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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Mindful Breathing (MB) Intervention; Behavioral: Usual Care (UC) Control Condition

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria

• Mean 24-hr SBP: 130-139 mmHg
• Female
• > 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

Exclusion Criteria (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

Kidney:

• 582-583 chronic glomerulonephritis
• 584-588 renal failure

Liver:

- 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

Other:

- Plan to relocate residence outside recruitment area during the intervention or follow- period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindful Breathing (MB); 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.	Behavioral: Mindful Breathing (MB) Intervention; The Mindful Breathing (MB)intervention is based on MBSR developed by Jon Kabat-Zinn. Participants will attend 8 individual weekly MB sessions. MB 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, from a non-evaluative or judgmental perspective. As attention wanders to concerns or thoughts, participants will be instructed to acknowledge and accept these without evaluation and return the focus of attention back to breathing. Participants in MB will have their breathing rate and PetCO2 monitored during the 8 training sessions with a breathing monitor.
Other: Usual Care (UC); 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.	Behavioral: Usual Care (UC) Control Condition; This control intervention is designed to account for the effects of nonspecific factors such as enrollment in a study to enhance health with the associated expectancy effects, staff attention, and measurement procedures including the monitoring of PetCO2 and (Blood Pressure) BP, and completion of questionnaires. Participants who are randomly assigned to the Usual Care condition will receive care as usual for the management of their prehypertensive condition. UC participants will receive their usual care and have access to all Kaiser Permanente (KP) health education resources, such as KP's interactive healthcare guide, and online "Healthy Lifestyle Programs". We will assess the extent to which participants in both MB and UC used these resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Measured using Ambulatory, 24-Hr BP monitor	Up to Week 25

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinic (resting) blood pressure	Up to Week 25

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Margaret A Chesney, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report. 2008 Dec 10;(12):1-23.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: December 15, 2010
• First Submitted That Met QC Criteria: December 21, 2010
• First Posted (Estimate): December 22, 2010

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Hypertension; Stress; Blood pressure; Breathing; PetCO2
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Hypertension; Respiratory Aspiration
• Other Study ID Numbers: 1R01AT005820 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No