<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/NCT04476368</url>
  </required_header>
  <id_info>
    <org_study_id>0120-575/2018/5</org_study_id>
    <nct_id>NCT04476368</nct_id>
  </id_info>
  <brief_title>Effect of Yoga in Pregnancy on Cardio-respiratory Adaptation to Challenge</brief_title>
  <acronym>YOGADAPT</acronym>
  <official_title>Effect of Yoga in Pregnancy on Cardiovascular and Respiratory Adaptation to Acute Psychological Challenge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Centre Ljubljana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Medical Centre Maribor</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medical Centre Ljubljana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Yoga has received considerable attention for its potential therapeutic benefits over the past&#xD;
      decades and it gradually became object of scientific scrutiny. There is currently extensive&#xD;
      literature supporting its use as a non-pharmacological tool for managing a variety of medical&#xD;
      problems. A few studies have also explored potential beneficial effects of practising yoga&#xD;
      during pregnancy on maternal and neonatal outcomes. An association between prenatal yoga and&#xD;
      decreased incidence of fetal growth restriction, preterm delivery, and labor abnormalities&#xD;
      resulting in operative delivery have been reported.&#xD;
&#xD;
      Exact mechanisms by which yoga could improve perinatal outcomes have not been elucidated yet.&#xD;
      One of such mechanisms could be the positive effect of yoga on autonomic nervous system&#xD;
      (ANS). Maternal cardiovascular system undergoes profound changes during pregnancy and ANS&#xD;
      plays a central role in adaptation to pregnancy-related hemodynamic changes. Increase in&#xD;
      peripheral vascular resistance that characterises hypertensive disorders in pregnancy with&#xD;
      fetal growth restriction is mediated by substantial increase in sympathetic vasoconstrictor&#xD;
      activity. Effects of yoga on ANS outside of pregnancy have already been investigated in&#xD;
      several studies. Heart rate variability (HRV) indices, used as a one of proxy measures for&#xD;
      ANS activity, showed significant shifts towards parasympathetic dominance following yoga&#xD;
      sessions. Another objective means of assessing ANS activity is measurement of phase&#xD;
      synchronisation between cardiovascular and respiratory systems following acute challenge. The&#xD;
      higher the cardiorespiratory synchronisation after acute challenge is, the higher is the&#xD;
      ability of ANS to flexibly adapt to challenge.&#xD;
&#xD;
      The objectives of the study are:&#xD;
&#xD;
      I. To examine whether there is a short-term shift in autonomic balance to the parasympathetic&#xD;
      branch of the ANS and ability of the cardiovascular and respiratory respiratory systems to&#xD;
      flexibly adapt to acute psychological challenge following sessions in pregnancy.&#xD;
&#xD;
      II. To investigate potential long- term effects of yoga practice during pregnancy on HRV and&#xD;
      cardio-respiratory synchronisation following acute psychological challenge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">April 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cardio-respiratory phase synchronisation index</measure>
    <time_frame>Change in cardio-respiratory phase synchronisation index from baseline (measured up to 30 minutes before yoga class/walk) to the end of exercise (measured up to 30 minutes after the end of yoga class/walk)</time_frame>
    <description>Cardio-respiratory phase synchronisation index measures synchronisation between the cardiovascular and respiratory system following acute psychological challenge. It's value is between 0 (no synchronisation) and 1 (complete synchronisation). The higher the value, the higher the ability of cardiovascular and respiratory systems to flexibly adapt to challenge (standardised memory task).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in LF/HF HRV ratio.</measure>
    <time_frame>Change in LF/HF HRV ratio from baseline (measured up to 30 minutes before yoga class/walk) to the end of exercise (measured up to 30 minutes after the end of yoga class/walk).</time_frame>
    <description>For frequency related HRV indices, we will run an autoregressive spectral analysis using Burg's algorithm (model order 24) after resampling and removing the trend of 2nd order. Low frequency (LF) will be defined as 0.04 - 0.15 Hz, high frequency (HF) will be defined as 0.15 - 0.40 Hz. The higher the LF/HF HRV ratio, the lower the parasympathetic tone.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BRS</measure>
    <time_frame>Change in BRS from baseline (measured up to 30 minutes before yoga class/walk) to the end of exercise (measured up to 30 minutes after the end of yoga class/walk).</time_frame>
