StrokeBRAINNCT04673994
Blood Flow Response and Acute INterval Exercise
An observational study of Stroke and High Intensity Interval Exercise, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, High Intensity Interval Exercise
- What is being tested?
- Single, acute bout of high intensity interval exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 3 Feb 2023
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit individuals with chronic stroke, age- and sex-matched controls (CON) and young healthy controls (CONyoung) within the community.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
- Conditions
- Stroke, High Intensity Interval Exercise
- Being tested
- Single, acute bout of high intensity interval exercise
- Keywords
- Cerebral Blood Velocity, Cerebral Autoregulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single, acute bout of high intensity interval exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Stroke | Individuals 40-80 years old who have had a stroke 6 months to 5 years ago. Receives: Behavioral: Single, acute bout of high intensity interval exercise | |
| CON | Control group (CON) comprised of age- and sex-matched healthy adults. Receives: Behavioral: Single, acute bout of high intensity interval exercise | |
| CONyoung | Healthy, young adult control group (CONyoung) who are age 18-30 years old. Receives: Behavioral: Single, acute bout of high intensity interval exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Middle Cerebral Artery Blood Velocity (MCAv)
blood velocity traveling through the middle cerebral artery measured using the transcranial Doppler ultrasound.
Measured: Pre-to-post intervention, ~40 minutes
Secondary outcomes (1)
Change in Dynamic Cerebrovascular Autoregulation (dCA)
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.
Measured: Pre-to-post intervention, ~40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start9 Dec 2020
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra A Billinger, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673994
- Sponsor's protocol ID
- STUDY00146161
- Acronym
- BRAIN
- Status last verified
- Feb 2023
- First submitted
- 8 Dec 2020
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartsch BL, Whitaker AA, Oloyede S, Waghmare S, Billinger SA. Feasibility of a Recumbent Stepper for Short-Interval, Low-Volume High-Intensity Interval Exercise in Stroke. J Neurol Phys Ther. 2025 Apr 1;49(2):82-89. doi: 10.1097/NPT.0000000000000482. Epub 2024 Jun 24.
PubMed 38913833
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrovascular Response During Interval Exercise in Chronic Stroke
- ClinicalTrials.gov ID
- NCT04673994
- Acronym / sponsor ID
- BRAIN / STUDY00146161
- Conditions
- Stroke, High Intensity Interval Exercise
- Keywords
- Cerebral Blood Velocity, Cerebral Autoregulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 17 Dec 2020 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Stroke | – | Behavioral: Single, acute bout of high intensity interval exerciseIndividuals 40-80 years old who have had a stroke 6 months to 5 years ago. |
| CON | – | Behavioral: Single, acute bout of high intensity interval exerciseControl group (CON) comprised of age- and sex-matched healthy adults. |
| CONyoung | – | Behavioral: Single, acute bout of high intensity interval exerciseHealthy, young adult control group (CONyoung) who are age 18-30 years old. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit individuals with chronic stroke, age- and sex-matched controls (CON) and young healthy controls (CONyoung) within the community.
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 |
|---|---|---|
| Single, acute bout of high intensity interval exerciseIndividuals 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. | Behavioural | CON, CONyoung, Chronic Stroke |
Primary outcome
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.
1 secondary outcome
Change in Dynamic Cerebrovascular Autoregulation (dCA)
Time frame: Pre-to-post intervention, ~40 minutes
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 9 Feb 2023.
- Derived from this study: PubMed 38913833Bartsch BL, Whitaker AA, Oloyede S, Waghmare S, Billinger SA. Feasibility of a Recumbent Stepper for Short-Interval, Low-Volume High-Intensity Interval Exercise in Stroke. J Neurol Phys Ther. 2025 Apr 1;49(2):82-89. doi: 10.1097/NPT.0000000000000482. Epub 2024 Jun 24.
- 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.
Sandra A Billinger, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and High Intensity Interval Exercise, run by University of Kansas Medical Center 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?
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 9 Feb 2023. 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?
Change in Middle Cerebral Artery Blood Velocity (MCAv) (time frame: Pre-to-post intervention, ~40 minutes). 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 NCT04673994, which also lists 1 linked publication.
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 9 Feb 2023.