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

This study is currently recruiting participants.

Verified May 2013 by University of California, San Francisco

Sponsor:

Collaborator:

National Center for Complementary and Alternative Medicine (NCCAM)

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01264627

First received: December 15, 2010

Last updated: May 16, 2013

Last verified: May 2013

History of Changes

Purpose

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.

Condition	Intervention
Hypertension	Behavioral: Mindful Breathing (MB) Intervention Behavioral: Usual Care (UC) Control Condition

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
Official Title:	Project Inspire: A New Translational Tool for Studying the Role of Breathing in Meditation

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Blood Pressure [ Time Frame: Up to Week 25 ] [ Designated as safety issue: No ]
Measured using Ambulatory, 24-Hr BP monitor

Secondary Outcome Measures:

Clinic (resting) blood pressure [ Time Frame: Up to Week 25 ] [ Designated as safety issue: No ]

Estimated Enrollment:	128
Study Start Date:	February 2011
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mindful Breathing (MB)	Behavioral: 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. As attention wanders to concerns, thoughts, events or ideas, the 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 eight training sessions with individual ambulatory breathing monitors.
Usual Care (UC)	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 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.

Arms

Assigned Interventions

Experimental: Mindful Breathing (MB)

Behavioral: 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. As attention wanders to concerns, thoughts, events or ideas, the 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 eight training sessions with individual ambulatory breathing monitors.

Usual Care (UC)

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 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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264627

Contacts

Contact: Wendy Adelson, MS

adelsonw@ocim.ucsf.edu

Locations

United States, California
Osher Center for Integratiev Medicine	Recruiting
San Francisco, California, United States, 94143
Contact: Wendy Adelson, MS adelsonw@ocim.ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Margaret A Chesney, PhD

University of California, San Francisco

More Information

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.

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01264627 History of Changes
Other Study ID Numbers:	1R01AT005820
Study First Received:	December 15, 2010
Last Updated:	May 16, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Hypertension
Blood pressure
Breathing
PetCO2
Stress

Additional relevant MeSH terms:

Respiratory Aspiration
Hypertension
Respiration Disorders
Respiratory Tract Diseases

Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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