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

Sponsor
State University of New York at Buffalo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05542238
Collaborator
(none)
10
1
2
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1.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: One bout of moderate-intensity sub-maximal aerobic exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury: A Pilot Study
Anticipated Study Start Date :
Sep 8, 2022
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Cardiac sympathetic function [During baseline pre the 20-min acute exercise]

    Low frequency component of blood pressure variability in mmHg^2

  2. Cardiac parasympathetic function [During baseline pre the 20-min acute exercise]

    High frequency component of heart rate variability in mm^2

  3. Cardiac sympathetic function [During face-cooling test pre the 20-min acute exercise]

    Low frequency component of blood pressure variability in mmHg^2

  4. Cardiac parasympathetic function [During face-cooling test pre the 20-min acute exercise]

    High frequency component of heart rate variability in mm^2

  5. Cardiac sympathetic function [During head-up tilt test pre the 20-min acute exercise]

    Low frequency component of blood pressure variability in mmHg^2

  6. Cardiac parasympathetic function [During head-up tilt test pre the 20-min acute exercise]

    High frequency component of heart rate variability in mm^2

  7. Cardiac sympathetic function [During cognitive tests pre the 20-min acute exercise]

    Low frequency component of blood pressure variability in mmHg^2

  8. Cardiac parasympathetic function [During cognitive tests pre the 20-min acute exercise]

    High frequency component of heart rate variability in mm^2

  9. Cardiac sympathetic function [During baseline post the 20-min acute exercise]

    Low frequency component of blood pressure variability in mmHg^2

  10. Cardiac sympathetic function [During face-cooling post the 20-min acute exercise]

    Low frequency component of blood pressure variability in mmHg^2

  11. Cardiac parasympathetic function [During face-cooling post the 20-min acute exercise]

    High frequency component of heart rate variability in mm^2

  12. Cardiac sympathetic function [During head-up tilt test post the 20-min acute exercise]

    Low frequency component of blood pressure variability in mmHg^2

  13. Cardiac parasympathetic function [During head-up tilt test post the 20-min acute exercise]

    High frequency component of heart rate variability in mm^2

  14. Cardiac sympathetic function [During cognitive tests post the 20-min acute exercise]

    Low frequency component of blood pressure variability in mmHg^2

  15. Cardiac parasympathetic function [During cognitive tests post the 20-min acute exercise]

    High frequency component of heart rate variability in mm^2

  16. Cerebrovascular functions [During baseline pre the 20-min acute exercise]

    Assessed by the middle and posterior cerebral artery velocity in centimeters per second

  17. Cerebrovascular functions [During the face-cooling test pre the 20-min acute exercise]

    Assessed by the middle and posterior cerebral artery velocity in centimeters per second

  18. Cerebrovascular functions [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

  19. Cerebrovascular functions [During the cognitive tests pre the 20-min acute exercise]

    Assessed by the middle and posterior cerebral artery velocity in centimeters per second

  20. Cerebrovascular functions [During baseline post the 20-min acute exercise]

    Assessed by the middle and posterior cerebral artery velocity in centimeters per second

  21. Cerebrovascular functions [During the face-cooling test post the 20-min acute exercise]

    Assessed by the middle and posterior cerebral artery velocity in centimeters per second

  22. Cerebrovascular functions [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

  23. Cerebrovascular functions [During the cognitive tests post the 20-min acute exercise]

    Assessed by the middle and posterior cerebral artery velocity in centimeters per second

  24. Cerebral oxygenation level [Change from baseline to the cognitive tests pre the 20-min acute exercise]

    Cerebral oxygenated hemoglobin in unknown unit

  25. Cerebral oxygenation level [Change from baseline to the cognitive tests post the 20-min acute exercise]

    Cerebral oxygenated hemoglobin in unknown unit

  26. Cognitive function [During baseline pre the 20-min acute exercise]

    Reaction time in second

  27. Cognitive function [During baseline pre the 20-min acute exercise]

    Error made during the cognitive test in number

  28. Cognitive function [During head-up tilt pre the 20-min acute exercise]

    Reaction time in second

  29. Cognitive function [During head-up tilt pre the 20-min acute exercise]

    Error made during the cognitive test in number

  30. Cognitive function [During baseline post the 20-min acute exercise]

    Reaction time in second

  31. Cognitive function [During baseline post the 20-min acute exercise]

    Error made during cognitive test in number

  32. Cognitive function [During head-up tilt post the 20-min acute exercise]

    Reaction time in second

  33. Cognitive function [During head-up tilt post the 20-min acute exercise]

    Error made during the cognitive test in number

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Rehabilitation Sciences at University at Buffalo Buffalo New York United States 14214

Sponsors and Collaborators

  • State University of New York at Buffalo

Investigators

  • Principal Investigator: Wenjie Ji, MS, University at Buffalo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wenjie Ji, PhD student, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT05542238
Other Study ID Numbers:
  • STUDY00006517
First Posted:
Sep 15, 2022
Last Update Posted:
Sep 15, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2022