<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/NCT03274193</url>
  </required_header>
  <id_info>
    <org_study_id>KMUHIRB-F(I)-20170087</org_study_id>
    <nct_id>NCT03274193</nct_id>
  </id_info>
  <brief_title>Effects of Yoga Training on Cardiovascular Reactivity to Psychological Stress in Patients With Hypertension</brief_title>
  <official_title>Effects of Yoga Training on Cardiovascular Reactivity to Psychological Stress in Patients With Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</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>
      The purpose of this study is to examine the effects of 12-week yoga training on blood&#xD;
      pressure, heart rate, heart rate variability, arterial stiffness, and total peripheral&#xD;
      resistance during rest and psychological stress in patients with hypertension. All eligible&#xD;
      participants will be randomly assigned to either yoga (n=40) or usual care control (n=40)&#xD;
      group. During the 1st lab visit, the experimenter will explain the purpose and procedures of&#xD;
      the study. If the participants understand and agree to participate in this study, they will&#xD;
      be asked to sign the informed consent. Next, participants will fill out questionnaires,&#xD;
      including demographic information, Physical Activity Readiness Questionnaire, perceived&#xD;
      stress scale, anxiety inventory, exercise behavior questionnaire, and quality of life scale.&#xD;
      Participant's resting blood pressure will be measured. Participants will then be instructed&#xD;
      to relax in a supine position for 15 minutes while ECG is recording. Next, participants will&#xD;
      perform 5 minutes of stroop task and 5 minutes of mental arithmetic task (mental stressors).&#xD;
      ECG and cardiac output will be monitored throughout the whole session. After the stress&#xD;
      period, participants will be asked to relax until heart rate becomes stable and return to&#xD;
      baseline. The participants will perform the sit-and-reach test. After completing all the&#xD;
      baseline testing, the yoga group will begin the training program which is 60 minutes per&#xD;
      session, 2 times per week for 12 weeks. The control group will be asked not to participate in&#xD;
      any exercise program during the course of the study. Participants will be filling out the&#xD;
      same questionnaires and receive measures of blood pressure, ECG, and cardiac output at week 6&#xD;
      and week 12. Additionally, participants will perform the stress tasks and the sit-and-reach&#xD;
      test again at week 12.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood pressure during rest from baseline to week 13</measure>
    <time_frame>Blood pressure during rest will be measured at baseline and week 13.</time_frame>
    <description>Blood pressure will be assessed with an OMRON blood pressure monitor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure during psychological stress from baseline to week 13</measure>
    <time_frame>Blood pressure during psychological stress will be measured at baseline and week 13.</time_frame>
    <description>Blood pressure will be assessed with an OMRON blood pressure monitor.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The yoga group will engage in the yoga training program which is 60 minutes per session, 2 times per week for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will be asked not to participate in any exercise program during the course of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga training program</intervention_name>
    <description>The hatha yoga program will be led by an experienced yoga instructor. Each 60 minutes session will consist of 10 minutes of breathing exercises (pranayama), 40 minutes of yoga pose practice (asana), and 10 minutes of supine meditation/relaxation (savasana). Yoga props, such as blocks and belts, will be used in accordance to each participant's particular body type and needs to help he/she achieve precise yoga postures safely and comfortably. The yoga poses are chosen for providing a restorative session and based on their purported relationship to restorative effects. Participants will be instructed to maintain their concentration and breath control at all times during the yoga session.</description>
    <arm_group_label>Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20-65 years of age&#xD;
&#xD;
          -  18.5 &lt;=BMI&lt;=29.9&#xD;
&#xD;
          -  have hypertension (clinical diagnosis)&#xD;
&#xD;
          -  resting systolic blood pressure 120-160 mmHg, resting diastolic blood pressure lower&#xD;
             than 110 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  regular exercise behaviors or current participation in yoga programs&#xD;
&#xD;
          -  have cardiovascular diseases, pulmonary diseases, diabetes&#xD;
&#xD;
          -  have musculoskeletal problems that may affect yoga pose practice (e.g., herniated&#xD;
             intervertebral disc, spondylolithesis, ankylosing spondylitis)&#xD;
&#xD;
          -  current pregnancy or breastfeeding&#xD;
&#xD;
          -  change of hypertension medication use within 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kaohsiung Medical University</name>
      <address>
        <city>Kaohsiung City</city>
        <zip>80708</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>August 19, 2022</last_update_submitted>
  <last_update_submitted_qc>August 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03274193
org study id: KMUHIRB-F(I)-20170087
nct id: NCT03274193
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effects of 12-week yoga training on blood
      pressure, heart rate, heart rate variability, arterial stiffness, and total peripheral
      resistance during rest and psychological stress in patients with hypertension. All eligible
      participants will be randomly assigned to either yoga (n=40) or usual care control (n=40)
      group. During the 1st lab visit, the experimenter will explain the purpose and procedures of
      the study. If the participants understand and agree to participate in this study, they will
      be asked to sign the informed consent. Next, participants will fill out questionnaires,
      including demographic information, Physical Activity Readiness Questionnaire, perceived
      stress scale, anxiety inventory, exercise behavior questionnaire, and quality of life scale.
      Participant's resting blood pressure will be measured. Participants will then be instructed
      to relax in a supine position for 15 minutes while ECG is recording. Next, participants will
      perform 5 minutes of stroop task and 5 minutes of mental arithmetic task (mental stressors).
      ECG and cardiac output will be monitored throughout the whole session. After the stress
      period, participants will be asked to relax until heart rate becomes stable and return to
      baseline. The participants will perform the sit-and-reach test. After completing all the
      baseline testing, the yoga group will begin the training program which is 60 minutes per
      session, 2 times per week for 12 weeks. The control group will be asked not to participate in
      any exercise program during the course of the study. Participants will be filling out the
      same questionnaires and receive measures of blood pressure, ECG, and cardiac output at week 6
      and week 12. Additionally, participants will perform the stress tasks and the sit-and-reach
      test again at week 12.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in blood pressure during rest from baseline to week 13
time frame: Blood pressure during rest will be measured at baseline and week 13.
description: Blood pressure will be assessed with an OMRON blood pressure monitor.
measure: Change in blood pressure during psychological stress from baseline to week 13
time frame: Blood pressure during psychological stress will be measured at baseline and week 13.
description: Blood pressure will be assessed with an OMRON blood pressure monitor.
arm group label: Yoga
arm group type: Experimental
description: The yoga group will engage in the yoga training program which is 60 minutes per session, 2 times per week for 12 weeks.
arm group label: Control
arm group type: No Intervention
description: The control group will be asked not to participate in any exercise program during the course of the study.
intervention type: Behavioral
intervention name: Yoga training program
description: The hatha yoga program will be led by an experienced yoga instructor. Each 60 minutes session will consist of 10 minutes of breathing exercises (pranayama), 40 minutes of yoga pose practice (asana), and 10 minutes of supine meditation/relaxation (savasana). Yoga props, such as blocks and belts, will be used in accordance to each participant's particular body type and needs to help he/she achieve precise yoga postures safely and comfortably. The yoga poses are chosen for providing a restorative session and based on their purported relationship to restorative effects. Participants will be instructed to maintain their concentration and breath control at all times during the yoga session.
arm group label: Yoga
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Stress, Psychological
sharing ipd: No