Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05542238
Recruitment Status : Recruiting
First Posted : September 15, 2022
Last Update Posted : May 1, 2023
Sponsor:
Information provided by (Responsible Party):
Wenjie Ji, State University of New York at Buffalo

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Spinal Cord Injuries Cardiovascular Abnormalities Cerebrovascular Disease; Sequelae Cognitive Impairment Behavioral: One bout of moderate-intensity sub-maximal aerobic exercise Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : September 6, 2022
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : March 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cardiac sympathetic function [ Time Frame: During baseline pre the 20-min acute exercise ]
    Low frequency component of blood pressure variability in mmHg^2

  2. Cardiac parasympathetic function [ Time Frame: During baseline pre the 20-min acute exercise ]
    High frequency component of heart rate variability in mm^2

  3. 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

  4. 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

  5. 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

  6. 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

  7. Cardiac sympathetic function [ Time Frame: During cognitive tests pre the 20-min acute exercise ]
    Low frequency component of blood pressure variability in mmHg^2

  8. Cardiac parasympathetic function [ Time Frame: During cognitive tests pre the 20-min acute exercise ]
    High frequency component of heart rate variability in mm^2

  9. Cardiac sympathetic function [ Time Frame: During baseline post the 20-min acute exercise ]
    Low frequency component of blood pressure variability in mmHg^2

  10. Cardiac sympathetic function [ Time Frame: During face-cooling post the 20-min acute exercise ]
    Low frequency component of blood pressure variability in mmHg^2

  11. Cardiac parasympathetic function [ Time Frame: During face-cooling post the 20-min acute exercise ]
    High frequency component of heart rate variability in mm^2

  12. 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

  13. 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

  14. Cardiac sympathetic function [ Time Frame: During cognitive tests post the 20-min acute exercise ]
    Low frequency component of blood pressure variability in mmHg^2

  15. Cardiac parasympathetic function [ Time Frame: During cognitive tests post the 20-min acute exercise ]
    High frequency component of heart rate variability in mm^2

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. Cerebral oxygenation level [ Time Frame: Change from baseline to the cognitive tests pre the 20-min acute exercise ]
    Cerebral oxygenated hemoglobin in unknown unit

  25. Cerebral oxygenation level [ Time Frame: Change from baseline to the cognitive tests post the 20-min acute exercise ]
    Cerebral oxygenated hemoglobin in unknown unit

  26. Cognitive function [ Time Frame: During baseline pre the 20-min acute exercise ]
    Reaction time in second

  27. Cognitive function [ Time Frame: During baseline pre the 20-min acute exercise ]
    Error made during the cognitive test in number

  28. Cognitive function [ Time Frame: During head-up tilt pre the 20-min acute exercise ]
    Reaction time in second

  29. Cognitive function [ Time Frame: During head-up tilt pre the 20-min acute exercise ]
    Error made during the cognitive test in number

  30. Cognitive function [ Time Frame: During baseline post the 20-min acute exercise ]
    Reaction time in second

  31. Cognitive function [ Time Frame: During baseline post the 20-min acute exercise ]
    Error made during cognitive test in number

  32. Cognitive function [ Time Frame: During head-up tilt post the 20-min acute exercise ]
    Reaction time in second

  33. Cognitive function [ Time Frame: During head-up tilt post the 20-min acute exercise ]
    Error made during the cognitive test in number


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05542238


Contacts
Layout table for location contacts
Contact: Wenjie Ji, MS 7169072508 wji4@buffalo.edu
Contact: Sue Ann Sisto, PhD 9739517358 suesisto@buffalo.edu

Locations
Layout table for location information
United States, New York
Department of Rehabilitation Sciences at University at Buffalo Recruiting
Buffalo, New York, United States, 14214
Contact: Wenjie Ji    716-907-2508    wji4@buffalo.edu   
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Layout table for investigator information
Principal Investigator: Wenjie Ji, MS University at Buffalo
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Wenjie Ji, PhD student, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT05542238    
Other Study ID Numbers: STUDY00006517
First Posted: September 15, 2022    Key Record Dates
Last Update Posted: May 1, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Cerebrovascular Disorders
Cardiovascular Abnormalities
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Congenital Abnormalities
Brain Diseases
Vascular Diseases
Cardiovascular Diseases