Clinical trial NCT04498442: A Study on Prevalence, Protection and Recovery From COVID-19 in Seasoned Yoga Practitioners in Comparison to Age and Gender Matched Controls
Official title: A Study on Prevalence, Protection and Recovery From COVID-19 in Seasoned Yoga Practitioners in Comparison to Age and Gender Matched Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Stress
Anxiety Depression
Keywords: covid-19
yoga
stress
anxiety
depression
well being
resilience
breathing exercises
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 8519
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in Perceived Stress Levels
timeFrame: Baseline, 6 weeks and 12 weeks.
Secondary outcomes:
measure: Changes in Resilience Levels
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Changes in Covid-19 Prevalence
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Changes in self-reported duration of fever and respiratory symptoms in COVID-19 positive participants
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Changes in self-reported readiness to return to work in COVID-19 positive participants
timeFrame: Baseline, 6 weeks and 12 weeks
Other outcomes:
measure: Changes in Mindfulness
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Changes in Dispositional Positive Emotions Scale (DPES- Joy subscale)
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Changes in 4 Item-Patient Health Questionnaire measuring Anxiety and Depression (PHQ-4) levels
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Changes in well being levels
timeFrame: Baseline, 6 weeks and 12 weeks
measure: Changes in Post Traumatic Growth Inventory (PTGI) scores
timeFrame: Baseline, 6 weeks and 12 weeks
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Balachundhar Subramaniam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.