Recruiting

RIC High Dose, RIC Low Dose

Sponsor:

Washington University School of Medicine

Code:

NCT07488793

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RIC high-dose standard blood pressure cuff

RIC high-dose automated blood flow restriction cuff

RIC low-dose standard blood pressure cuff

Study Details

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

Study ID

NCT07488793

Start date

Feb 23, 2026

Status verified date

Mar, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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

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.

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

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.

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

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.

Interventions

RIC 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.

RIC 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.

RIC 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.

Primary outcome measure

  • Brachial artery diameter change (cm) [ Time Frame: Baseline and up to 2 weeks post intervention ]
  • Arterial stiffness - Pulse wave velocity (PWV) [ Time Frame: Baseline and up to 2 weeks post intervention ]

Central Contacts and Locations

Central contacts

Kerri A Morgan, PhD

314-286-1659morgank@wustl.edu

Walker

3142737010walker.k@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63108

More Information

Sponsor

Washington University School of Medicine

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • remote ischemic conditioning
  • spinal cord injury
  • cardiometabolic health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-03-23.