Blood Flow Response and Acute INterval Exercise

Stroke Clinical Trial

— BRAIN  

Official title:

Cerebrovascular Response During Interval Exercise in Chronic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673994
• Other study ID #: STUDY00146161
• Status: Completed
• Start date: December 9, 2020
• Est. completion date: February 3, 2023

Study information

• Verified date: February 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: February 3, 2023
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• High Intensity Interval Exercise
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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