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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01264627
Enrollment
99
Registered
2010-12-22
Start date
2011-02-01
Completion date
2017-08-31
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Blood pressure, Breathing, PetCO2, Stress

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.

Interventions

BEHAVIORALMindful 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.

BEHAVIORALUsual 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood PressureUp to Week 25Measured using Ambulatory, 24-Hr BP monitor

Secondary

MeasureTime frame
Clinic (resting) blood pressureUp to Week 25

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026