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Cerebrovascular CirculationNCT02729428

MRI Biomarkers and Exercise

An observational study of Cerebrovascular Circulation, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall goal of observational study is to examine the age-related and habitual exercise training status-related differences in structural and functional changes in the human brain, detected by magnetic resonance (MR) imaging. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Cerebrovascular Circulation
What is being tested?
MRI
Type of treatment
Medical device
How many people
71 participants
Where
1 siteUnited States
Study dates
Apr 2016to Apr 2019
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 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects for this study will include healthy young adults (18-35 years old), sedentary older adults (55-75 years old), and healthy exercise trained older adults (55-75 years old). Both men and women will be eligible to participate in this study.

Who may be able to join

  • Between 18-35 or 55-75
  • Body mass index <34 kg/m2
  • Physically active (exercise more than 3 times per week for at least 30 min) or sedentary (no formal exercise over 1 hour per week)

Who cannot join

  • Current smoker
  • History or evidence of: hepatic disease, renal disease, hematological disease, peripheral vascular disease, stroke/neurovascular disease, diabetes, hypertension
  • Part of a vulnerable population (e.g. pregnant women, prisoner, individuals lacking capacity to consent, etc.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gymnasium-Natatorium

    Madison, Wisconsin, 53716

Other trials in United States

About this study

Official title: MRI Biomarkers of Risk in Sedentary and Exercise Trained Humans

The overall goal of observational study is to examine the age-related and habitual exercise training status-related differences in structural and functional changes in the human brain, detected by magnetic resonance (MR) imaging.

Read the detailed description

Normal aging reduces cerebral blood flow, brain volume, and cognitive function, thereby increasing the risk of dementia or Alzheimer's disease. Aging is associated with increased white matter hyperintensities (WMH) and appears to alter functional connectivity within the brain both of which associated with cognitive function (references). Observational studies suggest that regular physical activity is associated with improved cognitive function and higher cerebral blood flow 1,2. However, it is unknown if aging or exercise training status alters the structural and functional biomarkers that are predictive of cognitive decline. Thus, the overall goal of this project is to examine the age-related and exercise training status-related differences in structural and functional changes in the brain, detected by magnetic resonance (MR) imaging.

  1. To determine if white matter hyperintensities on MRI scans of the brain are altered by aging and exercise training status.
  2. To determine the interaction of aging and habitual physical activity on functional connectivity in the brain.
Being tested
MRI
Keywords
Aging, White Matter Hyperintensity Volume, Default Mode Network Connectivity, Cognitive Function, Cardiorespiratory Fitness, Magnetic Resonance Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDevice

    Participants will undergo an MRI scan

Study groups in NCT02729428
Study groupRoleWhat they receive
Exercise trained young adultsExercise trained young adults between the age of 18-35 years.
Receives: Device: MRI
Sedentary young adultsSedentary young adults between the age of 18-35 years.
Receives: Device: MRI
Exercise trained older adultsExercise trained older adults between the age of 55-75 years.
Receives: Device: MRI
Sedentary older adultsSedentary older adults between the age of 55-75 years.
Receives: Device: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. White Matter Hyperintensity Volume

    Utilize an MRI to measure brain volume when participant is at rest

    Measured: 60 minutes

Secondary outcomes (2)

  1. Default Mode Network Connectivity

    Utilize an MRI to measure functional connectivity in the brain when participant is at rest

    Measured: 60 minutes

  2. Middle Cerebral Artery Blood Flow Scan

    Utilize an MRI to measure middle cerebral artery blood flow in the brain when the participant is at rest

    Measured: 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2019
  4. Study completionApr 2019

Resources

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
Case-control
Time perspective
Prospective
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02729428
Sponsor's protocol ID
2015-1611
Other IDs
CVR-AAA4385, A176000, EDUC/KINESIOLOGY/KINESIO
Status last verified
Dec 2019
First submitted
24 Mar 2016
Last updated
9 Dec 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Erickson KI, Voss MW, Prakash RS, Basak C, Szabo A, Chaddock L, Kim JS, Heo S, Alves H, White SM, Wojcicki TR, Mailey E, Vieira VJ, Martin SA, Pence BD, Woods JA, McAuley E, Kramer AF. Exercise training increases size of hippocampus and improves memory. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3017-22. doi: 10.1073/pnas.1015950108. Epub 2011 Jan 31.

    PubMed 21282661

  • Ainslie PN, Cotter JD, George KP, Lucas S, Murrell C, Shave R, Thomas KN, Williams MJ, Atkinson G. Elevation in cerebral blood flow velocity with aerobic fitness throughout healthy human ageing. J Physiol. 2008 Aug 15;586(16):4005-10. doi: 10.1113/jphysiol.2008.158279. Epub 2008 Jul 17.

