Remote Ischemic Conditioning for PwSCI

NCT07488793 | Recruiting

• 2 other identifiers: 2025041641348401
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

remote ischemic conditioning; spinal cord injury; cardiometabolic health

Outcome Measures

Primary Outcomes (2)

• Brachial artery diameter change (cm)

  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.

  Baseline and up to 2 weeks post intervention

• Arterial stiffness - Pulse wave velocity (PWV)

  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.

  Baseline and up to 2 weeks post intervention

Secondary Outcomes (4)

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

  Baseline and up to 2-weeks post intervention

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

  Baseline and up to 2-weeks post intervention

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

  Baseline and up to 2-weeks post intervention

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

  Baseline and up to 2-weeks post intervention

Study Arms (3)

Remote ischemic conditions (RIC) high-dose using standard blood pressure cuff

ACTIVE COMPARATOR

A group provided 6-weeks of remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participant 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 participant will also complete a daily log of their RIC sessions.

Behavioral: RIC high-dose standard blood pressure cuff

Remote ischemic conditioning (RIC) high-dose using the automated blood flow restriction cuff

ACTIVE COMPARATOR

A group provided 6-weeks of remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participant 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 participant will also complete a daily log of their RIC sessions.

Behavioral: RIC high-dose automated blood flow restriction cuff

Remote ischemic conditioning (RIC) low-dose using standard blood pressure cuff

PLACEBO COMPARATOR

A group provided 6-weeks of remote ischemic conditioning (RIC) intervention within their home. 5 days a week the participant 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 participant will also complete a daily log of their RIC sessions.

Behavioral: RIC low-dose standard blood pressure cuff

Interventions

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.

Remote ischemic conditions (RIC) high-dose using standard blood pressure cuff

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.

Remote ischemic conditioning (RIC) high-dose using the automated blood flow restriction cuff

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.

Remote ischemic conditioning (RIC) low-dose using standard blood pressure cuff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Kerri A Morgan, PhD

  Washington University School of Medicine - Program in Occupational Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerri A Morgan, PhD

CONTACT

314-286-1659; morgank@wustl.edu

Walker

CONTACT

3142737010; walker.k@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Occupational Therapy and Neurology, Director, Research Division of Occupational Therapy

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 23, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)