Spinal Cord InjuriesNCT05542238
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
A study testing One bout of moderate-intensity sub-maximal aerobic exercise in people with Spinal Cord Injuries and Cardiovascular Abnormalities, run by State University of New York at Buffalo at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Cardiovascular Abnormalities, Cerebrovascular Disease; Sequelae
- What is being tested?
- One bout of moderate-intensity sub-maximal aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 18 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Department of Rehabilitation Sciences at University at Buffalo
Buffalo, New York, 14214
About this study
Official title: The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury: a Pilot Study
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.
- Conditions
- Spinal Cord Injuries, Cardiovascular Abnormalities, Cerebrovascular Disease; Sequelae, Cognitive Impairment
- Being tested
- One bout of moderate-intensity sub-maximal aerobic exercise
- Medical subject headings
- Spinal Cord Injuries, Cardiovascular Abnormalities, Cerebrovascular Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One bout of moderate-intensity sub-maximal aerobic exerciseBehavioural
The intervention is a 20-min acute exercise using arm ergometer
| Study group | Role | What they receive |
|---|---|---|
| CON | Active comparator | Age-and sex-matched healthy controls with exercise intervention Receives: Behavioral: One bout of moderate-intensity sub-maximal aerobic exercise |
| SCI | Experimental | Individuals with spinal cord injury Receives: Behavioral: One bout of moderate-intensity sub-maximal aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Measured: During baseline pre the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Measured: During baseline pre the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Measured: During face-cooling test pre the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Measured: During face-cooling test pre the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Measured: During head-up tilt test pre the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Measured: During head-up tilt test pre the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Measured: During cognitive tests pre the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Measured: During cognitive tests pre the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Measured: During baseline post the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Measured: During face-cooling post the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Measured: During face-cooling post the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Measured: During head-up tilt test post the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Measured: During head-up tilt test post the 20-min acute exercise
Cardiac sympathetic function
Low frequency component of blood pressure variability in mmHg^2
Measured: During cognitive tests post the 20-min acute exercise
Cardiac parasympathetic function
High frequency component of heart rate variability in mm^2
Measured: During cognitive tests post the 20-min acute exercise
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Measured: During baseline pre the 20-min acute exercise
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Measured: 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
Measured: 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
Measured: 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
Measured: During baseline post the 20-min acute exercise
Cerebrovascular functions
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Measured: 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
Measured: 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
Measured: During the cognitive tests post the 20-min acute exercise
Cerebral oxygenation level
Cerebral oxygenated hemoglobin in unknown unit
Measured: Change from baseline to the cognitive tests pre the 20-min acute exercise
Cerebral oxygenation level
Cerebral oxygenated hemoglobin in unknown unit
Measured: Change from baseline to the cognitive tests post the 20-min acute exercise
Cognitive function
Reaction time in second
Measured: During baseline pre the 20-min acute exercise
Cognitive function
Error made during the cognitive test in number
Measured: During baseline pre the 20-min acute exercise
Cognitive function
Reaction time in second
Measured: During head-up tilt pre the 20-min acute exercise
Cognitive function
Error made during the cognitive test in number
Measured: During head-up tilt pre the 20-min acute exercise
Cognitive function
Reaction time in second
Measured: During baseline post the 20-min acute exercise
Cognitive function
Error made during cognitive test in number
Measured: During baseline post the 20-min acute exercise
Cognitive function
Reaction time in second
Measured: During head-up tilt post the 20-min acute exercise
Cognitive function
Error made during the cognitive test in number
Measured: During head-up tilt post the 20-min acute exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start6 Sep 2022
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Why it stopped: We have enrolled all the required participants for this pilot study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenjie Ji, State University of New York at Buffalo
- Investigators
- Wenjie Ji, MS, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542238
- Sponsor's protocol ID
- STUDY00006517-Pilot
- Status last verified
- Mar 2025
- First submitted
- 7 Sep 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury: a Pilot Study
- ClinicalTrials.gov ID
- NCT05542238
