South Asian Women & Yoga Education Study
SAWYES
Yoga for Post-menopausal South Asian Women at Risk for Cardiovascular Disease: A Randomized Control Pilot Study
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2012
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedNovember 19, 2012
November 1, 2012
2.1 years
June 17, 2012
November 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Change in subjective well-being
baseline, at end of study (12 wks), & 3 months post-study
Change in perceived physical well-being
baseline, end of study (12 wks) & 3 months post-study
Change in insulin sensitivity
baseline, end of study (12 wks) & 3 months post-study
Change in inflammation
baseline, end of study (12 wks) & 3 months post-study
Change in serum total cholesterol
baseline, end of study (12 wks) & 3 months post-study
- +8 more secondary outcomes
Study Arms (2)
Yoga Intervention
EXPERIMENTALControl
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Jim Pattison Outpatient Care and Surgery Services, Cardiovascular Outpatient Clinic
Surrey, British Columbia, V3T 0G9, Canada
Kwantlen Polytechnic University
Surrey, British Columbia, V3W 2M8, Canada
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Amandah L Hoogbruin, PhD
Kwantlen Polytechnic University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Community & Health Studies Faculty member
Study Record Dates
First Submitted
June 17, 2012
First Posted
August 17, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2014
Study Completion
August 1, 2015
Last Updated
November 19, 2012
Record last verified: 2012-11