HypertensionNCT01264627
A New Translational Tool for Studying the Role of Breathing in Meditation
A study testing Mindful Breathing (MB) Intervention in people with Hypertension, run by University of California, San Francisco.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Mindful Breathing (MB) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2011to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 33Show fewer
- 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
Who cannot join
None listed.
About this study
Official title: Project Inspire: 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.
- Conditions
- Hypertension
- Being tested
- Mindful Breathing (MB) Intervention, Usual Care (UC) Control Condition
- Keywords
- Hypertension, Blood pressure, Breathing, PetCO2, Stress
- Medical subject headings
- Hypertension, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Breathing (MB) InterventionBehavioural
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 ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindful Breathing (MB) Intervention |
| 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. Receives: Behavioral: Usual Care (UC) Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Measured using Ambulatory, 24-Hr BP monitor
Measured: Up to Week 25
Secondary outcomes (1)
Clinic (resting) blood pressure
Measured: Up to Week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study start1 Feb 2011
- Primary completion31 Jul 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Margaret A Chesney, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264627
- Sponsor's protocol ID
- 1R01AT005820
- Other IDs
- 1R01AT005820
- Status last verified
- Nov 2020
- First submitted
- 15 Dec 2010
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19361005
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Inspire: A New Translational Tool for Studying the Role of Breathing in Meditation
- ClinicalTrials.gov ID
- NCT01264627
- Acronym / sponsor ID
- 1R01AT005820
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood pressure, Breathing, PetCO2, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Breathing (MB) | Experimental | Behavioral: Mindful Breathing (MB) InterventionThe 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. |
| Usual Care (UC) | Other | Behavioral: Usual Care (UC) Control ConditionUsual 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Breathing (MB) InterventionThe 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. | Behavioural | Mindful Breathing (MB) |
| Usual Care (UC) Control ConditionThis 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. | Behavioural | Usual Care (UC) |
Primary outcome
Blood Pressure
Time frame: Up to Week 25
Measured using Ambulatory, 24-Hr BP monitor
1 secondary outcome
Clinic (resting) blood pressure
Time frame: Up to Week 25
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 19361005Barnes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret A Chesney, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Breathing (MB) Intervention in people with Hypertension, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: Up to Week 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01264627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.