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Study to Measure Relaxation From Different Types of Focused Breathing Exercises

Primary Purpose

Breathing, Mind-body Practices, Yoga

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Focused Breathing
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breathing focused on measuring breathing, mind-body practices, yoga, meditation

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Focused breathing

Focused breathing 2

Arm Description

Focused deep breathing techniques used to produce specific physiological and psychological states

Focused deep breathing techniques used to produce specific physiological and psychological states

Outcomes

Primary Outcome Measures

Magnitude of changes in heart rate response to upright position

Secondary Outcome Measures

Magnitude of changes in heart rate variability measured as ratio of low frequency to high frequency ratio components (Hz)
Magnitude of changes in catecholamines in response to upright position

Full Information

First Posted
August 20, 2014
Last Updated
December 30, 2016
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02226744
Brief Title
Study to Measure Relaxation From Different Types of Focused Breathing Exercises
Official Title
Focused Breathing Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
No funds to complete study as anticipated, preliminary data used for future grant
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing, Mind-body Practices, Yoga, Meditation
Keywords
breathing, mind-body practices, yoga, meditation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focused breathing
Arm Type
Active Comparator
Arm Description
Focused deep breathing techniques used to produce specific physiological and psychological states
Arm Title
Focused breathing 2
Arm Type
Active Comparator
Arm Description
Focused deep breathing techniques used to produce specific physiological and psychological states
Intervention Type
Behavioral
Intervention Name(s)
Focused Breathing
Primary Outcome Measure Information:
Title
Magnitude of changes in heart rate response to upright position
Time Frame
10 minutes at baseline, 2 weeks and 6 weeks
Secondary Outcome Measure Information:
Title
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
Title
Magnitude of changes in catecholamines in response to upright position
Time Frame
10 minutes at baseline, 2 weeks, and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gurjeet S Birdee, MD MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Study to Measure Relaxation From Different Types of Focused Breathing Exercises

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