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
-
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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.
|
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.
|
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.
|
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.
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
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.