Breathing Interventions for Relaxation: Dosing Through Extended Exhale

Stress Clinical Trial

Official title:

Breathing Interventions for Relaxation: Dosing Through Extended Exhale

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870868
• Other study ID #: 160817
• Secondary ID: 1R61AT009340
• Status: Completed
• Phase: N/A
• Start date: October 14, 2016
• Est. completion date: December 19, 2018

Study information

• Verified date: May 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 19, 2018
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults
• Respiratory Aspiration
• Stress

Intervention

Behavioral:
• Slow breathing
Slow breathing techniques from yoga

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline
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.	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.	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.	Baseline
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.	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.	12-weeks