Autonomic Nervous System DiseaseNCT06274658
The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People With Spinal Cord Injury
An observational study of Autonomic Nervous System Disease and Spinal Cord Injuries, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Disease, Spinal Cord Injuries, Cognition
- What is being tested?
- High-intensity interval exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to 31 Jul 2025
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include people with SCI with level of injury T6 or above and age- and sex-matched non-injured controls.
Who may be able to join
- Diagnosed with a traumatic or non-traumatic spinal cord injury and have ≥4/5 strength in at least one cervical 5 myotome (elbow flexors), allowing to utilize the arm ergometer and level of injury at or above the 6th thoracic vertebra
- Classified as A, B, C, D (motor and sensory complete or incomplete) on the American Spinal Injury Association (ASIA) Impairment Scale (AIS)
- Longer than 6 months post the onset of injury and have been discharged to the community from inpatient rehabilitation prior to enrollment
- English is the first language
- At least one of the cerebral arteries (i.e., middle cerebral artery and/or posterior cerebral artery) can be found via transcranial Doppler
Who cannot join
- Medical conditions that preclude exercise, such as unstable angina, uncontrolled arrhythmias, a recent history of congestive heart failure that has not been evaluated and effectively treated, severe valvular disease, uncontrolled hypertension (i.e., resting systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg)
- Moderate-severe traumatic brain injury
- Diabetes
- Color blindness
- Pre-existing shoulder injuries
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University at Buffalo, South Campus
Buffalo, New York, 14214
About this study
Official title: The Effects of an Acute High-intensity Interval Training on Heart and Brain Function in People With Spinal Cord Injury
The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls.
Read the detailed description
This study will be a cohort control study involving two groups: individuals with SCI, whose level of injury is at the 6th thoracic vertebra or above, and age- and sex-matched controls. Eligible participants will be asked to visit the Laboratory located at 115 Kimball Tower, University at Buffalo South Campus, twice. The first visit takes up to 3 hours, and the second visit takes up to 5 hours.
- Being tested
- High-intensity interval exercise
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval exerciseBehavioural
Three high-intensity exercise bouts, each at 100% of maximal power output for 20 seconds, interspersed with active recovery periods of 120 seconds at 10% of maximal power output.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Injury | This group includes people with spinal cord injury and the level of injury is at the 6th thoracic vertebra or above. Receives: Behavioral: High-intensity interval exercise | |
| Non-injured Controls | This group includes age- and sex-matched non-injured control participants. Receives: Behavioral: High-intensity interval exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low frequency of systolic blood pressure variability
Biomarker for autonomic nervous system function
Measured: Baseline, Physiological tests pre- and 10 minutes post-exercise
High frequency of heart rate variability
Biomarker for autonomic nervous system function
Measured: Baseline, Physiological tests pre- and 10 minutes post-exercise
Blood pressure
Biomarker for autonomic nervous system function
Measured: Baseline, Physiological tests pre- and 10 minutes post-exercise
Heart rate
Biomarker for autonomic nervous system function
Measured: Baseline, Physiological tests pre- and 10 minutes post-exercise
Secondary outcomes (5)
Cerebral blood flow velocity
Biomarker for cerebrovascular function
Measured: Baseline, cognitive tests pre- and 10-minutes post-exercise
Symbol Digit Matched Test score
Assessment for cognitive function
Measured: Baseline, cognitive tests pre- and 10-minutes post-exercise
California Verbal Learning Test score
Assessment for cognitive function
Measured: Baseline, cognitive tests pre- and 10-minutes post-exercise
Color-Word Stroop Test score
Assessment for cognitive function
Measured: Baseline, cognitive tests pre- and 10-minutes post-exercise
Controlled Word Association Task score
Assessment for cognitive function
Measured: Baseline, cognitive tests pre- and 10-minutes post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start14 Feb 2024
- Primary completion30 Jun 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autonomic Nervous System DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT06274658
- Sponsor's protocol ID
- STUDY00006517
- Status last verified
- Aug 2025
- First submitted
- 13 Feb 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ji W, Wecht JM, Jo HJ, Stefanovic F, Miecznikowski J, Chiaravalloti ND, Sisto SA. Effects of a single bout of high-intensity-interval exercise on cardiovascular autonomic, cerebrovascular, and cognitive function in people with spinal cord injury: A study protocol. PLoS One. 2025 Jul 1;20(7):e0326861. doi: 10.1371/journal.pone.0326861. eCollection 2025.
