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Yogic Breathing and Guided Meditation for Long Covid Symptoms

Primary Purpose

COVID-19, Stress, Shortness of Breath

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathing and Wellness Webinar
Routine Daily Activity
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 focused on measuring Long COVID-19, Mental health, Anxiety, Stress, Breathing, Meditation, Yoga, Isha Kriya

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 18 and 70 years
  • Interested in attending the online Breathing and Wellness webinar.
  • Laboratory-confirmed (PCR) history of Covid-19 infection.
  • Long Covid condition diagnosis by a physician.
  • Able to read and comprehend English.
  • Currently residing in the United States.

Exclusion Criteria:

● Any medically limiting diagnosis that prevents a patient from doing the intervention or completing the assessments as determined by the PI such as severe Major Depression (under medication), Schizophrenia, Bipolar disorder.

Sites / Locations

  • Beth Israel Deaconess Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Webinar-Based Intervention

Control

Arm Description

Breathing and Wellness Webinar: two yogic breathing practices (Simha Kriya and Naddi Shuddi) and a guided meditation (Isha Kriya).

This group will be asked to wait for 3 weeks before being introduced to the Breathing and Wellness Webinar intervention which includes two yogic breathing practices (Simha Kriya and Naddi Shuddi) and a guided meditation (Isha Kriya).

Outcomes

Primary Outcome Measures

Compliance
The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency. This will be reported in "Number of days an intervention was practiced in a week". Participants completing at least 3 days of activity would be considered as compliant for that week.

Secondary Outcome Measures

Perceived Stress Scale (PSS)
PSS is a 10-question validated instrument that assesses stress. Participants are asked to rate on a scale of 0 (never) to 4 (very often) how often they agree with various statements.
Profile of Mood States (POMS)
This is a short validated survey used to measure six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A five-point scale ranging from "not at all" to "extremely" is administered and scores for each dimension contributes to calculation of positive and negative subscales in conjunction to total mood disturbance.
Quality of Life Survey (SF12)
SF12 is a validated self-reported measure of the impact of health on everyday quality of life. It evaluates domains of physical activities, social activities, usual role activities, bodily pain, general mental health, vitality and general health perception.
Multidimensional Dyspnea Profile (MDP)
MDP is a validated scale to assess the overall breathing discomfort, sensory qualities and emotional responses using 8 questions. It is not intended for a particular activity and can be used during rest, activity or during clinical care. For assessing Long Covid patients, the first three parts (breathing discomfort and sensory qualities) are commonly used.
Somatic Symptom Scale 8 Items (SS8)
SS8 is a validated brief questionnaire to assess common somatic symptoms including pain, shortness of breath, dizziness, fatigue and trouble sleeping. Participants are asked to rate on a scale of 0 (not at all) to 4 (very much) how often they agree with various statements. Items from each of the 8 questions are then summed to create a total perceived stress score.
Qualitative Assessments
The semi-structured individual interviews will allow us to gain rich, descriptive information about the participant's experience with the long COVID symptoms, treating physicians, and the effect of the provided practices on their symptoms. The focus group interviews will be semi-structured to ensure a systematic and flexible approach to data collection, allowing us to gain rich information about the participant's general experience with the current study and what matters to them as a Long COVID patients. The interviews will cover the following main topics: (1) Perceptions of the participants on their long COVID symptoms, (2) Perceptions of the participants on their treating physicians (3) the effect of the provided meditation practices on their long COVID symptoms (4) and what matters to the Long COVID patients as well as their general experience as participants in the current study.

