South Asian Women & Yoga Education Study

Cardiovascular Disease Clinical Trial

— SAWYES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01667835
• Other study ID #: KK11-04
• Status: Recruiting
• Phase: Phase 1
• First received: June 17, 2012
• Last updated: November 16, 2012
• Start date: November 2012
• Est. completion date: August 2015

Study information

• Verified date: November 2012
• Source: Kwantlen Polytechnic University
• Contact: Amandah L Hoogbruin, PhD
• Phone: 604 599 3144
• Email: amandah.hoogbruin[@]kwantlen.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

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.

Locations

Country	Name	City	State
Canada	Kwantlen Polytechnic University	Surrey	British Columbia
Canada	The Jim Pattison Outpatient Care and Surgery Services, Cardiovascular Outpatient Clinic	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Kwantlen Polytechnic University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No