- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05542238
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
March 3, 2025 updated by: Wenjie Ji, State University of New York at Buffalo
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury: a Pilot Study
The aims of this proposal are to: 1) investigate whether individuals with spinal cord injury (SCI) demonstrate cardiac autonomic, cerebrovascular, and cognitive dysfunctions compared to non-injured age- and sex-matched controls in the following conditions: supine rest and head-up tilt/face-cooling test; 2) examine if autonomic completeness/ incompleteness, physical activity, and psychological distress are predictors for dysfunctions during supine rest and head-up tilt/face cooling conditions in SCI individuals; 3) examine if one bout of moderate-intensity aerobic exercise temporarily improves cardiac autonomic and cerebrovascular functions and thereby improves cognition when in supine rest and head- up tilt/face cooling conditions.
The study will include an initial visit and an experimental visit to our lab.
Three groups of participants will be included in this study: Group 1, SCI with acute exercise; group 2, SCI with rest-control; and group 3, age- and sex-matched non-injured individuals.
Cardiovascular variables, such as heart rate variability, blood pressure variability, and cerebrovascular variables, such as cerebral blood flow velocity and oxygenated hemoglobin, and cognitive performance will be examined.
The investigator hypothesizes that individuals with SCI will have impaired cardiac autonomic, cerebrovascular, and cognitive functions compared to the non-injured controls, and an acute exercise can improve those functions.
Autonomic completeness/incompleteness, physical activity, and psychological distress are significant factors that predict cardiac autonomic, cerebrovascular, and cognitive functions in individuals with SCI.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
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
-
-
New York
-
Buffalo, New York, United States, 14214
- Department of Rehabilitation Sciences at University at Buffalo
-
-
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 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Spinal cord injury group:
- Males or females with chronic SCI (i.e. at least 6 months after the initial injury)
- International Standard for Neurological Classification of SCI (ISNCSCI) A-D
- Neurological level of injury C6 or below
- 18-55 years old
- Proficient in English
- Able to detect middle cerebral artery blood velocity (MCAv) and/or posterior cerebral artery blood velocity (PCAv) signals through TCD
Non-injured controls:
- Males or females without SCI
- 18-55 years old
- Proficient in English
- Able to detect MCAv and/or PCAv signals through TCD
Exclusion Criteria:
- Cardiovascular, pulmonary or respiratory diseases, or diabetes mellitus, any other diseases/disorders affecting cardiac autonomic nervous system, such as glaucoma and attention deficit hyperactivity disorder (ADHD)
- Color Blindness
- Pregnancy
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
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: CON
Age-and sex-matched healthy controls with exercise intervention
|
The intervention is a 20-min acute exercise using arm ergometer
|
|
Experimental: SCI
Individuals with spinal cord injury
|
The intervention is a 20-min acute exercise using arm ergometer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac sympathetic function
Time Frame: During baseline pre the 20-min acute exercise
|
Low frequency component of blood pressure variability in mmHg^2
|
During baseline pre the 20-min acute exercise
|
|
Cardiac parasympathetic function
Time Frame: During baseline pre the 20-min acute exercise
|
High frequency component of heart rate variability in mm^2
|
During baseline pre the 20-min acute exercise
|
|
Cardiac sympathetic function
Time Frame: During face-cooling test pre the 20-min acute exercise
|
Low frequency component of blood pressure variability in mmHg^2
|
During face-cooling test pre the 20-min acute exercise
|
|
Cardiac parasympathetic function
Time Frame: During face-cooling test pre the 20-min acute exercise
|
High frequency component of heart rate variability in mm^2
|
During face-cooling test pre the 20-min acute exercise
|
|
Cardiac sympathetic function
Time Frame: During head-up tilt test pre the 20-min acute exercise
|
Low frequency component of blood pressure variability in mmHg^2
|
During head-up tilt test pre the 20-min acute exercise
|
|
Cardiac parasympathetic function
Time Frame: During head-up tilt test pre the 20-min acute exercise
|
High frequency component of heart rate variability in mm^2
|
During head-up tilt test pre the 20-min acute exercise
|
|
Cardiac sympathetic function
Time Frame: During cognitive tests pre the 20-min acute exercise
|
Low frequency component of blood pressure variability in mmHg^2
|
During cognitive tests pre the 20-min acute exercise
|
|
Cardiac parasympathetic function
Time Frame: During cognitive tests pre the 20-min acute exercise
|
High frequency component of heart rate variability in mm^2
|
During cognitive tests pre the 20-min acute exercise
|
|
Cardiac sympathetic function
Time Frame: During baseline post the 20-min acute exercise
|
Low frequency component of blood pressure variability in mmHg^2
|
During baseline post the 20-min acute exercise
|
|
Cardiac sympathetic function
Time Frame: During face-cooling post the 20-min acute exercise
