Home-based remote ischemic conditioning for people with spinal cord injury
Remote Ischemic Conditioning Intervention to Enhance the Cardiometabolic Health of Persons With SCI
This project will try remote ischemic conditioning at home to see if it improves heart and metabolic health in adults with spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07488793 on ClinicalTrials.gov |
What this trial studies
This pilot randomized intervention enrolls adults with spinal cord injury to complete a 2-day baseline assessment, a 6-week home-based remote ischemic conditioning (RIC) intervention, and a 2-day post-intervention assessment. Participants are randomized to one of three groups: high-dose RIC using a standard blood pressure cuff, high-dose RIC using an automated blood flow restriction cuff, or low-dose RIC using a standard blood pressure cuff, with 30 home sessions delivered over six weeks. The trial collects cardiometabolic outcome measures and documents feasibility, adherence, barriers, and facilitators to implementing RIC in the home. Results will inform outcome selection and design for a larger efficacy trial.
Who should consider this trial
Good fit: Adults (18+) with spinal cord injury who live in the community, are medically stable, not currently engaged in exercise, can obtain physician approval, and can perform or receive help to complete home intervention sessions are ideal candidates.
Not a fit: Patients who are medically unstable or have recent heart conditions, recent blood clots, recent surgery, recent use of blood thinners, uncontrolled hypertension, peripheral artery disease, stage 3–4 pressure injuries, or Complex Regional Pain Syndrome are excluded and unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide an accessible, home-based way to improve cardiovascular and metabolic health and reduce long-term cardiometabolic risk after spinal cord injury.
How similar studies have performed: Remote ischemic conditioning has shown promise in cardiac and neurological settings, but repeated home-based RIC specifically for cardiometabolic outcomes after spinal cord injury is largely novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Diagnosis of SCI * Live within the community (not nursing facility) * Not actively engaged in physical activity for exercise * Not having the ability to participate in physical activity due to physical capacity or environmental barriers * Medically stable * Ability to obtain physician approval to participate in the study * Willingness to participate in a 2-day initial assessment visit at research testing location, 30 intervention sessions conducted independently by the participant or caregivers, 2-day post intervention assessment visit at research testing location. Exclusion Criteria: * Medically unstable * Have had a heart-related condition within the past year * Have had a blood clot in the past year * Have a stage 3 or 4 pressure injury * Have taken blood thinners in the past year * Have had surgery in the past year * Have uncontrolled hypertension * Have peripheral artery disease * Have Complex Regional Pain Syndrome (CRPS) in both arms * Have had nerve or tendon transfers in the arms in the past year * Have lymphedema in the arms * Have recent acute illness or injury (within the past 3 months) * Currently pregnant * Enrolled in another clinical trial * Are taking GLP-1 medications * Unable to provide consent * Currently engaged in physical activity for exercise
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Kerri A Morgan, PhD — Washington University School of Medicine - Program in Occupational Therapy
- Study coordinator: Kerri A Morgan, PhD
- Email: morgank@wustl.edu
- Phone: 314-286-1659
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.