A feasibility study of an early exercise intervention to improve health in individuals with acute spinal cord injury
- Conditions
- Acute spinal cord injuryInjury, Occupational Diseases, PoisoningInjury of spinal cord, level unspecified
- Registration Number
- ISRCTN57514022
- Lead Sponsor
- niversity of Bath
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36737096/ (added 06/02/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
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
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 (<4 weeks) MI or cardiac surgery
5. Intubation or tracheostomy
6. Individuals who self-report significant upper extremity pain (score of > 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 Women who become pregnant will be advised to notify clinical staff, and upon notification, will be withdrawn from the trial.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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> All measured at the completion of the study:<br> 1. Participant recruitment rate: the proportion of eligible patients who accept the invitation to participate in the research study<br> 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.<br> 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<br> 4. Completion rates for each outcome measure evaluated to determine if an outcome measure should be removed<br>
- Secondary Outcome Measures
Name Time Method