NCT05864950

Brief Summary

Brain blood flow will be measured during exercise using magnetic resonance imaging.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2024Jul 2026

First Submitted

Initial submission to the registry

May 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

March 6, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2.3 years

First QC Date

May 8, 2023

Last Update Submit

July 17, 2025

Conditions

Keywords

Magnetic Resonance ImagingExerciseBrain Blood Flow

Outcome Measures

Primary Outcomes (2)

  • Cerebral Hemodynamics

    The change in cross-sectional area of the cerebral arteries during exercise will be measured with MRI.

    One study visit, up to 120 minutes

  • Cerebral Blood Flow

    The change in intracranial blood flow during exercise will be measured with MRI.

    One study visit, up to 120 minutes

Study Arms (1)

Middle-Aged Adults

EXPERIMENTAL

Middle-Aged Adults between 55-69 years of age.

Device: MRI

Interventions

MRIDEVICE

Participants will undergo an MRI scan while performing exercise at two intensities (light and moderate/vigorous) using an MRI-compatible stepper device.

Middle-Aged Adults

Eligibility Criteria

Age55 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men or women between the ages of 55-69 years
  • Demonstrate an exercise history of engaging in aerobic physical activity at least 3 times per week for a minimum of 30 continuous minutes
  • Have experience using cardiovascular exercise equipment (e.g., treadmill, elliptical, upright or recumbent bicycle, stair-stepper)

You may not qualify if:

  • Outside of specified age range
  • Do not have experience using cardiovascular exercise equipment
  • Do not meet the physical activity criteria
  • Present with a history or evidence of hepatic, renal, hematological disease, cardiovascular disease including uncontrolled hypertension, peripheral vascular disease, stroke/neurovascular disease, and diabetes
  • have a body mass index ≥35 kg/m2
  • are ≥ 71 inches (180 cm) in height
  • have any contraindications to MRI
  • currently use or have a history of use of tobacco or illegal substances
  • have current and/or a history of depression or other mood related disorders (those with mild depression and/or anxiety that is controlled with medication and/or therapy will not be excluded)
  • vulnerable populations (e.g., pregnant women, prisoners, individuals lacking capacity to consent)
  • if the desired moderate/vigorous exercise intensity corresponds to \> 350 watts on the stepper device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Location

Related Publications (23)

  • Matthews KA, Xu W, Gaglioti AH, Holt JB, Croft JB, Mack D, McGuire LC. Racial and ethnic estimates of Alzheimer's disease and related dementias in the United States (2015-2060) in adults aged >/=65 years. Alzheimers Dement. 2019 Jan;15(1):17-24. doi: 10.1016/j.jalz.2018.06.3063. Epub 2018 Sep 19.

    PMID: 30243772BACKGROUND
  • Barnes JN, Corkery AT. Exercise Improves Vascular Function, but does this Translate to the Brain? Brain Plast. 2018 Dec 12;4(1):65-79. doi: 10.3233/BPL-180075.

    PMID: 30564547BACKGROUND
  • Mitchell GF. Effects of central arterial aging on the structure and function of the peripheral vasculature: implications for end-organ damage. J Appl Physiol (1985). 2008 Nov;105(5):1652-60. doi: 10.1152/japplphysiol.90549.2008. Epub 2008 Sep 4.

    PMID: 18772322BACKGROUND
  • Silvestrini M, Pasqualetti P, Baruffaldi R, Bartolini M, Handouk Y, Matteis M, Moffa F, Provinciali L, Vernieri F. Cerebrovascular reactivity and cognitive decline in patients with Alzheimer disease. Stroke. 2006 Apr;37(4):1010-5. doi: 10.1161/01.STR.0000206439.62025.97. Epub 2006 Feb 23.

    PMID: 16497984BACKGROUND
  • Vicenzini E, Ricciardi MC, Altieri M, Puccinelli F, Bonaffini N, Di Piero V, Lenzi GL. Cerebrovascular reactivity in degenerative and vascular dementia: a transcranial Doppler study. Eur Neurol. 2007;58(2):84-9. doi: 10.1159/000103642. Epub 2007 Jun 12.

    PMID: 17565221BACKGROUND
  • Rubanyi GM, Romero JC, Vanhoutte PM. Flow-induced release of endothelium-derived relaxing factor. Am J Physiol. 1986 Jun;250(6 Pt 2):H1145-9. doi: 10.1152/ajpheart.1986.250.6.H1145.

    PMID: 3487253BACKGROUND
  • Harvey PJ, Picton PE, Su WS, Morris BL, Notarius CF, Floras JS. Exercise as an alternative to oral estrogen for amelioration of endothelial dysfunction in postmenopausal women. Am Heart J. 2005 Feb;149(2):291-7. doi: 10.1016/j.ahj.2004.08.036.

    PMID: 15846267BACKGROUND
  • Black MA, Cable NT, Thijssen DH, Green DJ. Impact of age, sex, and exercise on brachial artery flow-mediated dilatation. Am J Physiol Heart Circ Physiol. 2009 Sep;297(3):H1109-16. doi: 10.1152/ajpheart.00226.2009. Epub 2009 Jul 24.

    PMID: 19633208BACKGROUND
  • Duckles SP, Miller VM. Hormonal modulation of endothelial NO production. Pflugers Arch. 2010 May;459(6):841-51. doi: 10.1007/s00424-010-0797-1. Epub 2010 Mar 7.

