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Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders (SCIBHI)

27 de septiembre de 2012 actualizado por: University of South Florida

A Pilot Randomized Intervention Study of Physical Exercise and Social Engagement in Chinese Elders

A pilot randomized clinical trial was conducted in a random sample of 120 non-demented Chinese elders (ages 60-79) living in a defined community in Shanghai, China to compare the effects of interventions (fast walking, Tai Chi, group intellectual discussion) to no intervention with respect to change in cognition and whole brain volume determined by repeated neuropsychological batteries and MRI scans. Aims included determining the feasibility of recruiting and retaining a random sample of people age 60+ for such a trial as well as collection of preliminary data on the efficacy of the interventions. The long-term goal of this research program is to determine whether sustained physical and/or mental exercise interventions are efficacious in delaying the onset of dementia and to understand the role and mechanisms of brain growth in this process.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Physical exercise has been shown to increase brain volume and improve cognition in randomized trials of non-demented elderly. Although greater social engagement was found to reduce dementia risk in observational studies, randomized trials of social interventions have not been reported. A representative sample of 120 elderly from Shanghai, China was randomized to four groups (Tai Chi, Walking, Social Interaction, No Intervention) for 40 weeks. Two MRI's were obtained, one before the intervention period, the other after. A neuropsychological battery was administered at baseline, 20 weeks and 40 weeks. Comparison of changes in brain volumes in intervention groups with the No Intervention group were assessed by t-tests. Time-intervention group interactions for neuropsychological measures were evaluated with repeated-measures mixed models.

Tipo de estudio

Intervencionista

Inscripción (Actual)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Porcelana
      • Shanghai, Porcelana
        • Huashan Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

60 años a 79 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • living in defined area
  • either sex
  • aged 60-79

Exclusion Criteria:

  • history of stroke, Parkinson's disease or other neurologic disease
  • inability to walk unassisted for two kilometers or maintain balance with feet side-by-side or semi-tandem for 10 seconds each
  • education-adjusted Chinese Mini-Mental Examination score < 26 (to exclude individuals with dementia or moderate cognitive impairment
  • cardiovascular or musculoskeletal conditions that would be contraindicated for the intervention programs
  • contraindications for MRI
  • diagnosis of any illness that would preclude participation in the full study
  • regular vigorous exercise or Tai Chi practice.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Fast walking
Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route. Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises. Prior to the first session, each participant was given a pedometer with their name on it. They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement. At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded. A record of the number of steps taken for every participant at each session over the 40 week period was maintained.
Otro: Fast walking
Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route. Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises. Prior to the first session, each participant was given a pedometer with their name on it. They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement. At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded. A record of the number of steps taken for every participant at each session over the 40 week period was maintained.
Comparador activo: Tai Chi
Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions. Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.
Otro: Tai Chi
Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions. Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.
Comparador activo: Intellectual stimulation
Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center. Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.
Otro: Intellectual stimulation
Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center. Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.
Comparador de placebos: Contact and testing only
The fourth group received no intervention. Contact was maintained by phone during the intervention period to reduce dropout. Participants were called four times during the 40 weeks intervention period by the study coordinator.
Otro: Contact and testing only

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in cognitive performance on battery of neuropsychological tests
Periodo de tiempo: Baseline, 4 months, 8 months
A comprehensive battery of neuropsychological tests was administered by a psychometrist.
Baseline, 4 months, 8 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in whole brain volume
Periodo de tiempo: Baseline, 8 months
Structural MRIs were obtained at baseline and 8 months to provide data from which change in whole brain volume was determined.
Baseline, 8 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of South Florida

Colaboradores

Fudan University

Investigadores

  • Investigador principal: James A Mortimer, Ph.D., University of South Florida

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2008

Finalización primaria (Actual)

1 de septiembre de 2009

Finalización del estudio (Actual)

1 de septiembre de 2009

Fechas de registro del estudio

Enviado por primera vez

26 de septiembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

27 de septiembre de 2012

Publicado por primera vez (Estimar)

28 de septiembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

28 de septiembre de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

27 de septiembre de 2012

Última verificación

1 de septiembre de 2012

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Byrd-ARG2007

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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