Spinal Cord Injuries
Conditions
Keywords
remote ischemic conditioning, spinal cord injury, cardiometabolic health
Brief 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.
Interventions
BEHAVIORALRIC high-dose standard blood pressure cuff
The 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 cuff
The 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 cuff
The 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.
Sponsors
Washington University School of Medicine
The Craig H. Neilsen Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brachial artery diameter change (cm) | Baseline and up to 2 weeks post intervention | Participants will undergo a Brachial Artery Reactivity Test (BART) via upper arm doppler ultrasound. The test will measure flow-mediated dilation and endothelium independent dilation of the brachial artery using a high-resolution transducer on the Vivid E95, E9, Vivid IQ (portable) or Vivid I (portable) systems. Brachial artery flow-mediated vasodilation correlates with measures of coronary artery endothelial function and can predict future adverse coronary events. Results will be reported as brachial artery diameter change between baseline and 30 seconds into test, unit of measure is cm. |
| Arterial stiffness - Pulse wave velocity (PWV) | Baseline and up to 2 weeks post intervention | This test is a non-invasive cardiovascular assessment that measures arterial stiffness. Arterial stiffness will be obtained by measuring carotid-femoral pulse wave velocity using the SphygmoCor XCEL system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation change - High sensitivity C reactive protein - hsCRP - (mg/L, reported as % change) | Baseline and up to 2-weeks post intervention | Participants will have blood drawn two times at initial assessment and two times at post assessment. The first draw will happen immediately before a session of remote ischemic conditioning (RIC) and then immediately after the session. The hsCRP results will measure inflammation within the body, elevated hsCRP levels are associated with an increased risk of cardiovascular disease. |
| Immune system activation/response change - Interleukin 6 - IL-6 - (pg/mL, reported as % change) | Baseline and up to 2-weeks post intervention | Participants will have blood drawn two times at initial assessment and two times at post assessment. The first draw will happen immediately before a session of remote ischemic conditioning (RIC) and then immediately after the session. The IL-6 results will measure pro- and anti- inflammatory responses, this will be reported as one score, higher levels are associated with an increased pro-inflammatory response and lower levels are associated with an anti-inflammatory response. |
| Low density lipoprotein cholesterol (LDL) change - (mg/dL, reported as % change) | Baseline and up to 2-weeks post intervention | Participants will have blood drawn one time at initial assessment and one time at post assessment. The LDL results will measure the amount of LDL within the blood. High levels of LDL can lead to plaque buildup in the arteries, increasing the risk of cardiovascular disease. |
| High-density lipoprotein cholesterol (HDL) change - (mg/dL, reported as % change) | Baseline and up to 2-weeks post intervention | Participants will have blood drawn one time at initial assessment and one time at post assessment. The HDL results will measure the amount of HDL within the blood. High levels of HDL are associated with a lower risk of cardiovascular disease. |
Countries
United States
Contacts
CONTACTKerri A Morgan, PhD
CONTACTWalker
PRINCIPAL_INVESTIGATORKerri A Morgan, PhD
Washington University School of Medicine - Program in Occupational Therapy
Outcome results
None listed