<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/NCT01667835</url>
  </required_header>
  <id_info>
    <org_study_id>KK11-04</org_study_id>
    <nct_id>NCT01667835</nct_id>
  </id_info>
  <brief_title>South Asian Women &amp; Yoga Education Study</brief_title>
  <acronym>SAWYES</acronym>
  <official_title>Yoga for Post-menopausal South Asian Women at Risk for Cardiovascular Disease: A Randomized Control Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kwantlen Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kwantlen Polytechnic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized, control pilot study is to measure the effects of a gentle, 12&#xD;
      week hatha yoga program on post-menopausal, obese, sedentary South Asian women at risk for&#xD;
      cardiovascular disease. Hatha yoga is a form of structured physical exercises known as&#xD;
      asanas, combined with breathing exercises called pranayama, and relaxation techniques. The&#xD;
      yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing&#xD;
      exercises (pranayama) that can be easily replicated and readily performed by individuals who&#xD;
      are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>baseline, at end of study (12 wks), &amp; 3 months post-study</time_frame>
    <description>blood pressure is measured as a specific physiologic index of cardiovascular risk.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in subjective well-being</measure>
    <time_frame>baseline, at end of study (12 wks), &amp; 3 months post-study</time_frame>
    <description>The Perceived Stress Scale and Abbreviated Duke Social Support Index will be used to measure subjective well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceived physical well-being</measure>
    <time_frame>baseline, end of study (12 wks) &amp; 3 months post-study</time_frame>
    <description>Pittsburgh Sleep Quality Index, Physical Activity Scale for the Elderly, and Exercise Regularly Scale will be used to measure change in perceived physical well-being</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin sensitivity</measure>
    <time_frame>baseline, end of study (12 wks) &amp; 3 months post-study</time_frame>
    <description>Fasting insulin &amp; glucose will be measured for change in insulin sensitivity as a related index of cardiovascular risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in inflammation</measure>
    <time_frame>baseline, end of study (12 wks) &amp; 3 months post-study</time_frame>
    <description>C-reactive protein will be measured for change in inflammation as a related index of cardiovascular risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum total cholesterol</measure>
    <time_frame>baseline, end of study (12 wks) &amp; 3 months post-study</time_frame>
    <description>Serum total cholesterol will be measured as a related index of cardiovascular risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum high-density lipoprotein (HDL) cholesterol</measure>
    <time_frame>baseline, end of study (12 wks) &amp; 3 months post-study</time_frame>
    <description>Serum high-density lipoprotein (HDL) cholesterol will be measured as a related index of cardiovascular risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum low-density lipoprotein (LDL) cholesterol</measure>
    <time_frame>baseline, end of study (12 wks) &amp; 3 months post-study</time_frame>
    <description>Serum low-density lipoprotein (LDL)cholesterol will be measured as a related index of cardiovascular risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum triglycerides</measure>
    <time_frame>baseline, end of study (12 wks) &amp; 3 months post-study</time_frame>
    <description>Serum triglycerides will be measured as a related index of cardiovascular risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference.</measure>
    <time_frame>baseline, end of study (12 wks) &amp; 3 months post-study</time_frame>
    <description>Waist circumference will be measured for change in visceral adiposity as a related index of cardiovascular risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change waist-hip ratio</measure>
    <time_frame>baseline, end of study (12 wks) &amp; 3 months post-study</time_frame>
    <description>Waist-hip ratio will be measured for change in visceral adiposity as a related index of cardiovascular risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass index (BMI)</measure>
    <time_frame>baseline, end of study (12 wks) &amp; 3 months post-study</time_frame>
    <description>Body mass index (BMI) will be measured for change in visceral adiposity as a related index of cardiovascular risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting heart rate</measure>
    <time_frame>baseline, end of study (12 wks) &amp; 3 months post-study</time_frame>
    <description>Resting heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>baseline, at end of study (12 wks), &amp; 3 months post-study</time_frame>
    <description>Heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Yoga Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga Intervention</intervention_name>
    <description>12 week 90 minute hatha yoga session offered three (3x) per week. Hatha yoga is a form of structured physical exercises known as asanas, combined with breathing exercises called pranayama, and relaxation techniques. The yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing exercises (pranayama) that can be easily replicated and readily performed by individuals who are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.</description>
