- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02132039
A Randomised Controlled Trial of Home-based Exercise Intervention for Caregivers of Persons With Dementia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The proposed study is a single-blind randomised controlled trial for two years. We will compare the efficacy of a home-based structured exercise programme (12-step sitting Tai Chi) for both carers and care recipients with a standard non-exercise social contact control in the treatment of depression among caregivers of persons with dementia. The study hypotheses include:
- The structured home-based exercise programme will reduce caregiver depression. (Primary outcome)
- The home-based exercise will improve caregivers' cognitive performance, quality of life and balance ability at the end of the study. (Secondary outcome)
- The home-based exercise will improve the cognitive performance, quality of life and balance ability of persons with dementia at the end of the study. (Secondary outcome)
- We also hypothesise that BDNF gene modulates mood changes in response to exercise intervention. (Secondary outcome)
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Wai Chi Chan
- Número de teléfono: (+852) 2255 4486
- Correo electrónico: waicchan@hku.hk
Ubicaciones de estudio
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Hong Kong, Porcelana
- Reclutamiento
- Hong Kong East Cluster, Hospital Authority
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Investigador principal:
- Kong Hing Leung
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Hong Kong, Porcelana
- Reclutamiento
- Hong Kong West Cluster, Hospital Authority
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Contacto:
- Wai Chi Chan
- Número de teléfono: (+852) 2255 4486
- Correo electrónico: waicchan@hku.hk
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Investigador principal:
- Wai Chi Chan
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Hong Kong, Porcelana
- Reclutamiento
- Kowloon West Cluster, Hospital Authority
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Investigador principal:
- Karen Wat
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Hong Kong, Porcelana
- Reclutamiento
- New Territories East Cluster, Hospital Authority
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Investigador principal:
- Linda Lam
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Hong Kong, Porcelana
- Terminado
- New Territories West Cluster, Hospital Authority
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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:
Caregivers
- 18 years of age and above
- Live with persons with dementia
- 15-item Geriatric Depression Scale (GDS) >0 and <8
- No regular (i.e. ≥ 3 times/week) Tai Chi practice or other forms of mind-body exercise (e.g. yoga, qigong, mindfulness training) in the past six months
- Understand Chinese
- If they are on an antidepressant, they will not be included in the study unless they have been receiving pharmacological treatment on a steady dose for three months
Care recipient
- Aged 60 years or above
- Dementia diagnosis confirmed by a physician
- Dependence in at least one Activities of daily living(ADL)
- Mini Mental State Examination (MMSE) > 10
- No regular (i.e. ≥ 3 times/week) Tai Chi practice or other forms of mind-body exercise (e.g. yoga, qigong, mindfulness training) in the past six months
Exclusion Criteria:
Caregivers
- Presence of psychotic symptoms, imminently suicidal, unstable medical conditions (e.g. recent heart attack, recent stroke, episodes of dizziness, fainting attacks) or significant orthopaedic problems rendering participants unsuitable for physical training
- Carers who are found to have mental conditions that warrants psychiatric assessment and/or treatment (e.g. GDS >8, i.e. local cut-off score for significant depressive symptoms, or suicidal) will be referred to appropriate units for follow up
Care recipient
- Presence of psychotic symptoms, unstable medical conditions (e.g. recent heart attack, recent stroke, episodes of dizziness, fainting attacks) or significant orthopaedic problems rendering participants unsuitable for physical training
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: 12-step sitting Tai Chi Chuan
The intervention is a simplified Tai Chi Chuan exercise, which consists of 12 steps, including weight shifting in different sitting positions, trunk and upper limb movements, and alternate thigh lift in a smooth and coordinated manner.
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The intervention consists of eight home-based sessions on 12-step sitting Tai Chi Chuan.
Each session will last for an hour.
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Comparador de placebos: Control
We provide participants in the control group with a level of social contact equivalent to the intervention group, which comprises structured conversations on topic other than physical activity.
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The control consists of eight home-based sessions on useful health-care information.
Each session will last for an hour.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline Hamilton Rating Scale for Depression in caregivers
Periodo de tiempo: Week 12
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The proportion of participants who are classified as responders by Hamilton Rating Scale for Depression (HAM-D-17).
HAM-D-17 is a widely used and reliable measure of depressive symptoms.
The scores range from 0 to 52, with higher scores indicating greater depression severity.
Response to intervention is defined as a reduction of HAM-D-17 total score by ≥50% from baseline to endpoint.
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Week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Berg Balance Scale in caregivers and care recipients
Periodo de tiempo: Week 12
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Berg Balance Scale (BBS)
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Week 12
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Mini Mental State Examination in caregivers and care recipients
Periodo de tiempo: Week 12
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Global cognitive function will be measured by Mini Mental State examination (MMSE)
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Week 12
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Quality of life in caregivers and care recipients
Periodo de tiempo: Week 12
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SF-12 Health Survey (SF-12)
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Week 12
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wai Chi Chan, The University of Hong Kong
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- 11121441
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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Lithuanian Sports UniversityTerminadoEnvejecimiento Saludable | Función cognitiva | Aprendizaje motorLituania
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The Hong Kong Polytechnic UniversityFood and Health Bureau, Hong KongReclutamientoDormir | Anciano | Atención plena | Tai Chi ChuanHong Kong
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University of BernSwiss Federal Institute of TechnologyTerminadoEstrés | Prevención primaria | Adulto | Tai-jiSuiza