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临床试验/NCT05542238
NCT05542238终止不适用

The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury: a Pilot Study

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
Cerebrovascular functions

研究概览

简要总结

The aims of this proposal are to: 1) investigate whether individuals with spinal cord injury (SCI) demonstrate cardiac autonomic, cerebrovascular, and cognitive dysfunctions compared to non-injured age- and sex-matched controls in the following conditions: supine rest and head-up tilt/face-cooling test; 2) examine if autonomic completeness/ incompleteness, physical activity, and psychological distress are predictors for dysfunctions during supine rest and head-up tilt/face cooling conditions in SCI individuals; 3) examine if one bout of moderate-intensity aerobic exercise temporarily improves cardiac autonomic and cerebrovascular functions and thereby improves cognition when in supine rest and head- up tilt/face cooling conditions. The study will include an initial visit and an experimental visit to our lab. Three groups of participants will be included in this study: Group 1, SCI with acute exercise; group 2, SCI with rest-control; and group 3, age- and sex-matched non-injured individuals. Cardiovascular variables, such as heart rate variability, blood pressure variability, and cerebrovascular variables, such as cerebral blood flow velocity and oxygenated hemoglobin, and cognitive performance will be examined. The investigator hypothesizes that individuals with SCI will have impaired cardiac autonomic, cerebrovascular, and cognitive functions compared to the non-injured controls, and an acute exercise can improve those functions. Autonomic completeness/incompleteness, physical activity, and psychological distress are significant factors that predict cardiac autonomic, cerebrovascular, and cognitive functions in individuals with SCI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Spinal cord injury group:
  • Males or females with chronic SCI (i.e. at least 6 months after the initial injury)
  • International Standard for Neurological Classification of SCI (ISNCSCI) A-D
  • Neurological level of injury C6 or below
  • 18-55 years old
  • Proficient in English
  • Able to detect middle cerebral artery blood velocity (MCAv) and/or posterior cerebral artery blood velocity (PCAv) signals through TCD
  • Non-injured controls:
  • Males or females without SCI
  • 18-55 years old
  • Proficient in English
  • Able to detect MCAv and/or PCAv signals through TCD

排除标准

  • Cardiovascular, pulmonary or respiratory diseases, or diabetes mellitus, any other diseases/disorders affecting cardiac autonomic nervous system, such as glaucoma and attention deficit hyperactivity disorder (ADHD)
  • Color Blindness
  • Pregnancy

结局指标

主要结局

Cerebrovascular functions

时间窗: During the cognitive tests post the 20-min acute exercise

Assessed by the middle and posterior cerebral artery velocity in centimeters per second

Cognitive function

时间窗: During head-up tilt post the 20-min acute exercise

Reaction time in second

Cardiac sympathetic function

时间窗: During cognitive tests post the 20-min acute exercise

Low frequency component of blood pressure variability in mmHg\^2

Cardiac parasympathetic function

时间窗: During cognitive tests post the 20-min acute exercise

High frequency component of heart rate variability in mm\^2

Cerebral oxygenation level

时间窗: Change from baseline to the cognitive tests post the 20-min acute exercise

Cerebral oxygenated hemoglobin in unknown unit

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wenjie Ji

PhD student

State University of New York at Buffalo

研究点 (2)

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