- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00708136
Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals (EWEB)
Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals - A Randomized Control Study
The proposed project is a Randomized Controlled study design. Seniors (age >65) willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. The first 60 subjects who upon questioning were judged to meet the following inclusion criteria:
- able to stand independently 90 seconds
- able to walk 10 meters (with cane if necessary)
- able to understand verbal instructions.
The exclusion criteria will be:
- Serious visual impairment
- Inability to ambulate independently (cane acceptable, walker not).
- Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
- Persons with impaired communication capabilities.
The whole project will be conducted over a period of 24 months. The proposed study is a randomized experimental intervention/ control group design. A total of 60 elderly volunteer subjects will be randomly assigned to two groups, exercise group (30) and control group (30). Twelve training periods will be performed with 8 subjects participating in training during each period (4 exercise groups). The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week).
Gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. The measuring techniques
- Medical background variables.
- Berg Balance Scale.
- Late life Function and Disability Instrument.
- Get up and go test - stand up and walk 3 meters turn around and walk back to the chair.
- Fall Efficacy Scale
- Fall incidence and fall severity.
- 6-minute walk test. The control group will not perform any specific balance training during the 12 week period.
These individuals from control will participate in a separate exercise program after the training period.
The water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. The water exercises also include perturbation exercises that trigger specific reflex-like balance responses. On each level the instructor can instantly modify an exercise to be more or less challenging for each participant.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Beer-Sheva, Israel, 84105
- SorokaUMC
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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:
- able to stand independently 90 seconds;
- able to walk 10 meters (with cane if necessary);
- able to understand verbal instructions.
Exclusion Criteria:
- Serious visual impairment;
- Inability to ambulate independently (cane acceptable, walker not).
- Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
- Persons with impaired communication capabilities.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Berg Balance Scale
Periodo de tiempo: before and 3 months after Training
|
before and 3 months after Training
|
|
Late life Function and Disability Instrument
Periodo de tiempo: before and after the training
|
before and after the training
|
|
Get up and go test
Periodo de tiempo: before and after 3 month of training
|
before and after 3 month of training
|
|
Step execution test under single and dual task
Periodo de tiempo: before and 3 months after Training
|
before and 3 months after Training
|
|
Stability tests
Periodo de tiempo: before and 3 months after Training
|
before and 3 months after Training
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: dagan Shvartz, MD, Ben-Gurion University of the Negev
Publicaciones y enlaces útiles
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
Otros números de identificación del estudio
- sor404605ctil
- ISRCTN4046
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. .