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Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline

19 de diciembre de 2016 actualizado por: Chang Gung Memorial Hospital

Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline

The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline. The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

75

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

  • Taiwán
      • Chiayi City, Taiwán, 613
        • Reclutamiento
        • Chiayi Chang Gung Memorial Hospital
        • Contacto:
      • Kaohsiung City, Taiwán, 83301
        • Reclutamiento
        • Kaohsiung Chang Gung Memorial Hospital
        • Contacto:
          • Ku-Chou Chang, MD
          • Número de teléfono: 2285 +886-7317123
          • Correo electrónico: kcchang@cgmh.org.tw
      • Keelung City, Taiwán, 204
        • Reclutamiento
        • Keeling Chang Gung Memorial Hospital
        • Contacto:
      • Taipei City, Taiwán, 105
        • Reclutamiento
        • Taipei Chang Gung Memorial Hospital
        • Contacto:
      • Taoyuan City, Taiwán, 333
        • Reclutamiento
        • Taoyuan Chang Gung Memorial Hospital
        • Contacto:
    • Taoyuan
      • Kwei-Shan, Taoyuan, Taiwán, 333
        • Reclutamiento
        • Chang Gung Memorial 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

20 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
  2. Age range from 20 to 90 years
  3. MMSE score ≥ 19
  4. MoCA<26
  5. Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
  6. Able to follow the study instruction
  7. Adequate cardiopulmonary function to perform aerobic exercise
  8. Able to walk with or without assistive devices

Exclusion Criteria:

  1. Unstable medical history (e.g., recent myocardial infarction) that might limit participation
  2. Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
  3. Current participation in another interventional trial

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Cognitive training group
One 60-min session of cognitive training. Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.
Conductual: Entrenamiento cognitivo
Comparador activo: Aerobic exercise training group
One 60-min session of aerobic exercise training. Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.
Conductual: Aerobic exercise training
Experimental: Sequential training group

One 30-min session of aerobic exercise training + one 30-min session of cognitive training.

Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.
Conductual: Sequential combination of aerobic exercise and cognitive training

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change scores of Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Useful Field of View (UFOV)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroop Color-Word test
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Dual-task test
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambiar las puntuaciones del marcador antioxidante
Periodo de tiempo: Línea de base, prueba posterior (un promedio esperado de 3 meses)
Se utilizarán marcadores antioxidantes para reflejar los cambios en el estrés oxidativo. En particular, estaremos analizando la capacidad antioxidante total (TAC).
Línea de base, prueba posterior (un promedio esperado de 3 meses)
Cambiar las puntuaciones del nivel de lípidos en plasma
Periodo de tiempo: Línea de base, prueba posterior (un promedio esperado de 3 meses)
Se evaluará la proporción de colesterol (colesterol total dividido por lípidos de alta densidad) para reflejar el nivel de lípidos en la sangre.
Línea de base, prueba posterior (un promedio esperado de 3 meses)
Change scores of serum BDNF level
Periodo de tiempo: Baseline, posttest (an expected average of 3 months)
Baseline, posttest (an expected average of 3 months)
Change scores of Glucose indicator
Periodo de tiempo: Baseline, posttest (an expected average of 3 months)
HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise.
Baseline, posttest (an expected average of 3 months)
Change scores of Functional Independence Measure (FIM)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroke Impact Scale (SIS)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Caregiver Burden (CB) scale
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of EuroQol (EQ)-5D questionnaire
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Timed up and go test (TUG)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Six-minute walk test (6MWT)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Mobility level
Periodo de tiempo: Baseline, posttest (an expected average of 3 months)
Baseline, posttest (an expected average of 3 months)
Change scores of International Physical Activity Questionnaires (IPAQ)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Fugl-Meyer Assessment (FMA)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Rivermead Mobility Index (RMI)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of muscle strength
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
We will evaluate isometric knee flexors and extensors muscle strength using handheld dynamometer. Also, we will use hand dynamometer to measure grip strength of the affected and less affected hand while the participant is seated, with the elbow at 90-degree flexion. We will record the mean value of 3 attempts.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Community Integration Questionnaire (CIQ)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Geriatric Depression Scale (GDS)
Periodo de tiempo: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Genotyping of the BDNF val66met polymorphism
Periodo de tiempo: Between baseline and posttest (an expected average of 3 months)
Between baseline and posttest (an expected average of 3 months)

Colaboradores e Investigadores

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

Patrocinador

Chang Gung Memorial Hospital

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 septiembre de 2015

Finalización primaria (Anticipado)

1 de agosto de 2018

Fechas de registro del estudio

Enviado por primera vez

6 de septiembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2015

Publicado por primera vez (Estimar)

16 de septiembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

20 de diciembre de 2016

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

19 de diciembre de 2016

Última verificación

1 de diciembre de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 104-4892A3

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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