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NCT Number: NCT07488793

Remote Ischemic Conditioning for PwSCI

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIC high-dose standard blood pressure cuff

Behavioral

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.

RIC high-dose automated blood flow restriction cuff

Behavioral

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.

RIC low-dose standard blood pressure cuff

Behavioral

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.

Primary outcomes

  1. Brachial artery diameter change (cm)

    Time frame: 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.

  2. Arterial stiffness - Pulse wave velocity (PWV)

    Time frame: 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 outcomes

  1. Inflammation change - High sensitivity C reactive protein - hsCRP - (mg/L, reported as % change)

    Time frame: 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.

  2. Immune system activation/response change - Interleukin 6 - IL-6 - (pg/mL, reported as % change)

    Time frame: 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.

  3. Low density lipoprotein cholesterol (LDL) change - (mg/dL, reported as % change)

    Time frame: 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.

  4. High-density lipoprotein cholesterol (HDL) change - (mg/dL, reported as % change)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kerri A Morgan, PhD

CONTACT

[email protected]

314-286-1659

Walker

CONTACT

[email protected]

3142737010

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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