Study to Measure Relaxation From Different Types of Focused Breathing Exercises

Yoga Clinical Trial

Official title:

Focused Breathing Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02226744
• Other study ID #: 131700
• Status: Terminated
• Phase: Phase 1
• First received: August 20, 2014
• Last updated: December 30, 2016
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2016
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breathing
• Meditation
• Mind-body Practices
• Respiratory Aspiration
• Yoga

Intervention

Behavioral:
• Focused Breathing

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of changes in heart rate response to upright position		10 minutes at baseline, 2 weeks and 6 weeks	No
Secondary	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	No
Secondary	Magnitude of changes in catecholamines in response to upright position		10 minutes at baseline, 2 weeks, and 6 weeks	No