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Recruiting NCT07488793

Remote Ischemic Conditioning for PwSCI

No phase Interventional Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RIC high-dose standard blood pressure cuff, RIC high-dose automated blood flow restriction cuff, RIC low-dose standard blood pressure cuff.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Behavioral 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
  • Behavioral 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 minute
  • Behavioral 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

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Inflammation change - High sensitivity C reactive protein - hsCRP - (mg/L, reported as % change) [Time frame: Baseline and up to 2-weeks post intervention]
  • Immune system activation/response change - Interleukin 6 - IL-6 - (pg/mL, reported as % change) [Time frame: Baseline and up to 2-weeks post intervention]
  • Low density lipoprotein cholesterol (LDL) change - (mg/dL, reported as % change) [Time frame: Baseline and up to 2-weeks post intervention]
  • High-density lipoprotein cholesterol (HDL) change - (mg/dL, reported as % change) [Time frame: Baseline and up to 2-weeks post intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT07488793 · 202504164 · 1348401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