Clinical trial NCT01667835: South Asian Women & Yoga Education Study
Official title: Yoga for Post-menopausal South Asian Women at Risk for Cardiovascular Disease: A Randomized Control Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cardiovascular Disease
Keywords: yoga
postmenopausal, sedentary South Asian women
Lead sponsor: Kwantlen Polytechnic University
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in blood pressure
timeFrame: baseline, at end of study (12 wks), & 3 months post-study
Secondary outcomes:
measure: Change in subjective well-being
timeFrame: baseline, at end of study (12 wks), & 3 months post-study
measure: Change in perceived physical well-being
timeFrame: baseline, end of study (12 wks) & 3 months post-study
measure: Change in insulin sensitivity
timeFrame: baseline, end of study (12 wks) & 3 months post-study
measure: Change in inflammation
timeFrame: baseline, end of study (12 wks) & 3 months post-study
measure: Change in serum total cholesterol
timeFrame: baseline, end of study (12 wks) & 3 months post-study
measure: Change in serum high-density lipoprotein (HDL) cholesterol
timeFrame: baseline, end of study (12 wks) & 3 months post-study
measure: Change in serum low-density lipoprotein (LDL) cholesterol
timeFrame: baseline, end of study (12 wks) & 3 months post-study
measure: Change in serum triglycerides
timeFrame: baseline, end of study (12 wks) & 3 months post-study
measure: Change in waist circumference.
timeFrame: baseline, end of study (12 wks) & 3 months post-study
measure: Change waist-hip ratio
timeFrame: baseline, end of study (12 wks) & 3 months post-study
measure: Change in body mass index (BMI)
timeFrame: baseline, end of study (12 wks) & 3 months post-study
measure: Change in resting heart rate
timeFrame: baseline, end of study (12 wks) & 3 months post-study
measure: Change in heart rate
timeFrame: baseline, at end of study (12 wks), & 3 months post-study
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: The Jim Pattison Outpatient Care and Surgery Services, Cardiovascular Outpatient Clinic
state: British Columbia
city: Surrey
country: Canada
facility: Kwantlen Polytechnic University
state: British Columbia
Study officials:
affiliation: Kwantlen Polytechnic University
name: Amandah L Hoogbruin, PhD
role: PRINCIPAL_INVESTIGATOR
References: