Remote Ischemic Conditioning for PwSCI

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07488793
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 23, 2026
Status verified
Mar 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Brachial artery diameter change (cm) [ Time Frame: Baseline and up to 2 weeks post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63108-

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