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Exercise, Age-Related Memory Decline, And Hippocampal Function

24 de marzo de 2020 actualizado por: Richard Sloan, New York State Psychiatric Institute
The purpose of this study is to test the hypothesis that aerobic exercise leads increased cerebral blood volume in the dentate gyrus of the hippocampus in a sample of young and older adults.

Descripción general del estudio

Descripción detallada

In the US, increased length of life and reduced morbidity and mortality have resulted in a growing number of older adults, the demographic "time bomb" often referred to in discussions of public policy. According to the Census Bureau, the population aged 65 and over will double in size within the next 25 years. Moreover, these older adults will live healthier lives than their predecessors. While this increased length of a healthy life is an undeniable societal benefit, it brings with it a major societal problem: an epidemic of aging-related cognitive decline. The need to develop interventions to address this growing problem is urgent. Aging-related cognitive dysfunction is not diffuse; rather it targets selected brain areas, in particular the frontal lobes and the hippocampal formation. The separate but interconnected subregions of the hippocampus are differentially vulnerable to pathogenic mechanisms, including the normal aging process. A range of in vivo and post-mortem studies have converged on the dentate gyrus (DG) as the hippocampal subregion differentially targeted by the aging process. As with pathogenic processes, any intervention that improves brain function does so with regional selectivity. One such intervention is physical exercise, which has been shown to improve both frontal lobe and hippocampal function. Using a high-resolution variant of functional magnetic resonance imaging (fMRI), the investigators have demonstrated that aerobic training selectively benefitted DG function both humans and mice. In addition, improvement in DG function was associated with improved performance on a word list learning task but not in tasks conventionally thought to be frontal lobe dependent. The human part of the study had significant shortcomings, however: it was small (N = 11), lacked a control group, enrolled only young subjects (age 20-45 years), and employed only a limited neuropsychological testing battery. The overall goal of this proposal is to use the high-resolution variant of fMRI to test the hypothesis that aerobic training will induce improvements in DG function in a sample of younger (age 20-35) and older (50-65) adults, assigned randomly to an active training condition or wait list control group. The investigators will use more comprehensive neuropsychological testing to examine the relationship between changes in DG function and selected cognitive capacities. Taken together with the observation that normal aging differentially targets the DG, this research program will establish that physical exercise is an effective approach for ameliorating the insidious cognitive slide that occurs in aging. Thus, the potential significance of this application is substantial.

Tipo de estudio

Intervencionista

Inscripción (Actual)

233

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

    • New York
      • New York, New York, Estados Unidos, 10032
        • Columbia University Medical Center

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 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Age 20-75 years
  2. English-speaking
  3. Ambulatory
  4. "Average" fitness as determined by ACSM's Guidelines for Exercise Testing and Prescription (for men, VO2max < 43 for age 20-39 years, < 38 for age 40-49 years, < 35 for age 50-59, < 31 for age 60-75; for women, < 36 for age < 30 years, < 34 for age 30-39 years, < 32 for age 40-49 years, <25 for age 50-59 years, < 24 for age 60-75 years
  5. BMI <35

Exclusion Criteria:

  1. Ischemic changes or abnormal resting cardiogram, abnormal blood pressure responses, or an significant ectopy during aerobic capacity testing
  2. Cardiovascular disease
  3. BMI > 35
  4. Uncontrolled high blood pressure (systolic blood pressure ≥ 140 mmHg; or diastolic blood pressure ≥ 90mmHg on two measures)
  5. Any condition for which aerobic training is counter-indicated, including persons with evidence or history of medical or orthopedic conditions which might make participation problematic.
  6. Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma. Prostatic carcinoma will not be grounds for exclusion.
  7. Active hepatic disease (not a history of hepatitis) or primary renal disease requiring dialysis, primary untreated endocrine diseases, e.g., Cushing's disease or primary hypothalamic failure or insulin dependent diabetes (Type I or II). Welltreated hypothyroidism will not be excluded.
  8. History of chemotherapy
  9. HIV infection
  10. Pregnant or lactating (participation allowed 3 months after ceasing lactation).
  11. Medications that alter inflammation or autonomic nervous system activity
  12. Any history of psychosis or ECT
  13. Current or recent (past one year) Major Depressive Disorder, Bipolar Disorder
  14. Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs.
  15. Dementia Rating Scale (DRS) score less than 135. Medical History Interview
  16. Neurological Disorders Dementia Rating Scale
  17. Stroke Telephone screen
  18. Alzheimer's Disease Telephone screen
  19. Smoking Telephone screen
  20. Prior participation in another Dr. Sloan Exercise Study
  21. MRI Exclusion Criteria: Cardiac Pacemaker; Internal Pump; Insulin Pump; Tattoo; eyeliner; Wire Sutures; Internal Metal Objects; Metal Slivers in Eye; Prosthesis; Hearing Aid Implants; Neurostimulator; Metal Fragments; Brain Aneurysm Clips; Vascular Clips; Breast Expander; Vena Cava Filter; Heart Valve; Metal Stents; Asthma; Hay-Fever; Sickle Cell Disease; Kidney Disease; Machinist or ever worked with heavy metals Interview; Contraindication to gadolinium, including prior adverse reaction to gadolinium, past or current history of severe breathing difficulty that has been treated by a physician (e.g., asthma, COPD, etc.), and sickle cell disease. History of renal impairment or estimated glomerular filtration rate <30 L/min/1.73m2 is also exclusionary; Machinist or ever worked with heavy metals Interview; Have had more than one MRI scans with Gadolinium

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: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: aerobic training
12 weeks of aerobic training, 4X/week
12 weeks of aerobic training, 4X/week
Comparador de placebos: wait list control
wait list control condition, 12 weeks to parallel the active intervention group
condición de control de lista de espera
Otros nombres:
  • Control de lista de espera

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
dentate gyrus cerebral blood volume
Periodo de tiempo: change from before (pre) to after (post) 12 weeks of training
change from before (pre) to after (post) 12 weeks of training

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
cognitive function
Periodo de tiempo: change from before (pre) to after (post) 12 weeks of training
measures of memory, executive function, attention/processing speed, language, and general intelligence
change from before (pre) to after (post) 12 weeks of training
aerobic capacity
Periodo de tiempo: change from before (pre) to after (post) 12 weeks of training
change from before (pre) to after (post) 12 weeks of training
cerebral blood flow
Periodo de tiempo: change from before (pre) to after (post) 12 weeks of training
arterial spin labeling fMRI
change from before (pre) to after (post) 12 weeks of training

Colaboradores e Investigadores

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

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.

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 (Actual)

1 de junio de 2011

Finalización primaria (Actual)

31 de diciembre de 2019

Finalización del estudio (Actual)

31 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

28 de julio de 2010

Primero enviado que cumplió con los criterios de control de calidad

5 de abril de 2011

Publicado por primera vez (Estimar)

6 de abril de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de marzo de 2020

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

24 de marzo de 2020

Última verificación

1 de marzo de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • #6219/#7161R
  • AG035015 (Otro identificador: CU)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

We will share our data with other investigators upon request.

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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