    <arm_group_label>Yoga Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40- 65 years old&#xD;
&#xD;
          -  Postmenopausal (amenorrhea for ≥ 12 months)&#xD;
&#xD;
          -  Overweight as evidenced by a body mass index (BMI) ≥ 25 kg/m2), or waist circumference&#xD;
             ≥ 80 cm, or have a first degree relative with diabetes or essential hypertension&#xD;
&#xD;
          -  Sedentary, do not do a regular exercise program (exercising for 20 minutes at&#xD;
             sufficient intensity to produce sweating less than 2x/week)&#xD;
&#xD;
          -  Self-identify as a South Asian (sometimes referred to as East Indian in Canada and may&#xD;
             be defined &quot;as any person who reports an ethnicity associated with the southern part&#xD;
             of Asia or who self-identifies as part of the South Asian visible minority group. This&#xD;
             definition encompasses people from a great diversity of ethnic backgrounds, including&#xD;
             those with Bangladeshi, Bengali, East Indian, Goan, Gujarati, Hindu, Ismaili,&#xD;
             Kashmiri, Nepali, Pakistani, Punjabi, Sikh, Sinhalese, South Asian, Sri Lankan and&#xD;
             Tamil ancestry. South Asians may have been born in Canada, on the Indian&#xD;
             sub-continent, in the Caribbean, in Africa, in Great Britain or elsewhere&#xD;
&#xD;
          -  Given consent to research protocol and willingness to be randomized to either the&#xD;
             treatment (yoga) or control (no yoga) group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have had a period within the last year&#xD;
&#xD;
          -  Are not between the ages of 40 and 65&#xD;
&#xD;
          -  Have experience with yoga within the last 12 months&#xD;
&#xD;
          -  Have any serious disease or condition such as diabetes, serious high blood pressure or&#xD;
             heart problems, kidney disease, severe asthma, cancer (except for skin cancer that is&#xD;
             not melanoma)&#xD;
&#xD;
          -  Have a major brain or nervous system diagnosis, such as Parkinson's disease or stroke&#xD;
&#xD;
          -  Have a severe infectious or other medical illness right now such as pneumonia&#xD;
&#xD;
          -  Use medications to lower blood sugar levels&#xD;
&#xD;
          -  Have serious back, hip, or neck problems or pain in joints or bones that would prevent&#xD;
             the safe completion of a gentle 12 week Hatha yoga program&#xD;
&#xD;
          -  Regularly use an assistive device (e.g., cane, walker) to walk&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amandah L Hoogbruin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kwantlen Polytechnic University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amandah L Hoogbruin, PhD</last_name>
    <phone>604 599 3144</phone>
    <email>amandah.hoogbruin@kwantlen.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Raymond Dong, FRCPC</last_name>
    <phone>604 838 8418</phone>
    <email>raydongheart@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Jim Pattison Outpatient Care and Surgery Services, Cardiovascular Outpatient Clinic</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3T 0G9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amandah L Hoogbruin, PhD</last_name>
      <phone>604 599 3144</phone>
      <email>amandah.hoogbruin@kwantlen.ca</email>
    </contact>
    <contact_backup>
      <last_name>Raymond Dong, FRCP(c)</last_name>
      <phone>604 686 6372</phone>
      <email>raydongheart@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Kwantlen Polytechnic University</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3W 2M8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Amandah L Hoogbruin, PhD</last_name>
      <phone>604 599 3144</phone>
      <email>amandah.hoogbruin@kwantlen.ca</email>
    </contact>
    <contact_backup>
      <last_name>Raymond Dong, FRCPC</last_name>
      <phone>604 838 8418</phone>
      <email>raydongcardio@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Amandah L Hoogbruin, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>June 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>November 16, 2012</last_update_submitted>
  <last_update_submitted_qc>November 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kwantlen Polytechnic University</investigator_affiliation>
    <investigator_full_name>Dr. Amandah Hoogbruin</investigator_full_name>
    <investigator_title>Principal Investigator, Community &amp; Health Studies Faculty member</investigator_title>
  </responsible_party>
  <keyword>yoga</keyword>
  <keyword>postmenopausal, sedentary South Asian women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT01667835
org study id: KK11-04
nct id: NCT01667835
lead sponsor: 
has dmc: No
The purpose of this randomized, control pilot study is to measure the effects of a gentle, 12
      week hatha yoga program on post-menopausal, obese, sedentary South Asian women at risk for
      cardiovascular disease. Hatha yoga is a form of structured physical exercises known as
      asanas, combined with breathing exercises called pranayama, and relaxation techniques. The
      yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing
      exercises (pranayama) that can be easily replicated and readily performed by individuals who
      are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Change in blood pressure
time frame: baseline, at end of study (12 wks), & 3 months post-study
description: blood pressure is measured as a specific physiologic index of cardiovascular risk.
