Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07488793

Remote Ischemic Conditioning for PwSCI

Remote Ischemic Conditioning Intervention to Enhance the Cardiometabolic Health of Persons With SCI

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
Washington University School of Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The long-term goal of this project is to improve the overall cardiometabolic health of persons with spinal cord injury (SCI). This pilot study will test the feasibility and acceptability of remote ischemic conditioning implemented in a home setting by persons with SCI and collect cardiometabolic health outcomes to inform appropriate outcomes for a future larger trial. Researchers will compare, RIC high dose using standard blood pressure cuff to RIC high dose using automated blood flow restriction cuff to RIC low dose using standard blood pressure cuff, to determine cardiometabolic health improvements amongst groups. Participants will: Complete an initial 2-day assessment, participate in a 6-week intervention using remote ischemic conditioning (RIC) within their home, complete a 2-day post assessment.

Detailed description

The goal of this clinical trial is to collect preliminary data on examining the effects of remote ischemic conditioning (RIC) on cardiometabolic health outcomes for persons with spinal cord injury (SCI). The main aims are: To identify barriers, facilitators and reasons for positive determinants for implementation of RIC in a home setting. To estimate improvements in cardiometabolic health of participants with SCI enrolled in an in-home, high-dose RIC intervention group compared to a low-dose RIC group. The long-term impact will be implementing evidence-based interventions that are achievable and accessible to persons with SCI for improving cardiovascular and metabolic morbidity and mortality outcomes.

Conditions

Interventions

TypeNameDescription
BEHAVIORALRIC high-dose standard blood pressure cuffThe RIC high-dose using a standard blood pressure cuff group will participate in 6-weeks of self or support-person applied/assisted remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participants will complete 1 session of 4 cycles of inflating/deflating a standard blood pressure cuff to 20 mmHg higher than their measured systolic blood pressure on an arm. The blood pressure cuff will be inflated and held for 5 minutes, then deflated (released) for 5 minutes and this will be repeated a total of 4 cycles. This process will take about 35 minutes to complete each day. The participants will also complete a daily log of their RIC sessions. The overall goal is to improve cardiometabolic health of persons with spinal cord injury.
BEHAVIORALRIC high-dose automated blood flow restriction cuffThe RIC high-dose automated blood flow restriction cuff group will participate in 6-weeks of self or support-person applied/assisted remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participants will complete 1 session of 4 cycles of inflation/deflation of an automated blood flow restriction cuff to 20 mmHg higher than their measured systolic blood pressure on an arm. The restriction cuff will inflate and hold for 5 minutes, then deflate (release) for 5 minutes and this will be repeated a total of 4 cycles. This process will take about 35 minutes to complete each day. The participants will also complete a daily log of their RIC sessions. The overall goal is to improve the cardiometabolic health of persons with spinal cord injury.
BEHAVIORALRIC low-dose standard blood pressure cuffThe RIC low-dose standard blood pressure cuff group will participate in 6-weeks of self or support-person applied/assisted remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participants will complete 1 session of 4 cycles of inflating/deflating a blood pressure cuff to 10 mmHg below their measured diastolic blood pressure on an arm. The blood pressure cuff will be inflated and held for 5 minutes, then deflated (released) for 5 minutes and this will be repeated a total of 4 cycles. This process will take about 35 minutes to complete each day. The participants will also complete a daily log of their RIC sessions.

Timeline

Start date
2026-02-23
Primary completion
2027-07-30
Completion
2027-07-30
First posted
2026-03-23
Last updated
2026-03-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07488793. Inclusion in this directory is not an endorsement.