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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: CON
Age-and sex-matched healthy controls with exercise intervention
Behavioral: One bout of moderate-intensity sub-maximal aerobic exercise
The intervention is a 20-min acute exercise using arm ergometer
Experimental: SCI
Individuals with spinal cord injury
Behavioral: One bout of moderate-intensity sub-maximal aerobic exercise
The intervention is a 20-min acute exercise using arm ergometer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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