Clinical trial NCT05139979: Yogic Breathing and Guided Meditation for Long Covid Symptoms
Official title: Yogic Breathing and Guided Meditation for Long Covid Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Stress
Shortness of Breath
Keywords: Long COVID-19
Mental health
Anxiety
Stress
Breathing
Meditation
Yoga
Isha Kriya
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Compliance
timeFrame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
measure: Profile of Mood States (POMS)
timeFrame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
measure: Quality of Life Survey (SF12)
timeFrame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
measure: Multidimensional Dyspnea Profile (MDP)
timeFrame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
measure: Somatic Symptom Scale 8 Items (SS8)
timeFrame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
measure: Qualitative Assessments
timeFrame: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Balachundar Subramaniam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.