- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05864950
Brain Blood Flow Responses During Exercise
October 26, 2023 updated by: University of Wisconsin, Madison
Influence of Biological Sex and Age on Cerebral Blood Flow and Vessel Function During Exercise: a Pilot Study
Brain blood flow will be measured during exercise using magnetic resonance imaging.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Detailed Description
Over 6 million Americans are living with Alzheimer's disease and related dementias and this number is expected to reach over 13 million by 2060.
Thus, there is an urgent need for interventions to prevent the development and progression of Alzheimer's disease and related dementias.
Regular exercise is currently the most promising strategy as it is repeatedly shown to have neuroprotective benefits.
Evidence suggests that the neuroprotective effects of exercise is the result of improved health of blood vessels.
Despite the vast amount of evidence on the benefit of exercise on the peripheral vasculature, there is little information regarding brain vascular responses during exercise.
This study will investigate the impact of exercise at varying intensities on brain blood flow during exercise, and will also examine the influence of age and sex.
Study Type
Observational
Enrollment (Estimated)
85
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53706
- University of Wisconsin-Madison
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Participants for this study will include healthy adults with a history of engaging in regular physical activity.
Both men and women, between 20-40 or 55-69 years, are eligible to participate in this study.
Description
Inclusion Criteria:
- Healthy men or women between the ages of 20-40 year or 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)
Exclusion Criteria:
- 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 ≥30 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Young Adults
Young Adults between 20-40 years of age.
|
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
Middle-Aged Adults between 55-69 years of age.
|
Participants will undergo an MRI scan while performing exercise at two intensities (light and moderate/vigorous) using an MRI-compatible stepper device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral Artery Dilation
Time Frame: One study visit, up to 120 minutes
|
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
Time Frame: One study visit, up to 120 minutes
|
The change in intracranial blood flow during exercise will be measured with MRI.
|
One study visit, up to 120 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jill N Barnes, PhD, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Barnes JN. Exercise, cognitive function, and aging. Adv Physiol Educ. 2015 Jun;39(2):55-62. doi: 10.1152/advan.00101.2014.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2023
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
May 8, 2023
First Submitted That Met QC Criteria
May 8, 2023
First Posted (Actual)
May 18, 2023
Study Record Updates
Last Update Posted (Actual)
October 27, 2023
Last Update Submitted That Met QC Criteria
October 26, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2022-0512
- A176000 (Other Identifier: University of Wisconsin, Madison)
- UWF (Other Identifier: University of Wisconsin Foundation)
- 1RF1NS117746-01 (U.S. NIH Grant/Contract)
- Protocol Version 3/22/2023 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Magnetic Resonance Imaging
-
BayerCompletedMagnetic Resonance Imaging | Magnetic Resonance AngiographyPoland, China, France, Germany, Hungary, Korea, Republic of, South Africa, Spain, Thailand, Taiwan, Czech Republic, Hong Kong, Italy, Kazakhstan, Russian Federation, Bosnia and Herzegovina, Greece, Canada, Vietnam, Kyrgyzstan
-
Centre Hospitalier Régional Metz-ThionvilleUniversity of LorraineRecruitingMagnetic Resonance ImagingFrance
-
Jessa HospitalActive, not recruitingMagnetic Resonance ImagingBelgium
-
BayerCompletedMagnetic Resonance ImagingUnited States, Korea, Republic of, France, Germany, Italy, Switzerland, United Kingdom
-
Boston Scientific CorporationCompletedMagnetic Resonance ImagingSpain, Hong Kong, Germany, Israel, United Kingdom, Italy, United States, Malaysia, Belgium
-
Centre Hospitalier Universitaire, AmiensCompletedMagnetic Resonance ImagingFrance
-
MegaPro Biomedical Co. Ltd.CompletedMagnetic Resonance ImagingTaiwan
-
BayerCompletedMagnetic Resonance ImagingJapan
-
BayerCompletedMagnetic Resonance ImagingPhilippines
-
BayerCompletedMagnetic Resonance Imaging | Myocardial Perfusion ImagingSwitzerland, Germany, Austria, Poland
Clinical Trials on MRI
-
Cambridge University Hospitals NHS Foundation TrustRecruitingBreast CancerUnited Kingdom
-
Assistance Publique Hopitaux De MarseilleActive, not recruitingMultiple SclerosisFrance
-
Seoul National University Bundang HospitalBayerCompletedTraumaKorea, Republic of
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedOsteosarcoma | Ewing Sarcoma | Paget's DiseaseUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Recurrent Adult Brain TumorUnited States
-
University of EdinburghActive, not recruiting
-
Assistance Publique - Hôpitaux de ParisUnknownBrain Injury, Coma | Cardiac Arrest (CA) | Traumatic Brain Injury (TBI) | Aneurysmal Subarachnoid Hemorrhages (aSAH)France
-
Sheba Medical CenterUnknown
-
American College of Radiology Imaging NetworkNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupUnknownBreast Cancer | BIRADS 3 | BIRADS 4 | BIRADS 5United States
-
Abbott Medical DevicesCompletedAdverse Effect of MRI on an Implanted Pacemaker Lead | Adverse Effect of MRI on an Implanted PacemakerUnited States, Netherlands, Australia, Belgium, Finland