Clinical trial NCT01264627: A New Translational Tool for Studying the Role of Breathing in Meditation
Official title: Project Inspire: A New Translational Tool for Studying the Role of Breathing in Meditation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Blood pressure
Breathing
PetCO2
Stress
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-12-22
Enrollment: 99
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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 (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

Primary outcomes:
measure: Blood Pressure
timeFrame: Up to Week 25
Secondary outcomes:
measure: Clinic (resting) blood pressure
timeFrame: Up to Week 25
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Margaret A Chesney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.