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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264627
• Other study ID #: 1R01AT005820
• Secondary ID: 1R01AT005820
• Status: Completed
• Phase: N/A
• Start date: February 1, 2011
• Est. completion date: August 31, 2017

Study information

• Verified date: November 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Respiratory Aspiration

Intervention

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) 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Center for Complementary and Integrative Health (NCCIH)

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Measured using Ambulatory, 24-Hr BP monitor	Up to Week 25
Secondary	Clinic (resting) blood pressure		Up to Week 25