NCT06274658

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

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 13, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 14, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

February 13, 2024

Last Update Submit

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.

Behavioral: High-intensity interval exercise

Non-injured Controls

This group includes age- and sex-matched non-injured control participants.

Behavioral: High-intensity interval exercise

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.

Non-injured ControlsSpinal Cord Injury

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Location

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.

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wenjie Ji, MS

    University at Buffalo

    PRINCIPAL INVESTIGATOR

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

Locations