- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03775941
Fitness on White Matter and Cognition in Aging
Neuroprotective Effects of Cardiorespiratory Fitness on White Matter Integrity and Cognition Across the Adult Lifespan
Descripción general del estudio
Estado
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
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Cross-Sectional Lifespan Connectomics Study
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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white matter (WM) microstructure integrity
Periodo de tiempo: Measured between 9:00 and 10:00 am on the single assessment day.
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fractional anisotropy (FA) diffusion tensor imaging (DTI)
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Measured between 9:00 and 10:00 am on the single assessment day.
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executive function (EF)
Periodo de tiempo: Measured between 12:30 and 2:30 pm on the single assessment day.
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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.
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Measured between 12:30 and 2:30 pm on the single assessment day.
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executive function (EF)
Periodo de tiempo: Measured between 11:00 am and 12:00 pm on the single assessment day.
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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.
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Measured between 11:00 am and 12:00 pm on the single assessment day.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- 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)?
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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