measure: Change in subjective well-being
time frame: baseline, at end of study (12 wks), & 3 months post-study
description: The Perceived Stress Scale and Abbreviated Duke Social Support Index will be used to measure subjective well-being.
measure: Change in perceived physical well-being
time frame: baseline, end of study (12 wks) & 3 months post-study
description: Pittsburgh Sleep Quality Index, Physical Activity Scale for the Elderly, and Exercise Regularly Scale will be used to measure change in perceived physical well-being
measure: Change in insulin sensitivity
time frame: baseline, end of study (12 wks) & 3 months post-study
description: Fasting insulin & glucose will be measured for change in insulin sensitivity as a related index of cardiovascular risk
measure: Change in inflammation
time frame: baseline, end of study (12 wks) & 3 months post-study
description: C-reactive protein will be measured for change in inflammation as a related index of cardiovascular risk
measure: Change in serum total cholesterol
time frame: baseline, end of study (12 wks) & 3 months post-study
description: Serum total cholesterol will be measured as a related index of cardiovascular risk
measure: Change in serum high-density lipoprotein (HDL) cholesterol
time frame: baseline, end of study (12 wks) & 3 months post-study
description: Serum high-density lipoprotein (HDL) cholesterol will be measured as a related index of cardiovascular risk
measure: Change in serum low-density lipoprotein (LDL) cholesterol
time frame: baseline, end of study (12 wks) & 3 months post-study
description: Serum low-density lipoprotein (LDL)cholesterol will be measured as a related index of cardiovascular risk
measure: Change in serum triglycerides
time frame: baseline, end of study (12 wks) & 3 months post-study
description: Serum triglycerides will be measured as a related index of cardiovascular risk
measure: Change in waist circumference.
time frame: baseline, end of study (12 wks) & 3 months post-study
description: Waist circumference will be measured for change in visceral adiposity as a related index of cardiovascular risk
measure: Change waist-hip ratio
time frame: baseline, end of study (12 wks) & 3 months post-study
description: Waist-hip ratio will be measured for change in visceral adiposity as a related index of cardiovascular risk
measure: Change in body mass index (BMI)
time frame: baseline, end of study (12 wks) & 3 months post-study
description: Body mass index (BMI) will be measured for change in visceral adiposity as a related index of cardiovascular risk
measure: Change in resting heart rate
time frame: baseline, end of study (12 wks) & 3 months post-study
description: Resting heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk
measure: Change in heart rate
time frame: baseline, at end of study (12 wks), & 3 months post-study
description: Heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk
arm group label: Yoga Intervention
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Yoga Intervention
description: 12 week 90 minute hatha yoga session offered three (3x) per week. Hatha yoga is a form of structured physical exercises known as asanas, combined with breathing exercises called pranayama, and relaxation techniques. The yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing exercises (pranayama) that can be easily replicated and readily performed by individuals who are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.
arm group label: Yoga Intervention
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amandah L Hoogbruin, PhD
role: Principal Investigator
affiliation: Kwantlen Polytechnic University
last name: Amandah L Hoogbruin, PhD
phone: 604 599 3144
email: amandah.hoogbruin@kwantlen.ca
last name: Raymond Dong, FRCPC
phone: 604 838 8418
email: raydongheart@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Kwantlen Polytechnic University
investigator full name: Dr. Amandah Hoogbruin
investigator title: Principal Investigator, Community & Health Studies Faculty member
mesh term: Cardiovascular Diseases