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Sudarshan Kriya Yoga and Cardiac Autonomic Control in Patients With Anxiety-Depression Disorders

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ClinicalTrials.gov Identifier: NCT02828072
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Eleonora Tobaldini, University of Milan

Brief Summary:
The effects of Sudarshan Kriya Yoga (SKY) on autonomic function in patients with anxiety-depression disorders is unknown. Thus, the authors will investigate cardiac autonomic control in a population of patients with anxiety-depression disorders which will undergo a specific SKY treatment.

Condition or disease Intervention/treatment Phase
Anxiety Depression Other: SKY therapy Drug: usual drug therapy Not Applicable

Detailed Description:

Several studies have demonstrated that adjuvant therapies as exercise and breathing training are effective in improving cardiac autonomic control (CAC) in patients with affective spectrum disorders. However, the effects of Sudarshan Kriya Yoga (SKY) on autonomic function in this population is unknown. To test the hypothesis that SKY training improves CAC, cardiorespiratory coupling and adaptive response of sympatho-vagal balance to orthostatic changes were evaluated in patients with anxiety and/or depression disorders.

The authors will enroll patients with a diagnosis of anxiety and/or depression disorders (DSM-IV) and they will divide them in two groups: 1) conventional therapy (Control) and 2) conventional therapy associated with SKY (Treatment) for 15 days. Anxiety and depression levels will be determined using quantitative questionnaires. For the assessment of CAC and cardiorespiratory coupling, cardiorespiratory traces will be analyzed using monovariate and bivariate autoregressive spectral analysis, respectively.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Sudarshan Kriya Yoga on Cardiac Autonomic Control and Anxiety/Depression Levels in Patients Affected by Anxiety-Depression Disorders
Study Start Date : March 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Sky
Sky treatment foe 15 days
Other: SKY therapy
slow breathing

Sham Comparator: control
standard medical therapy
Drug: usual drug therapy



Primary Outcome Measures :
  1. Changes in autonomic control [ Time Frame: 1 month ]
    Parameter derived from heart rate variability: LF/HF (marker of sympatho-vagal balance)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosis of anxiety-depression disorder

Exclusion Criteria:

  • absence of sinus rhythm on ECG
  • absence of any cardiovascular and metabolic disorder
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eleonora Tobaldini, Doctor, University of Milan
ClinicalTrials.gov Identifier: NCT02828072    
Other Study ID Numbers: SKY-1
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders