Breathing Interventions for Relaxation: Dosing Through Extended Exhale

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02870868
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 99
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.2
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults; Stress	Behavioral: Slow breathing	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Actual Study Start Date: Oct 14, 2016
• Actual Primary Completion Date: Dec 19, 2018
• Actual Study Completion Date: Dec 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Slow breathing with exhale greater than inhale	Behavioral: Slow breathing; Slow breathing techniques from yoga
Experimental: Slow breathing with exhale equal to inhale	Behavioral: Slow breathing; Slow breathing techniques from yoga

Outcome Measures

Primary Outcome Measures

1. Magnitude of change in high frequency heart rate variability [Baseline, 6 weeks, and 12 weeks]

   Measure of parasympathetic tone

2. Magnitude of change in PROMIS Anxiety scale [Baseline, 6 weeks, and 12 weeks]

   Measure of psychological stress

Secondary Outcome Measures

1. Magnitude of change in baroreflex sensitivity [Baseline, 6 weeks, and 12 weeks]

   Measure of parasympathetic tone

2. Magnitude of change in PROMIS Depression scale [Baseline, 6 weeks, and 12 weeks]

   Measure of negative affect

Other Outcome Measures

1. Magnitude of change in Perceived Stress Scale [Baseline, 6 weeks, and 12 weeks]

   Measure of changes in stress

2. Magnitude of change in Anxiety Sensitivity Index-3 [Baseline, 6 weeks, and 12 weeks]

   Measure of changes in stress

3. Magnitude of change in Beck Anxiety Inventory [Baseline, 6 weeks, and 12 weeks]

   Measure of changes in stress

4. Magnitude of change in Body Vigilance Scale [Baseline, 6 weeks, and 12 weeks]

   Measure of changes in stress

5. Magnitude of change in Panic Disorder Severity Scale [Baseline, 6 weeks, and 12 weeks]

   Measure of changes in stress

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt University Medical Center
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Gurjeet Birdee, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alfredo Gamboa, Assoc. Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT02870868
• Other Study ID Numbers: 160817
• First Posted: Aug 17, 2016
• Last Update Posted: Apr 5, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Alfredo Gamboa, Assoc. Professor, Vanderbilt University Medical Center: slow breathing; yoga; mind-body practicers

Study Results

No Results Posted as of Apr 5, 2019