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Fitness on White Matter and Cognition in Aging

16 de diciembre de 2018 actualizado por: Ryan Mace, Suffolk University

Neuroprotective Effects of Cardiorespiratory Fitness on White Matter Integrity and Cognition Across the Adult Lifespan

Cardiorespiratory fitness (CRF) is associated with decreased risk for mild cognitive impairment (MCI) and dementia. CRF is linked with more conserved gray and white matter (WM) volume, improved WM microstructural integrity, and better cognitive performance among healthy older adults. Additional research is needed to determine: (1) which WM tracts are most strongly related to CRF, (2) whether CRF-related benefits on WM translate to enhanced cognitive functioning, and (3) factors that mediate and moderate CRF effects. Higher CRF was hypothesized to be associated with stronger WM integrity, both globally and locally in WM tracts that connect frontal brain regions. The neuroprotective effects were hypothesized to be age-dependent, such that the association between CRF and WM integrity would be stronger in old age compared to younger age. Finally, higher CRF was hypothesized to predict stronger performance on tests of executive functioning (EF), partially mediated by frontal WM integrity. Delineation of specific neurocognitive effects of CRF may serve clinicians in individually tailoring wellness interventions to meet patients' specific cognitive concerns with aging.

Descripción general del estudio

Descripción detallada

Sample: Participant data from the "Cross-Sectional Lifespan Connectomics Study" of the Nathan Kline Institute - Rockland Sample (NKI-RS) will be analyzed for the present study. Zip code-based recruitment and monitoring enrollment for key demographic variables (e.g., age, sex, ethnicity) were used to maintain adequate representation of Rockland County and prevent sampling biases (e.g., cohort effects). NKI-RS eligibility was designed for inclusivity.

Procedure: All participants completed a medical evaluation, psychiatric interview, self-report questionnaires, standardized battery of cognitive tests, and neuroimaging at NKI. Complete details about the MRI measurement parameters can be located on the NKI-RS website for DTI and MPRAGE and protocols. Quality assurance of raw data, inclusive of monitoring standard operating procedures, error-handling, and compiling the data dictionary, is maintained by NKI-RS. Raw neuroimaging data was acquired by NKI-RS and processed at Suffolk University using TRACULA and FreeSurfer 5.3.

Statistical Plan: Analyses will be performed on de-identified phenotypic and neuroimaging data from adult NKI-RS participants available at the start of this study (October 2016). Analyses will evaluate the potential for CRF to modulate decline in WM integrity and EF observed with aging. Mixed-effects modeling will investigate the extent to which CRF predicts WM integrity, as both a global measurement of fractional anisotropy (FA) and FA within nine major WM tracts. Structural equation modeling will examine whether higher FA within frontal WM tracts partially mediates a positive relationship between CRF and EF. The role of age and clinical characteristics (e.g., cardiovascular risk factors, depression) will also be explored as covariates in the link between CRF, WM, and EF.

Tipo de estudio

De observación

Inscripción (Actual)

645

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 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Participants are community-dwelling adults from the "Cross-Sectional Lifespan Connectomics Study" of the Nathan Kline Institute - Rockland Sample (NKI-RS)-a large cross-sectional sample of adult brain development. NKI prospectively recruited community-dwelling residents of Rockland County, New York-a region that is socioeconomically comparable to United States demographics.

Descripción

NKI-RS eligibility criteria was designed for inclusivity. Nearly half of recruited individuals met criteria for at least one Diagnostic Statistical Manual - 4th Edition diagnosis based on a semi-structured clinical interview.

Inclusion Criteria (present study):

  • diffusion tensor imaging (DTI) without significant artifacts
  • T1-weighted structural imaging (Magnetization-Prepared Rapid Gradient-Echo; MPRAGE) without significant artifacts
  • CRF data from a standardized cycle ergometer test (commonly used for predicting maximal oxygen uptake; VO2 max).

Exclusion Criteria (per NKI-RS protocol):

  • severe psychiatric illness (bipolar disorder, schizophrenia disorder, schizoaffective disorder)
  • severe developmental disorders (autism spectrum disorders, intellectual disabilities)
  • current suicidal or homicidal ideation
  • severe cerebral trauma (stroke, moderate to severe traumatic brain injury, ischemic attack in the past two years)
  • severe neurodegenerative disorders (Parkinson's disease, Huntington's Disease, dementia)
  • a history of substance dependence in the past two years (with an exception for cannabis)
  • a lifetime history of psychiatric hospitalization
  • current pregnancy
  • MRI contraindications

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

Cohortes e Intervenciones

Grupo / Cohorte
Cross-Sectional Lifespan Connectomics Study

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
white matter (WM) microstructure integrity
Periodo de tiempo: Measured between 9:00 and 10:00 am on the single assessment day.
fractional anisotropy (FA) diffusion tensor imaging (DTI)
Measured between 9:00 and 10:00 am on the single assessment day.
executive function (EF)
Periodo de tiempo: Measured between 12:30 and 2:30 pm on the single assessment day.
Delis-Kaplan Executive Function System (D-KEFS) subtests will include the Trail Making Test, Design Fluency Test, Color-Word Interference Test, and Tower Tests. Scores from each subtest will be transformed into z-scores to yield the same units of measurement. Then, structural equation modeling (SEM) will aggregate these values quantify a construct of overall EF.
Measured between 12:30 and 2:30 pm on the single assessment day.
executive function (EF)
Periodo de tiempo: Measured between 11:00 am and 12:00 pm on the single assessment day.
Penn Computerized Neurocognitive Battery (CNB) subtests will include the CNB Letter N-back Test and Conditional Exclusion Test. Scores from each subtest will be transformed into z-scores to yield the same units of measurement. Then, structural equation modeling (SEM) will aggregate these values quantify a construct of overall EF.
Measured between 11:00 am and 12:00 pm on the single assessment day.

Colaboradores e Investigadores

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

Patrocinador

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 marzo de 2012

Finalización primaria (Actual)

1 de julio de 2016

Finalización del estudio

1 de julio de 2016

Fechas de registro del estudio

Enviado por primera vez

29 de noviembre de 2018

Primero enviado que cumplió con los criterios de control de calidad

11 de diciembre de 2018

Publicado por primera vez (Actual)

14 de diciembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de diciembre de 2018

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

16 de diciembre de 2018

Última verificación

1 de diciembre de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • NKI-RS
  • R01MH094639-01 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

The Nathan Kline Institute - Rockland Sample is a public, open-access data repository that is available upon approval of the NKI data usage agreement.

R code for all study analyses will be made available for reproducibility with open-access NKI-RS data.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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