Blood Flow Response and Acute INterval Exercise (BRAIN)

February 7, 2023 updated by: University of Kansas Medical Center

Cerebrovascular Response During Interval Exercise in Chronic Stroke

The objective of this project is to study the cerebrovascular response to a single bout of high intensity interval exercise (HIIT) in 25 individuals with chronic stroke compared to 25 age- and sex- matched healthy controls (CON). We will enroll 25 young healthy adults (CONyoung) as a reference group. Our hypothesis is that the cerebrovascular response in individuals with chronic stroke will be significantly lower: 1) during a single bout of HIIT, and 2) during the recovery immediately following and 30 minutes after HIIT, compared to CON.

This study has 2 visits at the University of Kansas Medical Center Research in Exercise and Cardiovascular Health Laboratory. For the first visit, we will perform questionnaires about heart health, physical activity and overall health. Participants will then complete a submaximal exercise test on a seated stepper. Participants will also have a familiarization session to practice HIIT. The second visit will include cerebrovascular measures before, during, immediately after, and 30 minutes after performing HIIT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

91

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
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We will recruit individuals with chronic stroke, age- and sex-matched controls (CON) and young healthy controls (CONyoung) within the community.

Description

Chronic Stroke Inclusion Criteria:

  • Age 40-80 years old
  • Treated for stroke 6 months to 5 years ago
  • Performs <150 minutes of moderate intensity exercise per week
  • Able to answer consenting questions and follow a 2-step command

Chronic Stroke Exclusion Criteria:

  • Stroke etiology due to COVID-19 pathology.
  • Symptoms of COVID-19 and/or Positive COVID-19 test within the past 3 months
  • Unable to stand from a sitting position without physical assistance
  • Recent joint replacement/surgery/poor motor control that limits ability to perform exercise on a recumbent stepper
  • Insulin injection dependent diabetes
  • Dependent on supplementary oxygen
  • History of other neurological disease (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease)
  • Unable to find TCD signal on the stroke-affected or non-affected MCA.

CON Inclusion Criteria:

  • Matched age ± 5 years to participant with chronic stroke
  • Matched sex to participant with chronic stroke
  • Performs <150 minutes of moderate intensity exercise per week
  • Able to answer consenting questions and follow a 2-step command

CON Exclusion Criteria:

  • Symptoms of COVID-19 and/or Positive COVID-19 test within the past 3 months
  • Unable to stand from a sitting position without physical assistance
  • Recent joint replacement/surgery/poor motor control that limits ability to perform exercise on a recumbent stepper
  • Insulin injection dependent diabetes
  • Dependent on supplementary oxygen
  • History of other neurological disease (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease)
  • Unable to find TCD signal on the right or left MCA.

CONyoung Inclusion Criteria:

  • Age 18-30 years old
  • Low cardiac risk (defined by the American College of Sports Medicine)
  • Able to find TCD signal on the right or left MCA

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Stroke
Individuals 40-80 years old who have had a stroke 6 months to 5 years ago.
Behavioral: Single, acute bout of high intensity interval exercise
Individuals will perform a single bout of high intensity interval exercise on a seated recumbent stepper. Participants will perform the pattern of high intensity interval exercise by switching between 1-minute high intensity stepping followed by 1-minute light, active recovery stepping for a total of 10 minutes.
CON
Control group (CON) comprised of age- and sex-matched healthy adults.
Behavioral: Single, acute bout of high intensity interval exercise
Individuals will perform a single bout of high intensity interval exercise on a seated recumbent stepper. Participants will perform the pattern of high intensity interval exercise by switching between 1-minute high intensity stepping followed by 1-minute light, active recovery stepping for a total of 10 minutes.
CONyoung
Healthy, young adult control group (CONyoung) who are age 18-30 years old.
Behavioral: Single, acute bout of high intensity interval exercise
Individuals will perform a single bout of high intensity interval exercise on a seated recumbent stepper. Participants will perform the pattern of high intensity interval exercise by switching between 1-minute high intensity stepping followed by 1-minute light, active recovery stepping for a total of 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Middle Cerebral Artery Blood Velocity (MCAv)
Time Frame: Pre-to-post intervention, ~40 minutes
blood velocity traveling through the middle cerebral artery measured using the transcranial Doppler ultrasound.
Pre-to-post intervention, ~40 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dynamic Cerebrovascular Autoregulation (dCA)
Time Frame: Pre-to-post intervention, ~40 minutes
Ability of the cerebrovascular system to maintain MCAv independent of changes in peripheral blood pressure. Measured using transcranial Doppler ultrasound and mean arterial pressure measured with every heart beat.
Pre-to-post intervention, ~40 minutes

Collaborators and Investigators

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

Sponsor

University of Kansas Medical Center

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)

December 9, 2020

Primary Completion (ACTUAL)

February 3, 2023

Study Completion (ACTUAL)

February 3, 2023

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (ACTUAL)

December 17, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00146161

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.

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