Clinical trial NCT02870868: Breathing Interventions for Relaxation: Dosing Through Extended Exhale
Official title: Breathing Interventions for Relaxation: Dosing Through Extended Exhale
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Stress
Keywords: slow breathing
yoga
mind-body practicers
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-08-17
Enrollment: 99
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Magnitude of Change in High Frequency Heart Rate Variability
timeFrame: Baseline
measure: Magnitude of Change in High Frequency Heart Rate Variability
timeFrame: 6 weeks
measure: Magnitude of Change in High Frequency Heart Rate Variability
timeFrame: 12 weeks
measure: Magnitude of Change in PROMIS Anxiety Scale
timeFrame: Baseline
measure: Magnitude of Change in PROMIS Anxiety Scale
timeFrame: 6 weeks
measure: Magnitude of Change in PROMIS Anxiety Scale
timeFrame: 12-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Gurjeet Birdee, MD
role: PRINCIPAL_INVESTIGATOR
References: