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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Hypertension

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01264627

1R01AT005820 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

99 participants in 2 patient groups

Mindful Breathing (MB)

Experimental group

Description:

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.

Treatment:

Behavioral: Mindful Breathing (MB) Intervention

Usual Care (UC)

Other group

Description:

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.

Treatment:

Behavioral: Usual Care (UC) Control Condition