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临床试验/NCT04234958
NCT04234958已完成不适用

Études Des Effets d'un Protocol de thérapie Manuelle ostéopathique Sur la variabilité de la fréquence Cardiaque

Université du Québec a Montréal1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2017年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
162
试验地点
1
主要终点
Heart rate variability

研究概览

简要总结

The adaptation of the heart to react to any stimulus is called heart rate variability (HRV). Moreover, HRV is now used as a health index. In fact, among the pathologies affecting HRV the most, there are the cardiovascular diseases and depressive disorders that take a predominant part in the investigator's actual societies, According to a recent literature overview, many factors influence HRV and they need to be determined in order to plan efficient research protocols. Moreover, the control of these factors can improve the HRV and therefore help the heart to have maximum capacity to fulfill its physiological functions. Valorizing a good HRV seems, according to the effects reported by several studies, to be a good opportunity to take into consideration and to apply.

Visceral osteopathy, even if it goes back to the founder of Osteopathy himself, Andrew Taylor Still, is at its debuts in terms of acknowledgement from a scientific point of view. The evidence of efficacy of osteopathy is not to be done anymore. However, it is now necessary to define the action mechanisms of the osteopathic techniques, particularly by using physiological variables, and starting from a biomechanical angle. In fact, Jean-Pierre Barral and others has developed visceral manipulation techniques based on the viscera anatomy.

The originality of this research can be found in the technical protocol, not used yet, the use of witness group, the measurements over four weeks to evaluate the effect of this protocol with time on chosen dependant variables, its reproducibility but also its inter-therapist variance. This objective if this study is to reinforce the proof level of the osteopathic approach on the cardiac physiology. HRV is a solid tool recognized for research, the variable is well isolated and the control group ensures an isolation of some confounding variables.

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
Single (Participant)

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •man or woman
  • •between 25 and 35 years old
  • •non smoking

排除标准

  • •diagnosed with anxiety or psychological disorder
  • •smoker, drug consumption
  • •diagnosed with renal disorder, cardiac disorder, functional somatic disorders, diabetes, chronic alcoholism, cancer or immunosuppressive disorders, stroke, aortic aneurysm,
  • •high level athletes
  • •thoracic trauma or surgeries
  • •does not fit Hexoskin vest for HRV measurements
  • •does not complete all sessions
  • •cannot stay lying down for 1 hour
  • •below 25 or above 35 years old
  • •student in manual therapy

研究组 & 干预措施

Experimental

Experimental

Participants received osteopathic treatment

干预措施: Osteopathic manipulative treatment (Other)

Sham

Sham Comparator

Participants received sham therapy

干预措施: Sham therapy (Other)

Control

No Intervention

Participants received no intervention

结局指标

主要结局

Heart rate variability

时间窗: 45 minutes

Real-time measurements of HRV before, during and after each intervention

次要结局

未报告次要终点

研究者

发起方
Université du Québec a Montréal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alain Steve Comtois

Professor

Université du Québec a Montréal

研究点 (1)

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