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Completed

NCT Number: NCT06274658

The Effects of an Acute High-intensity Exercise 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University at Buffalo, South Campus

Buffalo, New York, 14214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-Intensity Interval Exercise

Behavioral

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.

Primary outcomes

  1. Low frequency of systolic blood pressure variability

    Time frame: Baseline, Physiological tests pre- and 10 minutes post-exercise

    Biomarker for autonomic nervous system function

  2. High frequency of heart rate variability

    Time frame: Baseline, Physiological tests pre- and 10 minutes post-exercise

    Biomarker for autonomic nervous system function

  3. Blood pressure

    Time frame: Baseline, Physiological tests pre- and 10 minutes post-exercise

    Biomarker for autonomic nervous system function

  4. Heart rate

    Time frame: Baseline, Physiological tests pre- and 10 minutes post-exercise

    Biomarker for autonomic nervous system function

Secondary outcomes

  1. Cerebral blood flow velocity

    Time frame: Baseline, cognitive tests pre- and 10-minutes post-exercise

    Biomarker for cerebrovascular function

  2. Symbol Digit Matched Test score

    Time frame: Baseline, cognitive tests pre- and 10-minutes post-exercise

    Assessment for cognitive function

  3. California Verbal Learning Test score

    Time frame: Baseline, cognitive tests pre- and 10-minutes post-exercise

    Assessment for cognitive function

  4. Color-Word Stroop Test score

    Time frame: Baseline, cognitive tests pre- and 10-minutes post-exercise

    Assessment for cognitive function

  5. Controlled Word Association Task score

    Time frame: Baseline, cognitive tests pre- and 10-minutes post-exercise

    Assessment for cognitive function

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

The Effects of an Acute High-intensity Interval Training on Heart and Brain Function in People With Spinal Cord Injury

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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