Breathing Interventions for Relaxation: Dosing Through Extended Exhale

NCT ID: NCT02870868

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-14
• Study Completion Date: 2018-12-19

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.

Detailed 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.

Conditions

Healthy Adults; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Slow breathing with exhale greater than inhale

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.

Group Type: EXPERIMENTAL

Slow breathing

Intervention Type: BEHAVIORAL

Slow breathing techniques from yoga

Slow breathing with exhale equal to inhale

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.

Group Type: EXPERIMENTAL

Slow breathing

Intervention Type: BEHAVIORAL

Slow breathing techniques from yoga

Interventions

Slow breathing

Slow breathing techniques from yoga

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alfredo Gamboa

Assoc. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gurjeet Birdee, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R61AT009340

Identifier Type: NIH

Identifier Source: secondary_id

View Link

160817

Identifier Type: -

Identifier Source: org_study_id