Spinal cord injury Nervous System Diseases
Conditions
Interventions
This is a prospective, non-randomised, single-arm feasibility study, informed by prior research, PPIE input, and the multidisciplinary expertise of the study team. The study will evaluate the feasibil
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16 years and older 2. Diagnosed with cervical, thoracic, or lumbar SCI, and medically stable 3. Can provide informed consent and understand and follow instructions for assessment and intervention 4. Use a wheelchair for >=75% of their waking hours 5. Have sufficient elbow flexors strength to operate an arm-crank ergometer 6. Have access to a device and internet connection capable of running Zoom Due to the scope of this study being a feasibility study, the instructions will be given in English. We are aware of the translation services available in the NHS and will consider this for a future trial for the study to be fully inclusive. Additionally, the inclusion criteria for recruiting stakeholders to the qualitative focus group study are: 1. Aged 18 years and above 2. Qualified specialists for caring patients with spinal cord injury in the NHS SCI care pathways 3. At least 6 months experience in caring for people with SCI
Exclusion criteria
Exclusion criteria: 1. Presence of unstable or acute medical conditions that are contraindications for exercise 2. Clinical advice against unsupervised exercise from a consultant or physiotherapist 3. Participation in another research study targeting rehabilitation or health management
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participation rate measured using recruitment logs documenting number of participants recruited per month from NHS sites and community sources, supplemented where feasible by logs of individuals declining participation and qualitative feedback from focus groups at continuously during the recruitment period;Adherence to the intervention measured using number of completed sessions versus prescribed sessions recorded via class attendance logs and participant exercise diary, expressed as a percentage of total sessions offered at throughout the 12 week intervention period;Safety, including fatigue, shoulder pain, and adverse events measured using Fatigue Severity Scale, Wheelchair User’s Shoulder Pain Index, and self reported adverse events collected via participant report during biweekly telephone calls at baseline, every 2 weeks during the 12 week intervention, and end of intervention at 12 weeks;Attrition measured using study withdrawal records and completeness of follow up data from study database at assessed at end of intervention at 12 weeks and at any point of withdrawal during the study;Usability, perceived effectiveness and satisfaction measured using a self-reported online EXIT survey at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional capacity and cardiovascular fitness measured using Six-Minute Arm-Crank test (6-MAT) with recording of rating of perceived exertion RPE, heart rate HR and distance via arm ergometer and remote supervision at baseline, 12 weeks;Health-related quality of life across physical and mental health domains measured using Short Form 36 walk-wheel questionnaire (a modified version for SCI) at baseline, 12 weeks;Health-related quality of life and health utilities measured using EQ-5D-5L and SF-6D questionnaires with comparative analysis alongside SF-36 walk-wheel outputs at baseline, 12 weeks;Health care resource use measured using ModRUM questionnaire for self-reported resource use and Case Report Form for extraction of resource use data from NHS records at baseline, 12 weeks;Waist circumference measured using self-measured waist circumference in the supine position using a measuring tape by a carer or family member under remote supervision at baseline, 12 weeks;Bowel function measured using International Spinal Cord Injury Bowel Function Basic Data Set questionnaire at baseline, 12 weeks;Leisure time physical activity level measured using leisure time physical activity questionnaire at baseline, 12 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactChloe Chiou
Outcome results
None listed