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

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

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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