    PMID: 20213497BACKGROUND
  • Moreau KL, Stauffer BL, Kohrt WM, Seals DR. Essential role of estrogen for improvements in vascular endothelial function with endurance exercise in postmenopausal women. J Clin Endocrinol Metab. 2013 Nov;98(11):4507-15. doi: 10.1210/jc.2013-2183. Epub 2013 Oct 3.

    PMID: 24092827BACKGROUND
  • Miller KB, Howery AJ, Rivera-Rivera LA, Johnson SC, Rowley HA, Wieben O, Barnes JN. Age-Related Reductions in Cerebrovascular Reactivity Using 4D Flow MRI. Front Aging Neurosci. 2019 Oct 17;11:281. doi: 10.3389/fnagi.2019.00281. eCollection 2019.

    PMID: 31680935BACKGROUND
  • Ogoh S, Ainslie PN. Cerebral blood flow during exercise: mechanisms of regulation. J Appl Physiol (1985). 2009 Nov;107(5):1370-80. doi: 10.1152/japplphysiol.00573.2009. Epub 2009 Sep 3.

    PMID: 19729591BACKGROUND
  • Soucy KG, Ryoo S, Benjo A, Lim HK, Gupta G, Sohi JS, Elser J, Aon MA, Nyhan D, Shoukas AA, Berkowitz DE. Impaired shear stress-induced nitric oxide production through decreased NOS phosphorylation contributes to age-related vascular stiffness. J Appl Physiol (1985). 2006 Dec;101(6):1751-9. doi: 10.1152/japplphysiol.00138.2006.

    PMID: 17106067BACKGROUND
  • Smith KJ, Ainslie PN. Regulation of cerebral blood flow and metabolism during exercise. Exp Physiol. 2017 Nov 1;102(11):1356-1371. doi: 10.1113/EP086249. Epub 2017 Sep 30.

    PMID: 28786150BACKGROUND
  • Smith KJ, Wong LE, Eves ND, Koelwyn GJ, Smirl JD, Willie CK, Ainslie PN. Regional cerebral blood flow distribution during exercise: influence of oxygen. Respir Physiol Neurobiol. 2012 Oct 15;184(1):97-105. doi: 10.1016/j.resp.2012.07.014. Epub 2012 Aug 16.

    PMID: 22926137BACKGROUND
  • Ogoh S, Tsukamoto H, Hirasawa A, Hasegawa H, Hirose N, Hashimoto T. The effect of changes in cerebral blood flow on cognitive function during exercise. Physiol Rep. 2014 Sep 28;2(9):e12163. doi: 10.14814/phy2.12163. Print 2014 Sep 1.

    PMID: 25263210BACKGROUND
  • Caldwell HG, Coombs GB, Howe CA, Hoiland RL, Patrician A, Lucas SJE, Ainslie PN. Evidence for temperature-mediated regional increases in cerebral blood flow during exercise. J Physiol. 2020 Apr;598(8):1459-1473. doi: 10.1113/JP278827. Epub 2020 Feb 6.

    PMID: 31912506BACKGROUND
  • Macdonald JA, Beshish AG, Corrado PA, Barton GP, Goss KN, Eldridge MW, Francois CJ, Wieben O. Feasibility of Cardiovascular Four-dimensional Flow MRI during Exercise in Healthy Participants. Radiol Cardiothorac Imaging. 2020 Jun 18;2(3):e190033. doi: 10.1148/ryct.2020190033.

    PMID: 32734274BACKGROUND
  • Macdonald JA, Roberts GS, Corrado PA, Beshish AG, Haraldsdottir K, Barton GP, Goss KN, Eldridge MW, Francois CJ, Wieben O. Exercise-induced irregular right heart flow dynamics in adolescents and young adults born preterm. J Cardiovasc Magn Reson. 2021 Oct 21;23(1):116. doi: 10.1186/s12968-021-00816-2.

    PMID: 34670573BACKGROUND
  • Miller KB, Gallo SJ, Rivera-Rivera LA, Corkery AT, Howery AJ, Johnson SC, Rowley HA, Wieben O, Barnes JN. Vertebral artery hypoplasia influences age-related differences in blood flow of the large intracranial arteries. Aging Brain. 2021 Jun 24;1:100019. doi: 10.1016/j.nbas.2021.100019. eCollection 2021.

    PMID: 36911510BACKGROUND
  • Barnes JN. Exercise, cognitive function, and aging. Adv Physiol Educ. 2015 Jun;39(2):55-62. doi: 10.1152/advan.00101.2014.

    PMID: 26031719BACKGROUND
  • Ferretti MT, Iulita MF, Cavedo E, Chiesa PA, Schumacher Dimech A, Santuccione Chadha A, Baracchi F, Girouard H, Misoch S, Giacobini E, Depypere H, Hampel H; Women's Brain Project and the Alzheimer Precision Medicine Initiative. Sex differences in Alzheimer disease - the gateway to precision medicine. Nat Rev Neurol. 2018 Aug;14(8):457-469. doi: 10.1038/s41582-018-0032-9.

    PMID: 29985474BACKGROUND
  • Beam CR, Kaneshiro C, Jang JY, Reynolds CA, Pedersen NL, Gatz M. Differences Between Women and Men in Incidence Rates of Dementia and Alzheimer's Disease. J Alzheimers Dis. 2018;64(4):1077-1083. doi: 10.3233/JAD-180141.

    PMID: 30010124BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jill N Barnes, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 18, 2023

Study Start

March 6, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations