Sub-acute spinal cord injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
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 (
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
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are pregnant (women who become pregnant will be advised to notify clinical staff, and upon notification, will be withdrawn from the trial) 2.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 10/06/2025: At three 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): 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-A3. 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. Previous primary outcome measure: 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): 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 10/06/2025: Three 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): 1. Cardiac structure and function. Transthoracic echocardiography (TTE) will be performed using a Vivid iq ultrasound system (General Electric Medical, Norway) in accordance with recommendations of the American Society for Echocardiography at A1-A4. 2. Extracranial vascular/Cerebrovascular measures. Blood velocity and vessel diameter of the left and right common carotid artery (CCA), internal carotid artery (ICA), external carotid artery (ECA), and vertebral artery (VA) will be measured via ultrasound at A1-A4. 3. Heart rhythm disturbances and BP instability over a 24-hour period. Continuous electrocardiogram (ECG) and periodic (day time: every 15 minutes; night-time: every hour) brachial BP measurements will be recorded using a Holter monitor and ambulatory BP monitor (Welch Allyn Mobil-O-Graph), respectively at A2-A4. 4. Heart rate variability (HRV). The non-stationary balance between sympathetic and parasympathetic branches of the cardiac autonomic nervous system will be assessed using ECG in accordance with best practice recommendations at A1-A4. 5. Cardiorespiratory fitness. V?O2peak and peak power output will be determined using a graded CPET performed on an arm-crank ergometer until volitional exhaustion at A2-A4. Expired gases will be collected using a calibrated, portable metabolic cart (COSMED K5, Italy). 6. Cardiovascular disease risk blood biomarkers assessed at A1-A4. Biochemical outcomes include metabolic (i.e., triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, glucose, insulin) and inflammatory (i.e., leptin and adiponectin, interleukin-6, C-reactive protein) biomarkers. 7. Characterising weekly rehabilitation energy expenditure. Participants will wear an individually cal | — |
Countries
England, United Kingdom
Outcome results
None listed