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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Mindful Breathing (MB) Intervention; Behavioral: Usual Care (UC) Control Condition

• Registration Number: NCT01264627
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-22
• Study Start: 2011-02-01
• Primary Completion: 2017-07-31
• Study Completion: 2017-08-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindful Breathing (MB)	Mindful Breathing (MB) Intervention	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.
Usual Care (UC)	Usual Care (UC) Control Condition	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.

Primary Outcome Measures

Name	Time	Method
Blood Pressure	Up to Week 25	Measured using Ambulatory, 24-Hr BP monitor

Secondary Outcome Measures

Name	Time	Method
Clinic (resting) blood pressure	Up to Week 25