The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People With Spinal Cord Injury
1 other identifier
observational
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2024
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2024
CompletedStudy Start
First participant enrolled
February 14, 2024
CompletedFirst Posted
Study publicly available on registry
February 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedSeptember 3, 2025
August 1, 2025
1.4 years
February 13, 2024
August 26, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Low frequency of systolic blood pressure variability
Biomarker for autonomic nervous system function
Baseline, Physiological tests pre- and 10 minutes post-exercise
High frequency of heart rate variability
Biomarker for autonomic nervous system function
Baseline, Physiological tests pre- and 10 minutes post-exercise
Blood pressure
Biomarker for autonomic nervous system function
Baseline, Physiological tests pre- and 10 minutes post-exercise
Heart rate
Biomarker for autonomic nervous system function
Baseline, Physiological tests pre- and 10 minutes post-exercise
Secondary Outcomes (5)
Cerebral blood flow velocity
Baseline, cognitive tests pre- and 10-minutes post-exercise
Symbol Digit Matched Test score
Baseline, cognitive tests pre- and 10-minutes post-exercise
California Verbal Learning Test score
Baseline, cognitive tests pre- and 10-minutes post-exercise
Color-Word Stroop Test score
Baseline, cognitive tests pre- and 10-minutes post-exercise
Controlled Word Association Task score
Baseline, cognitive tests pre- and 10-minutes post-exercise
Study Arms (2)
Spinal Cord Injury
This group includes people with spinal cord injury and the level of injury is at the 6th thoracic vertebra or above.
Non-injured Controls
This group includes age- and sex-matched non-injured control participants.
Interventions
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.
Eligibility Criteria
This study will include people with SCI with level of injury T6 or above and age- and sex-matched non-injured controls.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University at Buffalo, South Campus
Buffalo, New York, 14214, United States
Related Publications (1)
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.
PMID: 40591703DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wenjie Ji, MS
University at Buffalo
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 13, 2024
First Posted
February 23, 2024
Study Start
February 14, 2024
Primary Completion
June 30, 2025
Study Completion
July 31, 2025
Last Updated
September 3, 2025
Record last verified: 2025-08