NCT05542238

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2024

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

September 7, 2022

Last Update Submit

March 3, 2025

Conditions

Spinal Cord InjuriesCardiovascular AbnormalitiesCerebrovascular Disease; SequelaeCognitive Impairment

Outcome Measures

Primary Outcomes (33)

  • Cardiac sympathetic function

    Low frequency component of blood pressure variability in mmHg\^2

    During baseline pre the 20-min acute exercise

  • Cardiac parasympathetic function

    High frequency component of heart rate variability in mm\^2

    During baseline pre the 20-min acute exercise

  • Cardiac sympathetic function

    Low frequency component of blood pressure variability in mmHg\^2

    During face-cooling test pre the 20-min acute exercise

  • Cardiac parasympathetic function

    High frequency component of heart rate variability in mm\^2

    During face-cooling test pre the 20-min acute exercise

  • Cardiac sympathetic function

    Low frequency component of blood pressure variability in mmHg\^2

    During head-up tilt test pre the 20-min acute exercise

  • Cardiac parasympathetic function

    High frequency component of heart rate variability in mm\^2

    During head-up tilt test pre the 20-min acute exercise

  • Cardiac sympathetic function

    Low frequency component of blood pressure variability in mmHg\^2

    During cognitive tests pre the 20-min acute exercise

  • Cardiac parasympathetic function

    High frequency component of heart rate variability in mm\^2

    During cognitive tests pre the 20-min acute exercise

  • Cardiac sympathetic function

    Low frequency component of blood pressure variability in mmHg\^2

    During baseline post the 20-min acute exercise

  • Cardiac sympathetic function

    Low frequency component of blood pressure variability in mmHg\^2

    During face-cooling post the 20-min acute exercise

  • Cardiac parasympathetic function

    High frequency component of heart rate variability in mm\^2

    During face-cooling post the 20-min acute exercise

  • Cardiac sympathetic function

    Low frequency component of blood pressure variability in mmHg\^2

    During head-up tilt test post the 20-min acute exercise

  • Cardiac parasympathetic function

    High frequency component of heart rate variability in mm\^2

    During head-up tilt test post the 20-min acute exercise

  • Cardiac sympathetic function

    Low frequency component of blood pressure variability in mmHg\^2

    During cognitive tests post the 20-min acute exercise

  • Cardiac parasympathetic function

    High frequency component of heart rate variability in mm\^2

    During cognitive tests post the 20-min acute exercise

  • Cerebrovascular functions

    Assessed by the middle and posterior cerebral artery velocity in centimeters per second

    During baseline pre the 20-min acute exercise

  • 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

  • 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

  • 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

  • Cerebrovascular functions

    Assessed by the middle and posterior cerebral artery velocity in centimeters per second

    During baseline post the 20-min acute exercise

  • 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

  • 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

  • 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

  • Cerebral oxygenation level

    Cerebral oxygenated hemoglobin in unknown unit

    Change from baseline to the cognitive tests pre the 20-min acute exercise

  • Cerebral oxygenation level

    Cerebral oxygenated hemoglobin in unknown unit

    Change from baseline to the cognitive tests post the 20-min acute exercise

  • Cognitive function

    Reaction time in second

    During baseline pre the 20-min acute exercise

  • Cognitive function

    Error made during the cognitive test in number

    During baseline pre the 20-min acute exercise

  • Cognitive function

    Reaction time in second

    During head-up tilt pre the 20-min acute exercise

  • Cognitive function

    Error made during the cognitive test in number

    During head-up tilt pre the 20-min acute exercise

  • Cognitive function

    Reaction time in second

    During baseline post the 20-min acute exercise

  • Cognitive function

    Error made during cognitive test in number

    During baseline post the 20-min acute exercise

  • Cognitive function

    Reaction time in second

    During head-up tilt post the 20-min acute exercise

  • Cognitive function

    Error made during the cognitive test in number

    During head-up tilt post the 20-min acute exercise

Study Arms (2)

CON

ACTIVE COMPARATOR

Age-and sex-matched healthy controls with exercise intervention

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

SCI

EXPERIMENTAL

Individuals with spinal cord injury

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

Interventions

One bout of moderate-intensity sub-maximal aerobic exerciseBEHAVIORAL

The intervention is a 20-min acute exercise using arm ergometer

CONSCI

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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
  • years old
  • Proficient in English
  • Able to detect MCAv and/or PCAv signals through TCD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Sciences at University at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesCardiovascular AbnormalitiesCerebrovascular DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesCardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBrain DiseasesVascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Wenjie Ji, MS

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 15, 2022

Study Start

September 6, 2022

Primary Completion

December 18, 2024

Study Completion

December 18, 2024

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)