Skip to main content
OpenTrials
Completed

NCT Number: NCT01264627

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindful Breathing (MB) Intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Blood Pressure

    Time frame: Up to Week 25

    Measured using Ambulatory, 24-Hr BP monitor

Secondary outcomes

  1. Clinic (resting) blood pressure

    Time frame: Up to Week 25

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Dec 22, 2010
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.