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

NCT ID: NCT01264627

Last Updated: 2020-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-01
• Study Completion Date: 2017-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindful Breathing (MB) Intervention

Intervention Type: 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.

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.

Group Type: OTHER

Usual Care (UC) Control Condition

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret A Chesney, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19361005 (View on PubMed)

Other Identifiers

1R01AT005820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01AT005820

Identifier Type: NIH

Identifier Source: org_study_id

View Link