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Completed

NCT Number: NCT02870868

Breathing Interventions for Relaxation: Dosing Through Extended Exhale

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.

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Key information

Conditions

Healthy Adults Hypoventilation Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Stress

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Slow breathing

Behavioral

Slow breathing techniques from yoga

Primary outcomes

  1. Magnitude of Change in High Frequency Heart Rate Variability

    Time frame: Baseline

    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.

  2. Magnitude of Change in High Frequency Heart Rate Variability

    Time frame: 6 weeks

    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.

  3. Magnitude of Change in High Frequency Heart Rate Variability

    Time frame: 12 weeks

    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.

  4. Magnitude of Change in PROMIS Anxiety Scale

    Time frame: Baseline

    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.

  5. Magnitude of Change in PROMIS Anxiety Scale

    Time frame: 6 weeks

    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. Magnitude of Change in PROMIS Anxiety Scale

    Time frame: 12-weeks

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2016
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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