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

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University at Buffalo (UB)

Status

Terminated

Conditions

Cognitive Impairment
Cardiovascular Abnormalities
Spinal Cord Injuries
Cerebrovascular Disease; Sequelae

Treatments

Behavioral: One bout of moderate-intensity sub-maximal aerobic exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05542238
STUDY00006517-Pilot

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Factorial Assignment

Masking

None (Open label)

6 participants in 2 patient groups

CON
Active Comparator group
Description:
Age-and sex-matched healthy controls with exercise intervention
Treatment:
Behavioral: One bout of moderate-intensity sub-maximal aerobic exercise
SCI
Experimental group
Description:
Individuals with spinal cord injury
Treatment:
Behavioral: One bout of moderate-intensity sub-maximal aerobic exercise

Trial contacts and locations

1

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Central trial contact

Sue Ann Sisto, PhD; Wenjie Ji, MS

Data sourced from clinicaltrials.gov

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