Cerebrovascular CirculationNCT05864950
Brain Blood Flow Responses During Exercise
A study testing MRI in people with Cerebrovascular Circulation and Magnetic Resonance Imaging, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Brain blood flow will be measured during exercise using magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 55 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Circulation, Magnetic Resonance Imaging
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53706
About this study
Official title: 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.
Read the 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.
- Being tested
- MRI
- Keywords
- Magnetic Resonance Imaging, Exercise, Brain Blood Flow
- Medical subject headings
- Motor Activity
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 while performing exercise at two intensities (light and moderate/vigorous) using an MRI-compatible stepper device.
| Study group | Role | What they receive |
|---|---|---|
| Middle-Aged Adults | Experimental | Middle-Aged Adults between 55-69 years of age. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Hemodynamics
The change in cross-sectional area of the cerebral arteries during exercise will be measured with MRI.
Measured: One study visit, up to 120 minutes
Cerebral Blood Flow
The change in intracranial blood flow during exercise will be measured with MRI.
Measured: One study visit, up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start6 Mar 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular CirculationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Jill N Barnes, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864950
- Sponsor's protocol ID
- 2022-0512
- Other IDs
- 1RF1NS117746-01, Protocol Version 3/22/2023, A176000, UWF
- Status last verified
- Jul 2026
- First submitted
- 8 May 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30243772Barnes 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.
PubMed 30564547Mitchell 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.
PubMed 18772322Silvestrini 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.
PubMed 16497984Vicenzini 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.
PubMed 17565221Rubanyi 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.
PubMed 3487253Harvey 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.
PubMed 15846267Black 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.
PubMed 19633208Duckles 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.
PubMed 20213497Moreau 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.
PubMed 24092827Miller 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.
PubMed 31680935Ogoh 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.
PubMed 19729591Soucy 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.
PubMed 17106067Smith 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.
PubMed 28786150Smith 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.
PubMed 22926137
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Biological Sex and Age on Cerebral Blood Flow and Vessel Function During Exercise: a Pilot Study
- ClinicalTrials.gov ID
- NCT05864950
- Acronym / sponsor ID
- 2022-0512
- Keywords
- Magnetic Resonance Imaging, Exercise, Brain Blood Flow
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 18 May 2023 (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.
Brain blood flow will be measured during exercise using magnetic resonance imaging.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle-Aged Adults | Experimental | Device: MRIMiddle-Aged Adults between 55-69 years of age. |
Who may qualify
- Ages
- 55 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIParticipants will undergo an MRI scan while performing exercise at two intensities (light and moderate/vigorous) using an MRI-compatible stepper device. | Device | Middle-Aged Adults |
Primary outcome
Cerebral Hemodynamics
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 30243772Matthews 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.
- Background: PubMed 30564547Barnes 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.
- Background: PubMed 18772322Mitchell 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.
- Background: PubMed 16497984Silvestrini 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.
- Background: PubMed 17565221Vicenzini 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.
- Background: PubMed 3487253Rubanyi 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.
- Background: PubMed 15846267Harvey 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.
- Background: PubMed 19633208Black 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.
- Background: PubMed 20213497Duckles 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.
- Background: PubMed 24092827Moreau 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.
- Background: PubMed 31680935Miller 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.
- Background: PubMed 19729591Ogoh 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.
- Individual participant dataSharing planned: No
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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.
Jill N Barnes, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Cerebrovascular Circulation and Magnetic Resonance Imaging, 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 11 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cerebral Hemodynamics (time frame: One study visit, up to 120 minutes). The study lists 2 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 NCT05864950, which also lists 23 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 13 Jul 2026.