Combined arm cycling and standard exercise training for improving trunk function after spinal cord injury
| ISRCTN | ISRCTN17864031 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17864031 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 289841 |
| Protocol serial number | IRAS 289841 |
| Sponsor | University of Birmingham |
| Funder | Inspire Foundation |
- Submission date
- 20/10/2020
- Registration date
- 29/10/2020
- Last edited
- 07/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Core control is essential for carrying out activities of daily living but is very often impaired after a spinal cord injury, hindering functional recovery. This project aims to study the effectiveness of combined arm cycling and standard exercise training in improving trunk function in individuals with a spinal cord injury. It is hoped that the arm cycling exercise will enhance the effectiveness of standard exercise training at improving trunk function in individuals with spinal cord injury.
Who can participate?
Adults (aged 18 years and above) with a stable, chronic cervical or thoracic, incomplete spinal cord injury are eligible to participate in the study. Additional inclusion criteria are to be able to voluntarily pedal the arm bike and to have some residual trunk control.
What does the study involve?
All participants will undertake exercise training for improving trunk control three times a week for 8 weeks. Of these, half of them will undertake an additional arm cycling exercise at home, and the other half will undertake static sitting exercise at home. Neural and functional assessments will be performed at the beginning and after 4 and 8 weeks. A follow-up assessment will be carried out at 8 weeks after completing the intervention.
What are the possible benefits and risks of participating?
Participants will benefit from the arm cycling exercise and rehabilitation training by directly exercising muscles of the arms and the core, thereby improving mobility and strength. Participants may experience muscle soreness of the arms and shoulders as a result of 30 minutes of arm cycling. However, the muscle soreness should last no longer than 3 days and can be eased by gentle stretching of the muscles. Some participants may experience a mild headache after the neural assessment. Taking a painkiller before the assessment or resting after the assessment usually can release the headache effectively.
Where is the study run from?
The study is run by a research team at the University of Birmingham in collaboration with the Midland Centre for Spinal Injuries at the Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT, and with the National Spinal Injuries Centre, Stoke Mandeville Hospital Buckinghamshire Healthcare NHS Trust (UK)
When is the study starting and how long is it expected to run for?
January 2021 to December 2024
Who is funding the study?
The INSPIRE Foundation (UK)
Who is the main contact?
Dr Chloe Chiou
s.chiou@bham.ac.uk
Contact information
Public
School of Sport, Exercise, and Rehabilitation Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0002-4200-5243 |
|---|---|
| Phone | +44 (0)121 414 5315 |
| s.chiou@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-arm randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Functional activity of upper extremities to improve trunk function after spinal cord injury |
| Study objectives | It is hypothesised that SCI participants undertaking the combined intervention will increase the ability to recruit trunk muscles for postural stability to a greater extent compared to those undertaking the therapeutic exercise training alone. |
| Ethics approval(s) | Approved 24/03/2021, West Midlands - Edgbaston Research Ethics Committee, REC ref: 21/WM/0047 |
| Health condition(s) or problem(s) studied | Stable, lower cervical or upper thoracic, incomplete spinal cord injury |
| Intervention | Participants will be randomized into one of the two groups: the experimental group and the control group using minimisation methods ensuring balance in prognostic factors (e.g. level of injury, years since injury) between groups. All participants will receive standard exercise training focusing on improving trunk control and postural stability 3 times per week for 8 weeks. Participants in the experimental group will undertake arm cycling exercise at home using a stationary arm bike provided by the research team for 30 minutes, 5 days per week, for 8 weeks. Participants in the control group will be instructed to practise static sitting without back support for the same amount of time. After completing the intervention, all participants will be followed up for 8 weeks to monitor whether the interventional effects outlast or not. Neurophysiological and functional assessments will be performed during the course of the intervention to monitor improvements in trunk control. Participants will stay in the trial for 16 weeks in total (8 weeks of intervention and 8 weeks of follow-up). |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Dynamic sitting balance assessed by multidirectional reach test at baseline, 4, 8 and 16 weeks |
| Key secondary outcome measure(s) |
1. Neuromuscular and corticospinal function of the trunk muscles measured using non-invasive transcranial magnetic stimulation at baseline, 4, 8 and 16 weeks |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | SCI participants will be included if they have: 1. A stable, lower cervical or upper thoracic, incomplete spinal cord injury. 2. Ability to voluntarily move the elbow to operate the arm bike. 3. Visible motor evoked potentials (MEPs) in erector spinae (ES) muscles induced by transcranial magnetic stimulation (TMS). This is to ensure changes in corticospinal function are measurable |
| Key exclusion criteria | Participants will be excluded if they meet the criteria for exclusion for the use of TMS (Rossi et al., 2011): 1. Metal implants, cardiac pacemaker, history of epilepsy or fits, previous brain injury, neurosurgery of the brain, neurological disorders other than spinal cord injury, psychological disorders, actively taking antidepressant or other neuromodulatory drugs 2. Participants are pregnant or breastfeeding 3. Participants are under the age of 18 |
| Date of first enrolment | 01/07/2021 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Birmingham
B15 2TT
United Kingdom
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHSFT
Oswestry
SY10 7AG
United Kingdom
Buckinghamshire Healthcare NHS Trust
Aylesbury
HP21 8AL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the principal investigator Dr Shinyi Chiou (s.chiou@bham.ac.uk). Neurophysiological and behavioural data that are fully anonymous will be accessible for research/academic purposes after the data are analysed and published in peer-reviewed journals (estimated January 2025 for 10 years, per University Data storage policy). Data will be shared as a spreadsheet and only for non-commercial use. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/08/2024: The following changes were made:
1. The overall study end date was changed from 03/01/2024 to 31/12/2024.
2. The intention to publish date was changed from 04/01/2024 to 31/12/2025.
30/03/2023: The recruitment end date was changed from 02/05/2023 to 31/12/2023.
11/05/2021: The following changes were made to the trial record:
1. Ethics approval details and trial website added.
2. The recruitment start date was changed from 03/05/2021 to 01/07/2021.
28/10/2020: Trial's existence confirmed by the Inspire Foundation.
