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临床试验/NCT01264627
NCT01264627已完成不适用

Project Inspire: A New Translational Tool for Studying the Role of Breathing in Meditation

University of California, San Francisco0 个研究点目标入组 99 人开始时间: 2011年2月1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
入组人数
99
主要终点
Blood Pressure

研究概览

简要总结

A recent National Health Interview Survey reported that breathing exercises were the second most common complementary and alternative medicine practice in the United States, following only the use of "natural products." With such widespread interest in breathing exercises, alone or as a component of practices such as meditation, a need exists for research that examines not only its efficacy, but also investigates potential mechanisms of action. Indeed, a recent National Center for Complementary and Alternative Medicine (NCCAM) Meditation Workshop recommended research to clarify biological pathways by which meditation practices, including breathing exercises, can impact health. To explore mechanisms underlying the health effects of breathing exercises, new translational tools are needed that can measure breathing patterns in both the clinic and natural environment. The primary objective of the present proposal is the application of a new technology to the investigation of pathways by which breathing exercises can affect health. For this project, the health-related outcome measure to be studied is a major cardiovascular risk factor, blood pressure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Mean 24-hr SBP: 130-139 mmHg
  • •> 50 years of age
  • •Post menopausal, defined as greater than or equal to one year without a menstrual cycle.
  • •Body Mass Index (BMI): 19-31
  • •English speaking (Patients not able to read and speak English will be excluded as the behavioral group interventions are conducted in English)
  • •Has a personal physician

排除标准

  • •(Individuals will be filtered in the KP OSCA database according to the following ICD-9 codes):
  • •Respiration:
  • •491.X chronic Bronchitis incl COPD
  • •492.X emphysema
  • •493.X asthma
  • •494-496; 500-519: all kinds of chronic pulmonary conditions
  • •Cardiovascular:
  • •404.9 chronic ischemic heart disease
  • •425.X cardiomyopathies
  • •428.X heart failure
  • •430-438 cerebrovascular diseases
  • •582-583 chronic glomerulonephritis
  • •584-588 renal failure
  • •571.X chronic liver disease and cirrhosis Smoker: 305.1
  • •Psychiatric:
  • •290-299 dementia/schizophrenia/ psychoses...
  • •303, 304 alcohol or drug dependence
  • •317-319 mental retardation
  • •Medications:
  • •All blood pressure medications
  • •All tranquilizers, benzodiazepins if prescribed regularly, e.g. every month
  • •All narcotics if prescribed regularly, e.g. every month
  • •Plan to relocate residence outside recruitment area during the intervention or follow- period

研究组 & 干预措施

Mindful Breathing (MB)

Experimental

The MB intervention is based off of the Mindfulness Based Stress Reduction Program developed by Jon Kabat-Zinn. Participants will be organized into cohorts of eight, and attend eight weekly MB sessions. Mindful breathing consists of closely "following the breath," throughout inhalation and exhalation, sustaining moment-to-moment awareness on the breathing process, and passively observing thoughts, affective states, perceptions and events, from a non-evaluative, non-judgmental perspective. No other intervention is included. No FDA drug or device is involved.

干预措施: Mindful Breathing (MB) Intervention (Behavioral)

Usual Care (UC)

Other

Usual Care consists of the standard care made available to participants through their primary physician. No intervention is included. No FDA drug or device is involved.

干预措施: Usual Care (UC) Control Condition (Behavioral)

结局指标

主要结局

Blood Pressure

时间窗: Up to Week 25

Measured using Ambulatory, 24-Hr BP monitor

次要结局

  • Clinic (resting) blood pressure(Up to Week 25)

研究者

申办方类型
Other
责任方
Sponsor

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