Breathing Interventions for Relaxation: Dosing Through Extended Exhale

NCT02870868 | Completed Results DMC

• 2 other identifiers: 1608171R61AT009340
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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

Keywords

slow breathing; yoga; mind-body practicers

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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.

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.

Behavioral: Slow breathing

Interventions

Slow breathing BEHAVIORAL

Slow breathing techniques from yoga

Slow breathing with exhale equal to inhale; Slow breathing with exhale greater than inhale

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 30 to 60 years
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alfredo Gamboa
• Organization: Vanderbilt University Medical Center

alfredo.gamboa@vumc.org

(615) 322-5000

Study Officials

• Gurjeet Birdee, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: October 14, 2016
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)