    <description>The sequence technique will be used for the assessment of baroreceptor sensitivity (BRS). This technique is based on identifying consecutive cardiac beats in which an increase in systolic blood pressure is accompanied by an increase in heart rate, or in which a decrease in systolic blood pressure is accompanied by a decrease in heart rate. The regression line between the systolic blood pressure and heart rate produces an estimate of BRS. The higher the BRS, the higher the parasympathetic tone.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Yoga</condition>
  <condition>Pregnancy</condition>
  <condition>Autonomic Nervous System</condition>
  <arm_group>
    <arm_group_label>yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in yoga group will be recruited during prenatal yoga classes at two locations: Maribor and Ljubljana. Women will be instructed to attend one class per week. Classes will consist of pregnancy-adapted yoga practices according to the system Yoga in Daily Life. They will be 90 min in duration and will consist of initial relaxation (10 to 15 min), followed by yoga postures (asanas) and stretching exercises (45 to 60 min), and final breathing (pranayama), concentration (dharana), and meditation (dhyana) techniques (20 to 30 min). Two certified yoga instructors will lead yoga classes. Measurements will be performed before and after yoga session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group will consist of healthy pregnant women attending regular prenatal visits at the departments of perinatology of the university medical centers Maribor and Ljubljana. Only women not attending any formal prenatal exercise program will be offered entrance in the study. Measurements in this group will be performed before and after a 20-30 minute walk.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>weekly yoga classes</intervention_name>
    <description>Weekly 90 min pregnancy-adapted yoga classes lead by certified yoga instructors.</description>
    <arm_group_label>yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>walk</intervention_name>
    <description>20-30 min easy walking</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy pregnant women with singleton pregnancies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple pregnancies&#xD;
&#xD;
          -  Cardiovascular disease (including hypertension and arrhythmias)&#xD;
&#xD;
          -  Taking medications that would affect heart rate or blood pressure&#xD;
&#xD;
          -  Psychiatric disorders&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Kidney disease&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Known fetal anomaly&#xD;
&#xD;
          -  Autoimmune disorders&#xD;
&#xD;
          -  Thyroid disease&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Alcohol/drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UMC Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC Maribor</name>
      <address>
        <city>Maribor</city>
        <zip>2000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 24, 2022</last_update_submitted>
  <last_update_submitted_qc>June 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
    <investigator_full_name>Miha Lucovnik</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>yoga</keyword>
  <keyword>pregnancy</keyword>
  <keyword>cardiorespiratory synchronisation</keyword>
  <keyword>hearth rate variability</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04476368
org study id: 0120-575/2018/5
nct id: NCT04476368
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Yoga has received considerable attention for its potential therapeutic benefits over the past
      decades and it gradually became object of scientific scrutiny. There is currently extensive
      literature supporting its use as a non-pharmacological tool for managing a variety of medical
      problems. A few studies have also explored potential beneficial effects of practising yoga
      during pregnancy on maternal and neonatal outcomes. An association between prenatal yoga and
      decreased incidence of fetal growth restriction, preterm delivery, and labor abnormalities
      resulting in operative delivery have been reported.

      Exact mechanisms by which yoga could improve perinatal outcomes have not been elucidated yet.
      One of such mechanisms could be the positive effect of yoga on autonomic nervous system
      (ANS). Maternal cardiovascular system undergoes profound changes during pregnancy and ANS
      plays a central role in adaptation to pregnancy-related hemodynamic changes. Increase in
      peripheral vascular resistance that characterises hypertensive disorders in pregnancy with
      fetal growth restriction is mediated by substantial increase in sympathetic vasoconstrictor
      activity. Effects of yoga on ANS outside of pregnancy have already been investigated in
      several studies. Heart rate variability (HRV) indices, used as a one of proxy measures for
      ANS activity, showed significant shifts towards parasympathetic dominance following yoga
      sessions. Another objective means of assessing ANS activity is measurement of phase
      synchronisation between cardiovascular and respiratory systems following acute challenge. The
      higher the cardiorespiratory synchronisation after acute challenge is, the higher is the
      ability of ANS to flexibly adapt to challenge.

