HealthyNCT03722953
Cerebrovascular Response to Acute Exercise
A study testing Aerobic Exercise in people with Healthy and Physical Activity, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Cerebrovascular function and peripheral vascular function will be measured in healthy young adults, before and after acute bouts of aerobic exercise at various intensities. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Physical Activity
- What is being tested?
- Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 9 Mar 2020
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 20-40 years old
- BMI < 30 kg/m2
- Recreationally active
- Experience running on a treadmill
Who cannot join
- Current smoker
- History or evidence of: hepatic disease, renal disease, hematological disease, cardiovascular disease, stroke/neurovascular disease, diabetes
- Taking blood pressure medication
- History of depression or other mood related disorders
- 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.
About this study
Official title: The Role of Shear Stress in the Cerebrovascular Response to Acute Exercise
Cerebrovascular function and peripheral vascular function will be measured in healthy young adults, before and after acute bouts of aerobic exercise at various intensities.
Read the detailed description
Acute bouts of aerobic exercise have been shown to enhance vascular reactivity of the peripheral circulation; however, the effects of a single exercise session on the cerebral circulation are unknown. This study will measure cerebrovascular function and peripheral vascular function before and after aerobic exercise at high and low intensities.
The research aims are:
- To determine if a single bout of aerobic exercise acutely enhances cerebrovascular function
- To determine the effect of aerobic exercise intensity and dose on cerebrovascular function in healthy adults.
- To determine if the acute exercise-induced changes in cerebrovascular function are associated with acute exercise-induced changes in peripheral vascular function in healthy adults.
- Conditions
- Healthy, Physical Activity
- Being tested
- Control, Aerobic Exercise
- Keywords
- Exercise, Treadmill, Vascular Function, Intensity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
- Ultrasound
- Blood Pressure
- Heart Rate
- Oxygen Saturation
Aerobic ExerciseOther
- Ultrasound
- Blood Pressure
- Heart Rate
- Oxygen Saturation
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Other | Control: Cerebrovascular function and peripheral vascular function will be measured.
Aerobic Exercise: Across four separate visits, participants will perform light intensity exercise, light intensity exercise plus an additional task, vigorous intensity exercise and vigorous intensity exercise to match the energy expenditure of light intensity exercise visit. Receives: Other: Control; Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular function
Utilize ultrasound to measure a change in blood flow velocity in response to a breathing test
Measured: Change in cerebrovascular function: measurements occur at baseline and 90 minutes post aerobic exercise to quantify magnitude of change.
Peripheral vascular function
Utilize ultrasound to measure a change in brachial artery diameter in response to reactive hyperemia
Measured: Change in peripheral vascular function: measurements occur at baseline and 60 minutes post aerobic exercise to quantify magnitude of change.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Dec 2018
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722953
- Sponsor's protocol ID
- 2018-0783
- Other IDs
- A176000, EDUC/KINESIOLOGY, Protocol Version 10/23/2018
- Status last verified
- Jun 2022
- First submitted
- 15 Oct 2018
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 22442028Richiardi J, Monsch AU, Haas T, Barkhof F, Van de Ville D, Radu EW, Kressig RW, Haller S. Altered cerebrovascular reactivity velocity in mild cognitive impairment and Alzheimer's disease. Neurobiol Aging. 2015 Jan;36(1):33-41. doi: 10.1016/j.neurobiolaging.2014.07.020. Epub 2014 Jul 24.
PubMed 25146454Sam K, Crawley AP, Conklin J, Poublanc J, Sobczyk O, Mandell DM, Venkatraghavan L, Duffin J, Fisher JA, Black SE, Mikulis DJ. Development of White Matter Hyperintensity Is Preceded by Reduced Cerebrovascular Reactivity. Ann Neurol. 2016 Aug;80(2):277-85. doi: 10.1002/ana.24712.
PubMed 27352039Shin HK, Jones PB, Garcia-Alloza M, Borrelli L, Greenberg SM, Bacskai BJ, Frosch MP, Hyman BT, Moskowitz MA, Ayata C. Age-dependent cerebrovascular dysfunction in a transgenic mouse model of cerebral amyloid angiopathy. Brain. 2007 Sep;130(Pt 9):2310-9. doi: 10.1093/brain/awm156. Epub 2007 Jul 16.
PubMed 17638859Barnes 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 23471946Tarumi T, Zhang R. Cerebral hemodynamics of the aging brain: risk of Alzheimer disease and benefit of aerobic exercise. Front Physiol. 2014 Jan 21;5:6. doi: 10.3389/fphys.2014.00006. eCollection 2014.
