Covid19NCT04498442
A Study on Prevalence, Protection and Recovery From COVID-19 in Seasoned Yoga Practitioners in Comparison to Age and Gender Matched Controls
A study testing Simha Kriya and Reading a Book in people with Covid19 and Stress, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Stress, Anxiety Depression
- What is being tested?
- Simha Kriya and Reading a Book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,519 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2020to 22 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- For both groups:
- Participants < 18 years of age
- Participant > 80 years of age
- Participants must be able to read and understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, 02215
About this study
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.
Read the 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:
- Self-reported duration of fever and respiratory symptoms in COVID-19 positive participants
- 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
- Being tested
- Simha Kriya, Reading a Book
- Keywords
- covid-19, yoga, stress, anxiety, depression, well being, resilience, breathing exercises
- Medical subject headings
- COVID-19, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simha KriyaBehavioural
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 BookBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Reading a Book |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks and 12 weeks.
Secondary outcomes (4)
Changes in Resilience Levels
The study aims to evaluate changes in resilience levels in survey participants and the effect yoga or reading a book has over them. We use a validated scale for this purpose named, Brief Resilience Scale. The scale identifies the individual's ability to bounce back or recover from a stress. This is the key secondary outcome for our study. We assess for change in resilience levels by analyzing the 6-item BRS, which computes a score for each participant by dividing total score obtained/number of questions responded; (range 6-30) and comparing it to pre \& post intervention results.
Measured: Baseline, 6 weeks and 12 weeks
Changes in Covid-19 Prevalence
The study aims to evaluate changes in Covid-19 prevalence in survey participants and the effect yoga or reading a book has over them. Based on the reported number of cases in the participant cohort we compute Period Prevalence for 3 specified time points. We assess for change in reported prevalence and stratify the results to match with region-wise prevalence.
Measured: Baseline, 6 weeks and 12 weeks
Changes in self-reported duration of fever and respiratory symptoms in COVID-19 positive participants
The study aims to evaluate changes in self-reported duration of fever and respiratory symptoms in Covid-19 positive survey participants and the effect yoga or reading a book has over them. Based on the reported number of positive cases in the participant cohort we compare the frequency of duration between the two cohorts i.e. yoga practitioners and control; followed by a comparison between the two control groups viz: yoga group vs idle group.
Measured: Baseline, 6 weeks and 12 weeks
Changes in self-reported readiness to return to work in COVID-19 positive participants
The study aims to evaluate changes in self-reported readiness to return to work in Covid-19 positive survey participants and the effect yoga or reading a book has over them. Based on the reported number of positive cases in the participant cohort we compare the frequency of readiness between the two cohorts i.e. yoga practitioners and control; followed by a comparison between the two control groups viz: yoga group vs idle group.
Measured: Baseline, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start22 May 2020
- Primary completion22 Oct 2020
- Study completion22 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 8,519 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Balachundhar Subramaniam, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498442
- Sponsor's protocol ID
- 2020P000433
- Status last verified
- Jul 2022
- First submitted
- 3 Aug 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35968476
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Prevalence, Protection and Recovery From COVID-19 in Seasoned Yoga Practitioners in Comparison to Age and Gender Matched Controls
- ClinicalTrials.gov ID
- NCT04498442
- Acronym / sponsor ID
- 2020P000433
- Conditions
- Covid19, Stress, Anxiety Depression
- Keywords
- covid-19, yoga, stress, anxiety, depression, well being, resilience, breathing exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,519 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Self-reported duration of fever and respiratory symptoms in COVID-19 positive participants
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Simha KriyaControl 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. |
| Control Idle | Placebo comparator | Behavioral: Reading a BookControl 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Participants has little to no experience with Isha school of yoga
- Should have practiced yoga routinely for < 1 Month (if previously experienced in yoga)
Key exclusion criteria (4 listed)
- Participants < 18 years of age
- Participant > 80 years of age
- Participants must be able to read and understand English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simha KriyaSimha-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. | Behavioural | Control Yoga |
| Reading a BookReading 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. | Behavioural | Control Idle |
Primary outcome
Change in Perceived Stress Levels
Time frame: 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.
4 secondary outcomes
Changes in Resilience Levels
Time frame: Baseline, 6 weeks and 12 weeks
Changes in Covid-19 Prevalence
Time frame: Baseline, 6 weeks and 12 weeks
Changes in self-reported duration of fever and respiratory symptoms in COVID-19 positive participants
Time frame: Baseline, 6 weeks and 12 weeks
Changes in self-reported readiness to return to work in COVID-19 positive participants
Time frame: Baseline, 6 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 35968476Upadhyay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balachundhar Subramaniam, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simha Kriya and Reading a Book in people with Covid19 and Stress, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Levels (time frame: Baseline, 6 weeks and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04498442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.