South Asian Women & Yoga Education Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Yoga Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Intervention<br> | Behavioral: Yoga Intervention<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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yoga, postmenopausal, sedentary South Asian women