Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischaemic Stroke: Protocol for Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Measurement of sudomotor and vasomotor function
研究概览
简要总结
This explorative prospective study aims to assess the effects of heart rate variability biofeedback (HRV biofeedback) in patients with acute ischaemic stroke. Furthermore, the investigators aim to examine the impact of the intervention on cardiac autonomic function and further autonomic parameters such as sudomotor (sympathetic perspiratory gland function) and vasomotor function (sympathetic arterial function). Patients testing is going to be conducted at the Department of Neurology, University Hospital Carl Gustave Carus, Dresden, Germany.
详细描述
Background:
Ischaemic stroke is among the most common causes for severe disability and death in the industrialized world with steadily increasing prevalence due to the demographic change. Thus more than 795,000 people yearly have a stroke in the United States of America, of which circa 610,000 people have new strokes or a stroke for the first time in their life (Benjamin, et al. 2017). Symptoms of ischaemic stroke patients include dysregulation of the autonomic nervous system such as cardiac and vascular autonomic dysfunction, which correlate with increased mortality and poor functional outcome. This study aims to assess the effects of heart rate variability biofeedback (HRV-Biofeedback) in patients with acute ischaemic stroke. Furthermore, the investigators aim to examine the impact of the intervention on cardiac autonomic function and further autonomic parameters such as sudomotor (sympathetic perspiratory gland function) and vasomotor function (sympathetic arterial function).
Methods/design:
An explorative prospective study is undertaken in 48 patients with acute ischaemic stroke who undergo either 9 x 10-minutes lasting biofeedback sessions over a period of 3 days, or sham-biofeedback (control-group) also over a period of 3 days under randomized controlled conditions.
The HRV-biofeedback technique is based on the recording and visualization of heart rate variability, which is visible in real-time for the patient on a computer screen. In the training sessions, the patient is instructed to breath in a predefined frequency, which has been shown to yield optimal neurologic-cardiac regulation (respiratory sinus arrhythmia) with high heart rate variability. Sham-biofeedback takes place under identical testing and environmental conditions with subjects looking at a computer screen but not having heart rate variability recorded and visualized. Moreover, the patients do not follow any breathing instructions, which could possibly have any influence on the heart rate variability. The sham intervention is applied to rule out any placebo effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Sham biofeedback intervention
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female subjects aged between 18 and 90
- •written and oral informed consent
- •evidence of an ischaemic lesion on cranial computed tomography scan or magnetic resonance imaging
排除标准
- •intake of any tricyclic antidepressant within the last 14 days
- •atrial fibrillation
- •prior diagnosed autonomic neuropathy
- •malignant cerebral infarct or indication for treatment at intensive care unit
- •aphasia or cognitive deficit with resulted inability to participate in Heart rate variability-biofeedback training
- •respiratory insufficiency
- •blindness, deafness or other physical limitations with resulted inability to participate in heart rate variability-biofeedback training
结局指标
主要结局
Measurement of sudomotor and vasomotor function
时间窗: Change from Baseline Measurement of sudomotor and vasomotor function at 3 days
Assessment of sudomotor and vasomotor function in patients with acute ischaemic stroke prior and after intervention
Severity of autonomic symptoms
时间窗: Change from Baseline Severity of autonomic symptoms at 3 days and at 3 months
Assessment of autonomic symptoms with Survey of Autonomic Symptoms
Heart rate variability in acute ischaemic stroke patients
时间窗: Change from Baseline Heart rate variability at 3 days
Measurement of heart rate variability in acute ischaemic stroke patients
次要结局
- Degree of disability in patients with acute ischemic stroke(Change from Baseline Functional Outcome at 3 days and at 3 months)
- Severity of neurological stroke symptoms(Change from Baseline Severity of neurological stroke symptoms at 3 days)
研究者
Timo Siepmann, MD
Assistant Professor, Doctor of Medicine, Principal Investigator, Head of neurological emergency room, University Hospital Carl Gustav Carus
University Hospital Carl Gustav Carus