- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01204021
Managing Stress and Social Ties for Health Aging
There has been a dramatic rise from 46% to 59% in the percentage of households with only 1-2 people from 1970 to 2000. A 40% increase in the number of people living alone is projected for 2010. Social isolation is consistently one of the strongest predictors mortality in older adults. Recent research is demonstrating that stress plays an important role linking social isolation with poor health. Socially isolated older adults are more likely to feel chronically stressed and overwhelmed with everyday life demands. Furthermore, isolated adults respond to stress differently, both psychologically and physiologically. Socially isolated and lonely older adults show long-term elevations in "inflammatory cytokines", which are signaling molecules related by immune cells. These Inflammatory cytokines play a role in a number of age-related diseases including cardiovascular disease, type-2 diabetes and arthritis. Novel, readily useable interventions aimed at decreasing isolation and "re-calibrating" stress responses might be helpful to older adults.
Tai Chi is an ancient Chinese form of calisthenics that promotes relaxation and decreases feelings of stress and as such, it may be a useful intervention for socially isolated, stressed older adults. However, its effects on stress responses are unknown. Tai Chi Chih (TCC) is a simplified, manualized, readily exportable form of Tai Chi particularly well-suited for older adults. This proposed study will test the effects of a TCC intervention with socially isolated older adults on loneliness, stress and health outcomes, including inflammatory assessment. Tai Chi-naïve participants who perceive themselves as socially isolated, as measured by the UCLA Loneliness Scale will be randomized to receive either Tai Chi or education control for a 12-week period. Subjects will undergo pre- and post-intervention stress assessment, including exposure to a psychological stress task, to assess whether Tai Chi affects how subjects physiologically and psychologically respond to stress.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults > 60 years old
- Have not done Tai Chi before
- Live in Los Angeles area
- Socially isolated
- Women must be post menopausal
Exclusion Criteria:
- Any physical debility that limits Tai Chi performance;
- Cognitive impairment (< 23 on the Mini-Mental State Exam);
- Current or recent history of smoking
- Immune suppression resulting from neoplastic disease
- Corticosteroid use or other therapy
- Significant underlying illness that would interfere or prevent completion of the study
- Acute conditions (e.g. viral infection w/in 2 weeks) that might confound interpretation of inflammatory data
- Current or recent (within 1 month) use of illicit drugs.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Tai Chi Chih
12 weeks of physical exercise in the form of Tai Chi Chih
|
12 weeks of weekly classes of Tai Chi Chih
Otros nombres:
|
Comparador activo: Stress Education Control
Stress management education
|
Weekly meetings, for 2 hours for 12 weeks discussing issues related to stress education.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Perceived Stress
Periodo de tiempo: 4-8 months
|
4-8 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Autonomic Activity and inflammatory signalling
Periodo de tiempo: 4-8 months
|
4-8 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sarosh J Motivala, Ph.D., University of California, Los Angeles
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
- AG028748-01-SST
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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