<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02223156</url>
  </required_header>
  <id_info>
    <org_study_id>DNR 2013/953-31/4</org_study_id>
    <nct_id>NCT02223156</nct_id>
  </id_info>
  <brief_title>Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation-MYPAF</brief_title>
  <acronym>MYPAF</acronym>
  <official_title>Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation-MYPAF, a Randomized Controlled Three Arms Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danderyd Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sophiahemmet University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Danderyd Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to investigate effect of Medi Yoga on quality of life,&#xD;
      biomedical factors and health care consumption, and to study gender differences between&#xD;
      individuals diagnosed with paroxysmal atrial fibrillation (PAF). Furthermore, an additional&#xD;
      purpose is to describe people's experiences of Medi Yoga and identify how Medi Yoga affects&#xD;
      their condition.&#xD;
&#xD;
      Hypothesis Individuals with PAF exercising Medi Yoga improve their quality of life and blood&#xD;
      pressure, heart rate and heart rate variability. Biological markers such as NT-proBNP and CRP&#xD;
      are positively affected, and that individuals seek less medical care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods / materials The chosen study design is a randomized Three arms controlled trial. The&#xD;
      study will be conducted at the Cardiology Clinic at Danderyd Hospital in Stockholm. One&#xD;
      hundred and thirty two individuals will be included and randomized to the intervention group&#xD;
      (yoga), Music relaxation group or control group (usual follow-up). Inclusion criteria are the&#xD;
      diagnosis of PAF and experience of symptomatic atrial fibrillation verified by ECG in the&#xD;
      last six months. Exclusion criteria are language difficulties, multi-diagnosis and/or&#xD;
      cognitive dysfunction (eg, diagnoses of mental illness, dementia) who are judged not to be&#xD;
      able to perform yoga. Individuals with persistent or permanent atrial fibrillation are also&#xD;
      excluded.&#xD;
&#xD;
      The subjects in the intervention group will practice yoga in groups for one hour once a week&#xD;
      for 12 weeks in the hospital, with the guidance of a trained yoga instructor. They will&#xD;
      receive written instructions on yoga exercises and a CD record to perform the yoga program at&#xD;
      home. Added to that, the standard treatment i.e. drugs, cardioversion or ablation. The music&#xD;
      relaxation group will listen to Music in half an hour in a group at the hospital.The control&#xD;
      group receives usual care.&#xD;
&#xD;
      Participants are followed for three months and the evaluation is done at baseline and after&#xD;
      three months. During these visits quality of life will be measured with two surveys, as well&#xD;
      as variables such as blood pressure, heart rate, biological markers (CRP , BNP) , and ECG and&#xD;
      24-hour ECG . Primary endpoint: quality of life. In order to obtain a five -point difference&#xD;
      in the quality of life, 132 subjects are required to achieve a power of 80 percent (p-value&#xD;
      0.05), including a loss rate of 20 percent. The calculation is based on the results of&#xD;
      Substudy I. Analytical methods that will be used are: multivariate analyzes eg logistic&#xD;
      regression, MANOVA, etc. and univariate analyzes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">April 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Three months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart rate variability</measure>
    <time_frame>three months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Episodes of arrythmia is decreasing</measure>
    <time_frame>three months</time_frame>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">132</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>MediYoga</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Music relaxation</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      BNP and CRP&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diagnosis of paroxysmal atrial fibrillation will be identified from the list&#xD;
        of patients scheduled for second visits at the Arrhythmia Polyclinic (&quot;Arytmimottagningen&quot;)&#xD;
        at the Cardiology Clinic, Danderyd Hospital. The selection will also be made from other&#xD;
        hospitals in the Stockholm County Council.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of PAF and experience of symptomatic atrial fibrillation verified by ECG in&#xD;
             the last six months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  language difficulties, multi-diagnosis and/or cognitive dysfunction (eg, diagnoses of&#xD;
             mental illness, dementia) who are judged not to be able to perform yoga. Individuals&#xD;
             with persistent or permanent atrial fibrillation are also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monica Rydell-Karlsson, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sophiahemmet University, Stockholm</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska Institute Danderyd hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Nilsson</last_name>
      <email>maria.nilsson@ds.se</email>
    </contact>
    <investigator>
      <last_name>Maria Nilsson, RN, Doctoral student</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Danderyd Hospital</investigator_affiliation>
    <investigator_full_name>Maria Nilsson</investigator_full_name>
    <investigator_title>RN</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02223156
org study id: DNR 2013/953-31/4
nct id: NCT02223156
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The main purpose of this study is to investigate effect of Medi Yoga on quality of life,
      biomedical factors and health care consumption, and to study gender differences between
      individuals diagnosed with paroxysmal atrial fibrillation (PAF). Furthermore, an additional
      purpose is to describe people's experiences of Medi Yoga and identify how Medi Yoga affects
      their condition.

      Hypothesis Individuals with PAF exercising Medi Yoga improve their quality of life and blood
      pressure, heart rate and heart rate variability. Biological markers such as NT-proBNP and CRP
      are positively affected, and that individuals seek less medical care.
Methods / materials The chosen study design is a randomized Three arms controlled trial. The
      study will be conducted at the Cardiology Clinic at Danderyd Hospital in Stockholm. One
      hundred and thirty two individuals will be included and randomized to the intervention group
      (yoga), Music relaxation group or control group (usual follow-up). Inclusion criteria are the
      diagnosis of PAF and experience of symptomatic atrial fibrillation verified by ECG in the
      last six months. Exclusion criteria are language difficulties, multi-diagnosis and/or
      cognitive dysfunction (eg, diagnoses of mental illness, dementia) who are judged not to be
      able to perform yoga. Individuals with persistent or permanent atrial fibrillation are also
      excluded.

      The subjects in the intervention group will practice yoga in groups for one hour once a week
      for 12 weeks in the hospital, with the guidance of a trained yoga instructor. They will
      receive written instructions on yoga exercises and a CD record to perform the yoga program at
      home. Added to that, the standard treatment i.e. drugs, cardioversion or ablation. The music
      relaxation group will listen to Music in half an hour in a group at the hospital.The control
      group receives usual care.

      Participants are followed for three months and the evaluation is done at baseline and after
      three months. During these visits quality of life will be measured with two surveys, as well
      as variables such as blood pressure, heart rate, biological markers (CRP , BNP) , and ECG and
      24-hour ECG . Primary endpoint: quality of life. In order to obtain a five -point difference
      in the quality of life, 132 subjects are required to achieve a power of 80 percent (p-value
      0.05), including a loss rate of 20 percent. The calculation is based on the results of
      Substudy I. Analytical methods that will be used are: multivariate analyzes eg logistic
      regression, MANOVA, etc. and univariate analyzes.
observational model: Case-Control
time perspective: Prospective
measure: Quality of life
time frame: Three months
measure: heart rate variability
time frame: three months
measure: Episodes of arrythmia is decreasing
time frame: three months
arm group label: MediYoga
arm group label: Music relaxation
arm group label: No treatment
BNP and CRP
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Monica Rydell-Karlsson, RN, PhD
role: Principal Investigator
affiliation: Sophiahemmet University, Stockholm
facility: 
status: Recruiting
contact: 
investigator: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Danderyd Hospital
investigator full name: Maria Nilsson
investigator title: RN
mesh term: Atrial Fibrillation