Program to reduce sedentary behavior in individuals with spinal cord injury
Acceptability, Fidelity, Safety and Preliminary Efficacy of a Sedentary Behaviour Intervention in Individuals With Spinal Cord Injury: a Pilot Study
This study is testing a new program that helps people with spinal cord injuries move more and sit less to see if it can improve their health and well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brunel University Academic / other |
| Locations | 1 site (Uxbridge, London) |
| Trial ID | NCT06957483 on ClinicalTrials.gov |
What this trial studies
This study evaluates a co-designed intervention aimed at reducing sedentary behavior among individuals with paraplegia, who are at increased risk for heart disease and stroke. The intervention, known as REACH-SCI, lasts eight weeks and includes the use of a wearable activity tracker that reminds participants to break up long periods of sitting. The study will assess the acceptability, fidelity, safety, and preliminary efficacy of this program, which has been tailored specifically for the needs of wheelchair users. Participants will engage in various components of the intervention while providing feedback on their experiences.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with self-reported paraplegia who primarily use a manual wheelchair for mobility.
Not a fit: Patients with self-reported heart conditions or other serious health issues that may be exacerbated by the intervention will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of cardiovascular disease in individuals with spinal cord injuries.
How similar studies have performed: While there is limited research specifically targeting sedentary behavior in individuals with paraplegia, similar interventions for other populations have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals with self-reported paraplegia i.e. complete or incomplete SCI at T1 or below. Traumatic, non-traumatic, complete and incomplete SCI will all be eligible. * At least 18 years of age. * Self-report using a manual wheelchair as their primary mode of mobility inside and outside of the home. * Able to travel to Brunel University of London to undertake study measurements. * Access to use of a smartphone or tablet with internet access. * Able to communicate in English at a level sufficient to understand the study, complete study measurements and engage fully with the intervention. * Able to provide informed consent. * Willing and able to provide fingertip blood samples and fast prior to measurement sessions. * Able to independently transfer to a treatment couch and lay supine to undertake anthropometric measurements. Exclusion Criteria: * Self-reported heart condition, chest pain, dizziness, bone or joint problem, or any other condition that may be exacerbated by doing physical activity, as indicated via responses to the PAR-Q+. * Self-reported history of uncontrolled autonomic dysreflexia in the past 12 months. * Self-reported pregnancy. * Currently participating in another research project that involves an intervention.
Where this trial is running
Uxbridge, London
- Brunel University of London — Uxbridge, London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Daniel Bailey, PhD — Brunel University
- Study coordinator: Daniel Cooper
- Email: daniel.cooper2@brunel.ac.uk
- Phone: +44 (0)1895 265363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.