Efficacy of Yoga on Salivary Cortisol Cardiovascular Risk Factors and Stress in Women With Type 2 Diabetes A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- salivary cortisol, FBS, HbA1C, Creatinine, Glomerular Filtration Rate, FLP, Urine micro-Albumin, Blood pressure
研究概览
简要总结
| Purpose: Evaluate the efficacy of Yoga Intervention on Biomarkers, Cardiovascular Risk Factors, and quality of life in Women with Type 2 Diabetes |
Methods: The present study will adopt a randomized control trail design. 160 Women with Type 2 Diabetes (80 - study group) and (80 - control group) who met the inclusion criteria will be recruited using the Stratified Block Randomization technique. In this study, the study group received the yoga intervention in addition to routine care. Yoga demonstration includes Breathing Exercise, Ardhakati Chakrasana, Padhasthasanam, Salabasanam, Bhujangasanam, Dhanurasanam, Pavanamuktasanam, Chin Mudra, Varuna Mudra, Sumana Mudra, Nadisuddi, Shanthi Asana will be given one to one basis followed by Yoga video will be shared for doing at home. Providing reminder calls, follow up and receiving Feedback done through a mobile phone, Pamphlet Education also given about Diabetes Mellitus - definition, causes, signs and symptoms, complications, diet, lifestyle modifications, exercise, and follow-up.
The participants in the control group will not receive yoga intervention and they will receive only pamphlet education and routine care. Pretest and post-test will be conducted for both study and control groups. The patients will be assessed for Biomarkers (Serum Cortisol, FBS, HbA1C, Creatinine, Glomerular Filtration Rate, FLP, Urine micro-Albumin. **Antropometric measurements (**Height, Weight, BMI, Waist Circumference, Hip Circumference, Waist Hip Ratio, Skin fold thickness, Body fat estimation, Blood pressure. Stress (Perceived stress scale). Quality of life (SF-36 Health scale for Quality of life).
Proposed Results: The selected yoga poses and mudras will maintainSerum Cortisol, FBS, HbA1C, Creatinine, Glomerular Filtration Rate, FLP, Urine micro-Albumin effectively. Importantly very useful in maintaining adequate Weight, BMI, Blood pressure levels. Definitely it will have positive impact on reducing Stress and improving the Quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •women with type 2 diabetes mellitus, HbA1c more than 8, Women or women’s family member those who use android based smart phones, Willing to participate in the study and Who are able to read English or Tamil language.
排除标准
- •Who donot use android mobile phones, Patients with CAD, CVA, CKD, Liver Failure, Seizure disorder, Proliferative Retinopathy, Chronic DM more than 10 years and Patients on oral contraceptive pills.
结局指标
主要结局
salivary cortisol, FBS, HbA1C, Creatinine, Glomerular Filtration Rate, FLP, Urine micro-Albumin, Blood pressure
时间窗: Pre-test- At the time of OPD visit | Post-test -After 3 months of pre test
次要结局
- Stress, Quality of life(Pre-test- At the time of OPD visit)
研究者
Maria Mazarrello A
Sri Ramachandra Institute of Higher Education and Research (DU)