Exploring the Effects of a Mindfulness-Based Intervention on Physiologic and Quality of Life Markers in Individuals With Spinal Cord Injury (SCI): A Pre-post Test Design
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in blood pressure
研究概览
简要总结
The purpose of this study is to determine if practicing mindfulness breathing exercises has an effect on the overall health of persons with SCI
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females aged 18-70 who are living with spinal cord injury
- •C5 to the T10 levels
- •Self-reported American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A-D
- •Eligible participants must be able to understand and provide consent, be in good health operationalized as free from acute treatable illness, pressure injury, and cardiovascular disease.
排除标准
- •Participants taking medications that alter chronotropic and pressor responses will be excluded.
- •Pregnant women will not be eligible to participate
研究组 & 干预措施
Mindfulness Exercise Group
Subjects will participate in a one-month mindfulness breathing-exercise program
干预措施: Mindfulness (Behavioral)
结局指标
主要结局
Change in blood pressure
时间窗: baseline, 1 month
Blood pressure (BP) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. BP will be collected as systolic over diastolic in mmHg units
Change in metabolism as measured by maximum oxygen consumption (VO2)
时间窗: baseline, 1 month
Metabolism as determined by oxygen consumption (VO2) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. VO2 is collected as mL/kg/min
Change in metabolism as measured by ventilation (VE)
时间窗: baseline, 1 month
Metabolism as determined by oxygen consumption (VE) will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. VE is measured in L/min
Change in Heart rate
时间窗: baseline, 1 month
heart rate will be collected in 5 minute intervals before, during and after the mindfulness sessions on 2 separate visits: baseline and post intervention visits. Heart rate will be recorded in beats per minute
次要结局
- Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III(baseline, 1 month)
研究者
Eduard Tiozzo, PhD
Principal Investigator
University of Miami