South Asian Women & Yoga Education Study

Phase 1

• Conditions: Cardiovascular Disease

• Registration Number: NCT01667835
• Lead Sponsor: Kwantlen Polytechnic University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-17
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-17
• Status Verified: 2012-11
• Study Start: 2012-11
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-19
• Primary Completion: 2014-12
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

The Jim Pattison Outpatient Care and Surgery Services, Cardiovascular Outpatient Clinic; 🇨🇦 Surrey, British Columbia, Canada

Kwantlen Polytechnic University; 🇨🇦 Surrey, British Columbia, Canada