Remote Ischemic Conditioning Intervention to Enhance the Cardiometabolic Health of Persons With SCI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Brachial artery diameter change (cm)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Brachial artery diameter change (cm)
时间窗: Baseline and up to 2 weeks post intervention
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.
Arterial stiffness - Pulse wave velocity (PWV)
时间窗: Baseline and up to 2 weeks post intervention
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.
次要结局
- 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)
研究者
Kerri Morgan
Associate Professor of Occupational Therapy and Neurology, Director, Research Division of Occupational Therapy
Washington University School of Medicine