South Asian Women & Yoga Education Study (SAWYES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Kwantlen Polytechnic University
Sponsor:
Information provided by (Responsible Party):
Dr. Amandah Hoogbruin, Kwantlen Polytechnic University
ClinicalTrials.gov Identifier:
NCT01667835
First received: June 17, 2012
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Behavioral: Yoga Intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Yoga for Post-menopausal South Asian Women at Risk for Cardiovascular Disease: A Randomized Control Pilot Study

Resource links provided by NLM:


Further study details as provided by Kwantlen Polytechnic University:

Primary Outcome Measures:
  • Change in blood pressure [ Time Frame: baseline, at end of study (12 wks), & 3 months post-study ] [ Designated as safety issue: No ]
    blood pressure is measured as a specific physiologic index of cardiovascular risk.


Secondary Outcome Measures:
  • Change in subjective well-being [ Time Frame: baseline, at end of study (12 wks), & 3 months post-study ] [ Designated as safety issue: No ]
    The Perceived Stress Scale and Abbreviated Duke Social Support Index will be used to measure subjective well-being.

  • Change in perceived physical well-being [ Time Frame: baseline, end of study (12 wks) & 3 months post-study ] [ Designated as safety issue: No ]
    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

  • Change in insulin sensitivity [ Time Frame: baseline, end of study (12 wks) & 3 months post-study ] [ Designated as safety issue: No ]
    Fasting insulin & glucose will be measured for change in insulin sensitivity as a related index of cardiovascular risk

  • Change in inflammation [ Time Frame: baseline, end of study (12 wks) & 3 months post-study ] [ Designated as safety issue: No ]
    C-reactive protein will be measured for change in inflammation as a related index of cardiovascular risk

  • Change in serum total cholesterol [ Time Frame: baseline, end of study (12 wks) & 3 months post-study ] [ Designated as safety issue: No ]
    Serum total cholesterol will be measured as a related index of cardiovascular risk

  • Change in serum high-density lipoprotein (HDL) cholesterol [ Time Frame: baseline, end of study (12 wks) & 3 months post-study ] [ Designated as safety issue: No ]
    Serum high-density lipoprotein (HDL) cholesterol will be measured as a related index of cardiovascular risk

  • Change in serum low-density lipoprotein (LDL) cholesterol [ Time Frame: baseline, end of study (12 wks) & 3 months post-study ] [ Designated as safety issue: No ]
    Serum low-density lipoprotein (LDL)cholesterol will be measured as a related index of cardiovascular risk

  • Change in serum triglycerides [ Time Frame: baseline, end of study (12 wks) & 3 months post-study ] [ Designated as safety issue: No ]
    Serum triglycerides will be measured as a related index of cardiovascular risk

  • Change in waist circumference. [ Time Frame: baseline, end of study (12 wks) & 3 months post-study ] [ Designated as safety issue: No ]
    Waist circumference will be measured for change in visceral adiposity as a related index of cardiovascular risk

  • Change waist-hip ratio [ Time Frame: baseline, end of study (12 wks) & 3 months post-study ] [ Designated as safety issue: No ]
    Waist-hip ratio will be measured for change in visceral adiposity as a related index of cardiovascular risk

  • Change in body mass index (BMI) [ Time Frame: baseline, end of study (12 wks) & 3 months post-study ] [ Designated as safety issue: No ]
    Body mass index (BMI) will be measured for change in visceral adiposity as a related index of cardiovascular risk

  • Change in resting heart rate [ Time Frame: baseline, end of study (12 wks) & 3 months post-study ] [ Designated as safety issue: No ]
    Resting heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk

  • Change in heart rate [ Time Frame: baseline, at end of study (12 wks), & 3 months post-study ] [ Designated as safety issue: No ]
    Heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga Intervention Behavioral: Yoga Intervention
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.
No Intervention: Control

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 40- 65 years old
  • Postmenopausal (amenorrhea for ≥ 12 months)
  • Overweight as evidenced by a body mass index (BMI) ≥ 25 kg/m2), or waist circumference ≥ 80 cm, or have a first degree relative with diabetes or essential hypertension
  • Sedentary, do not do a regular exercise program (exercising for 20 minutes at sufficient intensity to produce sweating less than 2x/week)
  • Self-identify as a South Asian (sometimes referred to as East Indian in Canada and may be defined "as any person who reports an ethnicity associated with the southern part of Asia or who self-identifies as part of the South Asian visible minority group. This definition encompasses people from a great diversity of ethnic backgrounds, including those with Bangladeshi, Bengali, East Indian, Goan, Gujarati, Hindu, Ismaili, Kashmiri, Nepali, Pakistani, Punjabi, Sikh, Sinhalese, South Asian, Sri Lankan and Tamil ancestry. South Asians may have been born in Canada, on the Indian sub-continent, in the Caribbean, in Africa, in Great Britain or elsewhere
  • Given consent to research protocol and willingness to be randomized to either the treatment (yoga) or control (no yoga) group.

Exclusion Criteria:

  • Have had a period within the last year
  • Are not between the ages of 40 and 65
  • Have experience with yoga within the last 12 months
  • Have any serious disease or condition such as diabetes, serious high blood pressure or heart problems, kidney disease, severe asthma, cancer (except for skin cancer that is not melanoma)
  • Have a major brain or nervous system diagnosis, such as Parkinson's disease or stroke
  • Have a severe infectious or other medical illness right now such as pneumonia
  • Use medications to lower blood sugar levels
  • Have serious back, hip, or neck problems or pain in joints or bones that would prevent the safe completion of a gentle 12 week Hatha yoga program
  • Regularly use an assistive device (e.g., cane, walker) to walk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667835

Contacts
Contact: Amandah L Hoogbruin, PhD 604 599 3144 amandah.hoogbruin@kwantlen.ca
Contact: Raymond Dong, FRCPC 604 838 8418 raydongheart@gmail.com

Locations
Canada, British Columbia
Kwantlen Polytechnic University Not yet recruiting
Surrey, British Columbia, Canada, V3W 2M8
Contact: Amandah L Hoogbruin, PhD    604 599 3144    amandah.hoogbruin@kwantlen.ca   
Contact: Raymond Dong, FRCPC    604 838 8418    raydongcardio@gmail.com   
Principal Investigator: Amandah L Hoogbruin, PhD         
The Jim Pattison Outpatient Care and Surgery Services, Cardiovascular Outpatient Clinic Recruiting
Surrey, British Columbia, Canada, V3T 0G9
Contact: Amandah L Hoogbruin, PhD    604 599 3144    amandah.hoogbruin@kwantlen.ca   
Contact: Raymond Dong, FRCP(c)    604 686 6372    raydongheart@gmail.com   
Sponsors and Collaborators
Kwantlen Polytechnic University
Investigators
Principal Investigator: Amandah L Hoogbruin, PhD Kwantlen Polytechnic University
  More Information

No publications provided

Responsible Party: Dr. Amandah Hoogbruin, Principal Investigator, Community & Health Studies Faculty member, Kwantlen Polytechnic University
ClinicalTrials.gov Identifier: NCT01667835     History of Changes
Other Study ID Numbers: KK11-04
Study First Received: June 17, 2012
Last Updated: November 16, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Kwantlen Polytechnic University:
yoga
postmenopausal, sedentary South Asian women

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014