Healthy Adults, Stress
Conditions
Keywords
slow breathing, yoga, mind-body practicers
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSlow breathing
Slow breathing techniques from yoga
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 30 to 60 years * English speaking
Exclusion criteria
* Hypertension * Heart disease: history of coronary artery disease, myocardial infarction, significant valvular disease, or congestive heart failure * Diabetes * Renal disease * Anxiety disorder * Depression * Other psychiatric conditions including schizophrenia or bipolar disorder * Attention-deficit-disorder or Attention-deficit-hyperactivity disorder * Musculoskeletal condition limiting capacity to perform simple movements such as chronic lower back pain or neck pain * Pulmonary disorder (asthma, chronic obstructive lung disease, obstructive sleep apnea) * Smoker * Currently taking blood pressure medications, oral diabetic medication or insulin * Current participation in a mind-body practice/program * Current cancer other than non- melanoma skin cancer * Regular swimmer * Plays wind or brass musical instruments After two weeks during screening period unable to: * Breathe 8 or less a minute * Breathe 3 or less breaths a minute * Practiced less than 3 times a week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnitude of Change in High Frequency Heart Rate Variability | Baseline | 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. |
| Magnitude of Change in PROMIS Anxiety Scale | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Slow Breathing With Exhale Greater Than Inhale Slow breathing: Slow breathing techniques from yoga | 49 |
| Slow Breathing With Exhale Equal to Inhale Slow breathing: Slow breathing techniques from yoga | 50 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Slow Breathing With Exhale Equal to Inhale | Slow Breathing With Exhale Greater Than Inhale | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 49 Participants | 99 Participants |
| Age, Continuous | 41.0 years STANDARD_DEVIATION 8.7 | 41.2 years STANDARD_DEVIATION 9.2 | 41.2 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 45 Participants | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| High Frequency Heart Rate Variability | 421 milliseconds^second STANDARD_DEVIATION 350 | 399 milliseconds^second STANDARD_DEVIATION 355 | 409 milliseconds^second STANDARD_DEVIATION 350 |
| PROMIS Anxiety Scale | 56.5 units on a scale STANDARD_DEVIATION 5.4 | 56.2 units on a scale STANDARD_DEVIATION 4.8 | 56.444 units on a scale STANDARD_DEVIATION 4.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 45 Participants | 34 Participants | 79 Participants |
| Region of Enrollment United States | 50 participants | 49 participants | 99 participants |
| Sex: Female, Male Female | 39 Participants | 39 Participants | 78 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 50 |
| other Total, other adverse events | 0 / 49 | 0 / 50 |
| serious Total, serious adverse events | 0 / 49 | 0 / 50 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Slow Breathing With Exhale Greater Than Inhale | Magnitude of Change in High Frequency Heart Rate Variability | 399 milliseconds^2 | Standard Deviation 355 |
| Slow Breathing With Exhale Equal to Inhale | Magnitude of Change in High Frequency Heart Rate Variability | 421 milliseconds^2 | Standard Deviation 350 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Slow Breathing With Exhale Greater Than Inhale | Magnitude of Change in High Frequency Heart Rate Variability | 376 milliseconds^2 | Standard Deviation 355 |
| Slow Breathing With Exhale Equal to Inhale | Magnitude of Change in High Frequency Heart Rate Variability | 485 milliseconds^2 | Standard Deviation 463 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Slow Breathing With Exhale Greater Than Inhale | Magnitude of Change in High Frequency Heart Rate Variability | 381 milliseconds^2 | Standard Deviation 393 |
| Slow Breathing With Exhale Equal to Inhale | Magnitude of Change in High Frequency Heart Rate Variability | 487 milliseconds^2 | Standard Deviation 476 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Slow Breathing With Exhale Greater Than Inhale | Magnitude of Change in PROMIS Anxiety Scale | 56.2 units on a scale | Standard Deviation 4.8 |
| Slow Breathing With Exhale Equal to Inhale | Magnitude of Change in PROMIS Anxiety Scale | 56.5 units on a scale | Standard Deviation 5.4 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Slow Breathing With Exhale Greater Than Inhale | Magnitude of Change in PROMIS Anxiety Scale | 52.4 units on a scale | Standard Deviation 5.1 |
| Slow Breathing With Exhale Equal to Inhale | Magnitude of Change in PROMIS Anxiety Scale | 53.9 units on a scale | Standard Deviation 4.4 |
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.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Slow Breathing With Exhale Greater Than Inhale | Magnitude of Change in PROMIS Anxiety Scale | 52.0 units on a scale | Standard Deviation 4.3 |
| Slow Breathing With Exhale Equal to Inhale | Magnitude of Change in PROMIS Anxiety Scale | 51.2 units on a scale | Standard Deviation 5.6 |