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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06274658
• Other study ID #: STUDY00006517
• Status: Recruiting
• Start date: February 14, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: State University of New York at Buffalo
• Contact: Wenjie Ji, MS
• Phone: 7169072508
• Email: wji4[@]buffalo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 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

2. Classified as A, B, C, D (motor and sensory complete or incomplete) on the American Spinal Injury Association (ASIA) Impairment Scale (AIS)

3. Longer than 6 months post the onset of injury and have been discharged to the community from inpatient rehabilitation prior to enrollment

4. English is the first language

5. 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:

1. 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)

2. Moderate-severe traumatic brain injury

3. Diabetes

4. Color blindness

5. Pre-existing shoulder injuries

6. Pregnancy

Related Conditions & MeSH terms

• Autonomic Nervous System Disease
• Autonomic Nervous System Diseases
• Cognition
• Nervous System Diseases
• Primary Dysautonomias
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• High-intensity interval exercise
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.

Locations

Country	Name	City	State
United States	University at Buffalo, South Campus	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low frequency of systolic blood pressure variability	Biomarker for autonomic nervous system function	Baseline, Physiological tests pre- and 10 minutes post-exercise
Primary	High frequency of heart rate variability	Biomarker for autonomic nervous system function	Baseline, Physiological tests pre- and 10 minutes post-exercise
Primary	Blood pressure	Biomarker for autonomic nervous system function	Baseline, Physiological tests pre- and 10 minutes post-exercise
Primary	Heart rate	Biomarker for autonomic nervous system function	Baseline, Physiological tests pre- and 10 minutes post-exercise
Secondary	Cerebral blood flow velocity	Biomarker for cerebrovascular function	Baseline, cognitive tests pre- and 10-minutes post-exercise
Secondary	Symbol Digit Matched Test score	Assessment for cognitive function	Baseline, cognitive tests pre- and 10-minutes post-exercise
Secondary	California Verbal Learning Test score	Assessment for cognitive function	Baseline, cognitive tests pre- and 10-minutes post-exercise
Secondary	Color-Word Stroop Test score	Assessment for cognitive function	Baseline, cognitive tests pre- and 10-minutes post-exercise
Secondary	Controlled Word Association Task score	Assessment for cognitive function	Baseline, cognitive tests pre- and 10-minutes post-exercise