Brain Blood Flow Responses During Exercise

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05864950

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Enrollment

Location

13.5

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Circulation Magnetic Resonance Imaging	Device: MRI

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

Study Type:

Observational

Anticipated Enrollment :

85 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Influence of Biological Sex and Age on Cerebral Blood Flow and Vessel Function During Exercise: a Pilot Study

Actual Study Start Date :

Apr 18, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Young Adults Young Adults between 20-40 years of age.	Device: MRI 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.	Device: MRI Participants will undergo an MRI scan while performing exercise at two intensities (light and moderate/vigorous) using an MRI-compatible stepper device.

Arm

Intervention/Treatment

Young Adults

Young Adults between 20-40 years of age.

Device: MRI

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.

Device: MRI

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

Outcome Measures

Primary Outcome Measures

Cerebral Artery Dilation [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 [One study visit, up to 120 minutes]
The change in intracranial blood flow during exercise will be measured with MRI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 ≥ 76 inches (193 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin-Madison	Madison	Wisconsin	United States	53706

Sponsors and Collaborators

University of Wisconsin, Madison
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator: Jill N Barnes, PhD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT05864950

Other Study ID Numbers:

2022-0512
1RF1NS117746-01
Protocol Version 3/22/2023
A176000

First Posted:

May 18, 2023

Last Update Posted:

May 19, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Wisconsin, Madison

Magnetic Resonance Imaging

Exercise

Brain Blood Flow

Study Results

No Results Posted as of May 19, 2023