Acute spinal cord injury Injury, Occupational Diseases, Poisoning Injury of spinal cord, level unspecified
Conditions
Interventions
The study will involve a total of three assessment visits (~5 hours each) which will take place before, at the midpoint and after an 18-week exercise intervention (or control group). For these visits,
week 6 and week 16. A small subset of participants will be asked to participate in a semi-structured interview over the phone or on a video call in weeks 9 and 18. Clinicians will also take part in t
Sponsors
University of Bath
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 2. Aged greater than 18 years 3. Individuals who have had their SCI for less than 6 months (any level injury/AIS grade assuming the remaining criteria are met) 4. Sufficient upper extremity motor function to complete arm crank ergometry exercise (we will acquire visual confirmation of the participant's ability to perform four upper extremity movements: elbow flexion against gravity, wrist extension against gravity, elbow extension against gravity, and making a fist with the thumb on the outside) 5. Use a wheelchair for at least 75% of their day
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 15/11/2022: Individuals presenting with any of the following will be excluded from participating in the trial: 1. Unresolved pressure ulcer 2. Upper limb pain that limits exercise 3. Recurrent acute infection or illness 4. Previous ( 60 on the Wheelchair Users Shoulder Pain Index (WUSPI) 7. Women who become pregnant will be advised to notify clinical staff, and upon notification, will be withdrawn from the trial. 8. Cognitive impairment deemed a risk by the healthcare team for participation in the trial (e.g. diagnosis of neurodegenerative disease) 9. Unable to understand explanations and/or provide informed consent 10. Any condition and/or behaviour that would pose undue personal risk or introduce bias into the trial Previous exclusion criteria: Individuals presenting with any of the following will be excluded from participating in the trial: 1. Unresolved pressure ulcer 2. Upper limb pain that limits exercise 3. Recurrent acute infection or illness 4. Previous MI or cardiac surgery 5. Taking medications for diagnosed type 1 or 2 diabetes 6. Intubation or tracheostomy 7. Currently taking anti-hypertensive medication (excluding drugs for acute autonomic dysreflexia) 8. Individuals who self-report significant upper extremity pain (score of > 60 on the Wheelchair Users Shoulder Pain Index (WUSPI) 9. Women who become pregnant will be advised to notify clinical staff, and upon notification, will be withdrawn from the trial. 10. Cognitive impairment deemed a risk by the healthcare team for participation in the trial (e.g. diagnosis of neurodegenerative disease) 11. Unable to understand explanations and/or provide informed consent 12. Any condition and/or behaviour that would pose undue personal risk or introduce bias into the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All measured at the completion of the study: 1. Participant recruitment rate: the proportion of eligible patients who accept the invitation to participate in the research study 2. Retention and adherence: the proportion of participants who complete the study and, for those in the intervention group, the proportion of intervention sessions completed. 3. The acceptability of the intervention, study design and outcome measures as well as participants’ and clinicians’ experiences with the intervention, assessed qualitatively using open-ended surveys and interview data for patient and staff groups analysed using thematic analysis 4. Completion rates for each outcome measure evaluated to determine if an outcome measure should be removed | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Shoulder pain measured using the Wheelchair Users Shoulder Pain Index (WUSPI) (questionnaire) weekly throughout the study 2. Free-living energy expenditure measured using a wrist-mounted physical activity monitor (GENEActive) at week 0, 9, 18 3. Cardiorespiratory fitness measured using the peak oxygen consumption test on an arm cycle ergometer at week 0, 9, 18 4. Insulin resistance/sensitivity measured using the oral glucose tolerance test (OGTT) at week 0, 9, 18 5. Cardiovascular disease risk measured using fasting blood samples (triglycerides, total cholesterol, non-esterified fatty acids, high-density lipoprotein (HDL) cholesterol and low-density lipoprotein (LDL) cholesterol) at week 0, 9, 18 6. Quality of life measured using the Medical Outcome Study SF-36 - wheelchair adapted (questionnaire) at week 0, 9, 18 7. Independence measured using the Spinal Cord Injury Measure - III (SCIM-III) (questionnaire) at week 0, 9, 18 | — |
Countries
England, United Kingdom
Outcome results
None listed