    PubMed 18635643

  • Bakker SL, de Leeuw FE, den Heijer T, Koudstaal PJ, Hofman A, Breteler MM. Cerebral haemodynamics in the elderly: the rotterdam study. Neuroepidemiology. 2004 Jul-Aug;23(4):178-84. doi: 10.1159/000078503.

    PubMed 15272220

  • Selim M, Jones R, Novak P, Zhao P, Novak V. The effects of body mass index on cerebral blood flow velocity. Clin Auton Res. 2008 Dec;18(6):331-8. doi: 10.1007/s10286-008-0490-z. Epub 2008 Aug 22.

    PubMed 18726054

  • Dandona P, James IM, Newbury PA, Woollard ML, Beckett AG. Cerebral blood flow in diabetes mellitus: evidence of abnormal cerebrovascular reactivity. Br Med J. 1978 Jul 29;2(6133):325-6. doi: 10.1136/bmj.2.6133.325.

    PubMed 687900

  • Barnes JN, Schmidt JE, Nicholson WT, Joyner MJ. Cyclooxygenase inhibition abolishes age-related differences in cerebral vasodilator responses to hypercapnia. J Appl Physiol (1985). 2012 Jun;112(11):1884-90. doi: 10.1152/japplphysiol.01270.2011. Epub 2012 Mar 22.

    PubMed 22442028

  • Lipsitz LA, Mukai S, Hamner J, Gagnon M, Babikian V. Dynamic regulation of middle cerebral artery blood flow velocity in aging and hypertension. Stroke. 2000 Aug;31(8):1897-903. doi: 10.1161/01.str.31.8.1897.

    PubMed 10926954

  • Kearney-Schwartz A, Rossignol P, Bracard S, Felblinger J, Fay R, Boivin JM, Lecompte T, Lacolley P, Benetos A, Zannad F. Vascular structure and function is correlated to cognitive performance and white matter hyperintensities in older hypertensive patients with subjective memory complaints. Stroke. 2009 Apr;40(4):1229-36. doi: 10.1161/STROKEAHA.108.532853. Epub 2009 Feb 26.

    PubMed 19246701

  • Smith EE, Greenberg SM. Beta-amyloid, blood vessels, and brain function. Stroke. 2009 Jul;40(7):2601-6. doi: 10.1161/STROKEAHA.108.536839. Epub 2009 May 14.

    PubMed 19443808

  • Barnes JN, Taylor JL, Kluck BN, Johnson CP, Joyner MJ. Cerebrovascular reactivity is associated with maximal aerobic capacity in healthy older adults. J Appl Physiol (1985). 2013 May 15;114(10):1383-7. doi: 10.1152/japplphysiol.01258.2012. Epub 2013 Mar 7.

    PubMed 23471946

  • Girouard H, Iadecola C. Neurovascular coupling in the normal brain and in hypertension, stroke, and Alzheimer disease. J Appl Physiol (1985). 2006 Jan;100(1):328-35. doi: 10.1152/japplphysiol.00966.2005.

    PubMed 16357086

  • Geda YE, Roberts RO, Knopman DS, Christianson TJ, Pankratz VS, Ivnik RJ, Boeve BF, Tangalos EG, Petersen RC, Rocca WA. Physical exercise, aging, and mild cognitive impairment: a population-based study. Arch Neurol. 2010 Jan;67(1):80-6. doi: 10.1001/archneurol.2009.297.

    PubMed 20065133

  • Baker LD, Frank LL, Foster-Schubert K, Green PS, Wilkinson CW, McTiernan A, Cholerton BA, Plymate SR, Fishel MA, Watson GS, Duncan GE, Mehta PD, Craft S. Aerobic exercise improves cognition for older adults with glucose intolerance, a risk factor for Alzheimer's disease. J Alzheimers Dis. 2010;22(2):569-79. doi: 10.3233/JAD-2010-100768.

    PubMed 20847403

  • Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer FM, Xiao J, Greenop KR, Almeida OP. Effect of physical activity on cognitive function in older adults at risk for Alzheimer disease: a randomized trial. JAMA. 2008 Sep 3;300(9):1027-37. doi: 10.1001/jama.300.9.1027.

    PubMed 18768414

  • Galetta F, Franzoni F, Plantinga Y, Ghiadoni L, Rossi M, Prattichizzo F, Carpi A, Taddei S, Santoro G. Ambulatory blood pressure monitoring and endothelium-dependent vasodilation in the elderly athletes. Biomed Pharmacother. 2006 Sep;60(8):443-7. doi: 10.1016/j.biopha.2006.07.013. Epub 2006 Aug 2.

    PubMed 16904861

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebrovascular Circulation, run by University of Wisconsin, Madison at 1 site in United States.

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 3 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 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Hyperintensity Volume (time frame: 60 minutes). 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 NCT02729428, which also lists 30 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 9 Dec 2019.

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