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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AT005820 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindful Breathing (MB) | Experimental | 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. |
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| Usual Care (UC) | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Measured using Ambulatory, 24-Hr BP monitor | Up to Week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinic (resting) blood pressure | Up to Week 25 |
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Inclusion Criteria
Exclusion Criteria (Individuals will be filtered in the KP OSCA database according to the following ICD-9 codes):
Respiration:
Cardiovascular:
Kidney:
Liver:
- 571.X chronic liver disease and cirrhosis Smoker: 305.1
Psychiatric:
Medications:
Other:
- Plan to relocate residence outside recruitment area during the intervention or follow- period
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| Name | Affiliation | Role |
|---|---|---|
| Margaret A Chesney, PhD | University of California, San Francisco | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19361005 | Background | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 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. |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |