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

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SKY therapy
usual drug therapy
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • diagnosis of anxiety-depression disorder

Exclusion Criteria:

  • absence of sinus rhythm on ECG
  • absence of any cardiovascular and metabolic disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Sky

    control

    Arm Description

    Sky treatment foe 15 days

    standard medical therapy

    Outcomes

    Primary Outcome Measures

    Changes in autonomic control
    Parameter derived from heart rate variability: LF/HF (marker of sympatho-vagal balance)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2016
    Last Updated
    July 6, 2016
    Sponsor
    University of Milan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02828072
    Brief Title
    Sudarshan Kriya Yoga and Cardiac Autonomic Control in Patients With Anxiety-Depression Disorders
    Official Title
    Effects of Sudarshan Kriya Yoga on Cardiac Autonomic Control and Anxiety/Depression Levels in Patients Affected by Anxiety-Depression Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Milan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sky
    Arm Type
    Experimental
    Arm Description
    Sky treatment foe 15 days
    Arm Title
    control
    Arm Type
    Sham Comparator
    Arm Description
    standard medical therapy
    Intervention Type
    Other
    Intervention Name(s)
    SKY therapy
    Intervention Description
    slow breathing
    Intervention Type
    Drug
    Intervention Name(s)
    usual drug therapy
    Primary Outcome Measure Information:
    Title
    Changes in autonomic control
    Description
    Parameter derived from heart rate variability: LF/HF (marker of sympatho-vagal balance)
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: diagnosis of anxiety-depression disorder Exclusion Criteria: absence of sinus rhythm on ECG absence of any cardiovascular and metabolic disorder

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28285240
    Citation
    Toschi-Dias E, Tobaldini E, Solbiati M, Costantino G, Sanlorenzo R, Doria S, Irtelli F, Mencacci C, Montano N. Sudarshan Kriya Yoga improves cardiac autonomic control in patients with anxiety-depression disorders. J Affect Disord. 2017 May;214:74-80. doi: 10.1016/j.jad.2017.03.017. Epub 2017 Mar 7.
    Results Reference
    derived

    Learn more about this trial

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

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