Efficacy of A Virtual, Video-based regular Yoga Protocol on the immune function, antioxidant status, stress hormone responses and psychological components in healthy population and patients recovered from COVID-19 in COVID pandemic Period: A randomized control trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change in the level of multiple cytokines.
研究概览
简要总结
The study will be conducted on two parallel parts. Part A will consist of a healthy population and Part B will include the COVID-19 recovered patients. A total of 50 in each arm will be recruited for the study. Intervention based on the allocation of group after randomization each participant will be given either Standard care or Comprehensive treatment module. Standard care will include medical management if required and general counselling including dietary counseling and physical activity advice. A Yoga based intervention module will be developed. After the development, the module will be sent to different experts for peer view and rating of different components of the module will be done. The internet-based yogic intervention will be delivered in the form of videos. It includes yogic exercise. It aims to balance mental and physical health through breathing techniques (Pranayama), postures (Asana), and meditation (Dhyana). The trial is expected to be completed within one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willingness to participate in the study.
- •Age between 20-65 years.
- •Access to the internet/smartphone/laptop to watch virtual video based yoga sessions.
排除标准
- •Individuals suffering from any kind of chronic diseases.
- •Individuals with physical limitations making them unable to perform yoga asanas.
- •Individuals with a history of alcohol abuse or smoking more than 5 cigarettes a day.
- •Individuals taking any kind of medications.
- •Individuals who are severely overweight (BMI> 35).
- •Individuals working in night shifts.
结局指标
主要结局
Change in the level of multiple cytokines.
时间窗: The assessment will be done at baseline (pre-intervention assessment) at 3 months and at 6 months (post intervention)
Reduction in stress hormones levels.
时间窗: The assessment will be done at baseline (pre-intervention assessment) at 3 months and at 6 months (post intervention)
Reduction in oxidative stress parameters such as malondialdehyde and F2-isoprostane.
时间窗: The assessment will be done at baseline (pre-intervention assessment) at 3 months and at 6 months (post intervention)
Improvement in antioxidant components such glutathione, catalase and superoxide dismutase activities.
时间窗: The assessment will be done at baseline (pre-intervention assessment) at 3 months and at 6 months (post intervention)
Improvement in the scores of DASS.
时间窗: The assessment will be done at baseline (pre-intervention assessment) at 3 months and at 6 months (post intervention)
次要结局
- Impact of Yoga practice on oxidative stress, antioxidant components, immune functions, and secretion of stress hormones, in healthy individuals and in patients who have recovered from Covid 19 infection.(Impact of Covid 19 infections on bio-parameters, such as oxidative stress, antioxidant components, immune functions, and secretion of stress hormones, in patients who have recovered from Covid 19 infections compared to healthy individuals.)