weeks
|
change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)
|
baseline and 11 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Cathy M Arnold, MSc, University of Saskatchewan
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
- BIO-REB 05-158
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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