A Study on Prevalence, Protection and Recovery From COVID-19 in Seasoned Yoga Practitioners in Comparison to Age and Gender Matched Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,519
- 试验地点
- 1
- 主要终点
- Change in Perceived Stress Levels
研究概览
简要总结
The study is a randomized controlled trail with an observational arm and aims at collecting information on the prevalence of COVID 19 infection in seasoned yoga practitioners by comparing it with the prevalence of COVID-19 infection prevalence rates among age and gender matched control participants who do not practice yoga.
The study hypothesizes that yoga practice promotes protection and enhances recovery from the COVID-19 infection. To prove the hypothesis, the study investigators are collecting and comparing responses from seasoned yoga practitioners to age and gender matched controls participants (who do not practice yoga routinely) regarding their recovery from the COVID 19 infection. Based on validated questionnaires on perceived stress, anxiety, depression, well-being, mindfulness, joy disposition, and resilience in participants over the study duration, the investigators also collect information on participant's mental and emotional predispositions.
详细描述
Background:
Globally, COVID-19 has resulted in more than 3 million confirmed cases with a continuing rise in numbers. Following the first case detection in the United States on January 20, 2020, there has been a steady rise in the reported cases resulting in all 50 states being affected by the disease. As of April 28, 2020, two million deaths globally have been attributed to this disease. This is an ongoing pandemic, and our understanding of it is continually evolving.
Measures such as social distancing and working remotely have been enforced worldwide to curb disease transmission. This has led to an increased number of people staying indoors and living a more sedentary lifestyle. Many clinicians and people in the community have raised concerns about maintaining good mental and emotional health along with physical health.
Amidst concerns for maintenance of holistic health, yoga in its forms of guided breathing, meditation, and mindfulnessare interventions people are practicing rigorously in the current times of uncertainty. These interventions require no external infrastructure, promote a sense of calm and well-being, improve sleep quality, and reduce stress and anxiety.
Need for the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Seasoned Yoga practitioners:
- •Participants must be a follower of Isha school of yoga
- •Must have completed Inner Engineering Online course/ practice Shambhavi Mahamudra Kriya/ Shakthi Chalana Kriya
- •Interest in participating in the study
- •For Controls:
- •Participants has little to no experience with Isha school of yoga
- •Should have practiced yoga routinely for < 1 Month (if previously experienced in yoga)
- •Interest in participating in the study
- •Age ( +/- 3 years) matched with the seasoned practitioner
- •Gender matched with seasoned practitioner
排除标准
- •For both groups:
- •Participants < 18 years of age
- •Participant > 80 years of age
- •Participants must be able to read and understand English.
研究组 & 干预措施
Yoga Practitioners
Yoga practitioners arm is the observational arm of the study, wherein participants who follow Isha school of yoga and have completed either of the three courses : Inner Engineering Online (IEO), Inner Engineering Completion (Shambhavi Mahamudra kriya) or Shakthi Chalana Kriya can be included in this group. The participant are advised to continue with their routine yoga practice with no change in the duration of practice or frequency of their practices. Participants of this group have expertise in yoga practice and have been practicing yoga for more than 6 weeks before study enrollment.
Control Yoga
Control Yoga is the active comparator arm of the study. Participants who are randomly allocated to this group, practice "Simha Kriya", a deep breathing exercise taught by the Isha School of yoga.
干预措施: Simha Kriya (Behavioral)
Control Idle
Control Idle is the active comparator arm of the study. Participants who are randomly allocated to this group, are advised to either read a book for 15 minutes each day or sit idle for 15 minutes. This is the true control group for the study
干预措施: Reading a Book (Behavioral)
结局指标
主要结局
Change in Perceived Stress Levels
时间窗: Baseline, 6 weeks and 12 weeks.
The study aims to evaluate changes in perceived levels of stress in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, Perceived Stress Scale. The scale measures the degree to which situations in participant's life are appraised as stressful. This is the primary outcome for our study. We assess for change in perceived stress levels by analyzing the PSS score for each participant and comparing it to pre \& post intervention results.
次要结局
- Changes in self-reported readiness to return to work in COVID-19 positive participants(Baseline, 6 weeks and 12 weeks)
- Changes in Covid-19 Prevalence(Baseline, 6 weeks and 12 weeks)
- Changes in Resilience Levels(Baseline, 6 weeks and 12 weeks)
- Changes in self-reported duration of fever and respiratory symptoms in COVID-19 positive participants(Baseline, 6 weeks and 12 weeks)
研究者
Balachundhar Subramaniam
PI
Beth Israel Deaconess Medical Center