Adults with spinal cord injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
The arm-crank exercise training (ACET) group will undertake 8 weeks of home-based ACET, 30 minutes/day, 5 days/week, at a moderate intensity. A stationary arm bike will be provided to each participati
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are aged 16 years old and above 2. Have a cervical or thoracic spinal cord injury (AIS A-D) 3. Have had the injury for 2 years or less 4. Have the ability to voluntarily move the elbow to operate the arm bike, bandage or active grip can be used to help holding the pedals
Exclusion criteria
Exclusion criteria: 1. Have ongoing issues with shoulder instability or shoulder pain 2. Are unable to use the bike due to lack of muscle activity to activate the bike (e.g., ASIA B or C at cervical level). This will assess case-by-case. 3. Have contraindications to exercise or have been advised to avoid exercise by their doctor (e.g., postural hypotension, ulcers, pregnancy) 4. Are not able to understand verbal explanations or written information given in English. 5. Are currently staying in a private medical centre or in a hospital for their continuing recovery from SCI. 6. Are currently participating in a trial involving an exercise intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure (pre- and post-intervention, unless specified): 1. Adherence to the intervention: exercise duration, intensity, and frequency recorded by the exercise diary will be analysed to evaluate participants’ adherence to the arm-crank exercise training (ACET). 2. An exit survey for usability, perceived effectiveness, and satisfaction will be used at post-intervention only. 3. Focus groups results. Participants in the intervention group will be invited to attend a focus group to discuss their views on the ACET intervention. The focus group will consist of between 5-8 participants, last <60 minutes, and will be conducted in person in a mutually agreed place or remotely via Zoom. An experienced moderator will run the focus group and data will be audio recorded via a secure password protected digital recording device. The recorded discussions will subsequently be transcribed by members of the research team for further analysis. 4. The recruitment rate: [(number recruited/number approached) x100%] 5. The retention rate: [(number completed/number recruited) x100%] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures (pre- and post-intervention) 1. Muscle activity of the key muscles below the level of injury during maximal and submaximal voluntary contractions (MVCs), measured by surface electromyography. 2. Functional reach tasks. This is to assess sitting balance. Participants will be instructed to reach to multiple directions (forward, right side, and left side) with one arm as far as they can without losing balance. Muscle activity of the trunk and movement of the trunk will be recorded using surface electromyography and inertial measurement units. 3. Modified Ashworth Scale (MAS). MAS is a clinical scale that measures resistance of a muscle in response to manual passive muscle stretching. It will be manually applied by a trained experimenter to assess spasticity in the knee extensors and ankle plantar flexor. 4. Fitness and endurance will be measured by the graded exercise test and 3-minutes arm test on an arm ergometer. 5. Mobility, assessed by accelerometer worn by the participant for 7 days. 6. Pain, psychological wellbeing and health-related quality of life will be assessed via questionnaires: a visual analogue scale, the Patient Health Questionnaire-9, Generalised Anxiety Disorder Assessment (GAD-7), and the short-form 36. | — |
Countries
England, United Kingdom
Outcome results
None listed