BRAIN: Blood Flow Response and Acute INterval Exercise

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04673994
Collaborator
(none)
75
1
20.7
3.6

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Single, acute bout of high intensity interval exercise

Study Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Cerebrovascular Response During Interval Exercise in Chronic Stroke
Actual Study Start Date :
Dec 9, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Change in Middle Cerebral Artery Blood Velocity (MCAv) [Pre-to-post intervention, ~40 minutes]

    blood velocity traveling through the middle cerebral artery measured using the transcranial Doppler ultrasound.

Secondary Outcome Measures

  1. Change in Dynamic Cerebrovascular Autoregulation (dCA) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kansas Medical Center Kansas City Kansas United States 66160

Sponsors and Collaborators

  • University of Kansas Medical Center

Investigators

  • Principal Investigator: Sandra A Billinger, PhD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT04673994
Other Study ID Numbers:
  • STUDY00146161
First Posted:
Dec 17, 2020
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Kansas Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2022