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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61AT009340 | 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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Breathing exercises are categorized as a mind-body practice. One in ten adults in the U.S. use breathing exercises for health purposes. The aim of this project is to examine if different slow breathing has different physiological and psychological effects.
Breathing exercises are categorized as a mind-body practice. One in ten adults in the U.S. use breathing exercises for health purposes. Slow breathing exercises are commonly used for stress reduction. Higher stress is associated with higher cardiovascular risk. Effective and standardized breathing interventions for stress reduction have not been developed or well-studied. For centuries, mind-body practitioners have proposed that, in addition to breathing slowly, extending the length of exhale relative to inhale increases the dose of relaxation. Few studies have tested this belief. The aim of this proposal is to examine if slow breathing while extending the exhale time relative to the inhale time increases physiological and psychological relaxation. The slow breathing exercises to be studied are based on breathing techniques from yoga. This is a12-week study among healthy adults randomized to daily slow breathing exercises of: (1) exhale greater than inhale versus (2) exhale equal to inhale in length. The first aim of the studies will be to compare 12 weeks of slow breathing with exhale greater than inhale on physiological stress as measured through autonomic tone. The second aim will be to compare changes in psychological stress as measured through validated stress and anxiety questionnaires. The final and third aim will be to measure the correlation between changes in physiological and psychological stress. This project will test if specific breathing techniques produce measurable and meaningful differences in stress in both healthy and disease populations. Because stress reduction is considered the major mechanism of mind-body practices, these studies will advance the field of mind-body science.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slow breathing with exhale greater than inhale | Experimental | Participants randomized to slow breathing with prolonged exhale to inhale ratio received progressive increases in expiration relative to inspiration based on initial assessment until they reached a goal breath length or longest comfortable breath. Prior to performing the breathing practice, subjects in this exhale>inhale condition performed the same yoga movements as the exhale-inhale group. |
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| Slow breathing with exhale equal to inhale | Experimental | Participants randomized to slow breathing with equal inspiration and expiration received progressive increases in both inspiration and expiration over 4 weeks until they reach a goal breath length or longest comfortable breath. Goal breaths were assigned based on initial breath assessment. Prior to performing the breathing practice, participants performed a few standardized yoga movements. The purpose of movements was to prepare the subject to sit and focus on breathing. Subjects randomized to exhale=inhale will receive progressive increases in both inspiration and expiration until they reach a goal breath length. Goal breaths will be assigned based on initial breath assessment. Prior to performing the breathing practice, subjects will perform a set of standardized breathing practices. The purpose of these few breathing practices is to prepare the subject to sit and focus on breathing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slow breathing | Behavioral | Slow breathing techniques from yoga |
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| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of Change in High Frequency Heart Rate Variability | This is a proxy measure of parasympathetic tone. In normal healthy adults, the average value is around 600 ms^2 (miliseconds*miliseconds). In hypertensive adults, the average value is around 100 ms^2. In patients with autonomic failure (who lacks parasympathetic tone), the average value is around 20 ms^2. | Baseline |
| Magnitude of Change in High Frequency Heart Rate Variability | This is a proxy measure of parasympathetic tone. In normal healthy adults, the average value is around 600 ms^2 (miliseconds*miliseconds). In hypertensive adults, the average value is around 100 ms^2. In patients with autonomic failure (who lacks parasympathetic tone), the average value is around 20 ms^2. | 6 weeks |
| Magnitude of Change in High Frequency Heart Rate Variability | This is a proxy measure of parasympathetic tone. In normal healthy adults, the average value is around 600 ms^2 (miliseconds*miliseconds). In hypertensive adults, the average value is around 100 ms^2. In patients with autonomic failure (who lacks parasympathetic tone), the average value is around 20 ms^2. | 12 weeks |
| Magnitude of Change in PROMIS Anxiety Scale | Measure of psychological stress taken at baseline before any study intervention. The scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety. | Baseline |
| Magnitude of Change in PROMIS Anxiety Scale | Measure of psychological stress taken at baseline before any study intervention. The scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety. |
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Inclusion Criteria:
Exclusion Criteria:
After two weeks during screening period unable to:
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| Name | Affiliation | Role |
|---|---|---|
| Gurjeet Birdee, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Slow Breathing With Exhale Greater Than Inhale | Slow breathing performed with time of exhale longer than inhale |
| FG001 | Slow Breathing With Exhale Equal to Inhale | Slow breathing performed with time of exhale equal to inhale |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Slow Breathing With Exhale Greater Than Inhale | Slow breathing: Slow breathing techniques from yoga |
| BG001 | Slow Breathing With Exhale Equal to Inhale | Slow breathing: Slow breathing techniques from yoga |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Magnitude of Change in High Frequency Heart Rate Variability | This is a proxy measure of parasympathetic tone. In normal healthy adults, the average value is around 600 ms^2 (miliseconds*miliseconds). In hypertensive adults, the average value is around 100 ms^2. In patients with autonomic failure (who lacks parasympathetic tone), the average value is around 20 ms^2. | Posted | Mean | Standard Deviation | milliseconds^2 | Baseline |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Slow Breathing With Exhale Greater Than Inhale | Slow breathing: Slow breathing techniques from yoga |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheadedness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alfredo Gamboa | Vanderbilt University Medical Center | (615) 322-5000 | alfredo.gamboa@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2018 | Jan 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007040 | Hypoventilation |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| 6 weeks |
| Magnitude of Change in PROMIS Anxiety Scale | Measure of psychological stress taken at baseline before any study intervention. The scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety. | 12-weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| High Frequency Heart Rate Variability | Erroneous electrocardiographic measurements for spectral analyses | Mean | Standard Deviation | milliseconds^second |
|
| PROMIS Anxiety Scale | Measure of psychological stress taken at baseline before any study intervention. The scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety. | Missing data | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Magnitude of Change in High Frequency Heart Rate Variability | This is a proxy measure of parasympathetic tone. In normal healthy adults, the average value is around 600 ms^2 (miliseconds*miliseconds). In hypertensive adults, the average value is around 100 ms^2. In patients with autonomic failure (who lacks parasympathetic tone), the average value is around 20 ms^2. | Posted | Mean | Standard Deviation | milliseconds^2 | 6 weeks |
|
|
|
| Primary | Magnitude of Change in High Frequency Heart Rate Variability | This is a proxy measure of parasympathetic tone. In normal healthy adults, the average value is around 600 ms^2 (miliseconds*miliseconds). In hypertensive adults, the average value is around 100 ms^2. In patients with autonomic failure (who lacks parasympathetic tone), the average value is around 20 ms^2. | Posted | Mean | Standard Deviation | milliseconds^2 | 12 weeks |
|
|
|
| Primary | Magnitude of Change in PROMIS Anxiety Scale | Measure of psychological stress taken at baseline before any study intervention. The scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
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| Primary | Magnitude of Change in PROMIS Anxiety Scale | Measure of psychological stress taken at baseline before any study intervention. The scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Primary | Magnitude of Change in PROMIS Anxiety Scale | Measure of psychological stress taken at baseline before any study intervention. The scale ranges from 0 (no anxiety) to 100 (maximal anxiety). In the normal adult population, the average of the PROMIS Cooperative Group. (2011). Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety score is 50. A higher score correlates with increased anxiety and a lower score correlates with lower anxiety. | Posted | Mean | Standard Deviation | units on a scale | 12-weeks |
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| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Slow Breathing With Exhale Equal to Inhale | Slow breathing: Slow breathing techniques from yoga | 0 | 50 | 0 | 50 | 0 | 50 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|