NCT01667835Unknown1 期
Yoga for Post-menopausal South Asian Women at Risk for Cardiovascular Disease: A Randomized Control Pilot Study
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Change in blood pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in blood pressure
时间窗: baseline, at end of study (12 wks), & 3 months post-study
blood pressure is measured as a specific physiologic index of cardiovascular risk.
次要结局
- 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)
- Change in serum high-density lipoprotein (HDL) cholesterol(baseline, end of study (12 wks) & 3 months post-study)
- Change in serum low-density lipoprotein (LDL) cholesterol(baseline, end of study (12 wks) & 3 months post-study)
- Change in serum triglycerides(baseline, end of study (12 wks) & 3 months post-study)
- Change in waist circumference.(baseline, end of study (12 wks) & 3 months post-study)
- Change waist-hip ratio(baseline, end of study (12 wks) & 3 months post-study)
- Change in body mass index (BMI)(baseline, end of study (12 wks) & 3 months post-study)
- Change in resting heart rate(baseline, end of study (12 wks) & 3 months post-study)
- Change in heart rate(baseline, at end of study (12 wks), & 3 months post-study)
研究者
Dr. Amandah Hoogbruin
Principal Investigator, Community & Health Studies Faculty member
Kwantlen Polytechnic University
研究点 (4)
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