A Study on Prevalence, Protection and Recovery From COVID-19 in Seasoned Yoga Practitioners in Comparison to Age and Gender Matched Controls

NCT ID: NCT04498442

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8519 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-22
• Study Completion Date: 2020-10-22

Brief 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.

Conditions

Covid19; Stress; Anxiety Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Simha Kriya

Intervention Type: BEHAVIORAL

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.

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

Group Type: PLACEBO_COMPARATOR

Reading a Book

Intervention Type: BEHAVIORAL

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.

Interventions

Simha Kriya

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.

Intervention Type: BEHAVIORAL

Reading a Book

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

For both groups:

• Participants < 18 years of age
• Participant > 80 years of age
• Participants must be able to read and understand English.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Balachundhar Subramaniam

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Balachundhar Subramaniam, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, United States

Countries

United States

References

Upadhyay P, Narayanan S, Khera T, Kelly L, Mathur PA, Shanker A, Novack L, Perez-Robles R, Hoffman KA, Sadhasivam SK, Subramaniam B. Perceived Stress, Resilience, and Wellbeing in Seasoned Isha Yoga Practitioners Compared to Matched Controls During the COVID-19 Pandemic. Front Public Health. 2022 Jul 29;10:813664. doi: 10.3389/fpubh.2022.813664. eCollection 2022.

Reference Type: DERIVED

PMID: 35968476 (View on PubMed)

Other Identifiers

2020P000433

Identifier Type: -

Identifier Source: org_study_id