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

NCT04498442 | Completed

• 1 other identifier: 2020P000433
• Study Type: interventional
• Target: 8,519
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Stress; Anxiety Depression

Keywords

covid-19; yoga; stress; anxiety; depression; well being; resilience; breathing exercises

Outcome Measures

Primary Outcomes (1)

• Change in Perceived Stress Levels

  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.

  Baseline, 6 weeks and 12 weeks.

Secondary Outcomes (4)

• Changes in Resilience Levels

  Baseline, 6 weeks and 12 weeks

• Changes in Covid-19 Prevalence

  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

• Changes in self-reported readiness to return to work in COVID-19 positive participants

  Baseline, 6 weeks and 12 weeks

Other Outcomes (5)

• Changes in Mindfulness

  Baseline, 6 weeks and 12 weeks

• Changes in Dispositional Positive Emotions Scale (DPES- Joy subscale)

  Baseline, 6 weeks and 12 weeks

• Changes in 4 Item-Patient Health Questionnaire measuring Anxiety and Depression (PHQ-4) levels

  Baseline, 6 weeks and 12 weeks

Study Arms (3)

Yoga Practitioners

NO INTERVENTION

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

ACTIVE COMPARATOR

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.

Behavioral: Simha Kriya

Control Idle

PLACEBO COMPARATOR

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

Behavioral: Reading a Book

Interventions

Simha Kriya 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 Yoga

Reading a Book 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.

Control Idle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• For both groups:
• Participants \< 18 years of age
• Participant \> 80 years of age
• Participants must be able to read and understand English.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 35968476 DERIVED

MeSH Terms

Conditions

COVID-19; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Balachundhar Subramaniam, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 4, 2020
• Study Start: May 22, 2020
• Primary Completion: October 22, 2020
• Study Completion: October 22, 2020
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)