PubMed 40591703
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Acute High-intensity Interval Training on Heart and Brain Function in People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06274658
- Acronym / sponsor ID
- STUDY00006517
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 23 Feb 2024 (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 heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls.
Detailed description
This study will be a cohort control study involving two groups: individuals with SCI, whose level of injury is at the 6th thoracic vertebra or above, and age- and sex-matched controls. Eligible participants will be asked to visit the Laboratory located at 115 Kimball Tower, University at Buffalo South Campus, twice. The first visit takes up to 3 hours, and the second visit takes up to 5 hours.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury | – | Behavioral: High-intensity interval exerciseThis group includes people with spinal cord injury and the level of injury is at the 6th thoracic vertebra or above. |
| Non-injured Controls | – | Behavioral: High-intensity interval exerciseThis group includes age- and sex-matched non-injured control participants. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include people with SCI with level of injury T6 or above and age- and sex-matched non-injured controls.
Key inclusion criteria (5 listed)
- Diagnosed with a traumatic or non-traumatic spinal cord injury and have ≥4/5 strength in at least one cervical 5 myotome (elbow flexors), allowing to utilize the arm ergometer and level of injury at or above the 6th thoracic vertebra
- Classified as A, B, C, D (motor and sensory complete or incomplete) on the American Spinal Injury Association (ASIA) Impairment Scale (AIS)
- Longer than 6 months post the onset of injury and have been discharged to the community from inpatient rehabilitation prior to enrollment
- English is the first language
- At least one of the cerebral arteries (i.e., middle cerebral artery and/or posterior cerebral artery) can be found via transcranial Doppler
Key exclusion criteria (6 listed)
- Medical conditions that preclude exercise, such as unstable angina, uncontrolled arrhythmias, a recent history of congestive heart failure that has not been evaluated and effectively treated, severe valvular disease, uncontrolled hypertension (i.e., resting systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg)
- Moderate-severe traumatic brain injury
- Diabetes
- Color blindness
- Pre-existing shoulder injuries
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 |
|---|---|---|
| High-intensity interval exerciseThree high-intensity exercise bouts, each at 100% of maximal power output for 20 seconds, interspersed with active recovery periods of 120 seconds at 10% of maximal power output. | Behavioural | Non-injured Controls, Spinal Cord Injury |
Primary outcome
Low frequency of systolic blood pressure variability
Time frame: Baseline, Physiological tests pre- and 10 minutes post-exercise
Biomarker for autonomic nervous system function
High frequency of heart rate variability
Time frame: Baseline, Physiological tests pre- and 10 minutes post-exercise
Biomarker for autonomic nervous system function
Blood pressure
Time frame: Baseline, Physiological tests pre- and 10 minutes post-exercise
Biomarker for autonomic nervous system function
Heart rate
Time frame: Baseline, Physiological tests pre- and 10 minutes post-exercise
Biomarker for autonomic nervous system function
5 secondary outcomes
Cerebral blood flow velocity
Time frame: Baseline, cognitive tests pre- and 10-minutes post-exercise
Symbol Digit Matched Test score
Time frame: Baseline, cognitive tests pre- and 10-minutes post-exercise
California Verbal Learning Test score
Time frame: Baseline, cognitive tests pre- and 10-minutes post-exercise
Color-Word Stroop Test score
Time frame: Baseline, cognitive tests pre- and 10-minutes post-exercise
Controlled Word Association Task score
Time frame: Baseline, cognitive tests pre- and 10-minutes post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Derived from this study: PubMed 40591703Ji W, Wecht JM, Jo HJ, Stefanovic F, Miecznikowski J, Chiaravalloti ND, Sisto SA. Effects of a single bout of high-intensity-interval exercise on cardiovascular autonomic, cerebrovascular, and cognitive function in people with spinal cord injury: A study protocol. PLoS One. 2025 Jul 1;20(7):e0326861. doi: 10.1371/journal.pone.0326861. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Autonomic Nervous System Disease and Spinal Cord Injuries, 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 3 Sep 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Low frequency of systolic blood pressure variability (time frame: Baseline, Physiological tests pre- and 10 minutes post-exercise). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06274658, which also lists 1 linked publication.
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 3 Sep 2025.