Remote Ischemic Conditioning for PwSCI

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT07488793 · 202504164 · 1348401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