An interventional study of One bout of moderate-intensity sub-maximal aerobic exercise in Spinal Cord Injuries, Cardiovascular Abnormalities and Cerebrovascular Disease; Sequelae, sponsored by State University of New York at Buffalo. Terminated at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Supportive care
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 6 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Spinal cord injury group:
Non-injured controls:
Exclusion Criteria:
Age-and sex-matched healthy controls with exercise intervention
Behavioral: One bout of moderate-intensity sub-maximal aerobic exercise
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
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg\^2
Time frame: During baseline pre the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm\^2
Time frame: During baseline pre the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg\^2
Time frame: During face-cooling test pre the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm\^2
Time frame: During face-cooling test pre the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg\^2
Time frame: During head-up tilt test pre the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm\^2
Time frame: During head-up tilt test pre the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg\^2
Time frame: During cognitive tests pre the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm\^2
Time frame: During cognitive tests pre the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg\^2
Time frame: During baseline post the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg\^2
Time frame: During face-cooling post the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm\^2
Time frame: During face-cooling post the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg\^2
Time frame: During head-up tilt test post the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm\^2
Time frame: During head-up tilt test post the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg\^2
Time frame: During cognitive tests post the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm\^2
Time frame: During cognitive tests post the 20-min acute exercise
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Time frame: During baseline pre the 20-min acute exercise
Cerebrovascular functions
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
Cerebrovascular functions
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
Cerebrovascular functions
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
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Time frame: During baseline post the 20-min acute exercise
Cerebrovascular functions
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
Cerebrovascular functions
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
Cerebrovascular functions
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
Cerebral oxygenation level
Cerebral oxygenated hemoglobin in unknown unit
Time frame: Change from baseline to the cognitive tests pre the 20-min acute exercise
Cerebral oxygenation level
Cerebral oxygenated hemoglobin in unknown unit
Time frame: Change from baseline to the cognitive tests post the 20-min acute exercise
Cognitive function
Reaction time in second
Time frame: During baseline pre the 20-min acute exercise
Cognitive function
Error made during the cognitive test in number
Time frame: During baseline pre the 20-min acute exercise
Cognitive function
Reaction time in second
Time frame: During head-up tilt pre the 20-min acute exercise
Cognitive function
Error made during the cognitive test in number
Time frame: During head-up tilt pre the 20-min acute exercise
Cognitive function
Reaction time in second
Time frame: During baseline post the 20-min acute exercise
Cognitive function
Error made during cognitive test in number
Time frame: During baseline post the 20-min acute exercise
Cognitive function
Reaction time in second
Time frame: During head-up tilt post the 20-min acute exercise
Cognitive function
Error made during the cognitive test in number
Time frame: During head-up tilt post the 20-min acute exercise
Plan to share: No
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This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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State University of New York at Buffalo