Breathing Interventions for Relaxation: Dosing Through Extended Exhale

Study Overview
=================
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.

Conditions
-----------------
Healthy Adults, Stress

Intervention / Treatment
-----------------
* Behavioral: Slow breathing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slow breathing with exhale greater than inhale<br> | Behavioral: Slow breathing<br>* Slow breathing techniques from yoga<br>|
| Experimental: Slow breathing with exhale equal to inhale<br> | Behavioral: Slow breathing<br>* Slow breathing techniques from yoga<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnitude of change in high frequency heart rate variability | Measure of parasympathetic tone | Baseline, 6 weeks, and 12 weeks | 
| Magnitude of change in PROMIS Anxiety scale | Measure of psychological stress | Baseline, 6 weeks, and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnitude of change in baroreflex sensitivity | Measure of parasympathetic tone | Baseline, 6 weeks, and 12 weeks | 
| Magnitude of change in PROMIS Depression scale | Measure of negative affect | Baseline, 6 weeks, and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
yoga, slow breathing, mind-body practicers