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

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ClinicalTrials.gov Identifier: NCT01264627
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Mindful Breathing (MB) Intervention Behavioral: Usual Care (UC) Control Condition Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Project Inspire: A New Translational Tool for Studying the Role of Breathing in Meditation
Actual Study Start Date : February 1, 2011
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : August 31, 2017

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.

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.




Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: Up to Week 25 ]
    Measured using Ambulatory, 24-Hr BP monitor


Secondary Outcome Measures :
  1. Clinic (resting) blood pressure [ Time Frame: Up to Week 25 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264627


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

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01264627     History of Changes
Other Study ID Numbers: 1R01AT005820 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

Keywords provided by University of California, San Francisco:
Hypertension
Blood pressure
Breathing
PetCO2
Stress

Additional relevant MeSH terms:
Hypertension
Respiratory Aspiration
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes