Fitness on White Matter and Cognition in Aging
Neuroprotective Effects of Cardiorespiratory Fitness on White Matter Integrity and Cognition Across the Adult Lifespan
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Real)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Cross-Sectional Lifespan Connectomics Study
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
white matter (WM) microstructure integrity
Prazo: 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)
Prazo: 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)
Prazo: 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
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NKI-RS
- R01MH094639-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .