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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02226744
Other study ID # 131700
Secondary ID
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


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
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