South Asian Women & Yoga Education Study (SAWYES)

Yoga for Post-menopausal South Asian Women at Risk for Cardiovascular Disease: A Randomized Control Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: Yoga Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	blood pressure is measured as a specific physiologic index of cardiovascular risk.	baseline, at end of study (12 wks), & 3 months post-study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subjective well-being	The Perceived Stress Scale and Abbreviated Duke Social Support Index will be used to measure subjective well-being.	baseline, at end of study (12 wks), & 3 months post-study
Change in perceived physical well-being	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	baseline, end of study (12 wks) & 3 months post-study
Change in insulin sensitivity	Fasting insulin & glucose will be measured for change in insulin sensitivity as a related index of cardiovascular risk	baseline, end of study (12 wks) & 3 months post-study
Change in inflammation	C-reactive protein will be measured for change in inflammation as a related index of cardiovascular risk	baseline, end of study (12 wks) & 3 months post-study
Change in serum total cholesterol	Serum total cholesterol will be measured as a related index of cardiovascular risk	baseline, end of study (12 wks) & 3 months post-study
Change in serum high-density lipoprotein (HDL) cholesterol	Serum high-density lipoprotein (HDL) cholesterol will be measured as a related index of cardiovascular risk	baseline, end of study (12 wks) & 3 months post-study
Change in serum low-density lipoprotein (LDL) cholesterol	Serum low-density lipoprotein (LDL)cholesterol will be measured as a related index of cardiovascular risk	baseline, end of study (12 wks) & 3 months post-study
Change in serum triglycerides	Serum triglycerides will be measured as a related index of cardiovascular risk	baseline, end of study (12 wks) & 3 months post-study
Change in waist circumference.	Waist circumference will be measured for change in visceral adiposity as a related index of cardiovascular risk	baseline, end of study (12 wks) & 3 months post-study
Change waist-hip ratio	Waist-hip ratio will be measured for change in visceral adiposity as a related index of cardiovascular risk	baseline, end of study (12 wks) & 3 months post-study
Change in body mass index (BMI)	Body mass index (BMI) will be measured for change in visceral adiposity as a related index of cardiovascular risk	baseline, end of study (12 wks) & 3 months post-study
Change in resting heart rate	Resting heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk	baseline, end of study (12 wks) & 3 months post-study
Change in heart rate	Heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk	baseline, at end of study (12 wks), & 3 months post-study

Collaborators and Investigators

• Sponsor: Kwantlen Polytechnic University
• Investigators: Principal Investigator: Amandah L Hoogbruin, PhD, Kwantlen Polytechnic University

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: June 17, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Estimate): November 19, 2012
• Last Update Submitted That Met QC Criteria: November 16, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: yoga; postmenopausal, sedentary South Asian women
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: KK11-04