      The objectives of the study are:

      I. To examine whether there is a short-term shift in autonomic balance to the parasympathetic
      branch of the ANS and ability of the cardiovascular and respiratory respiratory systems to
      flexibly adapt to acute psychological challenge following sessions in pregnancy.

      II. To investigate potential long- term effects of yoga practice during pregnancy on HRV and
      cardio-respiratory synchronisation following acute psychological challenge.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in cardio-respiratory phase synchronisation index
time frame: Change in cardio-respiratory phase synchronisation index from baseline (measured up to 30 minutes before yoga class/walk) to the end of exercise (measured up to 30 minutes after the end of yoga class/walk)
description: Cardio-respiratory phase synchronisation index measures synchronisation between the cardiovascular and respiratory system following acute psychological challenge. It's value is between 0 (no synchronisation) and 1 (complete synchronisation). The higher the value, the higher the ability of cardiovascular and respiratory systems to flexibly adapt to challenge (standardised memory task).
measure: Change in LF/HF HRV ratio.
time frame: Change in LF/HF HRV ratio from baseline (measured up to 30 minutes before yoga class/walk) to the end of exercise (measured up to 30 minutes after the end of yoga class/walk).
description: For frequency related HRV indices, we will run an autoregressive spectral analysis using Burg's algorithm (model order 24) after resampling and removing the trend of 2nd order. Low frequency (LF) will be defined as 0.04 - 0.15 Hz, high frequency (HF) will be defined as 0.15 - 0.40 Hz. The higher the LF/HF HRV ratio, the lower the parasympathetic tone.
measure: BRS
time frame: Change in BRS from baseline (measured up to 30 minutes before yoga class/walk) to the end of exercise (measured up to 30 minutes after the end of yoga class/walk).
description: The sequence technique will be used for the assessment of baroreceptor sensitivity (BRS). This technique is based on identifying consecutive cardiac beats in which an increase in systolic blood pressure is accompanied by an increase in heart rate, or in which a decrease in systolic blood pressure is accompanied by a decrease in heart rate. The regression line between the systolic blood pressure and heart rate produces an estimate of BRS. The higher the BRS, the higher the parasympathetic tone.
arm group label: yoga
arm group type: Experimental
description: Participants in yoga group will be recruited during prenatal yoga classes at two locations: Maribor and Ljubljana. Women will be instructed to attend one class per week. Classes will consist of pregnancy-adapted yoga practices according to the system Yoga in Daily Life. They will be 90 min in duration and will consist of initial relaxation (10 to 15 min), followed by yoga postures (asanas) and stretching exercises (45 to 60 min), and final breathing (pranayama), concentration (dharana), and meditation (dhyana) techniques (20 to 30 min). Two certified yoga instructors will lead yoga classes. Measurements will be performed before and after yoga session.
arm group label: control
arm group type: Active Comparator
description: Control group will consist of healthy pregnant women attending regular prenatal visits at the departments of perinatology of the university medical centers Maribor and Ljubljana. Only women not attending any formal prenatal exercise program will be offered entrance in the study. Measurements in this group will be performed before and after a 20-30 minute walk.
intervention type: Other
intervention name: weekly yoga classes
description: Weekly 90 min pregnancy-adapted yoga classes lead by certified yoga instructors.
arm group label: yoga
intervention type: Other
intervention name: walk
description: 20-30 min easy walking
arm group label: control
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Slovenia
responsible party type: Principal Investigator
investigator affiliation: University Medical Centre Ljubljana
investigator full name: Miha Lucovnik
investigator title: professor
sharing ipd: Yes