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

Study Overview
=================
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.

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

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Mindful Breathing (MB) Intervention
* Behavioral: Usual Care (UC) Control Condition


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Breathing (MB)<br>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. | Behavioral: Mindful Breathing (MB) Intervention<br>* 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.<br>|
| Other: Usual Care (UC)<br>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. | Behavioral: Usual Care (UC) Control Condition<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Measured using Ambulatory, 24-Hr BP monitor | Up to Week 25 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinic (resting) blood pressure |  | Up to Week 25 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Blood pressure, Breathing, PetCO2, Stress