Blood Brain Flow and Exercise

December 13, 2019 updated by: University of Wisconsin, Madison

Cerebral Vasodilator Responses in Sedentary and Exercise Trained Humans

Cerebral vasodilator responses to CO2 will be measured in young healthy adults, healthy sedentary older adults, and healthy exercise trained older adults. This variable will be examined before and after administering the cyclooxygenase inhibitor indomethacin, which has been shown to blunt cerebral vasodilator responses. In addition, the investigators will examine these counter-regulatory hemodynamic mechanisms to hypoperfusion caused by indomethacin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Normal aging reduces cerebral blood flow and cognitive function. Aging also appears to alter functional connectivity within the brain, which is associated with cognitive functioning. Observational studies suggest that regular physical activity is associated with higher cerebral blood flow and improved cognitive function. However, the mechanistic links among regular physical activity and cerebral blood flow with advancing age are unknown. In this context, it is unclear if aging or exercise training status alters the neurovascular coupling of blood flow in the brain. Thus, the overall goal of this study is to examine the age-related changes in cerebral vasodilatory capacity, an important homeostatic mechanism and marker for effective regulation of cerebral perfusion, in order to determine how it is mechanistically linked to cognition. Additionally, the investigators will explore the potential beneficial effect of physical activity on the relationships between cerebral vasodilation and cognition in humans.

The research aims are:

  1. To determine if cerebral vasodilator responses are affected by age and exercise training status in healthy adults.
  2. To compare the effect of cyclooxygenase inhibition on cerebral vasodilator responses in healthy adults.
  3. To determine the neurovascular counter-regulatory response to cyclooxygenase inhibition in healthy adults.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Early Phase 1

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

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53716
        • Gymnasium-Natatorium

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Young subjects between 18-35 years old
  • Older subjects between 55-75 years old
  • Nonsmokers
  • Physically active (exercise more than 3 times per week for at least 30 minutes)
  • Sedentary (no formal exercise over 1 hour per week).

Exclusion Criteria:

  • Outside of the specified age range
  • Present with history or evidence of hepatic, renal, or hematological disease; peripheral vascular disease; stroke/neurovascular disease; diabetes; hypertension
  • Take medications that indicate hepatic, renal, hematological disease; cardiovascular disease, including hypertension; stroke/neurovascular disease; and diabetes
  • Body mass index >34 kg/m2
  • Take physician-prescribed medications that may interact with indomethacin: 1) cardiovascular drugs (e.g. angiotensin-converting-enzyme inhibitor (ACE inhibitors), angiotensin II receptor blockers (ARB's), Diuretics); 2) drugs that would increase bleeding risk (e.g. warfarin, heparin, clopidogrel, rivaroxaban, other NSAIDs); or 3) drugs associated with increased renal toxicity (e.g. cyclosporin, tacrolimus)
  • Vulnerable populations (i.e. pregnant women, prisoners, individuals lacking capacity to consent, etc.)

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug

Control-Hypercapnic Trials: Three stepwise CO2 elevations will be applied to the patient by adding fractional concentration of inspired CO2 (FICO2) at 2%, 4%, and 6% each time, balanced with room air. The end tidal CO2 (PetCO2) will be elevated and maintained constant for three minutes at each target level. Breath-by-breath changes in minute ventilation (VE) and PetCO2 will be measured.

Drug-Indomethacin: Healthy volunteers, indomethacin suspension will be orally administered at 1.2 mg/kg. After drug administration, the patient will rest quietly for 90 minutes.
Other: Control
  1. Transcranial Doppler
  2. Blood Pressure
  3. Heart Rate
  4. Oxygen Saturation
Drug: Indomethacin
  1. Transcranial Doppler
  2. Blood Pressure
  3. Heart Rate
  4. Oxygen Saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral Vasodilator Responses
Time Frame: Measurement at baseline
Utilize a Transcranial Doppler to measure blood flow velocity in response to inhaled carbon dioxide.
Measurement at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral Vasodilator Responses
Time Frame: Measurement beginning 60 minutes post drug and measured through 180 minutes
Utilize a Transcranial Doppler to measure blood flow velocity in response to inhaled carbon dioxide.
Measurement beginning 60 minutes post drug and measured through 180 minutes
Blood Pressure
Time Frame: Measurement at baseline and beginning 60 minutes post drug and measured through 180 minutes
Measurement at baseline and beginning 60 minutes post drug and measured through 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

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

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)

June 1, 2016

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 12, 2016

Study Record Updates

Last Update Posted (Actual)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0331
  • A176000 (Other Identifier: University of Wisconsin, Madison)
  • EDUC/KINESIOLOGY/KINESIO (Other Identifier: UW Madison)
  • CVR-AAA4385 (Other Identifier: UW-Madison Study Staff)
  • 4R00HL118154-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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