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The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, Cardiovascular Abnormalities, Cerebrovascular Disease; Sequelae

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One bout of moderate-intensity sub-maximal aerobic exercise
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Rehabilitation Sciences at University at BuffaloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CON

SCI

Arm Description

Age-and sex-matched healthy controls with exercise intervention

Individuals with spinal cord injury

Outcomes

Primary Outcome Measures

Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebral oxygenation level
Cerebral oxygenated hemoglobin in unknown unit
Cerebral oxygenation level
Cerebral oxygenated hemoglobin in unknown unit
Cognitive function
Reaction time in second
Cognitive function
Error made during the cognitive test in number
Cognitive function
Reaction time in second
Cognitive function
Error made during the cognitive test in number
Cognitive function
Reaction time in second
Cognitive function
Error made during cognitive test in number
Cognitive function
Reaction time in second
Cognitive function
Error made during the cognitive test in number

Secondary Outcome Measures

Full Information

First Posted
September 7, 2022
Last Updated
April 28, 2023
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT05542238
Brief Title
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
Official Title
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Cardiovascular Abnormalities, Cerebrovascular Disease; Sequelae, Cognitive Impairment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CON
Arm Type
Active Comparator
Arm Description
Age-and sex-matched healthy controls with exercise intervention
Arm Title
SCI
Arm Type
Experimental
Arm Description
Individuals with spinal cord injury
Intervention Type
Behavioral
Intervention Name(s)
One bout of moderate-intensity sub-maximal aerobic exercise
Intervention Description
The intervention is a 20-min acute exercise using arm ergometer
Primary Outcome Measure Information:
Title
Cardiac sympathetic function
Description
Low frequency component of blood pressure variability in mmHg^2
Time Frame
During baseline pre the 20-min acute exercise
Title
Cardiac parasympathetic function
Description
High frequency component of heart rate variability in mm^2
Time Frame
During baseline pre the 20-min acute exercise
Title
Cardiac sympathetic function
Description
Low frequency component of blood pressure variability in mmHg^2
Time Frame
During face-cooling test pre the 20-min acute exercise
Title
Cardiac parasympathetic function
Description
High frequency component of heart rate variability in mm^2
Time Frame
During face-cooling test pre the 20-min acute exercise
Title
Cardiac sympathetic function
Description
Low frequency component of blood pressure variability in mmHg^2
Time Frame
During head-up tilt test pre the 20-min acute exercise
Title
Cardiac parasympathetic function
Description
High frequency component of heart rate variability in mm^2
Time Frame
During head-up tilt test pre the 20-min acute exercise
Title
Cardiac sympathetic function
Description
Low frequency component of blood pressure variability in mmHg^2
Time Frame
During cognitive tests pre the 20-min acute exercise
Title
Cardiac parasympathetic function
Description
High frequency component of heart rate variability in mm^2
Time Frame
During cognitive tests pre the 20-min acute exercise
Title
Cardiac sympathetic function
Description
Low frequency component of blood pressure variability in mmHg^2
Time Frame
During baseline post the 20-min acute exercise
Title
Cardiac sympathetic function
Description
Low frequency component of blood pressure variability in mmHg^2
Time Frame
During face-cooling post the 20-min acute exercise
Title
Cardiac parasympathetic function
Description
High frequency component of heart rate variability in mm^2
Time Frame
During face-cooling post the 20-min acute exercise
Title
Cardiac sympathetic function
Description
Low frequency component of blood pressure variability in mmHg^2
Time Frame
During head-up tilt test post the 20-min acute exercise
Title
Cardiac parasympathetic function
Description
High frequency component of heart rate variability in mm^2
Time Frame
During head-up tilt test post the 20-min acute exercise
Title
Cardiac sympathetic function
Description
Low frequency component of blood pressure variability in mmHg^2
Time Frame
During cognitive tests post the 20-min acute exercise
Title
Cardiac parasympathetic function
Description
High frequency component of heart rate variability in mm^2
Time Frame
During cognitive tests post the 20-min acute exercise
Title
Cerebrovascular functions
Description
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Time Frame
During baseline pre the 20-min acute exercise
Title
Cerebrovascular functions
Description
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Time Frame
During the face-cooling test pre the 20-min acute exercise
Title
Cerebrovascular functions
Description
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Time Frame
During the head-up tilt test pre the 20-min acute exercise
Title
Cerebrovascular functions
Description
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Time Frame
During the cognitive tests pre the 20-min acute exercise
Title
Cerebrovascular functions
Description
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Time Frame
During baseline post the 20-min acute exercise
Title
Cerebrovascular functions
Description
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Time Frame
During the face-cooling test post the 20-min acute exercise
Title
Cerebrovascular functions
Description
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Time Frame
During the head-up tilt test post the 20-min acute exercise
Title
Cerebrovascular functions
Description
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Time Frame
During the cognitive tests post the 20-min acute exercise
Title
Cerebral oxygenation level
Description
Cerebral oxygenated hemoglobin in unknown unit
Time Frame
Change from baseline to the cognitive tests pre the 20-min acute exercise
Title
Cerebral oxygenation level
Description
Cerebral oxygenated hemoglobin in unknown unit
Time Frame
Change from baseline to the cognitive tests post the 20-min acute exercise
Title
Cognitive function
Description
Reaction time in second
Time Frame
During baseline pre the 20-min acute exercise
Title
Cognitive function
Description
Error made during the cognitive test in number
Time Frame
During baseline pre the 20-min acute exercise
Title
Cognitive function
Description
Reaction time in second
Time Frame
During head-up tilt pre the 20-min acute exercise
Title
Cognitive function
Description
Error made during the cognitive test in number
Time Frame
During head-up tilt pre the 20-min acute exercise
Title
Cognitive function
Description
Reaction time in second
Time Frame
During baseline post the 20-min acute exercise
Title
Cognitive function
Description
Error made during cognitive test in number
Time Frame
During baseline post the 20-min acute exercise
Title
Cognitive function
Description
Reaction time in second
Time Frame
During head-up tilt post the 20-min acute exercise
Title
Cognitive function
Description
Error made during the cognitive test in number
Time Frame
During head-up tilt post the 20-min acute exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjie Ji, MS
Phone
7169072508
Email
wji4@buffalo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sue Ann Sisto, PhD
Phone
9739517358
Email
suesisto@buffalo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenjie Ji, MS
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Sciences at University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjie Ji
Phone
716-907-2508
Email
wji4@buffalo.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury

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