PubMed 24478719Mitchell 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 18772322Ranjan V, Xiao Z, Diamond SL. Constitutive NOS expression in cultured endothelial cells is elevated by fluid shear stress. Am J Physiol. 1995 Aug;269(2 Pt 2):H550-5. doi: 10.1152/ajpheart.1995.269.2.H550.
PubMed 7544542LASSEN NA. Cerebral blood flow and oxygen consumption in man. Physiol Rev. 1959 Apr;39(2):183-238. doi: 10.1152/physrev.1959.39.2.183. No abstract available.
PubMed 13645234Endres M, Gertz K, Lindauer U, Katchanov J, Schultze J, Schrock H, Nickenig G, Kuschinsky W, Dirnagl U, Laufs U. Mechanisms of stroke protection by physical activity. Ann Neurol. 2003 Nov;54(5):582-90. doi: 10.1002/ana.10722.
PubMed 14595647Tinken TM, Thijssen DH, Hopkins N, Black MA, Dawson EA, Minson CT, Newcomer SC, Laughlin MH, Cable NT, Green DJ. Impact of shear rate modulation on vascular function in humans. Hypertension. 2009 Aug;54(2):278-85. doi: 10.1161/HYPERTENSIONAHA.109.134361. Epub 2009 Jun 22.
PubMed 19546374Dawson EA, Green DJ, Cable NT, Thijssen DH. Effects of acute exercise on flow-mediated dilatation in healthy humans. J Appl Physiol (1985). 2013 Dec;115(11):1589-98. doi: 10.1152/japplphysiol.00450.2013. Epub 2013 Sep 12.
PubMed 24030665Iadecola C, Zhang F. Nitric oxide-dependent and -independent components of cerebrovasodilation elicited by hypercapnia. Am J Physiol. 1994 Feb;266(2 Pt 2):R546-52. doi: 10.1152/ajpregu.1994.266.2.R546.
PubMed 7511352Molina C, Sabin JA, Montaner J, Rovira A, Abilleira S, Codina A. Impaired cerebrovascular reactivity as a risk marker for first-ever lacunar infarction: A case-control study. Stroke. 1999 Nov;30(11):2296-301. doi: 10.1161/01.str.30.11.2296.
PubMed 10548661Buratti L, Viticchi G, Falsetti L, Balucani C, Altamura C, Petrelli C, Provinciali L, Vernieri F, Silvestrini M. Thresholds of impaired cerebral hemodynamics that predict short-term cognitive decline in asymptomatic carotid stenosis. J Cereb Blood Flow Metab. 2016 Oct;36(10):1804-1812. doi: 10.1177/0271678X15613526. Epub 2015 Oct 27.
PubMed 26661219
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Shear Stress in the Cerebrovascular Response to Acute Exercise
- ClinicalTrials.gov ID
- NCT03722953
- Acronym / sponsor ID
- 2018-0783
- Conditions
- Healthy, Physical Activity
- Keywords
- Exercise, Treadmill, Vascular Function, Intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 29 Oct 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.
Cerebrovascular function and peripheral vascular function will be measured in healthy young adults, before and after acute bouts of aerobic exercise at various intensities.
Detailed description
Acute bouts of aerobic exercise have been shown to enhance vascular reactivity of the peripheral circulation; however, the effects of a single exercise session on the cerebral circulation are unknown. This study will measure cerebrovascular function and peripheral vascular function before and after aerobic exercise at high and low intensities.
The research aims are:
- To determine if a single bout of aerobic exercise acutely enhances cerebrovascular function
- To determine the effect of aerobic exercise intensity and dose on cerebrovascular function in healthy adults.
- To determine if the acute exercise-induced changes in cerebrovascular function are associated with acute exercise-induced changes in peripheral vascular function in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Other | Other: Control, Other: Aerobic ExerciseControl: Cerebrovascular function and peripheral vascular function will be measured. Aerobic Exercise: Across four separate visits, participants will perform light intensity exercise, light intensity exercise plus an additional task, vigorous intensity exercise and vigorous intensity exercise to match the energy expenditure of light intensity exercise visit. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 20-40 years old
- BMI < 30 kg/m2
- Recreationally active
- Experience running on a treadmill
Key exclusion criteria (5 listed)
- Current smoker
- History or evidence of: hepatic disease, renal disease, hematological disease, cardiovascular disease, stroke/neurovascular disease, diabetes
- Taking blood pressure medication
- History of depression or other mood related disorders
- Part of a vulnerable population (e.g. pregnant women, prisoner, individuals lacking capacity to consent, etc.)
