Clinical trial NCT05542238: 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
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Cardiovascular Abnormalities
Cerebrovascular Disease; Sequelae
Cognitive Impairment
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Cardiac sympathetic function
timeFrame: During baseline pre the 20-min acute exercise
measure: Cardiac parasympathetic function
timeFrame: During baseline pre the 20-min acute exercise
measure: Cardiac sympathetic function
timeFrame: During face-cooling test pre the 20-min acute exercise
measure: Cardiac parasympathetic function
timeFrame: During face-cooling test pre the 20-min acute exercise
measure: Cardiac sympathetic function
timeFrame: During head-up tilt test pre the 20-min acute exercise
measure: Cardiac parasympathetic function
timeFrame: During head-up tilt test pre the 20-min acute exercise
measure: Cardiac sympathetic function
timeFrame: During cognitive tests pre the 20-min acute exercise
measure: Cardiac parasympathetic function
timeFrame: During cognitive tests pre the 20-min acute exercise
measure: Cardiac sympathetic function
timeFrame: During baseline post the 20-min acute exercise
measure: Cardiac sympathetic function
timeFrame: During face-cooling post the 20-min acute exercise
measure: Cardiac parasympathetic function
timeFrame: During face-cooling post the 20-min acute exercise
measure: Cardiac sympathetic function
timeFrame: During head-up tilt test post the 20-min acute exercise
measure: Cardiac parasympathetic function
timeFrame: During head-up tilt test post the 20-min acute exercise
measure: Cardiac sympathetic function
timeFrame: During cognitive tests post the 20-min acute exercise
measure: Cardiac parasympathetic function
timeFrame: During cognitive tests post the 20-min acute exercise
measure: Cerebrovascular functions
timeFrame: During baseline pre the 20-min acute exercise
measure: Cerebrovascular functions
timeFrame: During the face-cooling test pre the 20-min acute exercise
measure: Cerebrovascular functions
timeFrame: During the head-up tilt test pre the 20-min acute exercise
measure: Cerebrovascular functions
timeFrame: During the cognitive tests pre the 20-min acute exercise
measure: Cerebrovascular functions
timeFrame: During baseline post the 20-min acute exercise
measure: Cerebrovascular functions
timeFrame: During the face-cooling test post the 20-min acute exercise
measure: Cerebrovascular functions
timeFrame: During the head-up tilt test post the 20-min acute exercise
measure: Cerebrovascular functions
timeFrame: During the cognitive tests post the 20-min acute exercise
measure: Cerebral oxygenation level
timeFrame: Change from baseline to the cognitive tests pre the 20-min acute exercise
measure: Cerebral oxygenation level
timeFrame: Change from baseline to the cognitive tests post the 20-min acute exercise
measure: Cognitive function
timeFrame: During baseline pre the 20-min acute exercise
measure: Cognitive function
timeFrame: During baseline pre the 20-min acute exercise
measure: Cognitive function
timeFrame: During head-up tilt pre the 20-min acute exercise
measure: Cognitive function
timeFrame: During head-up tilt pre the 20-min acute exercise
measure: Cognitive function
timeFrame: During baseline post the 20-min acute exercise
measure: Cognitive function
timeFrame: During baseline post the 20-min acute exercise
measure: Cognitive function
timeFrame: During head-up tilt post the 20-min acute exercise
measure: Cognitive function
timeFrame: During head-up tilt post the 20-min acute exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Department of Rehabilitation Sciences at University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Wenjie Ji, MS
role: PRINCIPAL_INVESTIGATOR
References: