A Randomized Control Trial to compare the effect of Yoga with usual care vs usual care in the patients of coronary artery disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To compare LVEF in two groups.
研究概览
简要总结
Background of the study:
Yoga has quickly risen to one of the most common complementary and alternative medicine practiced worldwide. Yoga has been used in the primary and secondary prevention of Cardiovascular disease(CVD) including Coronary artery disease(CAD). Many evidences suggest that yoga is safe and efficacious in reducing various risk factors of CAD such as stress, anxiety, depression, diabetes, obesity and hypertension. Yoga can be helpful in any form of preventive measure for CAD. If used as primordial preventive measure can lead to significant reduction in cardiovascular and many more non- communicable diseases.
Purpose of Trial:
Yoga has been associated with improvement in general health, cardiovascular risk prevention factors, and other NCDs. Yoga has shown improvement in BMI, Blood pressure, lipid profile, lesion progression in CAD. However, the biomolecules through which yoga acts on body is unclear in CAD. Thus this study investigates different risk factors of CAD. The study aims to investigate various immunological, inflammatory and neuropsychological markers of CAD patients. The study will aid in revealing the biomolecule that brings about the positive health effect in yoga practitioners. The study will generate evidence for the efficacy of Yoga protocol which is used in CAD care, later it will help in slowing down the progression of disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of 18 to 65 years who underwent PCI 2 -6 weeks prior to enrollment 2.Those who have LVEF of more than 40 % 3.Those who are not planned for revascularization during the study period 4.Those who have fair to good functional capacity.
排除标准
- •1.Patients who are not willing to participate will be excluded, 2.Those who refractory or class III angina.
- •3.Those who have refractory or uncontrolled hypertension 4.Those who have physical disability and pregnant women 5.Life threatening arrhythmia 6.Obese persons and patients on hormonal therapy will be excluded 7.Any other significant chronic illness.
- •8.Those who are under other CR program.
结局指标
主要结局
To compare LVEF in two groups.
时间窗: First 3 months and followup for next 3 months.
To compare inflammatory markers in two groups.
时间窗: First 3 months and followup for next 3 months.
To compare effect on psychological issues.
时间窗: First 3 months and followup for next 3 months.
To investigate effect of genetic polymorphism on outcome
时间窗: First 3 months and followup for next 3 months.
To compare outcome on BMI, Lipid Profile.
时间窗: First 3 months and followup for next 3 months.
次要结局
- 1.To compare changes in BMI and Lipid Profile(2. To investigate the effect of genetic polymorphism)