- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06274658
The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People With Spinal Cord Injury
August 26, 2025 updated by: Wenjie Ji, State University of New York at Buffalo
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14214
- University at Buffalo, South Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
This study will include people with SCI with level of injury T6 or above and age- and sex-matched non-injured controls.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Spinal Cord Injury
This group includes people with spinal cord injury and the level of injury is at the 6th thoracic vertebra or above.
|
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.
|
|
Non-injured Controls
This group includes age- and sex-matched non-injured control participants.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Low frequency of systolic blood pressure variability
Time Frame: Baseline, Physiological tests pre- and 10 minutes post-exercise
|
Biomarker for autonomic nervous system function
|
Baseline, Physiological tests pre- and 10 minutes post-exercise
|
|
High frequency of heart rate variability
Time Frame: Baseline, Physiological tests pre- and 10 minutes post-exercise
|
Biomarker for autonomic nervous system function
|
Baseline, Physiological tests pre- and 10 minutes post-exercise
|
|
Blood pressure
Time Frame: Baseline, Physiological tests pre- and 10 minutes post-exercise
|
Biomarker for autonomic nervous system function
|
Baseline, Physiological tests pre- and 10 minutes post-exercise
|
|
Heart rate
Time Frame: Baseline, Physiological tests pre- and 10 minutes post-exercise
|
Biomarker for autonomic nervous system function
|
Baseline, Physiological tests pre- and 10 minutes post-exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cerebral blood flow velocity
Time Frame: Baseline, cognitive tests pre- and 10-minutes post-exercise
|
Biomarker for cerebrovascular function
|
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
|
Assessment for cognitive function
|
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
|
Assessment for cognitive function
|
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
|
Assessment for cognitive function
|
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
|
Assessment for cognitive function
|
Baseline, cognitive tests pre- and 10-minutes post-exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wenjie Ji, MS, University at Buffalo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2024
Primary Completion (Actual)
June 30, 2025
Study Completion (Actual)
July 31, 2025
Study Registration Dates
First Submitted
February 13, 2024
First Submitted That Met QC Criteria
February 20, 2024
First Posted (Actual)
February 23, 2024
Study Record Updates
Last Update Posted (Estimated)
September 3, 2025
Last Update Submitted That Met QC Criteria
August 26, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Spinal Cord Injuries
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Physical Conditioning, Human
- Exercise
- High-Intensity Interval Training
Other Study ID Numbers
- STUDY00006517
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injuries
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingInjury, Spinal Cord
-
Khon Kaen UniversityUnknownInjuries, Spinal Cord
-
Universidade do Vale do ParaíbaCompletedInjuries, Spinal Cord
-
Institut GuttmannNot yet recruitingSpinal Cord Injury | Spinal Cord Disease | Spinal Cord Injuries (SCI) | Traumatic Spinal Cord InjuriesSpain
-
InVivo TherapeuticsTerminated
-
Ekso BionicsBurke Medical Research InstituteCompletedInjuries, Spinal CordUnited States
-
ReWalk Robotics, Inc.Unknown
-
Chang Gung Memorial HospitalNot yet recruitingSpine Injury | Complete Spinal Cord Injury | Incomplete Spinal Cord Injury | Cord Injury, Spinal | Cord Infarction Spinal
-
Kessler FoundationNot yet recruitingSpinal Cord Injury | Spinal Cord Disease | Spinal Cord Injuries (SCI)United States
Clinical Trials on High-intensity interval exercise
-
University of GuelphCompletedPost-Exercise Hypotension | Ambulatory Blood Pressure Monitoring | High-intensity Interval ExerciseCanada
-
Laboratoire des Adaptations Métaboliques à l'Exercice...CREPS Auvergne Rhône-Alpes / VichyCompletedOverweight | PostmenopausalFrance
-
Norwegian University of Science and TechnologySt. Olavs Hospital; Liverpool John Moores University; Australian Catholic UniversityCompletedPolycystic Ovary SyndromeAustralia, Norway
-
Norwegian University of Science and TechnologySt. Olavs Hospital; Liverpool John Moores University; Australian Catholic UniversityCompletedPolycystic Ovary SyndromeAustralia, Norway
-
New York State Psychiatric InstituteColumbia UniversityCompleted
-
Steno Diabetes Center CopenhagenRecruiting
-
Kaohsiung Medical University Chung-Ho Memorial...Ministry of Science and Technology, TaiwanRecruiting
-
Nationwide Children's HospitalCompleted
-
Ahlia UniversityCairo UniversityCompletedObesity | Diabetes | Exercise | Nonalcoholic Fatty Liver DiseaseEgypt
-
University of AlbertaAlberta Diabetes InstituteCompletedExercise Intensity, Glycemic Control and Abdominal Fat in People With Type 2 Diabetes: A Pilot StudyType 2 Diabetes MellitusCanada