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

Time is of the essence: the impact of early initiated upper-body aerobic exercise on cardiovascular health following spinal cord injury

Registry ID
ISRCTN99941302
Source registry
ISRCTN
Status
No longer recruiting
Study type
INTERVENTIONAL
Sponsor
University of Birmingham
Enrollment
42
Start date
2023-06-01
Completion date
2026-06-30
Last update
2026-08-17

Conditions

Summary

Sub-acute spinal cord injury

Detailed description

Current interventions as of 10/06/2025: This study will involve a total of 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). Following another visit 36 weeks after discharge from the hospital (A4) will be for Health Related Quality of Life assessments only. These assessment visits can be split across two separate days if requested by the participant (either due to fatigue or perceived burden) or the clinical management team. During these visits, a trained phlebotomist will take a fasting (>10 hours) blood sample from a forearm vein. Central arterial stiffness (primary outcome measure) will be determined, along with ultrasound assessments performed by a trained sonographer to determine cardiac structure and function. Cerebrovascular outcomes will also be assessed (blood flow velocity and vessel diameter of extracranial arteries) as well as cognitive function, using a shortened neuropsychological test battery. Participants will be asked to complete three health-related quality of life questionnaires and wear devices to capture heart rhythm disturbances, heart rate variability and blood pressure instability over a 24-hour period. For A2-A3, participants will also be asked to wear a physical activity monitor for 5 days, perform a cardiopulmonary exercise test (CPET) to exhaustion on an arm-crank ergometer and undergo a motor function assessment to determine sitting balance. Participants will also be asked to complete a usability and satisfaction questionnaire at the end of the intervention period. Participants will be invited to participate in two, one-to-one, semi-structure interviews via Zoom at completion of the intervention and at follow-up to discuss their views on the intervention received and the impact of the intervention on their recovery and integration into the community. In person focus groups will also be performed with staff (clinicians

Interventions

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

Locations

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