Healthy AdultsNCT02870868
Breathing Interventions for Relaxation: Dosing Through Extended Exhale
A study testing Slow breathing in people with Healthy Adults and Stress, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Stress
- What is being tested?
- Slow breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2016to 19 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 30 to 60 years
- English speaking
Who cannot join
- Hypertension
- Heart disease: history of coronary artery disease, myocardial infarction, significant valvular disease, or congestive heart failure
- Diabetes
- Renal disease
- Anxiety disorder
- Depression
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the 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.
- Conditions
- Healthy Adults, Stress
- Being tested
- Slow breathing
- Keywords
- slow breathing, yoga, mind-body practicers
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow breathingBehavioural
Slow breathing techniques from yoga
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Slow breathing |
| 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. Receives: Behavioral: Slow breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start14 Oct 2016
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Alfredo Gamboa, Vanderbilt University Medical Center
- Investigators
- Gurjeet Birdee, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870868
- Sponsor's protocol ID
- 160817
- Other IDs
- 1R61AT009340
- Status last verified
- May 2024
- First submitted
- 12 Aug 2016
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Interventions for Relaxation: Dosing Through Extended Exhale
- ClinicalTrials.gov ID
- NCT02870868
- Acronym / sponsor ID
- 160817
- Conditions
- Healthy Adults, Stress
- Keywords
- slow breathing, yoga, mind-body practicers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Posted 29 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow breathing with exhale greater than inhale | Experimental | Behavioral: Slow breathingParticipants 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. |
| Slow breathing with exhale equal to inhale | Experimental | Behavioral: Slow breathingParticipants 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 30 to 60 years
- English speaking
Key exclusion criteria (20 listed)
- Hypertension
- Heart disease: history of coronary artery disease, myocardial infarction, significant valvular disease, or congestive heart failure
- Diabetes
- Renal disease
- Anxiety disorder
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 |
|---|---|---|
| Slow breathingSlow breathing techniques from yoga | Behavioural | Slow breathing with exhale equal to inhale, Slow breathing with exhale greater than inhale |
Primary outcome
Magnitude of Change in High Frequency Heart Rate Variability
Time frame: 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 High Frequency Heart Rate Variability
Time frame: 6 weeks
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 High Frequency Heart Rate Variability
Time frame: 12 weeks
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
Time frame: 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.
Magnitude of Change in PROMIS Anxiety Scale
Time frame: 6 weeks
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.
Magnitude of Change in PROMIS Anxiety Scale
Time frame: 12-weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Gurjeet Birdee, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow breathing in people with Healthy Adults and Stress, run by Vanderbilt University Medical Center at 1 site in United States.
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 2 inclusion and 20 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Magnitude of Change in High Frequency Heart Rate Variability (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2024; AzTrials last refreshed its copy on 27 Oct 2026.