- Acronym / sponsor ID
- STUDY00006517-Pilot
- Conditions
- Spinal Cord Injuries, Cardiovascular Abnormalities, Cerebrovascular Disease; Sequelae, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We have enrolled all the required participants for this pilot study.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CON | Active comparator | Behavioral: One bout of moderate-intensity sub-maximal aerobic exerciseAge-and sex-matched healthy controls with exercise intervention |
| SCI | Experimental | Behavioral: One bout of moderate-intensity sub-maximal aerobic exerciseIndividuals with spinal cord injury |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One bout of moderate-intensity sub-maximal aerobic exerciseThe intervention is a 20-min acute exercise using arm ergometer | Behavioural | CON, SCI |
Primary outcome
Cardiac sympathetic function
Time frame: During baseline pre the 20-min acute exercise
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
Time frame: During baseline pre the 20-min acute exercise
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Time frame: During face-cooling test pre the 20-min acute exercise
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
Time frame: During face-cooling test pre the 20-min acute exercise
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Time frame: During head-up tilt test pre the 20-min acute exercise
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
Time frame: During head-up tilt test pre the 20-min acute exercise
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Time frame: During cognitive tests pre the 20-min acute exercise
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
Time frame: During cognitive tests pre the 20-min acute exercise
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Time frame: During baseline post the 20-min acute exercise
Low frequency component of blood pressure variability in mmHg^2
Cardiac sympathetic function
Time frame: During face-cooling post the 20-min acute exercise
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
Time frame: During face-cooling post the 20-min acute exercise
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Time frame: During head-up tilt test post the 20-min acute exercise
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
Time frame: During head-up tilt test post the 20-min acute exercise
High frequency component of heart rate variability in mm^2
Cardiac sympathetic function
Time frame: During cognitive tests post the 20-min acute exercise
Low frequency component of blood pressure variability in mmHg^2
Cardiac parasympathetic function
Time frame: During cognitive tests post the 20-min acute exercise
High frequency component of heart rate variability in mm^2
Cerebrovascular functions
Time frame: During baseline pre the 20-min acute exercise
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Time frame: During the face-cooling test pre the 20-min acute exercise
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Time frame: During the head-up tilt test pre the 20-min acute exercise
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Time frame: During the cognitive tests pre the 20-min acute exercise
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Time frame: During baseline post the 20-min acute exercise
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Time frame: During the face-cooling test post the 20-min acute exercise
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Time frame: During the head-up tilt test post the 20-min acute exercise
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebrovascular functions
Time frame: During the cognitive tests post the 20-min acute exercise
Assessed by the middle and posterior cerebral artery velocity in centimeters per second
Cerebral oxygenation level
Time frame: Change from baseline to the cognitive tests pre the 20-min acute exercise
Cerebral oxygenated hemoglobin in unknown unit
Cerebral oxygenation level
Time frame: Change from baseline to the cognitive tests post the 20-min acute exercise
Cerebral oxygenated hemoglobin in unknown unit
Cognitive function
Time frame: During baseline pre the 20-min acute exercise
Reaction time in second
Cognitive function
Time frame: During baseline pre the 20-min acute exercise
Error made during the cognitive test in number
Cognitive function
Time frame: During head-up tilt pre the 20-min acute exercise
Reaction time in second
Cognitive function
Time frame: During head-up tilt pre the 20-min acute exercise
Error made during the cognitive test in number
Cognitive function
Time frame: During baseline post the 20-min acute exercise
Reaction time in second
Cognitive function
Time frame: During baseline post the 20-min acute exercise
Error made during cognitive test in number
Cognitive function
Time frame: During head-up tilt post the 20-min acute exercise
Reaction time in second
Cognitive function
Time frame: During head-up tilt post the 20-min acute exercise
Error made during the cognitive test in number
Results and safety
The study was stopped early (reason given: We have enrolled all the required participants for this pilot study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenjie Ji, MS principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One bout of moderate-intensity sub-maximal aerobic exercise in people with Spinal Cord Injuries and Cardiovascular Abnormalities, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We have enrolled all the required participants for this pilot study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac sympathetic function (time frame: During baseline pre the 20-min acute exercise). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.