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

NCT01264627 | Completed

• 1 other identifier: 1R01AT005820
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

Hypertension; Blood pressure; Breathing; PetCO2; Stress

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Measured using Ambulatory, 24-Hr BP monitor

  Up to Week 25

Secondary Outcomes (1)

• Clinic (resting) blood pressure

  Up to Week 25

Study Arms (2)

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.

Behavioral: Mindful Breathing (MB) Intervention

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.

Behavioral: Usual Care (UC) Control Condition

Interventions

Mindful Breathing (MB) Intervention BEHAVIORAL

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.

Mindful Breathing (MB)

Usual Care (UC) Control Condition BEHAVIORAL

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.

Usual Care (UC)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Respiration:
• X chronic Bronchitis incl COPD
• X emphysema
• X asthma
• ; 500-519: all kinds of chronic pulmonary conditions
• Cardiovascular:
• chronic ischemic heart disease
• X cardiomyopathies
• X heart failure
• cerebrovascular diseases
• Kidney:
• chronic glomerulonephritis
• renal failure
• Liver:
• \- 571.X chronic liver disease and cirrhosis Smoker: 305.1

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Related Publications (1)

• 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.

  PMID: 19361005 BACKGROUND

MeSH Terms

Conditions

Hypertension; Respiratory Aspiration

Interventions

Methods

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Margaret A Chesney, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 22, 2010
• Study Start: February 1, 2011
• Primary Completion: July 31, 2017
• Study Completion: August 31, 2017
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share