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Completed

NCT Number: NCT04673994

Blood Flow Response and Acute INterval Exercise

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single, acute bout of high intensity interval exercise

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

Cerebrovascular Response During Interval Exercise in Chronic Stroke

Acronym: BRAIN

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2020
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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