A Study on Prevalence, Protection and Recovery From COVID-19 in Seasoned Yoga Practitioners in Comparison to Age and Gender Matched Controls
Condition: Covid19; Stress; Anxiety Depression
MeSH terms: COVID-19; Depression
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

      The study aims at collecting information on the prevalence of COVID 19 infection in seasoned
      yoga practitioners and comparing it with the prevalence of COVID-19 infection prevalence
      rates among age and gender matched control participants.

      The study hypothesizes that yoga practice promotes protection and enhances recovery from the
      COVID-19 infection. To prove the hypothesis, the study investigators intend to collect and
      compare responses from seasoned yoga practitioners and age and gender matched controls
      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 study investigators also intend to
      collect information on participant's mental and emotional predispositions.

      Through this Randomized Controlled Trial, the following specific aims are to be accomplished:

      Specific Aim 1: To compare prevalence rates of diagnosed COVID-19 infection between the
      seasoned yoga practitioners and age and gender matched controls at baseline and at 6 and 12
      weeks.

      Specific Aim 2: To Compare Protection and Recovery from COVID 19 infection between seasoned
      yoga practitioners and controls as demonstrated by:

        1. Self-reported duration of fever and respiratory symptoms in COVID-19 positive
           participants

        2. Self-reported readiness to return to work (or a feeling of being physically and mentally
           fit) This is the key secondary outcome of the study.

      Specific aim 3: To quantitatively assess the effects of yoga practices between seasoned
      practitioners and the control groups on measures such as perceived stress, resilience, and
      overall wellbeing by use of validated scales.

      We also aim to do exploratory analysis by comparing the different yoga practices and their
      duration between the 3 study groups to establish a dose-response curve if possible.

      Note: The term "yoga" used throughout this document is defined as mindfulness practices which
      involve deep breathing exercises and meditation, and excludes strenuous physical exercise.
    

Intervention name(s): Simha Kriya; Reading a Book
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Simha-Kriya involves deep breathing exercises and meditation. It is the practice of extending the breath, expanding our lung capacity and mental concentration and energizing the body. Simha Kriya, when practiced intentionally will unite the mental, physical, and spiritual body through the breath. For the purpose of this study we advocate practice of Simha Kriya at least once a day.; Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. Reading a book is often inculcated into mindfulness research due to it's impact on the personality and attitude. The simple act of reading a book can have a significant impact on their attitudes and can help them cope better with stress. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely for 15 minutes each day. Reading a book could potentially be substituted with sitting idle for 15 minutes if participants wishes to.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this prospective randomized control trial, the effects of yoga practices are being compared between seasoned yoga practitioners with two controls who are age and gender matched and living in the same neighborhood.
One control group acts as active control who receives active intervention in the form of yoga activities during the study duration. The study provides its active control group an opportunity to learn and practice Simha-Kriya which involves deep breathing exercises and meditation. In contrast, the other control group acts as a placebo control and performs either reading activities or remains idle for 15 minutes throughout the study period.
The participants will be requested to complete a set of surveys as a part of the research activity. These surveys include validated scales on stress, resilience and well-being; and objective questions on COVID-19 infection and medical history.
Masking: None (Open Label)
Primary purpose: Other
Keywords: covid-19; yoga; stress; anxiety; depression; well being; resilience; breathing exercises