- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03775941
Fitness on White Matter and Cognition in Aging
Neuroprotective Effects of Cardiorespiratory Fitness on White Matter Integrity and Cognition Across the Adult Lifespan
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cross-Sectional Lifespan Connectomics Study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
white matter (WM) microstructure integrity
Time Frame: 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.
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executive function (EF)
Time Frame: 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)
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NKI-RS
- R01MH094639-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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