Cognitive DeclineNCT03775941
Fitness on White Matter and Cognition in Aging
An observational study of Cognitive Decline and Executive Dysfunction, run by Suffolk University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Executive Dysfunction, Cardiovascular Risk Factor
- How many people
- 645 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- 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)
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- a lifetime history of psychiatric hospitalization
- current pregnancy
- MRI contraindications
About this study
Official title: 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.
Read the 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.
- Keywords
- Neuroimaging, White matter, Cardiorespiratory fitness, Physical activity, Cognitive aging, Executive function, Cognitive reserve
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cross-Sectional Lifespan Connectomics Study | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
white matter (WM) microstructure integrity
fractional anisotropy (FA) diffusion tensor imaging (DTI)
Measured: Measured between 9:00 and 10:00 am on the single assessment day.
executive function (EF)
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: Measured between 12:30 and 2:30 pm on the single assessment day.
executive function (EF)
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: Measured between 11:00 am and 12:00 pm on the single assessment day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study startMar 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suffolk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Mace, Suffolk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775941
- Sponsor's protocol ID
- NKI-RS
- Other IDs
- R01MH094639-01
- Status last verified
- Dec 2018
- First submitted
- 29 Nov 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Nooner KB, Colcombe SJ, Tobe RH, Mennes M, Benedict MM, Moreno AL, Panek LJ, Brown S, Zavitz ST, Li Q, Sikka S, Gutman D, Bangaru S, Schlachter RT, Kamiel SM, Anwar AR, Hinz CM, Kaplan MS, Rachlin AB, Adelsberg S, Cheung B, Khanuja R, Yan C, Craddock CC, Calhoun V, Courtney W, King M, Wood D, Cox CL, Kelly AM, Di Martino A, Petkova E, Reiss PT, Duan N, Thomsen D, Biswal B, Coffey B, Hoptman MJ, Javitt DC, Pomara N, Sidtis JJ, Koplewicz HS, Castellanos FX, Leventhal BL, Milham MP. The NKI-Rockland Sample: A Model for Accelerating the Pace of Discovery Science in Psychiatry. Front Neurosci. 2012 Oct 16;6:152. doi: 10.3389/fnins.2012.00152. eCollection 2012.
PubMed 23087608Andrade MA, Raposo A, Andrade A. Exploring the late maturation of an intrinsic episodic memory network: A resting-state fMRI study. Dev Cogn Neurosci. 2024 Dec;70:101453. doi: 10.1016/j.dcn.2024.101453. Epub 2024 Sep 26.
PubMed 39368283
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective Effects of Cardiorespiratory Fitness on White Matter Integrity and Cognition Across the Adult Lifespan
- ClinicalTrials.gov ID
- NCT03775941
- Acronym / sponsor ID
- NKI-RS
- Keywords
- Neuroimaging, White matter, Cardiorespiratory fitness, Physical activity, Cognitive aging, Executive function, Cognitive reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- Suffolk UniversityUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross-Sectional Lifespan Connectomics Study | – | – |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 23087608Nooner KB, Colcombe SJ, Tobe RH, Mennes M, Benedict MM, Moreno AL, Panek LJ, Brown S, Zavitz ST, Li Q, Sikka S, Gutman D, Bangaru S, Schlachter RT, Kamiel SM, Anwar AR, Hinz CM, Kaplan MS, Rachlin AB, Adelsberg S, Cheung B, Khanuja R, Yan C, Craddock CC, Calhoun V, Courtney W, King M, Wood D, Cox CL, Kelly AM, Di Martino A, Petkova E, Reiss PT, Duan N, Thomsen D, Biswal B, Coffey B, Hoptman MJ, Javitt DC, Pomara N, Sidtis JJ, Koplewicz HS, Castellanos FX, Leventhal BL, Milham MP. The NKI-Rockland Sample: A Model for Accelerating the Pace of Discovery Science in Psychiatry. Front Neurosci. 2012 Oct 16;6:152. doi: 10.3389/fnins.2012.00152. eCollection 2012.
- Derived from this study: PubMed 39368283Andrade MA, Raposo A, Andrade A. Exploring the late maturation of an intrinsic episodic memory network: A resting-state fMRI study. Dev Cogn Neurosci. 2024 Dec;70:101453. doi: 10.1016/j.dcn.2024.101453. Epub 2024 Sep 26.
- NKI-RS DTI protocolLink provided by the sponsor.
- NKI-RS MPRAGE protocolLink provided by the sponsor.
- NKI-RS data usage agreementLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Decline and Executive Dysfunction, run by Suffolk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
white matter (WM) microstructure integrity (time frame: Measured between 9:00 and 10:00 am on the single assessment day.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03775941, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.