Full Information

First Posted
September 23, 2021
Last Updated
October 6, 2022
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05139979
Brief Title
Yogic Breathing and Guided Meditation for Long Covid Symptoms
Official Title
Yogic Breathing and Guided Meditation for Long Covid Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to assess the impact of brief digitally delivered breathing practice and guided meditation on post-Covid physical and mental symptoms in Long Covid Patients.
Detailed Description
Long Covid symptoms can last weeks to months after the initial Covid infection or can appear weeks after. It can occur in those with mild disease or asymptomatic patients. Most commonly reported symptoms of Long Covid are: Tiredness or fatigue Difficulty thinking or concentrating (sometimes referred to as "brain fog") Headache Loss of smell or taste Dizziness on standing Fast-beating or pounding heart (also known as heart palpitations) Chest pain Difficulty breathing or shortness of breath Cough Joint or muscle pain Depression or anxiety Fever Symptoms that get worse after physical or mental activities To this date, nearly 180 million people have been infected with Covid19 and over 3 million have lost their lives worldwide. The increasing prevalence of patients with Long Covid symptoms and the lack of effective solutions to address their condition, creates an urgent need for non-pharmacological interventions that are effective and scalable and can be delivered online to accommodate for the limitations due to the Covid pandemic. Yogic Breathing and Meditation techniques have been shown to have various health benefits including improving pulmonary function and mental health. Prominent health institutions are recommending breathing exercise to their Covid patients to assist their respiratory recovery9. Meditation and breathing is also shown to help with Covid related stress and anxiety. This study is a waitlisted randomized controlled trial conducted in 2 phases: Phase 1: If participants are in the intervention group, they will be asked to learn and practices two Yogic Breathing practices (Simha Kriya and Nadi Shuddhi) and a guided meditation (Isha Kriya) for 3 weeks They will be asked to complete a set of questionnaires at baseline and the end of each week. Participants in the waitlisted control group will be asked to perform their regular daily routine as they wait to be enrolled into the intervention at the end of 3 weeks. The waitlisted control group will also be recruited for semi-structured individual interviews during this time. Phase 2: The waitlisted control group will begin the intervention at week 3 and continue until week 6. They will be asked to continue completing the questionnaires at the end of each week. The intervention group will be asked to complete a final follow-up questionnaire at the end of week 6. The intervention group will also be recruited for semi-structured individual interviews during this time. Focus group discussions with both the intervention and control groups are conducted at the end of the study to collect general information about the participant's general experience with the current study and what matters to them as a Long COVID patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Stress, Shortness of Breath
Keywords
Long COVID-19, Mental health, Anxiety, Stress, Breathing, Meditation, Yoga, Isha Kriya

