Study Stopped
No funds to complete study as anticipated, preliminary data used for future grant
Study to Measure Relaxation From Different Types of Focused Breathing Exercises
Focused Breathing Study
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 20, 2014
CompletedFirst Posted
Study publicly available on registry
August 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 2, 2017
December 1, 2016
1.3 years
August 20, 2014
December 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Magnitude of changes in heart rate response to upright position
10 minutes at baseline, 2 weeks and 6 weeks
Secondary Outcomes (2)
Magnitude of changes in heart rate variability measured as ratio of low frequency to high frequency ratio components (Hz)
Baseline, 2 weeks, and 6 weeks
Magnitude of changes in catecholamines in response to upright position
10 minutes at baseline, 2 weeks, and 6 weeks
Study Arms (2)
Focused breathing
ACTIVE COMPARATORFocused deep breathing techniques used to produce specific physiological and psychological states
Focused breathing 2
ACTIVE COMPARATORFocused deep breathing techniques used to produce specific physiological and psychological states
Interventions
Eligibility Criteria
You may qualify if:
- Age 30 to 50 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 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gurjeet S Birdee, MD MPH
Vanderbilt University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 20, 2014
First Posted
August 27, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 2, 2017
Record last verified: 2016-12