Yogic Breathing and Guided Meditation for Long Covid Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Yogic Breathing and Guided Meditation for Long Covid Symptoms

Conditions
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COVID-19, Stress, Shortness of Breath

Intervention / Treatment
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* Behavioral: Breathing and Wellness Webinar
* Other: Routine Daily Activity


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Webinar-Based Intervention<br>Breathing and Wellness Webinar: two yogic breathing practices (Simha Kriya and Naddi Shuddi) and a guided meditation (Isha Kriya). | Behavioral: Breathing and Wellness Webinar<br>* 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.<br>|
| Placebo Comparator: Control<br>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). | Other: Routine Daily Activity<br>* Participants in the control group are asked to perform routine daily activities until enrolled into the intervention arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks. | 
| 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. | For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks. | 
| 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. | For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks. | 
| 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. | For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks. | 
| 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. | For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks. | 
| 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. | For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long COVID-19, Mental health, Anxiety, Stress, Breathing, Meditation, Yoga, Isha Kriya