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Upon enrollment and randomization, the intervention group will be followed weekly for 3 weeks as well as on week 6. The waitlisted control group will be followed for 3 weeks as controls and will then learn the intervention and be followed for additional 3 weeks (total of 6 weeks).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Webinar-Based Intervention
Arm Type
Experimental
Arm Description
Breathing and Wellness Webinar: two yogic breathing practices (Simha Kriya and Naddi Shuddi) and a guided meditation (Isha Kriya).
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This group will be asked to wait for 3 weeks before being introduced to the Breathing and Wellness Webinar intervention which includes two yogic breathing practices (Simha Kriya and Naddi Shuddi) and a guided meditation (Isha Kriya).
Intervention Type
Behavioral
Intervention Name(s)
Breathing and Wellness Webinar
Intervention Description
Simha Kriya : a 3-minute energizing breathing practice to expand lung capacity and improve immunity, to be practiced twice daily. Nadi Shuddhi - a gentle 4-minute breathing practice for creating mental balance and relaxation, to be practiced for a minimum of 4 minutes daily. Isha Kriya - a 15-minute guided meditation that incorporates the breath and the awareness to create mental clarity and health, to be practiced at least once (ideally twice) daily.
Intervention Type
Other
Intervention Name(s)
Routine Daily Activity
Intervention Description
Participants in the control group are asked to perform routine daily activities until enrolled into the intervention arm.
Primary Outcome Measure Information:
Title
Compliance
Description
The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency. This will be reported in "Number of days an intervention was practiced in a week". Participants completing at least 3 days of activity would be considered as compliant for that week.
Time Frame
For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Secondary Outcome Measure Information:
Title
Perceived Stress Scale (PSS)
Description
PSS is a 10-question validated instrument that assesses stress. Participants are asked to rate on a scale of 0 (never) to 4 (very often) how often they agree with various statements.
Time Frame
For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Title
Profile of Mood States (POMS)
Description
This is a short validated survey used to measure six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A five-point scale ranging from "not at all" to "extremely" is administered and scores for each dimension contributes to calculation of positive and negative subscales in conjunction to total mood disturbance.
Time Frame
For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Title
Quality of Life Survey (SF12)
Description
SF12 is a validated self-reported measure of the impact of health on everyday quality of life. It evaluates domains of physical activities, social activities, usual role activities, bodily pain, general mental health, vitality and general health perception.
Time Frame
For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Title
Multidimensional Dyspnea Profile (MDP)
Description
MDP is a validated scale to assess the overall breathing discomfort, sensory qualities and emotional responses using 8 questions. It is not intended for a particular activity and can be used during rest, activity or during clinical care. For assessing Long Covid patients, the first three parts (breathing discomfort and sensory qualities) are commonly used.
Time Frame
For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Title
Somatic Symptom Scale 8 Items (SS8)
Description
SS8 is a validated brief questionnaire to assess common somatic symptoms including pain, shortness of breath, dizziness, fatigue and trouble sleeping. Participants are asked to rate on a scale of 0 (not at all) to 4 (very much) how often they agree with various statements. Items from each of the 8 questions are then summed to create a total perceived stress score.
Time Frame
For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Title
Qualitative Assessments
Description
The semi-structured individual interviews will allow us to gain rich, descriptive information about the participant's experience with the long COVID symptoms, treating physicians, and the effect of the provided practices on their symptoms. The focus group interviews will be semi-structured to ensure a systematic and flexible approach to data collection, allowing us to gain rich information about the participant's general experience with the current study and what matters to them as a Long COVID patients. The interviews will cover the following main topics: (1) Perceptions of the participants on their long COVID symptoms, (2) Perceptions of the participants on their treating physicians (3) the effect of the provided meditation practices on their long COVID symptoms (4) and what matters to the Long COVID patients as well as their general experience as participants in the current study.
Time Frame
For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18 and 70 years Interested in attending the online Breathing and Wellness webinar. Laboratory-confirmed (PCR) history of Covid-19 infection. Long Covid condition diagnosis by a physician. Able to read and comprehend English. Currently residing in the United States. Exclusion Criteria: ● Any medically limiting diagnosis that prevents a patient from doing the intervention or completing the assessments as determined by the PI such as severe Major Depression (under medication), Schizophrenia, Bipolar disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balachundar Subramaniam, MD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Centre
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32784198
Citation
Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. No abstract available.
Results Reference
background
PubMed Identifier
33836148
Citation
Taquet M, Geddes JR, Husain M, Luciano S, Harrison PJ. 6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records. Lancet Psychiatry. 2021 May;8(5):416-427. doi: 10.1016/S2215-0366(21)00084-5. Epub 2021 Apr 6.
Results Reference
background
PubMed Identifier
22978245
Citation
Abel AN, Lloyd LK, Williams JS. The effects of regular yoga practice on pulmonary function in healthy individuals: a literature review. J Altern Complement Med. 2013 Mar;19(3):185-90. doi: 10.1089/acm.2011.0516. Epub 2012 Sep 14.
Results Reference
background
PubMed Identifier
31543632
Citation
Budhi RB, Payghan S, Deepeshwar S. Changes in Lung Function Measures Following Bhastrika Pranayama (Bellows Breath) and Running in Healthy Individuals. Int J Yoga. 2019 Sep-Dec;12(3):233-239. doi: 10.4103/ijoy.IJOY_43_18.
Results Reference
background
PubMed Identifier
32665843
Citation
Rangasamy V, Thampi Susheela A, Mueller A, F H Chang T, Sadhasivam S, Subramaniam B. The effect of a one-time 15-minute guided meditation (Isha Kriya) on stress and mood disturbances among operating room professionals: a prospective interventional pilot study. F1000Res. 2019 Mar 26;8:335. doi: 10.12688/f1000research.18446.1. eCollection 2019.
Results Reference
background
PubMed Identifier
33692706
Citation
Maric V, Mishra J, Ramanathan DS. Using Mind-Body Medicine to Reduce the Long-Term Health Impacts of COVID-Specific Chronic Stress. Front Psychiatry. 2021 Feb 22;12:585952. doi: 10.3389/fpsyt.2021.585952. eCollection 2021. No abstract available.
Results Reference
background
PubMed Identifier
33935886
Citation
Rain M, Subramaniam B, Avti P, Mahajan P, Anand A. Can Yogic Breathing Techniques Like Simha Kriya and Isha Kriya Regulate COVID-19-Related Stress? Front Psychol. 2021 Apr 15;12:635816. doi: 10.3389/fpsyg.2021.635816. eCollection 2021.
Results Reference
background
PubMed Identifier
33835830
Citation
Narayanan S, Tennison J, Cohen L, Urso C, Subramaniam B, Bruera E. Yoga-Based Breathing Techniques for Health Care Workers During COVID-19 Pandemic: Interests, Feasibility, and Acceptance. J Altern Complement Med. 2021 Aug;27(8):706-709. doi: 10.1089/acm.2020.0536. Epub 2021 Apr 9.
Results Reference
background
Links:
URL
http://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-long-term-effects/art-20490351
Description
Related Info
URL
http://covid19.who.int
Description
Related Info
URL
http://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/coronavirus-recovery-breathing-exercises
Description
Related Info

Learn more about this trial

Yogic Breathing and Guided Meditation for Long Covid Symptoms

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