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临床试验/NCT03858309
NCT03858309已完成不适用

Quantifying the Influence of Yogic Breathwork on Cerebrospinal Fluid Circulation

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
CSF Flow Velocities

研究概览

简要总结

The purpose of this research study is to determine the influence of yoga breathing practices on cerebrospinal fluid (CSF) circulation, and to find out primarily if a regular practice of 8-week yoga breathing would enhance CSF circulation as well as if the intervention would improve participant's quality of life, quality of sleep, and reduce existing stress. Participants will be randomized into two arms for different breathing practices.

详细描述

The purpose of this research protocol is to determine the influence of an 8-week breathing intervention on cerebrospinal fluid (CSF) circulation among healthy participants using a non-invasive real-time phase-contrast magnetic imaging (RT-PCMRI) technique. This aim will be examined by studying the changes in each participant's pre- and post-intervention CSF flow dynamics using the non-invasive RT-PCMRI technique during two MRI scans (one before and one after the 8-week intervention).

The study protocol consists of 20 healthy participants (two groups; 10 in each group with different breathing practices) undergoing an 8-week intervention, and pre-and post-intervention outcome measures.

The two 8-week interventions will be guided by two separate certified experienced yoga teachers. Both interventions will consist of 60-minute weekly group on-site sessions (1day/week) with a 20-minute daily home sessions (in between on-site sessions; 6 days/week) using home-aid practice materials. Participants' respiration data will be objectively tracked using a wearable respiration tracker device.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - 18-65 years of age, able to provide their consent to be in the study, available and able to participate in study activities, who can lie in supine, able to walk 15 feet, who have no prior/current mind-body practice inducing breath awareness or training such as yoga, meditation, Ta-Chi, Qi-Gong.

排除标准

  • - Inability to provide informed consent, MRI contraindications, need for muscle relaxants or anti-anxiety drugs in order to tolerate MRI, history of neurological disorders, head trauma with loss of consciousness, craniospinal disorders, spinal injury, sleep disorders, allergic or respiratory disorders, major or uncontrolled psychiatric illness or major depression, lung and heart problems, any condition requiring the use of medication that acts on the brain like stimulants, sedatives current substance abuse issues, pregnancy or nursing.

结局指标

主要结局

CSF Flow Velocities

时间窗: Baseline (pre-intervention) and post-intervention (after 8 weeks).

We have collected cerebrospinal fluid (CSF) flow measurements during a set of breathing practices while subjects were inside the MRI scanner. MRI-based CSF flow was quantified at the level of Foramen Magnum. Data processing included the extraction of velocity waveforms of the CSF motion ( i.e, CSF velocity in cm/s) and subsequent analysis of CSF velocities across different breathing conditions. Positive CSF velocities indicate fluid motion in the cranial (upward) direction, whereas negative velocities represent fluid motion in the caudal (downward) direction. For the registry, descriptive statistics of CSF velocities (mean and standard deviation) are reported at pre- and post-intervention for participants completing both MRI visits with analyzable CSF data (Group 1 n=7, Group 2 n=7). No inferential statistical tests or change score analyses are included in the registry submission; all reported results are descriptive only.

次要结局

  • Systolic and Diastolic Blood Pressure(Baseline (pre-intervention) and post-intervention (after 8 weeks).)
  • Body Mass Index (BMI)(Baseline (pre-intervention) and post-intervention (after 8 weeks).)
  • Daily Home Practice Frequency(8 weeks (daily home practice over the course of 8-week intervention).)
  • Daily Home Practice Duration(8 weeks (daily home practice over the course of 8-week intervention).)

研究者

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

Selda Yildiz

Senior Research Associate

Oregon Health and Science University

研究点 (2)

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