Study to Measure Relaxation From Different Types of Focused Breathing Exercises

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02226744

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breathing Mind-body Practices Yoga Meditation	Behavioral: Focused Breathing	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Focused Breathing Study

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Magnitude of changes in heart rate response to upright position [10 minutes at baseline, 2 weeks and 6 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gurjeet Birdee, Assistant Professor, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT02226744

Other Study ID Numbers:

131700

First Posted:

Aug 27, 2014

Last Update Posted:

Jan 2, 2017

Last Verified:

Dec 1, 2016

Keywords provided by Gurjeet Birdee, Assistant Professor, Vanderbilt University Medical Center

Additional relevant MeSH terms:

Respiratory Aspiration

Study Results

No Results Posted as of Jan 2, 2017