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 |
|---|---|---|
| Control1. Ultrasound 2. Blood Pressure 3. Heart Rate 4. Oxygen Saturation | Other | Aerobic Exercise |
| Aerobic Exercise1. Ultrasound 2. Blood Pressure 3. Heart Rate 4. Oxygen Saturation | Other | Aerobic Exercise |
Primary outcome
Cerebrovascular function
Time frame: Change in cerebrovascular function: measurements occur at baseline and 90 minutes post aerobic exercise to quantify magnitude of change.
Utilize ultrasound to measure a change in blood flow velocity in response to a breathing test
Peripheral vascular function
Time frame: Change in peripheral vascular function: measurements occur at baseline and 60 minutes post aerobic exercise to quantify magnitude of change.
Utilize ultrasound to measure a change in brachial artery diameter in response to reactive hyperemia
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 2 Oct 2024.
- Background: PubMed 22442028Barnes 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.
- Background: PubMed 25146454Richiardi J, Monsch AU, Haas T, Barkhof F, Van de Ville D, Radu EW, Kressig RW, Haller S. Altered cerebrovascular reactivity velocity in mild cognitive impairment and Alzheimer's disease. Neurobiol Aging. 2015 Jan;36(1):33-41. doi: 10.1016/j.neurobiolaging.2014.07.020. Epub 2014 Jul 24.
- Background: PubMed 27352039Sam K, Crawley AP, Conklin J, Poublanc J, Sobczyk O, Mandell DM, Venkatraghavan L, Duffin J, Fisher JA, Black SE, Mikulis DJ. Development of White Matter Hyperintensity Is Preceded by Reduced Cerebrovascular Reactivity. Ann Neurol. 2016 Aug;80(2):277-85. doi: 10.1002/ana.24712.
- Background: PubMed 17638859Shin HK, Jones PB, Garcia-Alloza M, Borrelli L, Greenberg SM, Bacskai BJ, Frosch MP, Hyman BT, Moskowitz MA, Ayata C. Age-dependent cerebrovascular dysfunction in a transgenic mouse model of cerebral amyloid angiopathy. Brain. 2007 Sep;130(Pt 9):2310-9. doi: 10.1093/brain/awm156. Epub 2007 Jul 16.
- Background: PubMed 23471946Barnes 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.
- Background: PubMed 24478719Tarumi T, Zhang R. Cerebral hemodynamics of the aging brain: risk of Alzheimer disease and benefit of aerobic exercise. Front Physiol. 2014 Jan 21;5:6. doi: 10.3389/fphys.2014.00006. eCollection 2014.
- 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 7544542Ranjan V, Xiao Z, Diamond SL. Constitutive NOS expression in cultured endothelial cells is elevated by fluid shear stress. Am J Physiol. 1995 Aug;269(2 Pt 2):H550-5. doi: 10.1152/ajpheart.1995.269.2.H550.
- Background: PubMed 13645234LASSEN NA. Cerebral blood flow and oxygen consumption in man. Physiol Rev. 1959 Apr;39(2):183-238. doi: 10.1152/physrev.1959.39.2.183. No abstract available.
- Background: PubMed 14595647Endres M, Gertz K, Lindauer U, Katchanov J, Schultze J, Schrock H, Nickenig G, Kuschinsky W, Dirnagl U, Laufs U. Mechanisms of stroke protection by physical activity. Ann Neurol. 2003 Nov;54(5):582-90. doi: 10.1002/ana.10722.
- Background: PubMed 19546374Tinken TM, Thijssen DH, Hopkins N, Black MA, Dawson EA, Minson CT, Newcomer SC, Laughlin MH, Cable NT, Green DJ. Impact of shear rate modulation on vascular function in humans. Hypertension. 2009 Aug;54(2):278-85. doi: 10.1161/HYPERTENSIONAHA.109.134361. Epub 2009 Jun 22.
- Background: PubMed 24030665Dawson EA, Green DJ, Cable NT, Thijssen DH. Effects of acute exercise on flow-mediated dilatation in healthy humans. J Appl Physiol (1985). 2013 Dec;115(11):1589-98. doi: 10.1152/japplphysiol.00450.2013. Epub 2013 Sep 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Healthy and Physical Activity, 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 4 inclusion and 5 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 2 Oct 2024. 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?
Cerebrovascular function (time frame: Change in cerebrovascular function: measurements occur at baseline and 90 minutes post aerobic exercise to quantify magnitude of change.). 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 NCT03722953, which also lists 25 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 2 Oct 2024; AzTrials last refreshed its copy on 28 Oct 2026.