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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05542238
• Other study ID #: STUDY00006517-Pilot
• Status: Suspended
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: August 30, 2025

Study information

• Verified date: February 2024
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: August 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• Cerebrovascular Disease; Sequelae
• Cerebrovascular Disorders
• Cognitive Impairment
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• One bout of moderate-intensity sub-maximal aerobic exercise
The intervention is a 20-min acute exercise using arm ergometer

Locations

Country	Name	City	State
United States	Department of Rehabilitation Sciences at University at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac sympathetic function	Low frequency component of blood pressure variability in mmHg^2	During baseline pre the 20-min acute exercise
Primary	Cardiac parasympathetic function	High frequency component of heart rate variability in mm^2	During baseline pre the 20-min acute exercise
Primary	Cardiac sympathetic function	Low frequency component of blood pressure variability in mmHg^2	During face-cooling test pre the 20-min acute exercise
Primary	Cardiac parasympathetic function	High frequency component of heart rate variability in mm^2	During face-cooling test pre the 20-min acute exercise
Primary	Cardiac sympathetic function	Low frequency component of blood pressure variability in mmHg^2	During head-up tilt test pre the 20-min acute exercise
Primary	Cardiac parasympathetic function	High frequency component of heart rate variability in mm^2	During head-up tilt test pre the 20-min acute exercise
Primary	Cardiac sympathetic function	Low frequency component of blood pressure variability in mmHg^2	During cognitive tests pre the 20-min acute exercise
Primary	Cardiac parasympathetic function	High frequency component of heart rate variability in mm^2	During cognitive tests pre the 20-min acute exercise
Primary	Cardiac sympathetic function	Low frequency component of blood pressure variability in mmHg^2	During baseline post the 20-min acute exercise
Primary	Cardiac sympathetic function	Low frequency component of blood pressure variability in mmHg^2	During face-cooling post the 20-min acute exercise
Primary	Cardiac parasympathetic function	High frequency component of heart rate variability in mm^2	During face-cooling post the 20-min acute exercise
Primary	Cardiac sympathetic function	Low frequency component of blood pressure variability in mmHg^2	During head-up tilt test post the 20-min acute exercise
Primary	Cardiac parasympathetic function	High frequency component of heart rate variability in mm^2	During head-up tilt test post the 20-min acute exercise
Primary	Cardiac sympathetic function	Low frequency component of blood pressure variability in mmHg^2	During cognitive tests post the 20-min acute exercise
Primary	Cardiac parasympathetic function	High frequency component of heart rate variability in mm^2	During cognitive tests post the 20-min acute exercise
Primary	Cerebrovascular functions	Assessed by the middle and posterior cerebral artery velocity in centimeters per second	During baseline pre the 20-min acute exercise
Primary	Cerebrovascular functions	Assessed by the middle and posterior cerebral artery velocity in centimeters per second	During the face-cooling test pre the 20-min acute exercise
Primary	Cerebrovascular functions	Assessed by the middle and posterior cerebral artery velocity in centimeters per second	During the head-up tilt test pre the 20-min acute exercise
Primary	Cerebrovascular functions	Assessed by the middle and posterior cerebral artery velocity in centimeters per second	During the cognitive tests pre the 20-min acute exercise
Primary	Cerebrovascular functions	Assessed by the middle and posterior cerebral artery velocity in centimeters per second	During baseline post the 20-min acute exercise
Primary	Cerebrovascular functions	Assessed by the middle and posterior cerebral artery velocity in centimeters per second	During the face-cooling test post the 20-min acute exercise
Primary	Cerebrovascular functions	Assessed by the middle and posterior cerebral artery velocity in centimeters per second	During the head-up tilt test post the 20-min acute exercise
Primary	Cerebrovascular functions	Assessed by the middle and posterior cerebral artery velocity in centimeters per second	During the cognitive tests post the 20-min acute exercise
Primary	Cerebral oxygenation level	Cerebral oxygenated hemoglobin in unknown unit	Change from baseline to the cognitive tests pre the 20-min acute exercise
Primary	Cerebral oxygenation level	Cerebral oxygenated hemoglobin in unknown unit	Change from baseline to the cognitive tests post the 20-min acute exercise
Primary	Cognitive function	Reaction time in second	During baseline pre the 20-min acute exercise
Primary	Cognitive function	Error made during the cognitive test in number	During baseline pre the 20-min acute exercise
Primary	Cognitive function	Reaction time in second	During head-up tilt pre the 20-min acute exercise
Primary	Cognitive function	Error made during the cognitive test in number	During head-up tilt pre the 20-min acute exercise
Primary	Cognitive function	Reaction time in second	During baseline post the 20-min acute exercise
Primary	Cognitive function	Error made during cognitive test in number	During baseline post the 20-min acute exercise
Primary	Cognitive function	Reaction time in second	During head-up tilt post the 20-min acute exercise
Primary	Cognitive function	Error made during the cognitive test in number	During head-up tilt post the 20-min acute exercise