|
Low frequency component of blood pressure variability in mmHg^2
|
During face-cooling post the 20-min acute exercise
|
|
Cardiac parasympathetic function
Time Frame: During face-cooling post the 20-min acute exercise
|
High frequency component of heart rate variability in mm^2
|
During face-cooling post the 20-min acute exercise
|
|
Cardiac sympathetic function
Time Frame: During head-up tilt test post the 20-min acute exercise
|
Low frequency component of blood pressure variability in mmHg^2
|
During head-up tilt test post the 20-min acute exercise
|
|
Cardiac parasympathetic function
Time Frame: During head-up tilt test post the 20-min acute exercise
|
High frequency component of heart rate variability in mm^2
|
During head-up tilt test post the 20-min acute exercise
|
|
Cardiac sympathetic function
Time Frame: During cognitive tests post the 20-min acute exercise
|
Low frequency component of blood pressure variability in mmHg^2
|
During cognitive tests post the 20-min acute exercise
|
|
Cardiac parasympathetic function
Time Frame: During cognitive tests post the 20-min acute exercise
|
High frequency component of heart rate variability in mm^2
|
During cognitive tests post the 20-min acute exercise
|
|
Cerebrovascular functions
Time Frame: During baseline pre the 20-min acute exercise
|
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
|
During baseline pre the 20-min acute exercise
|
|
Cerebrovascular functions
Time Frame: During the face-cooling test pre the 20-min acute exercise
|
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
|
During the face-cooling test pre the 20-min acute exercise
|
|
Cerebrovascular functions
Time Frame: During the head-up tilt test pre the 20-min acute exercise
|
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
|
During the head-up tilt test pre the 20-min acute exercise
|
|
Cerebrovascular functions
Time Frame: During the cognitive tests pre the 20-min acute exercise
|
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
|
During the cognitive tests pre the 20-min acute exercise
|
|
Cerebrovascular functions
Time Frame: During baseline post the 20-min acute exercise
|
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
|
During baseline post the 20-min acute exercise
|
|
Cerebrovascular functions
Time Frame: During the face-cooling test post the 20-min acute exercise
|
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
|
During the face-cooling test post the 20-min acute exercise
|
|
Cerebrovascular functions
Time Frame: During the head-up tilt test post the 20-min acute exercise
|
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
|
During the head-up tilt test post the 20-min acute exercise
|
|
Cerebrovascular functions
Time Frame: During the cognitive tests post the 20-min acute exercise
|
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
|
During the cognitive tests post the 20-min acute exercise
|
|
Cerebral oxygenation level
Time Frame: Change from baseline to the cognitive tests pre the 20-min acute exercise
|
Cerebral oxygenated hemoglobin in unknown unit
|
Change from baseline to the cognitive tests pre the 20-min acute exercise
|
|
Cerebral oxygenation level
Time Frame: Change from baseline to the cognitive tests post the 20-min acute exercise
|
Cerebral oxygenated hemoglobin in unknown unit
|
Change from baseline to the cognitive tests post the 20-min acute exercise
|
|
Cognitive function
Time Frame: During baseline pre the 20-min acute exercise
|
Reaction time in second
|
During baseline pre the 20-min acute exercise
|
|
Cognitive function
Time Frame: During baseline pre the 20-min acute exercise
|
Error made during the cognitive test in number
|
During baseline pre the 20-min acute exercise
|
|
Cognitive function
Time Frame: During head-up tilt pre the 20-min acute exercise
|
Reaction time in second
|
During head-up tilt pre the 20-min acute exercise
|
|
Cognitive function
Time Frame: During head-up tilt pre the 20-min acute exercise
|
Error made during the cognitive test in number
|
During head-up tilt pre the 20-min acute exercise
|
|
Cognitive function
Time Frame: During baseline post the 20-min acute exercise
|
Reaction time in second
|
During baseline post the 20-min acute exercise
|
|
Cognitive function
Time Frame: During baseline post the 20-min acute exercise
|
Error made during cognitive test in number
|
During baseline post the 20-min acute exercise
|
|
Cognitive function
Time Frame: During head-up tilt post the 20-min acute exercise
|
Reaction time in second
|
During head-up tilt post the 20-min acute exercise
|
|
Cognitive function
Time Frame: During head-up tilt post the 20-min acute exercise
|
Error made during the cognitive test in number
|
During head-up tilt post the 20-min acute exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wenjie Ji, MS, University at Buffalo
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)
September 6, 2022
Primary Completion (Actual)
December 18, 2024
Study Completion (Actual)
December 18, 2024
Study Registration Dates
First Submitted
September 7, 2022
First Submitted That Met QC Criteria
September 13, 2022
First Posted (Actual)
September 15, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 3, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00006517-Pilot
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
product manufactured in and exported from the U.S.
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.
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