跳至主要内容
临床试验/NCT02417155
NCT02417155已完成不适用

Increasing Plasma Adrenaline Levels Through Breathing Techniques - an Explorative Study

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Concentration of plasma adrenaline within arm 1

研究概览

简要总结

Inflammatory cytokines play a pivotal role in rheumatoid arthritis (RA) and innovative non-pharmacological therapies aimed at limiting cytokine production are highly warranted. Adrenaline, a neurotransmitter of the autonomic sympathetic nervous system, attenuates cytokine production. Along these lines, endogenous modulation of sympathetic activity could limit inflammation and therefore represent a treatment modality that would empower RA patients to exert self-control over disease activity. However, both the autonomic nervous system and the inflammatory response are regarded as systems that cannot be voluntarily influenced. Nevertheless, results from two recent studies demonstrate that this is possible through techniques developed by 'iceman' Wim Hof, namely meditation, exposure to cold, and breathing exercises. Hof himself and healthy volunteers trained by him were able to voluntarily activate the sympathetic nervous system, resulting in adrenaline release and subsequent suppression of the inflammatory response during experimental human endotoxemia (a model of systemic inflammation elicited by administration of lipopolysaccharide [LPS] in healthy volunteers). Interestingly, while having been taught all three techniques, during the endotoxemia experiment the trained subjects (like Hof himself) predominantly practiced the breathing exercises consisting of two different techniques. A 'hyper/hypoventilation' technique, characterized by cycles of hyperventilation followed by breath retention and a 'strength ventilation' technique consisting of deep inhalations and exhalations followed by breath holding. These techniques resulted in intermittent hypoxia and cyclic shifts in acid-base balance. Based on these observations and previous studies, the investigators hypothesize that these breathing techniques account for the increased production of adrenaline and thus for the suppressed inflammatory response but it is unclear which of these two techniques is most important.

详细描述

The main objective of the study is to compare the increase in plasma adrenaline levels during the two different breathing techniques in a group of healthy volunteers trained by Hof. Also, the investigators investigate whether it is necessary to be trained by Hof and if a relatively short instruction instead of the extensive training is sufficient. Additionally, the investigators want to evaluate the influence of the training and breathing techniques on pain thresholds.

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 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age ≥18 and ≤35 yrs

排除标准

  • Experience with the methods of Wim Hof or other breathing techniques
  • Use of any medication
  • Use of recreational drugs within 21 days prior to the experiment day
  • Use of caffeine or alcohol within 1 day prior to the experimental day.
  • Surgery or trauma with significant blood loss or blood donation within 3 months prior to the experimental day.
  • Participation in another clinical trial within 3 months prior to the experimental day.
  • History, signs, or symptoms of cardiovascular disease
  • History of atrial or ventricular arrhythmia
  • Hypertension (RR systolic >160 or RR diastolic >90)
  • Hypotension (RR systolic <100 or RR diastolic <50)
  • Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block
  • History of asthma, or any other pulmonary disease
  • C reactive protein (CRP) > 20 mg/L, White blood count (WBC) > 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before the experimental day.

结局指标

主要结局

Concentration of plasma adrenaline within arm 1

时间窗: 1 day

Our primary endpoint is the difference between plasma adrenaline levels during the hyper/hypoventilation technique and the strength ventilation technique within the HTR group.

次要结局

  • Body temperature(1 day)
  • Plasma interleukine 10 concentration(1 day)
  • Leukocyte counts and differentiation(1 day)
  • Cortisol (plasma)(1 day)
  • Noradrenaline(1 day)
  • Pain threshold(1 day)
  • Concentration of plasma adrenaline within arms 2, 3, 4(1 day)
  • Heart rate, blood pressure(1 day)
  • Blood gas parameters(1 day)
  • concentration of plasma adrenaline between arms 1, 2, 3, 4(1 day)
  • Blood pressure(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验