Time is of the essence: how starting upper-body aerobic exercise early after a spinal cord injury can affect heart health

Not Applicable

• Conditions: Sub-acute spinal cord injury; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN99941302
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-02
• Last Update Posted: 13 June 2023
• Study Completion: 2026-05-17

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

For patients:
1. At least 18 years old
2. Males and females
3. Have had a motor-complete SCI (AIS A or B) at the cervical or thoracic level (between C5 - T12) within 3 months.
4. Are cleared by their medical team to begin standard of care rehabilitation
5. Can move their shoulders and arms voluntarily to operate the arm-crank ergometer
6. Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions.
7. Consent: demonstrates an understanding of the study and willingness to participate, as evidenced by voluntary written informed consent

For staff:
1. Currently be a member of the medical team supporting sub-acute spinal cord injured patients at MCSI
2. Be at least 18 years old
3. Be involved in the clinical care/rehabilitation of patients (e.g., clinician, occupational therapist, or physical therapist)

Exclusion Criteria

For patients:
1. Participants are pregnant (women who become pregnant will be advised to notify clinical staff, and upon notification, will be withdrawn from the trial)
2. Participants are under the age of 18 years
3. Participants have an SCI lower than the T12 neurological level
4. Participants have an SCI above the C5 neurological level, intubation, a trachea in situ or require mechanical ventilation
5. Have medical complications from the injury that in the opinion of the healthcare team would restrict or prevent the participation in exercise rehabilitation, pose an undue personal risk or introduce bias into the trial
6. Co-occurring traumatic brain injury or cognitive impairment that either impacts the ability to follow study instructions and/or provide informed consent
7. Unable to provide full informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
At four assessment visits (~4 hours each); with two taking place before (A1, A2) and one immediately after a 10-week exercise intervention (or standard of care control) (A3), with another visit 36 weeks after discharge from the hospital (A4):<br>Arterial stiffness. Arterial pulse waveforms will be acquired at two locations (carotid and femoral arteries) simultaneously to determine pulse transit time and carotid-to-femoral pulse wave velocity (cfPWV) at A1-A4. The Vicorder (Smart Medical, UK) system will be used with standard vascular cuffs, which has been shown to be a quick and highly reproducible technique for assessing cfPWV that is operator independent.