- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03775941
Fitness on White Matter and Cognition in Aging
Neuroprotective Effects of Cardiorespiratory Fitness on White Matter Integrity and Cognition Across the Adult Lifespan
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Cross-Sectional Lifespan Connectomics Study
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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white matter (WM) microstructure integrity
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NKI-RS
- R01MH094639-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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