Study to Measure Relaxation From Different Types of Focused Breathing Exercises

December 30, 2016 updated by: Gurjeet Birdee, Vanderbilt University Medical Center

Focused Breathing Study

Mind-body practices, such as yoga, ta'i chi, mindfulness and biofeedback, commonly use slow breathing techniques to induce physiological and mental relaxation. Medical research suggests that slow breathing techniques induce physiological relaxation. This 6 week study will compare the effects of different types of breathing. The hypothesis is that different breathing techniques produce different physiological and mental changes.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 30 to 50 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 yoga such as chronic lower back pain, chronic neck pain
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Focused breathing
Focused deep breathing techniques used to produce specific physiological and psychological states
Behavioral: Focused Breathing
Active Comparator: Focused breathing 2
Focused deep breathing techniques used to produce specific physiological and psychological states
Behavioral: Focused Breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Magnitude of changes in heart rate response to upright position
Time Frame: 10 minutes at baseline, 2 weeks and 6 weeks
10 minutes at baseline, 2 weeks and 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Magnitude of changes in heart rate variability measured as ratio of low frequency to high frequency ratio components (Hz)
Time Frame: Baseline, 2 weeks, and 6 weeks
Baseline, 2 weeks, and 6 weeks
Magnitude of changes in catecholamines in response to upright position
Time Frame: 10 minutes at baseline, 2 weeks, and 6 weeks
10 minutes at baseline, 2 weeks, and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Estimate)

January 2, 2017

Last Update Submitted That Met QC Criteria

December 30, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131700

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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