This trial is active, not recruiting.

Condition hypertension
Treatments mindful breathing (mb) intervention, usual care (uc) control condition
Sponsor University of California, San Francisco
Collaborator National Center for Complementary and Integrative Health (NCCIH)
Start date February 2011
End date September 2016
Trial size 128 participants
Trial identifier NCT01264627, 1R01AT005820


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
mindful breathing (mb) intervention
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. As attention wanders to concerns, thoughts, events or ideas, the 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 eight training sessions with individual ambulatory breathing monitors.
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 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 Outcomes

Blood Pressure
time frame: Up to Week 25

Secondary Outcomes

Clinic (resting) blood pressure
time frame: Up to Week 25

Eligibility Criteria

Female participants at least 50 years old.

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

Additional Information

Official title Project Inspire: A New Translational Tool for Studying the Role of Breathing in Meditation
Principal investigator Margaret A Chesney, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of California, San Francisco.